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NCT ID: NCT03947294 Terminated - Cancer Clinical Trials

The ICALIC 2 International Multicentric Study

ICALIC2
Start date: May 7, 2019
Phase:
Study type: Observational

Clinicians need to measure energy expenditure (EE) by indirect calorimetry (IC) to optimize nutritional support for a better clinical outcome, especially in patients with chronic conditions or with high risk of under- and over- feeding. However, IC is rarely used in clinical routine because the devices currently on the market are of tedious use, imprecise and expensive. An easy-to-use, accurate and inexpensive IC device (Q-NRG® CE marking n°MED 9811) has been developed to meet specifications made by and for clinicians. The ease of use of this new IC device has been first evaluated in mechanical ventilation mode. This second phase aims at evaluating the ease of use, the stability and the feasibility of the measurements with this new IC device in canopy and face mask modes for spontaneously breathing adult patients.

NCT ID: NCT03935126 Terminated - Clinical trials for Age-related Macular Degeneration

Global Atrophie Biomarker Evaluation Study (GABiE)

GABiE
Start date: May 7, 2019
Phase:
Study type: Observational

To investigate the use of microperimetry and SS-OCT in assessing the natural changes of retinal sensitivity and anatomy in the perilesional zone of geographic atrophy areas in patients with dry age-related macular degeneration.

NCT ID: NCT03933410 Terminated - Urea Cycle Disorder Clinical Trials

UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder

UNLOCKED
Start date: September 17, 2019
Phase: Phase 2
Study type: Interventional

UNLOCKED: A Phase 2 Trial to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care

NCT ID: NCT03926637 Terminated - Multiple Sclerosis Clinical Trials

Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis

Start date: June 17, 2019
Phase:
Study type: Observational

The primary objective is to evaluate the feasibility of the Multiple Sclerosis Performance Test (MSPT) in a clinical care setting when used by participants with Multiple Sclerosis (MS).

NCT ID: NCT03921996 Terminated - Prostate Cancer Clinical Trials

Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer

Start date: August 27, 2019
Phase: Phase 3
Study type: Interventional

For patients with intermediate-risk prostate cancer plus a predicted risk of >5% for positive lymph nodes and with high-risk prostate cancer, international guidelines recommend ePLND along with the RP. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. We hypothesize that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

NCT ID: NCT03905343 Terminated - Breast Cancer Clinical Trials

Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC

Start date: June 25, 2019
Phase: Phase 3
Study type: Interventional

The aim of this trial is to assess if patients treated with the combination of ribociclib and endocrine therapy respond to treatment as fast as patients treated with chemotherapy only, without decreasing their quality of life (QoL).

NCT ID: NCT03902977 Terminated - Clinical trials for Breast Cancer Female

Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection

Quilting
Start date: February 19, 2019
Phase: N/A
Study type: Interventional

Breast cancer is the most frequent type of cancer among Swiss women (5'700 cases diagnosed every year). Mastectomy is indicated when breast conservative surgery is not possible or by patient wish. Axillary lymph nodes dissection (ALND) is indicated primarily for node-positive breast cancer. Postoperative seroma after mastectomy and axillary clearance is a common complication, occurring in 25 to more than 60% of patients with breast cancer. After mastectomy and/or ALND conventional wound closure commonly uses suction drain to prevent seroma. However, seroma frequently occurs after drain removal. Excessive fluid accumulation in seroma stretches the skin, resulting in patient discomfort, impaired ipsilateral shoulder function and higher risk of surgical site infection and prolongs the hospitalization. In rare cases, a fibrous encapsulated seroma is resistant to conservative treatment and requires surgical resection. Thus, seroma may also impact health care costs requiring longer hospital stay or unplanned outpatient visits and may delay adjuvant therapy. Recent data suggest that quilting suture through flap fixation reduces the incidence of seroma. Therefore, quilting suture has the potential to increase patients' quality of life, as well as to shorten the length of hospital stay and to reduce hospital costs, providing the rationale for this study.The aim of our project is to compare the efficacy of quilting suture with that of conventional closure without quilting in reducing the drainage quantity, the length of hospitalisation and the prevalence of seroma following mastectomy and/or axilla for breast cancer, as well as the patient reported pain increasing patient quality of life. The final goal is the omission of axillary drainage in the future. All randomised patients will be followed for 12 weeks. Patients will fill in 2 questionnaires (EQ5-D: European Quality of Life and Brief Pain Inventory: BPI). The Health Economic Analysis form (HEA) will be completed by the investigator collecting the patient data. Total duration of study: 2.5 years. There are 2 treatments groups 50% of the study participants will be treated with quilting suture and 50% with conventional closure. Patients are randomly divided into the 2 groups. All patients are blinded to the surgical treatment.This means that they do not know which surgical treatment they have received (quilting suture or conventional closure), The operating surgeon will not see the after the operation. Seroma assessment will be performed by other medical personnel, that do not know which surgical treatment has been given. In case of seroma a physician (not the operating surgeon) will perform the aspiration of seroma if needed.

NCT ID: NCT03890120 Terminated - Clinical trials for Primary Sclerosing Cholangitis

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

PRIMIS
Start date: March 27, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

NCT ID: NCT03886649 Terminated - Clinical trials for Non-Hodgkin Lymphoma

Copanlisib in Combination With Venetoclax in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.

Start date: November 4, 2019
Phase: Phase 1
Study type: Interventional

A significant number of patients with non-Hodgkin lymphoma (NHL) are not cured with available treatments and will eventually relapse. Those patients might not be able to tolerate more bone marrow toxicity, limiting their treatment options. Preclinical in vitro studies have demonstrated a synergism of venetoclax and copanlisib in different lymphomas. This may represent a safe and effective therapy for patients who relapsed or did not respond to standard therapy. The primary objective of this phase I trial is to establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of copanlisib in combination with venetoclax in patients with relapsed or refractory B-cell NHL.

NCT ID: NCT03878563 Terminated - Liver Cirrhoses Clinical Trials

Alterations in Intestinal Mucosal Barrier Visualized by Confocal Laser Endomicroscopy in Liver Cirrhosis: a Pilot Trial (AMBIC)

AMBIC
Start date: November 20, 2017
Phase:
Study type: Observational

Clinical trial with medical devices. A diagnostic trial conducted to find a better (less invasive) procedure for predicting the onset of spontaneous bacterial peritonitis(SBP), which is a complication of liver cirrhosis with ascites.The current recommendation for primary prophylaxis of SBP include a low protein content of the ascitic fluid or a gastrointestinal bleeding. This trial will use the CLE (confocal laser endomicroscopy) technic in order to quantify the intestinal permeability in patients with liver cirrhosis and correlate this to the onset of spontaneous bacterial peritonitis.We aim to evaluate a new diagnostic tool (the confocal laser endoscopy(CLE) technique -cellvizio- in the setting of endoscopy and defining parameters that are altered in cirrhotic patients of different severity and being at risk of developing a SBP (spontaneous bacterial peritonitis).The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for time to occurrence of spontaneous bacterial peritonitis. Defining a correlation between the quantified loss of intestinal integrity and i) total protein concentration in the ascitic fluid and ii) stadium of liver disease (Child class A, B or C)