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NCT ID: NCT01966653 Active, not recruiting - Clinical trials for Urinary Tract Infections

Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women

AIDA-WP2
Start date: October 2013
Phase: Phase 4
Study type: Interventional

Developed before the establishment of a structured process for drug assessment, nitrofurantoin is now being prescribed frequently given the rise in multi-resistant gram-negative pathogens. Doubts remain regarding fosfomycin's long-term clinical effectiveness. A randomized, controlled trial is needed to explore the clinical effectiveness and better define the side effect profiles of both nitrofurantoin and fosfomycin. This multi-center open trial will randomize 600 non-pregnant women at three international sites (200 each in Poland, Switzerland, and Israel) at increased risk for carriage of resistant uropathogens and with suspicion of uncomplicated lower urinary tract infection to receive either oral nitrofurantoin 100 mg three times daily for 5 days or a single 3g dose of oral fosfomycin. Patients will be followed for clinical and bacteriologic response at days 14 and 28 post therapy completion. The study hypothesis holds that nitrofurantoin will be superior to fosfomycin in clinical efficacy at final follow-up.

NCT ID: NCT01960504 Active, not recruiting - Clinical trials for Coronary Artery Disease

First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)

BIOSOLVE-II
Start date: October 2013
Phase: N/A
Study type: Interventional

BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).

NCT ID: NCT01957436 Active, not recruiting - Clinical trials for Metastatic Prostate Cancer

A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer

PEACE1
Start date: November 13, 2013
Phase: Phase 3
Study type: Interventional

This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

NCT ID: NCT01942603 Active, not recruiting - Cutaneous Melanoma Clinical Trials

Minimal SN Tumor Burden

Minitub
Start date: July 2009
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to collect data in order to discover whether melanoma patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND) or not. Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal basin as the SN. However, if the positive (or metastatic) SN is only minimally involved, some centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND procedure does not increase survival for patients with a minimal SN tumor burden, but can add prognostic information, potentially useful in the subsequent decision-making process. However, this is a surgical operation for the patient, which might be accompanied by significant side effects. Moreover, only approximately 20% of patients with a metastatic SN have further lymph node metastases in the same basin, which means that about 4 patients out of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN positive patients could be safely spared from a CLND. It has been demonstrated that breast cancer patients with minimal SN tumor burden can be safely managed with nodal observation only, without performing a CLND. There is evidence that the same situation exists in melanoma as well, but this needs to be validated and this is why we are conducting this registry. The results of this registry will be crucial to establish an accepted standard of care (CLND or nodal observation) for melanoma patients with minimal SN tumor burden.

NCT ID: NCT01939249 Active, not recruiting - Clinical trials for Coronary Artery Disease

Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent

BIOFLOW-IV
Start date: September 2013
Phase: N/A
Study type: Interventional

BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.

NCT ID: NCT01931371 Active, not recruiting - Anal Fistula Clinical Trials

Anal Fistula Plug Versus Endorectal Advancement Flap

AFPERAF
Start date: May 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.

NCT ID: NCT01921556 Active, not recruiting - COPD Clinical Trials

The Improving Care in Chronic Obstructive Lung Disease Study A Cluster Randomized Trial

CAROL
Start date: September 2013
Phase: N/A
Study type: Interventional

Background The Swiss health ministry launched a national quality program "QualiCCare" in 2011 to improve healthcare for patients with COPD. The aim of this study is to determine whether participation in the COPD quality initiative ("QualiCCare") improves adherence to recommended clinical processes and shows impact on patients COPD care and on quality of life in patients with COPD.

NCT ID: NCT01909453 Active, not recruiting - Melanoma Clinical Trials

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma

COLUMBUS
Start date: September 16, 2013
Phase: Phase 3
Study type: Interventional

This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: 1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or 3. vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: 1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)

NCT ID: NCT01902043 Active, not recruiting - Diabetes Mellitus Clinical Trials

CoDiab-VD: a Population-based Cohort on Quality of Care of Patients With Diabetes in the Canton of Vaud (Switzerland)

CoDiab-VD
Start date: September 2011
Phase:
Study type: Observational

Diabetes, one of the most prevalent chronic disease (~ 9% worldwide), represents a major public health burden in terms of morbidity, disability and mortality. Caring for patients with diabetes requires effective collaboration between healthcare providers, teamwork, self-management education and use of evidence-based medicine. However, these processes of care are complex and often suboptimal. Improving quality of diabetes care is thus needed to reduce the health and societal burden of this disease. In the canton of Vaud, a state in Switzerland with more than 700,000 inhabitants, a recent population-based study has shown that the prevalence of diabetes was around 7%. Data on the quality of diabetes care is scarce and quality of care data are still infrequently and unsystematically collected in Switzerland. In addition, when data are available, they focus on intermediate outcomes as well as clinical and biological cardiovascular risk factors. Population-based data on patient-reported outcomes are not considered. In 2010, the Public Health Department of the canton of Vaud initiated the development of a regional diabetes program entitled "Programme cantonal Diabète" (PcD). It aimed both at decreasing the incidence of diabetes and improving care for patients with diabetes. To tailor the program to the healthcare needs of patients and healthcare professionals involved in diabetes care, an exploratory study using qualitative methods was conducted in 2010. This was followed by a population-based survey conducted in fall 2011 and summer 2012. The objectives of the survey were to characterize patients with diabetes and assess the quality of the care they received. In addition, the results of the survey were used to help targeting unmet needs and possible areas of improvements, and constituted the patients' baseline measurement for the evaluation of the PcD. The CoDiab-VD cohort emerged from that initial project; its specific objectives were 1) to follow over time the quality of diabetes care, 2) to explore topics that the PcD needed for its development, 3) to assess the impact of the PcD on the care of patients with diabetes, and 4) to evaluate the coverage of the PcD in the canton of Vaud.

NCT ID: NCT01889056 Active, not recruiting - Healthy Clinical Trials

Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans

Start date: February 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the brain, especially under hypoxic conditions. It has been shown in animal studies and human studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence for central modulatory effects of Epo in the brain but high dose of Epo is needed to overcome the blood brain barrier. In a double blind placebo controlled crossover study we will investigate the effects of a single high dose of Epo on cognitive function and exercise capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000 IU) and will perform a computerized cognitive test battery, a breathing test, a maximal exercise capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The primary outcome of the study will be the cognitive function. - Trial with medicinal product