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NCT ID: NCT03300440 Active, not recruiting - Depression Clinical Trials

PROVIT The Influence of Probiotics on Body and Mind in Individuals With Psychiatric Disorders

Start date: June 21, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to explore the effects of probiotics in individuals with a clinically relevant depression on psychiatric symptoms and cognition, inflammatory parameters, as well as gene-expression. The study is conducted as a placebo-controlled, randomized, double-blind, prospective, monocentric clinical study, with a two-arm parallel group design. Individuals in the intervention group receive the multispecies probiotics "Omnibiotics Stress Repair" in addition to vitamin B7, while individuals in the control group receive "Placebo" in addition to vitamin B7.

NCT ID: NCT03291002 Active, not recruiting - Melanoma (Skin) Clinical Trials

Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC

Start date: September 25, 2017
Phase: Phase 1
Study type: Interventional

This study evaluates intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma. Patients will receive CV8102 as single agent or in combination with SoC anti-PD-1 therapy.

NCT ID: NCT03287024 Active, not recruiting - Clinical trials for Pulmonary Artery Stenosis

BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.

NCT ID: NCT03274492 Active, not recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

POLARIX
Start date: November 16, 2017
Phase: Phase 3
Study type: Interventional

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

NCT ID: NCT03267316 Active, not recruiting - Colorectal Cancer Clinical Trials

A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors

CANFOUR
Start date: September 19, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and preliminary antitumor activity of CAN04 both as a monotherapy and in combination with standard of care treatment in subjects with solid cancer tumors. Following completion of the first part, the dose escalation cohorts, and determination of maximum tolerated dose or recommended phase 2 dose (MTD/RP2D), safety and tolerability will be further evaluated in an expanded cohort of subjects with pancreatic or lung cancer, as monotherapy or in combination with the standard of care treatment and to identify the RP2D of CAN04 in combination with standard of care. In addition, early signs of efficacy during treatment with CAN04 will be investigated.

NCT ID: NCT03241459 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

TRANSCEND
Start date: October 23, 2017
Phase: N/A
Study type: Interventional

To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.

NCT ID: NCT03219775 Active, not recruiting - Metastatic Cancer Clinical Trials

Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma

TITAN-TCC
Start date: July 6, 2017
Phase: Phase 2
Study type: Interventional

TITAN-TCC (0416-ASG) is a Phase 2, open-label study of nivolumab (BMS-936558) monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated* and platinum-based pretreated, 2nd and 3rd line, advanced or metastatic transitional cell carcinoma subjects. Nivolumab is a fully human PD-1 antibody which blocks the respective immune checkpoint in a ligand (PD-L1/PD-L2) independent manner. [*Update from Jan-2020: First-line cohort was stopped and the inclusion of these patients was terminated]

NCT ID: NCT03217006 Active, not recruiting - Clinical trials for Coronary Artery Disease

Randomization of Single vs Multiple Arterial Grafts

ROMA
Start date: January 7, 2018
Phase: N/A
Study type: Interventional

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

NCT ID: NCT03214796 Active, not recruiting - Clinical trials for Decompensated Cirrhosis

Effect of Albumin Infusion on Oxidative Albumin Modification, Albumin Binding Capacity and Plasma Thiol Status

ALB-INFUS
Start date: January 3, 2017
Phase:
Study type: Observational

The aim of this study is to investigate the effect of albumin infusion on oxidative albumin modification, on plasma thiol status and on albumin binding capacity for DS in patients who routinely receive albumin infusion for various indications and to relate these findings with neurohumoral parameters, bacterial products such as endotoxin, and neutrophil function

NCT ID: NCT03213275 Active, not recruiting - Microbiome Clinical Trials

The Premature Gut Microbiome and the Influence on Neonatal Immunity, Brain Development and White Matter Injury

PreMiBraIn
Start date: October 11, 2017
Phase:
Study type: Observational

Recent advances in neonatal intensive care have dramatically increased the survival rate of extremely premature infants but the number of survivors with severe morbidity and lifelong neurodevelopmental impairment remains high. Perinatal white matter injury is the predominant form of brain injury in premature infants, often leading to adverse neurodevelopmental outcome. Intrauterine and neonatal infection and inflammation have been identified as major risk factors of neonatal brain injury. The fragile gut microbiome of premature infants seems to play an important role in health and disease as distortions of the microbiome occur prior to sepsis and necrotizing enterocolitis. Furthermore, the close link of the gut microbiome to neurological and psychiatric diseases in animal models suggests that the microbiome may influence brain maturation and development in preterm infants. Recent studies have underlined the importance of regulatory T cells as well as γδ T cells in brain injury, which can be directly influenced by the gut microbiome. It is therefore likely that an underdeveloped or distorted gut microbiome affects host immune response and may be a risk factor for neurodevelopmental disabilities in extremely premature infants who are already challenged by the unphysiologic early extrauterine environment after premature birth which affects maturation of the gut microbiome and immune system as well as neurophysiological maturation alike. Therefore, the overarching aim of the PreMiBraIn study is to elucidate the role of the gut-immune-brain axis on neonatal brain injury and its impact on long-term neurodevelopmental outcome of extremely premature infants. The study cohort will consist of a total of 60 extremely premature infants with a gestational age < 28 weeks and birth weight < 1000 grams. The investigators seek to characterize the orchestrated dynamics of the maturation of the gut microbiome and the subsequent impact on maturation of innate and adaptive immune mechanisms as well as neurophysiological maturation and neurodevelopmental outcome. Furthermore, the investigators will assess the value of the microbiome as a prognostic indicator for neonatal brain injury as well as short- and long-term neurodevelopmental outcome of extremely premature infants. This goal will be achieved by state-of-the-art techniques using 16s rRNA gene sequencing of the gut microbiome, holistic analysis of T cell biology using flow cytometry, whole transcriptome analysis and proteomics as well as neurophysiological measurements (amplitude-integrated EEG, near-infrared spectroscopy, visual evoked potentials) and cranial MRI of extremely premature infants. Short- and long-term neurological outcome will be investigated using Bayley Scales of Infant Development, Third Edition at one and two years corrected age, and Kaufmann-Assessment Battery for Children at five years of age. The investigators expect to find microbiome signatures that are predictive for later neurodevelopmental disabilities which may then be used for early screening and intervention and may suggest personalized therapeutic options. The prospects of precision medicine targeting the gut-immune-brain axis in extremely premature infants hold the opportunity to improve the overall outcome of these high-risk patients.