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NCT ID: NCT03817346 Completed - Clinical trials for Safety and Tolerability

Study of Ascending Single Oral Dose of GT-002 in Healthy Volunteers

GAB-001
Start date: December 17, 2018
Phase: Phase 1
Study type: Interventional

This study does not target any disease or condition in itself, but is evaluating the safety, tolerability and pharmacokinetics of single oral doses of GT-002 in the setting of healthy volunteers. A longer-term objective is to apply the findings from this study to design and later conduct a clinical development programme of GT-002 as a medication to treat schizophrenia.

NCT ID: NCT03814564 Completed - Circulatory Failure Clinical Trials

ASSESSment of Perfusion, Oxygen Saturation, Endothelial Function and Coagulation in Circulatory SHOCK

ASSESS-SHOCK
Start date: April 1, 2019
Phase:
Study type: Observational

The objective of the observational cohort study is (1) to deduce whether measurements of peripheral near-infrared spectroscopy (NIRS) (lower limb) associate with the development of organ dysfunction as assessed by daily Sequential Orfgan Failure Score (SOFA) in the Intensive Care Unit (ICU), (2)whether cerebral (frontal) tissue haemoglobin oxygen saturation (StO2) values are associated with delirium in the ICU and (3) the association of frontal and peripheral StO2 with other micro- and macrohemodynamic parameters in this patient group , (4) to deduce the associations between shock, endotheliopathy, disseminated intravascular coagulation (DIC) and tissue perfusion and, last, the feasibility of central and peripheral NIRS monitoring in shock patients in the ICU using the Medtronic INVOS NIRS StO2 appliances. In addition, the investigators target to evaluate (5) the incidence, evolution, and outcome of sepsis-associated DIC, and (6) the associations between a) continuous hemodynamic data, b) laboratory data (such as syndecan-1 (SDC-1), vascular adhesion protein 1 (VAP1), CD73, heparin binding protein (HBP), endostatin, chromogranin, mitochondrial function tests,blood count d-dimer, international normalized ratio (INR), neuron specific enolase and metabolomics data) (7) and study associations of singlenucleotide polymorphisms with developing organ dysfunction and 90-day mortality. To compare the hemodynamic alterations of burn patients to septic patients with the intention to find new ways to monitor and manage hemodynamic and particularly microcirculation in burn patients.

NCT ID: NCT03795064 Completed - Venous Ulcer Clinical Trials

Immediate Versus Early Endovenous Ablation In Venous Ulcer

Start date: December 5, 2018
Phase: N/A
Study type: Interventional

The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.

NCT ID: NCT03785925 Completed - Neoplasm Metastasis Clinical Trials

A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

PIVOT-10
Start date: April 29, 2019
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

NCT ID: NCT03785847 Completed - Clinical trials for Respiration Disorders

Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children

Start date: December 20, 2018
Phase:
Study type: Observational

The study includes a comprehensive health examination with focus on respiratory health and the TBFV recordings using impedance pneumography (Ventica®) during sleep at night in healthy children.

NCT ID: NCT03785405 Completed - Heart Failure Clinical Trials

CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

Start date: May 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.

NCT ID: NCT03783234 Completed - Frailty Clinical Trials

Triage Assessment and NEWS-score as Risk Predictor in Older Frailty Adults in the ED

Start date: December 11, 2018
Phase:
Study type: Observational

Emergency Department Triage Systems have not been shown to sufficiently recognize frail elderly patients in need of urgent assessment and care. In this prospective, observational study the performance of the 3-level triage system and the National Early Warning Score (NEWS) 2 are assessed (separately and combined) for predicting adverse outcomes in older frailty patients visiting in the ED. Observational data for this study is gathered as part of GAOPS - main study (ClinicalTrials.gov Identifier: NCT03751319).

NCT ID: NCT03775538 Completed - Parkinson Disease Clinical Trials

Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study

Start date: July 5, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an extension to the HP-CD-CL-2002 clinical study. It evaluates the long-term safety and tolerability of CDNF in patients with Parkinson's disease when dosed directly into the brain using an implanted investigational drug delivery system (DDS). Long-term safety of the DDS is also being evaluated. All patients will receive monthly infusions of either mid- or high-dose of CDNF for a period of 6 months.

NCT ID: NCT03774303 Completed - Pain Clinical Trials

Effectiveness of Mobile Application Intervention in Day Surgery

Start date: January 19, 2018
Phase: N/A
Study type: Interventional

In Finland about 50% of surgical operations for all under 16 years of age are made as day surgery which means that the patient comes to the hospital and is discharged on the day of the operation. Day surgery will continue to grow in the next few years. Its benefits include shorter hospitalization, family reunion and rapid recovery. The preschool children and their parents who come in for day surgery feel fear, anxiety and stress, which depend on the amount of knowledge and its quality. By developing the preparation of preschool children and their parents for day surgery, and by testing new methods more attention can be paid to the special features of day surgery, supporting the families, and increasing family involvement in the whole process. The purpose of this study is to describe and evaluate the effectiveness of a new mobile application intervention compared to the effectiveness of the traditional preparing method when measuring preschool children's fear and pain and their parents' anxiety and stress. The aim is to produce new information and to develop day surgery of preschool children. The study consist of two phases. The first phase of the research is a systematic literature review and meta-analysis. The purpose of the review is to assess and describe the methods previously used in the preparation of parental day surgery and their effectiveness for preschool children fear and pain and parents' anxiety and stress. The second phase of the study is carried out as a randomized controlled trial (=RCT). The parents of the preschool children are randomized to the mobile application group (n = 50-60) and the control group (n = 50-60). The sample size is based on power-analysis, with anxiety as the primary outcome. The material for the second phase of the study is collected at the day surgery department of the Oulu University Hospital. The study group is prepared for day surgery with a new mobile application and the control group according to the traditional preparing method. The study examines the effectiveness of a new intervention compared to the effectiveness of the traditional preparing method when measuring preschool children's fear and pain and their parents' anxiety and stress. The collected data are analyzed using the Mann-Whitney, t-test, Khi square test, and Fisher's accurate test.

NCT ID: NCT03766581 Completed - Clinical trials for Acute Ischemic Stroke

A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel

AXIOMATIC-SSP
Start date: January 27, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.