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NCT ID: NCT02328131 Recruiting - H. Pylori Infection Clinical Trials

European Registry on the Management of Helicobacter Pylori Infection

Start date: June 2013
Phase:
Study type: Observational

The great diversity of regimens and treatment lines, the different efficacy of these, mostly due to the increase in bacterial antibiotic resistance and regional differences, requires a continuous critical analysis of clinical practice, evaluating systematically the efficacy and safety of the different regimens and the cost-effectiveness of the different diagnostic-therapeutic strategies. This will help in the design of an efficient and optimized treatment that will reduce number of re-treatments, diagnostic tests and the appearance of associated pathologies such as peptic ulcers, gastrointestinal bleeding and, probably, gastric cancers. Therefore, the evaluation of real clinical practice using non-interventionist registries will help to improve the design and organization of European Consensus on the management of H. pylori infection, which is the best way to establish healthcare efficiency. Primary aim To obtain a database registering systematically over a year a large and representative sample of routine clinical practice of European gastroenterologists in order to produce descriptive studies of the management of H. pylori infection. Secondary aims 1. To evaluate H. pylori infection consensus and clinical guidelines implementation in different countries. 2. To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori. 3. To evaluate accessibility to healthcare technologies and drugs used in the management of H. pylori infection. 4. To allow the development of partial and specific analysis by the participating researchers after approval by the Registry's Scientific Committee Methodology Non-interventionist prospective multicentre international registry promoted by the European Helicobacter Study Group. A renowned gastroenterologist from each country was selected as Local Coordinator (30 countries). They will in turn select up to ten gastroenterologists per country that will register the routine clinical practice consultations they receive over 10 years in an electronic Case Report Form (e-CRF). Variables retrieved will include clinical, diagnostic, treatment, eradication confirmation and outcome data. The database will allow researchers to perform specific subanalysis after approval by the Scientific Committee of the study.

NCT ID: NCT02328027 Terminated - Clinical trials for Rheumatoid Arthritis

99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)

Start date: December 11, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This was a monocentric, open label, Phase I-IIa study. Eligible patients who signed the ICF received two single intravenous (IV) bolus of the imaging agent 99mTc-rhAnnexin V-128. The first dose was administered on Day 1, and the second dose on Day 42 (±2 weeks). All patients were to start a new disease modifying treatment for RA or AS on Day 2. This disease modifying treatment was at the discretion of the investigator and was not chosen by the sponsor. Safety was monitored at every visit. Whole body scintigraphic imaging was performed at Day 1 and Day 42 after 99mTc-rhAnnexin V-128 dosing. Clinical disease assessments were performed at screening, Day 42 and Day 90 to assess response to RA or AS treatment. Blood was drawn to test for 99mTc-rhAnnexin V-128 immunogenicity at screening and on Days 30, 56 and 90. Patients participating in the pharmacokinetic (PK)/dosimetric sub-study had additional assessments in the 24 hours following the Day 1 dose of 99mTc-rhAnnexin V-128.

NCT ID: NCT02326142 Terminated - Preterm Labor Clinical Trials

A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth

TERM
Start date: March 2015
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the efficacy of a single dose of OBE001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.

NCT ID: NCT02325661 Completed - Actinic Keratosis Clinical Trials

Open Uncontrolled Validation Study for the German Version of the Actinic Keratosis Quality of Life Questionnaire (AKQoL)

AKQOLVS
Start date: October 2014
Phase: N/A
Study type: Interventional

The objective of this study is to translate the "AKQoL"-questionnaire which measures the quality of life of patients with actinic keratosis into German and to validate it for the Swiss population. By using the technique of cognitive interviewing the investigators are focussing on the patients' understanding of the questions. The first session of cognitive interviews will show, where there is need for improvement in terms of misinterpreted phrases or vaguely worded questions. The goal is to rephrase the questions according to the feedback of the patients. The revised version will then be presented to a new population.

NCT ID: NCT02324959 Recruiting - Stroke Clinical Trials

Acupuncture and Computer-based Training to Improve Attention Deficits in Patients After Stroke

ACoTrain
Start date: November 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether acupuncture and computer-based attention training can be combined for more effective post-stroke attentional deficits.

NCT ID: NCT02324231 Completed - Cancer Clinical Trials

SPOG 2015 FN Definition. A Multi-center Non-inferiority Trial on Safety of a High Versus Low Temperature Limit Defining Fever in Pediatric Patients With Cancer at Risk for Fever in Chemotherapy-induced Neutropenia

Start date: April 2016
Phase: N/A
Study type: Interventional

In a multi-center open-label cluster-randomized controlled parallel-group multiple crossover non-inferiority trial in children and adolescents up to 20 years diagnosed with cancer requiring chemotherapy, primarily the safety, and secondarily the efficacy and other endpoints, of a high (39.0°C) versus low (38.5°C) temperature limit defining fever (TLDF) for the diagnosis of fever in chemotherapy-induced neutropenia (FN) is studied. Safety is assessed by the rate of safety relevant events per chemotherapy exposure time, a composite endpoint including serious medical complications and bacteremia during FN. Patients are repeatedly randomized (cluster: study site) to the high or the low TLDF every month, resulting in possible multiple crossovers in one patient. The high TLDF is declared not to be inferior regarding safety compared to the low TLDF if non-inferiority of the rate ratio of safety relevant events is proven, with a single-sided non-inferiority margin of 1.33, applying mixed Poisson regression.

NCT ID: NCT02324140 Completed - Inflammation Clinical Trials

Inflammatory Response in Aortic Valve Replacement

Start date: June 2012
Phase: N/A
Study type: Observational

The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical access route).

NCT ID: NCT02323997 Completed - Cervical Cancer Clinical Trials

Human Papillomavirus in Cervical Cancer and Pre-cancer in Switzerland: The CIN3+Plus Study

CIN3+plus
Start date: January 2015
Phase:
Study type: Observational

This study will investigate the types of HPV in samples from women with cervical pre-cancer and cancer and gather information to help investigate the impact of HPV vaccination in Switzerland.

NCT ID: NCT02323126 Terminated - Clinical trials for Non Small Cell Lung Cancer

Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer

Start date: February 9, 2015
Phase: Phase 2
Study type: Interventional

To determine the efficacy and safety of nivolumab in combination with EGF816 and of nivolumab in combination with INC280 in previously treated NSCLC patients

NCT ID: NCT02322437 Completed - Mental Disorders Clinical Trials

Home Treatment for Acute Psychiatric Care

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

This study aims to evaluate whether psychiatric home treatment is an effective and efficient alternative to acute inpatient care in mental hospitals. A one-year prevalence cohort of psychiatric patients in need of hospitalization are randomly assigned to either treatment at inpatient wards (treatment as usual) or a new care model with the additional option of treating patients at their homes by mobile care teams. The primary focus is on checking whether optional home treatment leads to a reduction of inpatient days during a two-year follow-up period. In addition, the two service models will be compared regarding treatment cost and outcomes as well as satisfaction of patients and their relatives with psychiatric care. Furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be examined by a highly trained clinical assessor to test and verify the diagnoses and the clinical ratings made by the staff members of the mental hospital under routine everyday conditions.