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NCT ID: NCT04404517 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks

IntnsificADA
Start date: October 1, 2019
Phase: Phase 3
Study type: Interventional

RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.

NCT ID: NCT04403997 Recruiting - Chromoendoscopy Clinical Trials

Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease

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

Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI

NCT ID: NCT04402346 Recruiting - Pancreas; Fistula Clinical Trials

Radiofrequency-assisted Transection of the Pancreas vs Stapler

TRANSPAIRE
Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Main objective: The main end-point of this study is to compare in a randomized clinical trial that radiofrequency-assisted pancreas transection (RF) reduces the incidence of postoperative pancreatic fistula (POPF) compared to the classical method of transection (stapler). As secondary end-points, other clinical and demographic variables of the patients will be evaluated (sex, age, ASA classification, consistency of the pancreas, as well as the type of procedure, open or laparoscopic surgery, estimated intraoperative bleeding, pancreatic duct size, duration of intervention, type of tumor and quality of lymphatic resection). Methodology: Phase III prospective multicenter study in patients undergoing distal pancreatectomy for any origin. All consecutive patients who undergo a distal pancreatectomy for any cause in a multicenter setting will be included. A simple randomization of the participants to the RFA group or to the control group (stapler) will be carried out. The incidence of pancreatic fistula will be assessed as main variable; predictive multivariable models with multiple regression for quantitative variables, logistic regression for categorical variables and Cox regression for survival analyzes. In addition to histological study, molecular analysis of resection specimen and clinical and radiological follow-up with volumetry of necrosis in the area of post-pancreatectomy transection will be performed.

NCT ID: NCT04402073 Recruiting - Medulloblastoma Clinical Trials

Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma

PersoMed-I
Start date: November 11, 2022
Phase: Phase 2
Study type: Interventional

Medulloblastoma is a rare brain malignancy, mainly affecting children. Treatment of this rapidly growing tumor begins with maximal surgical removal plus radiation and chemotherapy. Treatment toxicity is high. Post-pubertal and pediatric medulloblastomas are biologically and prognostically different, which mandates age-adapted treatment strategies. Patients after puberty bear an intermediate to high prognostic risk. This means that a large number of these patients, are faced with death and/or disability (mainly neurocognitive). Therefore, the scientific and medical need is high. One of the genetic subgroups of medulloblastoma, the SHH-subgroup (Sonic HedgeHog- subgroup), is highly overrepresented in medulloblastoma patients after puberty. This subgroup can be treated with a targeted therapy. The investigators will therefore randomize patients and treat SHH-subgroup patients with sonidegib and a reduction of radiotherapy dose in the experimental arm of the trial. The hypothesis that this personalized risk-adapted therapy will improve outcomes in view of increased efficacy and decreased toxicity.

NCT ID: NCT04400630 Recruiting - Bipolar Disorder Clinical Trials

Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study)

FINEXT-BD
Start date: November 5, 2019
Phase: N/A
Study type: Interventional

This is a study that aimed to deep in the physiopathology of BD and see how, through potential modifiable areas of the patients' lifestyle, the prognosis and evolution of the pathology can be improved.

NCT ID: NCT04397783 Recruiting - Clinical trials for Colorectal Neoplasms

Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy

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

TITLE: "Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ". DESIGN: Randomized, open and parallel clinical trial so patients will be assigned to the cruciate incision group or longitudinal incision with a 1: 1 allocation ratio. POPULATION: Patients undergoing colorectal cancer surgery a definitive end colostomy. OBJECTIVES: The main objective is to compare the parastomal hernia rate diagnosed by imaging at 2 years after surgery. Secondary objectives are: 1. Clinically relevant parastomal hernia rate by physical examination 2 years after surgery. 2. Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs of care of the stoma in the immediate or late postoperative period); 3) Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale. 4) Ease / difficulty in the management of stomatherapy devices by patients using VAS (Visual Analogue Scale). DESCRIPTION OF THE INTERVENTION: An end colostomy without placement of a prophylactic mesh will be performed in all patients. In the group 1A, a longitudinal incision will be made in the anterior rectus fascia and in the posterior fascia, with two Prolene sutures at the ends of the incision of the anterior aponeurosis. In patients of group 1B, a cruciate incision will be made in the anterior rectus fascia, as well as in the posterior fascia. DURATION OF THE STUDY: The expected duration of the study is 3 years. PATIENT FOLLOW UP TIME: The planned follow-up time is 2 years. EXPECTED RECRUITMENT TIME: 12 months.

NCT ID: NCT04396574 Recruiting - Migraine Clinical Trials

A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

PIONEER-PEDS2
Start date: June 30, 2020
Phase: Phase 3
Study type: Interventional

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

NCT ID: NCT04396236 Recruiting - Migraine Clinical Trials

A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

PIONEER-PEDS1
Start date: June 15, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.

NCT ID: NCT04396080 Recruiting - Clinical trials for Clinical Performance

Prospective Clinical Trial of Onlay-carrying Patients

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

A record of the type of onlay will be made with respect to its extension, tooth or teeth to be treated, the material of clothing and the substrate on which the adhesion and cementing method, as well as the type of antagonist. To complete it, a complete clinical oral examination will be performed with oral mirrors, examination probes, joint paper, disposable gloves, masks, paper napkins, plastic cups, dental equipment lighting lamp, cold spray , photogrammed camera, including an intraoral scan to have a 3D file of the patient's condition on the day of embedding placement. Once treatment is complete, the patient should go to routine check-ups in which a full intraoral exploration and data collection intended to be carried out analyze the following variables (USPHS modificated): possible decemented and fractured, decay and marginal integrity, sensitivity or loss of vitality, as well as the degree of patient satisfaction (VAS).

NCT ID: NCT04393324 Recruiting - COVID-19 Clinical Trials

The Critical Care Response to the COVID-19 Pandemic in Madrid

Tetrix
Start date: April 24, 2020
Phase:
Study type: Observational [Patient Registry]

Description of the adaptation of ICUs in the region of Madrid to que surge in demand of critical care due to COVID-19