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NCT ID: NCT04075084 Recruiting - Atrial Fibrillation Clinical Trials

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

BIOSTREAM-ICM
Start date: October 28, 2019
Phase:
Study type: Observational [Patient Registry]

This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.

NCT ID: NCT04073836 Recruiting - Cerebral Palsy Clinical Trials

GMA and Peri in Moderate-late Preterms

Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

To analyze the relationship between the early diagnosis of cerebral palsy with the risk factors of this pathology in moderate and late premature infants

NCT ID: NCT04073420 Recruiting - Clinical trials for Valve Disease, Heart

Medtronic Cardiac Surgery PMCF Registry

Start date: December 2, 2019
Phase:
Study type: Observational [Patient Registry]

This registry is being conducted to support ongoing post-market surveillance activities.

NCT ID: NCT04071847 Recruiting - Parkinson Disease Clinical Trials

Abbott DBS Post-Market Study of Outcomes for Indications Over Time

ADROIT
Start date: November 26, 2019
Phase:
Study type: Observational

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

NCT ID: NCT04070898 Recruiting - Colon Cancer Clinical Trials

Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.

Start date: September 15, 2019
Phase: N/A
Study type: Interventional

INTRODUCTION: Recommendations for peroperative bladder catheterization remain a controversial issue since it is a procedure that is not without complications. Most of the current suggestions derive from open surgery data that have been extrapolated to Enhanced Recovery After Surgery (ERAS) or Fast-Track programs ranging between 24-48 hours. The objective of the present study is to find the perfect balance with a better degree of evidence than the current one between the reduction of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery. Methods: Multicenter, prospective, controlled, randomized non-inferiority study on the management of the bladder catheter in patients undergoing scheduled laparoscopic colon surgery, randomized in two study groups: experimental group (removal of the bladder catheter after surgery ) and control group (removal of the catheter at 24 hours) after the surgical intervention. The main objective of the present study is to reduce the permanence of the bladder catheter trying to find the balance of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery As secondary objectives we will consider the decrease in the incidence of urinary tract infections within the first 30 days as well as the reduction in hospital stay and morbidity related to the bladder catheter.

NCT ID: NCT04070677 Recruiting - Acute Esophagitis Clinical Trials

Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients

Start date: June 15, 2019
Phase: N/A
Study type: Interventional

Radiation-induced esophagitis is an acute, dose-limiting toxicity in oncologic treatment. Since it can lead to interruption of treatment, hospitalization, and even death, clinicians should be aware of this condition as an adverse effect of oncologic therapies, in order to prevent interruption of treatment, as it has been associated with reduced survival. ZIVEREL® is a new, over-the-counter medical device that comes as an oral solution in a 10-ml stick pack. It is composed of hyaluronic acid, chondroitin sulfate, and poloxamer 407 and Women plays a role in the symptomatic relief of esophagitis induced by radiotherapy alone or radiochemotherapy in oncologic patients. ZIVEREL® acts naturally and exerts a protective action by reinforcing the effect of the elements that make up the extracellular matrix, where the connective tissue provides the architecture, proteoglycans maintain the fluid-electrolyte balance, and glycoproteins maintain the intracellular substrate responsible for cell-cell reactions and cell-matrix reactions. The objective of this study is to evaluate whether administration of ZIVEREL® diminishes the grade of acute radiation-induced esophagitis and the incidence of severe esophagitis in oncologic patients treated with radiotherapy or radiochemotherapy.

NCT ID: NCT04069611 Recruiting - Diabetes Clinical Trials

Non Surgical Therapy of Periodontitis in Diabetes Patients: the Adjunctive Use of Probiotics

ProDiabet
Start date: January 30, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the clinical and microbiological performance of a probiotic formulation (Sunstar GUM Periobalance) as adjunctive to non-surgical periodontal therapy in patients with diabetes. The null hypothesis is that the adjunctive use of this probiotic formulation would not have any additional benefit over scaling and root planning in the number of residual pockets or in the microbiological impact of the treatment. Conversely, the alternative hypothesis is that the adjunctive use of this formulation would improve the clinical results of non-surgical periodontal therapy when compared to scaling and root planing alone, through a modification of the subgingival biofilm composition.

NCT ID: NCT04068597 Recruiting - Multiple Myeloma Clinical Trials

Study to Evaluate CCS1477 in Haematological Malignancies

Start date: August 9, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

NCT ID: NCT04067336 Recruiting - Clinical trials for Acute Myeloid Leukemia

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

Start date: September 12, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue in patients with NPM1-m AML.

NCT ID: NCT04066452 Recruiting - Heart Failure Clinical Trials

Prevalence of Amyloidosis in Heart Failure (PREVAMIC)

PREVAMIC
Start date: February 3, 2020
Phase:
Study type: Observational

TITLE: Study of Prevalence of Amyloidosis in Heart Failure: PREVAMIC. DESIGN: Multicenter, observational, cross-sectional, prospective, cohort study with a one-year follow-up. 44 hospitals from Spain will participate. OBJECTIVES. PRIMARY: To estimate the current prevalence of different types of cardiac amyloidosis (CA) in patients with heart failure, aged 65 years and older, with LVH > 12 mm and any LVEF value, managed in Internal Medicine departments. SECONDARY: To describe the clinical, laboratory and echocardiographic features of patients with CA. To compare one-year readmissions and mortality rates in patients with and without CA. INCLUSION CRITERIA: Inpatients or outpatients with heart failure, aged ≥ 65 years, both genders, under the care of internists. They should have a NYHA Class II-IV, echocardiogram performed in the previous 24 months, any value of LVEF, LVH: septum or posterior wall > 12 mm, diuretic treatment in the last 6 months and NTproBNP> 1800 pg/ml or BNP> 400 pg/ml in acute hear failure, or NT-proBNP >600 pg/ml o BNP >150 pg/ml in stable condition. POPULATION: Heart failure outpatients or inpatients of Internal Medicine Services. It is expected to include around 450 patients. ANALYSIS: To calculate the prevalence of TTR-CA and other types of CA. To compare the clinical, analytical, echocardiographic, and readmissions and mortality rates during one-year in patients with and without CA.