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NCT ID: NCT03905330 Completed - Clinical trials for Progressive Familial Intrahepatic Cholestasis (PFIC)

A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)

MARCH-PFIC
Start date: July 9, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).

NCT ID: NCT03903315 Completed - Lung Cancer Clinical Trials

Central Malignant Airway Obstructions: Medical Treatment Alone Versus Endoscopic and Medical Treatmen

EVERMORE
Start date: August 1, 2019
Phase:
Study type: Observational

The obstruction of the central airways (CAO) may be caused by a large variety of malignant and non malignant processes, and it may present with a variety of symptoms ranging from mild shortness of breath to life-threatening respiratory failure. The epidemiologic impact of lung cancer leads to an increasing number of patients developing complications of proximal endobronchial disease. An estimated 20-30% of patients with lung cancer will develop complications associated with airway obstruction, e.g. dyspnea, pneumonia and atelectasis, and up to 40% of lung cancer deaths may be attributed to locoregional disease. Although lung cancer patients with CAO are not candidates for surgical resection, more than 80% of these patients can receive palliative treatment using interventional bronchoscopy; in addiction, almost the 85% of these procedures reach luminal clearance and endoscopic success in terms of symptomatic relief, of pulmonary function and quality of life. There are no definitive data about factors such as type of disease or site of the lesion which may affect the use of a single or a combined endoscopic modality or stenting in the treatment of airway obstructions. A Dalar's retrospective study showed that airway stenting is a useful treatment modality besides the other interventional bronchoscopic procedures: it not only provides rapid relief of symptoms and an improved quality of life, but also gives additional time for adjuvant chemo-radiotherapy that might provide prolonged survival. Since Dumon introduced the first dedicated endoluminal airway stent, there was a clear immediate relief of respiratory symptoms and significant quality survival in most patients (9). In a Miyazawa's study all patients with malignant central airway obstruction had significant improvements in dyspnea and also in spirometry after stenting, and the author suggested that the correct positioning of the stent at the choke point leads to maximal symptomatic benefit in these patients. The choice of different airway stents can be made based on the nature (intrinsic, extrinsic or combined) and site of the lesion: for example the Dumon stent can be preferred in lesions of trachea and right main bronchus, the Ultraflex stent on the left and stenosis beyond the main bronchi. The underlying disease, the site of lesion and treatment modality are known as independent predictors of survival. Complications related to the placement of stents include re-obstructions of the lumen by tumor, granuloma formation at the stent side, mucous plugging and migration of the stent; with the use of laser, both perforation of airway wall and fire. Regarding laser resection for malignant airway obstruction, it is associated with improved survival rates (60% of patients alive at 7 months in one study). As these studies were not randomized trials, it is impossible to conclude that the laser therapy was responsible for the improved survival, but it is likely that laser therapy provided a rapid and safe means of relieving central airway obstruction, which is associated with a high mortality rate. The strategy and modality of treatment for malignant central airway obstructions depends not only on the endoscopic characteristics and location of the lesions, but also on the patient's comorbidities, pulmonary function, previous treatment and life expectancy. The primary purpose of treatment with interventional bronchoscopy alone remains to improve symptom control and quality of life, not to improve the prognosis. However, the advent of molecular-targeted therapy may change the impact of interventional bronchoscopy, especially in lung cancer patients with EGFR mutations: in a Tomoyuki case report there is the first description of the use of endoscopic treatment plus molecular-targeted therapy as combination treatment, with benefits in terms of patient's general conditions and quality of life. Moreover, some researchers have reported cases of malignant lymphoma patients with central airway obstruction who were successfully treated using interventional bronchoscopy followed by systemic chemotherapy. The aim of this study is to evaluate the differences between patients with central malignant airway obstruction treated only with medical therapy versus patients submitted to endoscopic plus medical therapy in terms of prognosis, quality of life and access to health services.

NCT ID: NCT03902392 Completed - Clinical trials for Allergic Contact Dermatitis

Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis

Grapolyphen
Start date: April 16, 2018
Phase: N/A
Study type: Interventional

Nickel (Ni)-mediated allergic contact dermatitis (ACD) is a very common disease worldwide. Our previous findings demonstrated that in vitro supplementation of polyphenols, extracted from seeds of red grape (Nero di Troia cultivar), to peripheral lymphomonocytes from Ni-mediated ACD patients could reduce release of T helper (h)1 [interferon (IFN)-] and Th2 [interleukin (IL)-4] cytokines, on the one hand. On the other hand, IL-10 (an anti-inflammatory cytokine) levels increased with a reduction of IL-17 (an inflammatory cytokine). Also levels of nitric oxide (NO) decreased in response to polyphenol pretreatment.

NCT ID: NCT03901729 Completed - Heart Failure (HF) Clinical Trials

A Trial to Study BAY1753011 in Patients With Congestive Heart Failure

AVANTI
Start date: May 29, 2019
Phase: Phase 2
Study type: Interventional

To assess the efficacy of 30 mg of BAY1753011, with or without furosemide, versus furosemide alone in patients with heart failure and objective evidence of congestion.

NCT ID: NCT03901339 Completed - Clinical trials for Metastatic Breast Cancer

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

TROPiCS-02
Start date: May 8, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

NCT ID: NCT03900546 Completed - Critically Ill Clinical Trials

Arterial Tone Influence on Cardiac Output Measured by PRAM

Start date: March 2014
Phase:
Study type: Observational

This study evaluates the role of arterial tone in the accuracy of cardiac output (CO) measurement by Pressure Recording Analytical Method (PRAM). Patients receiving noradrenaline who need for clinical reason to change the noradrenaline dose will be enrolled. We use echocardiography as reference method of CO measurement.

NCT ID: NCT03900455 Completed - Pressure Ulcer Risk Clinical Trials

Prevention of Pressure Ulcer on the Sacrum

Multischiume
Start date: October 21, 2019
Phase: N/A
Study type: Interventional

The aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.

NCT ID: NCT03899974 Completed - Clinical trials for Postprandial Hyperglycemia

Metabolic Effects of High-amylose Wheat-based Breads

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The amylose-amylopectin ratio influences starch properties. A higher amylose content is associated with slower starch digestion thus reducing the postprandial plasma glucose response and improving the overall postprandial metabolism. So far, limited evidence is available on the metabolic effect of wheat-based foods rich in amylose. This randomised controlled study investigated the acute metabolic effects of amylose-rich wheat-based breads in overweight subjects focusing on potential mechanisms.

NCT ID: NCT03899935 Completed - Obesity Clinical Trials

Laparoscopy for Endometriosis in Obese Patients

Start date: January 1, 2010
Phase:
Study type: Observational

Evaluation of surgical outcomes of endometriosis laparoscopic surgery in obese patients.

NCT ID: NCT03899766 Completed - Venipuncture Clinical Trials

Support Activities for the Reduction of Distress and Pain in Children During Venipuncture

Start date: February 12, 2016
Phase:
Study type: Observational

To evaluate the efficacy of Health Support Activities (Animal Assisted Intervention, Clows, Musicians) in the reduction of pain and distress in children undergoing venipuncture. Hypothesis: the investigators expect a reduction in in pain and distress.