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NCT ID: NCT03245450 Completed - Rhabdomyosarcoma Clinical Trials

Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors

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

The Phase 1 part of the study is conducted to determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with relapsed/refractory solid tumors (excluding central nervous system [CNS] tumors). The Phase 2 part of the study is conducted to assess the objective response rate (ORR) and duration of response (DOR) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and ewing sarcoma (EWS).

NCT ID: NCT03243773 Completed - Acute Heart Failure Clinical Trials

Evaluation of Lung Ultrasound in Acute Heart Failure

ELUSIA
Start date: March 1, 2016
Phase:
Study type: Observational

Acute heart failure is a life threatening condition requiring rapid diagnosis and treatment. However, the differentiation between heart failure and other conditions presenting with acute dyspnea is notoriously difficult in the emergency room. Point-of-care lung ultrasound is a simple, rapid and noninvasive technique directly visualizing fluid content in the lung as evidence for acute heart failure. A number of publications showed the diagnostic utility of lung ultrasound in the diagnosis of heart failure, but many open questions remain. The goal of this study is to evaluate the diagnostic accuracy of lung ultrasound to predict a cardiac origin of dyspnea in unselected patients in the emergency room as compared to standard evaluation. Further goals are to evaluate if lung ultrasound provides additional diagnostic information as compared to clinical examination, NT-proBNP and chest X-ray, to compare the diagnostic accuracy of lung ultrasound in different patient subgroups (heart failure with preserved vs reduced ejection fraction, de novo vs decompensated chronic heart failure, age ≥75 vs <75 years, women vs men and presence vs absence of concomitant pulmonary disease) and to compare demographics and clinical characteristics in different patient populations. 300 patients, aged ≥18 years presenting to the emergency room (ER) with acute dyspnoe as principal complaint will undergo initial clinical assessment of the likely etiology of dyspnea by the ER physician in charge. The second assessment by the same physician will include results of NT-proBNP according to predefined cutoffs. Final diagnosis ("Gold Standard") will be done by two experienced investigators after patient discharge taking into account the complete medical record except the results of lung ultrasound. Assessment of chest X-ray and lung ultrasound by investigators will be preforemd blinded regarding all other results.

NCT ID: NCT03243435 Completed - Clinical trials for Breast Cancer Female

Sienna+MR Long-term Uptake

Start date: July 2016
Phase: N/A
Study type: Observational

In a previous study in 2012/2013 patients were injected a superparamagnetic iron oxide for sentinel lymph node detection. In this follow up study we want to investigate how much of this tracer is still detectable.

NCT ID: NCT03242993 Completed - Clinical trials for Metastatic Ovarian Cancer

[18F]-AZAFOL AS POSITRON EMISSION TOMOGRAPHY (PET) TRACER in FR Positive Cancer Imaging

Start date: April 1, 2017
Phase: Phase 1
Study type: Interventional

This is a clinical trial category C as this is a first in man trial with an unapproved investigational product. Nevertheless the risk is considered low due to the low dose ≤ 10μg. No toxicity effects were observed preclinically at a dose >1000 -fold the intended dose. Open-labeled, non-blinded, non-placebo controlled, multicenter study. Primary objective: Assessment of biodistribution and FR-specific tumor detection of [18F]- AzaFol as a PET imaging agent in patients with FR-positive and FR-negative metastatic cancer of the ovaries or lungs. Secondary objective: Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-AzaFol (Dosimetry)

NCT ID: NCT03242928 Completed - Clinical trials for Cocaine-related Disorder

Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)

Start date: December 4, 2017
Phase: Phase 2
Study type: Interventional

This study assessed whether AFQ056 had a beneficial effect by reducing cocaine use in Cocaine Use Disorder (CUD) patients as assessed by Timeline Follow-Back cocaine self-report.

NCT ID: NCT03242837 Completed - Clinical trials for Psychological Stress

Psychobiological Evaluation of the Army Resilience Training

OpPHX
Start date: August 14, 2017
Phase: N/A
Study type: Interventional

This study evaluates the influence of a resilience training on psychobiological factors which are related to stress and resilience in young healthy male cadets. Half of participants will join in the resilience training, while the other half take part in a control-training (diversity management training).

NCT ID: NCT03242096 Completed - Coronary Restenosis Clinical Trials

Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon

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

Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter

NCT ID: NCT03241121 Completed - Obesity Clinical Trials

Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome

Start date: September 29, 2017
Phase: N/A
Study type: Interventional

SwissChronoFood - Study of eating patterns with a smartphone app and the metabolic effects of time restricted feeding in metabolic syndrome The purpose of this study is to assess eating patterns among teenagers and adults with a new method, going beyond the pen-and-paper food diaries, and to investigate whether time restricted feeding leads to weight loss, improvement in lipid and glucose metabolism in individuals with components of the metabolic syndrome

NCT ID: NCT03240133 Completed - Clinical trials for Hereditary Angioedema (HAE)

Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema

Start date: July 31, 2017
Phase: Phase 2
Study type: Interventional

This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks) or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject diary entries completed at pre-defined times post-dose.

NCT ID: NCT03238625 Completed - Anesthesia Clinical Trials

Painless Local Anaesthesia With Bicarbonate Admixture

Start date: August 1, 2017
Phase: Phase 2
Study type: Interventional

This study examines whether the injection of local anesthesia mixed with sodium bicarbonate in the ratio of 3:1 creates a less burning sensation and is as effective regarding the anesthetic effect as in the ratio of 9:1.