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NCT ID: NCT03911128 Recruiting - Clinical trials for Leukemia, Acute Lymphoblastic

A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

Start date: August 29, 2019
Phase:
Study type: Observational

The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design. The pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries/study-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study. The study only includes "standard of care" treatment included in the master protocol.

NCT ID: NCT03910374 Recruiting - Clinical trials for Cranial Sutures; Closure

Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction

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

Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques.

NCT ID: NCT03906786 Recruiting - Type1diabetes Clinical Trials

Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.

Start date: March 7, 2019
Phase: N/A
Study type: Interventional

Type 1 diabetes requires a high level of involvement of patients to obtain good control by following complex therapeutic recommendations. Motivational Interviewing has proven to be effective in changing behaviors in sedentary people, with addictions and with obesity. Our objective is to evaluate the impact of an intervention with Motivational Interviewing in patients with type 1 diabetes, through a randomized controlled clinical trial. At least sixty patients with type 1 diabetes will be included with HbA1c> 8% that will be randomized with a ratio of 1: 1. In the intervention group, Motivational Interviewing will be applied in the routine clinical appointments with the Endocrinologist, while the control group will receive the same visits but in a traditional way. The primary result will be self-care behaviors according to a validated questionnaire. Secondary outcomes include: HbA1c, number of hypoglycemia, motivation with self-care, self-efficacy, quality of life, compliance with patients' own objectives, lipid profile, weight and blood pressure. The professionals will be trained in Motivational Interviewing with the objective of favoring the adherence to self-care, the motivation of the patient and improving doctor-patient relationship. They will also be evaluated through a specific questionnaire.

NCT ID: NCT03905057 Recruiting - Clinical trials for Erectile Dysfunction Following Radical Prostatectomy

Early Shockwave Therapy for Post-RP ED

Start date: March 26, 2018
Phase: N/A
Study type: Interventional

This pilot study aims to explore the feasibility, safety and effectiveness of two different extracorporeal shock wave therapy (ESWT) protocols for patients receiving nerve-sparing radical prostatectomy (RP).

NCT ID: NCT03902704 Recruiting - Clinical trials for Difficult Intubation

Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.

NCT ID: NCT03901742 Recruiting - Clinical trials for Protein-Energy Malnutrition

Usefulness of Protein-enriched Infant Formula in Pediatric Intensive Care.

Start date: December 28, 2016
Phase: N/A
Study type: Interventional

A multicenter prospective randomized controlled trial (RCT) will be performed in three hospitals. Patients meeting inclusion criteria will be randomly allocated to one of three enteral feeding formula with different protein content. Blood and urine test, nitrogen balance assessment and energy expenditure testing by indirect calorimetry will be performed at the beginning of nutrition regimen and at 24 hours, 72 hours and 5-7 days after initiation. The sample size for this trial is estimated as 90 participants, with approximately 30 participants in each group. The data analysis will be by intention to treat. This RCT will provide new data about the amount of protein needed to improve levels of serum protein and nitrogen balance, surrogate of protein balance, in critically ill infants receiving enteral nutrition.

NCT ID: NCT03899792 Recruiting - Soft Tissue Sarcoma Clinical Trials

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

LIBRETTO-121
Start date: June 13, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

NCT ID: NCT03899155 Recruiting - Cancer Clinical Trials

Pan Tumor Rollover Study

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

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

NCT ID: NCT03894228 Recruiting - Pregnancy Clinical Trials

Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)

Start date: May 21, 2019
Phase:
Study type: Observational [Patient Registry]

This is a prospective, observational, multicenter registry, which will enrol pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain. In addition, each incident gestation will be followed-up during pregnancy, and children born to those mothers will be followed-up over 4 years to determine the incidence of serious adverse events (such as alteration of developmental status, infections, neoplasia or any other serious adverse events) during the study period. In order to harmonize the inclusion of adverse events and complications, only serious adverse events will be registered . The main variable will be the development of serious infection in children as this is the outcome that had controversial results in previous studies.

NCT ID: NCT03891056 Recruiting - Diabetes Mellitus Clinical Trials

Metabolic Surgery; Gastric Bypass vs Sleeve Gastrectomy; Efects Over Type 2 DM With Bad Metabolic Control (MSO1CT)

MSO1CT
Start date: January 15, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to compare the efficacy of laparoscopic gastric bypass versus vertical gastrectomy for the resolution of DM in patients with BMI 30-35.