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NCT ID: NCT05385978 Recruiting - Obese Clinical Trials

A Study of Distal Jejunal-release Dextrose in Obese Participants

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to evaluate the efficacy and safety of APHD-012 (distal jejunal-release dextrose [Aphaia technology, AT]) in obese participants.

NCT ID: NCT05385614 Recruiting - Depression Clinical Trials

Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual

de-press-2
Start date: May 2022
Phase: N/A
Study type: Interventional

Depression is one of the most frequent and devastating psychiatric diseases with a substantial bur-den for patients and society. It is specifically associated with dysfunctional activity in brain networks subserving cognitive control of emotional information processing. Normalization of this activity is a hallmark of various treatment approaches. Computerized training of cognitive control has shown antidepressant effects in experimental lab settings and small clinical pilot trials. However, motiva-tion, treatment adherence, and access for patients are major challenges that limit its broader use. To address these challenges, we developed a software application (de:)press®) that integrates gamification elements in a standard cognitive control task to support motivation, usage time, usabil-ity, and therefore symptom reduction. In a previous pilot trial, we were able to document that de:)press® is superior to a non-gamified standard cognitive control training in reducing depression symptomatology. Based on these data, we now designed a full-size confirmatory trial for the pur-pose of testing the hypothesis that de:)press® provides a positive healthcare effect by means of reduction in depression severity compared to treatment as usual (TAU). In this randomized, con-trolled, clinical trial 112 patients will be randomized to the intervention group (IG) with de:)press® additional to TAU, or the control group (CG) receiving only TAU. For a period of 6 weeks, the IG is provided with de:)press®. To prove a stable efficacy of de:)press®, the primary endpoint is the dif-ference in the Montgomery-Åsberg Depression Scale (MADRS) change 4 weeks after the end of training between IG and CG.

NCT ID: NCT05385354 Recruiting - Clinical trials for Pancreatic Duct Dilatation

Main Pancreatic Duct Diameter

Start date: May 3, 2022
Phase:
Study type: Observational

The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound at four different parts: - Pancreatic head - Pancreatic neck - Pancreatic body - Pancreatic tail

NCT ID: NCT05384691 Recruiting - Anemia Clinical Trials

Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions

LENNON
Start date: September 27, 2022
Phase: Phase 2
Study type: Interventional

Anemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS), that are non-transfusion dependent

NCT ID: NCT05384613 Recruiting - Pain Clinical Trials

Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators

Start date: May 12, 2022
Phase:
Study type: Observational

Retrospective cohort study to investigate the adherence to the process indicators for pain management, sedation management and management of delirium on outcome indicators and cost/revenues in individual patients and subcohorts.

NCT ID: NCT05383963 Recruiting - Sepsis Clinical Trials

Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome

Start date: July 15, 2022
Phase:
Study type: Observational

Retrospective observational study to develop a Machine Learning Algorithm to evaluate parameters collected from routine data for the diagnosis of sepsis and septic shock and their influence on time to diagnosis and patient outcome.

NCT ID: NCT05383352 Recruiting - Clinical trials for Metastatic Pancreatic Adenocarcinoma

A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas

SIRACUSA
Start date: May 30, 2022
Phase: Phase 1
Study type: Interventional

The aim of this study is to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas. Adult participants with metastatic pancreatic adenocarcinoma will receive Test Product (TP) and Reference Product (RP) Onivyde in line with its approved indication. The order in which they receive them depends on the group to which they are randomly assigned, this will be referred to as the crossover phase. The average study duration for each participant until end of crossover phase is estimated to be approximately 3 months. After completion of the crossover phase, participants who in the opinion of the investigator will benefit from the treatment will be offered to enter the extension phase where they will receive the commercial Onivyde (RP) until disease progression, withdrawal, unacceptable toxicity or death. Metastatic pancreatic adenocarcinoma is a cancer that has spread (metastasized) beyond the area of the pancreas to other organs of the body. Onivyde is approved for the treatment of metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy, in combination with 5-fluorouracil (5-FU) and leucovorin (LV).

NCT ID: NCT05382715 Recruiting - Colitis, Ulcerative Clinical Trials

A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis

COLIBRI
Start date: May 30, 2022
Phase:
Study type: Observational

The purpose of this study is to monitor the use, effectiveness and treatment persistence with Ozanimod (Zeposia®) as well as quality of life in participants undergoing treatment for moderate-to-severe ulcerative colitis (UC).

NCT ID: NCT05382299 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

ASCENT-03
Start date: July 20, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

NCT ID: NCT05382286 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

ASCENT-04
Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).