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NCT ID: NCT02451943 Active, not recruiting - Soft Tissue Sarcoma Clinical Trials

A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma

ANNOUNCE
Start date: September 14, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.

NCT ID: NCT02451111 Terminated - Follicular Lymphoma Clinical Trials

Rituximab With or Without Ibrutinib for Patients With Advanced Follicular Lymphoma

Start date: November 6, 2015
Phase: Phase 2
Study type: Interventional

Follicular lymphomas FL has been traditionally approached either by an initial watch and wait policy in the asymptomatic patient, or with single agent treatments with the purpose of maintaining a good quality of life for a prolonged time.The combination of rituximab and ibrutinib has been tested in clinical trials and appeared to be well tolerated and active. Since ibrutinib seems to achieve better results when administered for prolonged time as shown in CLL, the investigators have chosen to compare its combination with rituximab to the prolonged rituximab-only schedule that was already shown to be very active in the SAKK 35/03 trial. The aim of the study is to investigate the efficacy, safety and tolerability of the treatment combination of Ibrutinib and Rituximab for patients with advanced follicular lymphoma in need of therapy.

NCT ID: NCT02451072 Completed - Healthy Clinical Trials

The Role of 5-HT2A Receptor in the Perception of Self and Personal Meaning in Healthy Volunteers

Start date: March 2015
Phase: N/A
Study type: Interventional

Aim of the present study is to investigate the neuronal correlates of self and of personal meaning as well as the role of the serotonin (5-HT) 2A receptor system in these processes using functional magnetic resonance imaging (fMRI) and psychometric and cognitive measures.

NCT ID: NCT02450461 Completed - Asthma Clinical Trials

Breath Analysis in Asthma

Start date: April 2015
Phase: N/A
Study type: Observational

The purpose of this study is to answer the question whether a disease-specific profile of breath in patients with asthma can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

NCT ID: NCT02450331 Terminated - Clinical trials for Carcinoma, Transitional Cell

A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

IMvigor010
Start date: October 5, 2015
Phase: Phase 3
Study type: Interventional

This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.

NCT ID: NCT02449811 Completed - Clinical trials for Essential Hypertension

RAS Peptide Profiles in Patients With Arterial Hypertension

Start date: April 2015
Phase:
Study type: Observational

Randomized, open-label, parallel-group study conducted at a single center in Switzerland. Patients diagnosed with primary arterial hypertension requiring antihypertensive drug Treatment as well as patients after a 4 week wash out period (Amendment 07/2016) will be recruited at the University Hospital Basel, Switzerland. Subjects will be randomized to either the angiotensin-converting enzyme inhibitor-, angiotensin receptor blocker-, calcium channel blocker- or hydrochlorothiazide-treatment arm. Drug treatment follows current guidelines issued by the European Society of Hypertension. Treatment-naive patients will be started on an intermediate dose monotherapy (treatment period 1). In all patients who do not reach blood pressure targets after 4 weeks, the dose of the monotherapy drug will be doubled (high dose, treatment period 2). Sampling for the analysis of RAS peptide profiles, measurement of drug concentrations in plasma and non-invasive hemodynamic measurements will be done. A control group with 20 age and gender matched, healthy and normotensive subjects will be recruited to establish the characteristics of the RAS peptide profiles in a comparable but normotensive population.

NCT ID: NCT02449772 Completed - Clinical trials for Alcoholic Intoxication

Emergency Department (ED) Triage of Alcohol Abuse

Start date: April 2015
Phase: N/A
Study type: Observational

Retrospective study of adult patients (> 16 y) admitted to Geneva University Hospitals with alcohol abuse. Triage criteria will be reviewed. Patients characteristics and patient flow in the ED will be described.

NCT ID: NCT02449512 Suspended - Clinical trials for Neurogenic Lower Urinary Tract Dysfunction

Somatosensory Evoked Potentials From the Lower Urinary Tract

Start date: January 2026
Phase:
Study type: Observational

Spinal cord injury and other systemic neurological diseases (Multiple Sclerosis, Parkinson's disease) affect the integrity of lower urinary tract (LUT) function, leading to neurogenic lower urinary tract dysfunction (NLUTD). The urodynamic investigation is the current "gold-standard" for evaluating LUT function. Nevertheless, the sensory situation of the LUT cannot be investigated objectively. Furthermore, the current classification of the severity of the NLUTD due to spinal cord injury (SCI) does not represent the sensory situation of the LUT. Additional investigations therefore need to be established for assessing the sensory situation of the LUT. Somatosensory evoked potentials (SEPs) are an established method for investigating the processing of sensory nervous activity. However, SEPs from the LUT of SCI individuals have not yet been investigated. A novel technique, i.e. diffusion tensor imaging (DTI), allows to process magnetic resonance images (MRI) in order to visualize nerve fibers. Using DTI, the innervation of the bladder after SCI can be visualized. The structural presentation of bladder innervation will be compared with the functional results, i.e. the SEP of the LUT in SCI individuals. The primary objective of the proposed study is to elicit and characterize (latency, amplitude) the somatosensory evoked potentials (SEPs) from the bladder in individuals suffering from neurogenic lower urinary tract dysfunction as a result of spinal cord injury. Furthermore, the SEPs from the bladder will be compared with the SEPs from peripheral nerves (N. tibialis, N. pudendus, N. medianus). Moreover, the latency and amplitude of the SEPs from the bladder of individuals with somato-sensory complete spinal cord injury will be compared with those from the bladder of individuals with somato-sensory incomplete spinal cord injury. Finally, the structural innervation of the bladder after SCI will be compared with the remaining sensory function.

NCT ID: NCT02447666 Completed - Clinical trials for Myelodysplastic Syndrome

Study With Azacitidine in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome (MDS) and Juvenile Myelomonocytic Leukemia (JMML)

Start date: September 15, 2015
Phase: Phase 2
Study type: Interventional

Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT). Objectives Primary Objective The primary objective is to assess the treatment effect on response rate (MDS: either complete remission [CR], partial remission [PR], or marrow CR; JMML: either clinical complete remission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a matched-pairs analysis of historical data. Secondary Objective The secondary objective is to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population. Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on Simon's Optimal 2 stage study design. The sample size has been calculated to allow evaluation of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the experimental arms will also individually be compared against a historical control arm using data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS) registry by means of a matched-pairs analysis; matched for predefined subject baseline characteristics defined before any results from this study are known post Stage 1. If matched pair is not viable then other methodologies will be explored to evaluate and compare response rates reported in literature and also in registry database Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie, subjects that receive at least 1 dose of investigational product [IP]) will be enrolled at approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be stopped.

NCT ID: NCT02444416 Recruiting - Acute Heart Failure Clinical Trials

Prospective Registry of Acute Heart Failure

Start date: December 2014
Phase:
Study type: Observational

Context: Heart failure is associated with a high morbidity and mortality rate and represents a significant worldwide public health burden. In European countries, the total amount of the expenses related to heart failure represents 1 to 2% of the total health budget with 75% spent during hospitalizations, making heart failure the most expensive pathology in cardiology. Acute heart failure (AHF) has a poor prognosis despite improvements in therapy. Hospital mortality is 2 to 4% the risk of death or readmission in the six months following hospitalization is high. Patients hospitalized for heart failure represent a very heterogeneous population in terms of etiologies, clinical presentations and/or co-morbidities. Consequently, this implies variable outcomes in terms of morbidity and mortality, probably due to their different prognostic factors. The precise spectrum of etiologies and prognostic factors of AHF in non selected populations has not been exhaustively studied and only a few predictive models concerning AHF have been validated. Ischemic heart disease, valvulopathy, arrhythmias, infections, hypertension and lack of therapeutic compliance are often quoted as being the factors triggering heart failure. Some triggering factors (ischemic heart disease, pulmonary infections, acute renal failure) seem to be strongly associated with a poor prognosis in terms of hospital/out-patient mortality and re-hospitalization rate. The complex relation between heart failure and acute renal failure is defined by the cardio-renal syndrome. Thirty percent of patients hospitalized for AHF will be diagnosed with an acute renal failure at admission or with worsening kidney failure during hospitalization. It seems that heart failure and cardio-renal syndrome are two distinct entities with a different prognosis. The type of acute renal failure (functional, renal or post-renal) in these patients and the prognostic value of these etiologies is still not firmly established. A thorough determination of the etiologies and prognostic factors of AHF are necessary in order to allow the identification of high-risk patients and the improvement of heart failure management. Objectives: - To create an observational registry of all patients hospitalized for a AHF - To determine the precise prevalence of etiologies and the prognostic factors of AHF in a non selected population. Among the prognostic factors, to establish the specific role of acute renal failure - To establish the optimal initial assessment of patients hospitalized for heart failure - To validate and compare with prospective data the results of a retrospective cohort study carried out at the University Hospital of Geneva who established the re-hospitalization and mortality outcome of patients hospitalized for heart failure. Method: Creation of an observational registry associated with a biobank including patients hospitalized for AHF in the Department of General Internal medicine (SMIG) and in the Departments of Specialties at the University Hospital of Geneva. Anticipated results: - To identify the prevalence of the etiologies and the prognostic factors of the heart failure - To establish the optimal initial assessment of the patients hospitalized for a heart failure. Among the prognostic factors, to establish the specific role of acute renal failure - To validate and compare results of a retrospective cohort study carried out at the University Hospital of Geneva which established the re-hospitalization and mortality outcome of patients hospitalized AHF - To improve the management of hospitalized patients with AHF with a robust identification of the etiologies and a better identification of high-risk patients.