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NCT ID: NCT03958877 Recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

Start date: October 18, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.

NCT ID: NCT03958305 Recruiting - Clinical trials for Uterine Cervical Neoplasms

SUCCOR-Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer

SUCCOR
Start date: May 16, 2019
Phase:
Study type: Observational

SUCCOR study tries to understand the outcomes of European patients with stage IB1 cervical cancer (FIGO 2009)1, that underwent a radical hysterectomy for cervical cancer in 2013-2014 within the ESGO area (European Society of Gynecologic Oncology)

NCT ID: NCT03957902 Recruiting - Colorectal Cancer Clinical Trials

Assessment of Direct Biomarkers of Aspirin Action to Develop a Precision Chemoprevention Therapy of Colorectal Cancer

Start date: May 6, 2019
Phase: Phase 2
Study type: Interventional

Acetylsalicylic acid (ASA) seems the ideal colorectal cancer (CRC) chemoprevention agent. Several ongoing trials are testing the effect of ASA as co-therapy in CRC. The mechanisms of action, the appropriate dose and the ideal target population are unknown. The investigators have demonstrated that doses of 100 mg of ASA induce direct and partial but persistent acetylation of the cyclooxygenase (COX) isoenzyme COX-1 in the normal colorectal mucosa. The primary objective is to perform a study of aspirin by using a proteomic assay for comparing platelet COX-1 and CRC mucosal COX-1 after different doses of ASA. Secondary objectives are: the measurement of prostaglandin E2 (PGE2) and phosphorylated S6 protein (p-S6) levels in CRC mucosa, the assessment of indirect biomarker of aspirin action (serum thromboxane B2 (TXB2) and urinary levels of 11-dehydro-TXB2 (TX-M)), the evaluation of systemic biomarkers of inflammatory/tumorigenic COX-2 by assessing urinary levels of major metabolite of PGE2 (PGE-M). Methods: Phase II randomized clinical trial in 60 patients with newly diagnosed CRC in 3 groups of 20 patients receiving 100 or 300 mg/day, or 100 mg/12 hours of enteric-coated ASA for 3±1 weeks, prior to definitive treatment by surgery. Main outcome: Acetylation of COX-1 and COX-2. Eicosanoid levels in target organs. Expected results: Evidence for the current uncertainty about the mechanisms of action and the dose required to obtain the best chemopreventive effect with ASA in CRC. Confirm acetylation of COX as a key biomarker of efficacy with ASA.

NCT ID: NCT03956563 Recruiting - Vaginal Atrophy Clinical Trials

Effect of Hybrid Laser 10600+1540 nm on GSM

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

The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser treatment. The secondary objectives are: 1. Confirm the performance of 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 9 months post-laser treatment, and compare it with the results at 3 months. 2. Evaluate the improvement of the GSM urinary symptoms and urinary incontinence (UI) and their impact on the Quality of Life, at each timepoint after the first laser treatment. 3. To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment - For the GSM symptoms - For the urinary symptoms and UI 4. To assess the patient's satisfaction with the laser treatment. - For the GSM symptoms - For the urinary symptoms and UI.

NCT ID: NCT03955445 Recruiting - C3 Glomerulopathy Clinical Trials

Long-term Efficacy, Safety and Tolerability of LNP023 in C3G

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

This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of LNP023 in subjects with C3 glomerulopathy

NCT ID: NCT03954574 Recruiting - Clinical trials for Pulmonary Circulation Diseases

Pulmonary Hemodynamics During Exercise - Research Network

PEX-NET
Start date: December 1, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.

NCT ID: NCT03950466 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Real Life Pediatric Obstructive Sleep Apnea

RELIPOSA
Start date: January 1, 2018
Phase:
Study type: Observational

OBJECTIVES: PRIMARY: To analyze the cognitive alterations in children with Obstructive Sleep Apnea OSA in different age groups and changes at 12 months after treatment with a protocol based on usual clinical practice. DESIGN: Observational, longitudinal, prospective, and multicenter study.

NCT ID: NCT03950232 Recruiting - Ulcerative Colitis Clinical Trials

An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

ELEVATE UC OLE
Start date: September 5, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

NCT ID: NCT03950076 Recruiting - Atrial Fibrillation Clinical Trials

EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)

ENRICH-AF
Start date: September 20, 2019
Phase: Phase 4
Study type: Interventional

To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.

NCT ID: NCT03948373 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Normotensive OSA Patients With Dipper Circadian Blood Pressure Pattern

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

The principal objective is to evaluate the effect of CPAP treatment on blood pressure (BP) in normotensive patients with dipper circadian pattern with sleep apnea-hypopnea syndrome (SAHS). The secondary objectives are: i) To evaluate the prevalence of the different circadian patterns of BP in ambulatory blood pressure monitoring (ABPM) ii) To establish the relationship between CPAP compliance and BP response; iii) Identify which ABPM variables and biomarkers are related to BP response; iv) Evaluate changes in the biomarkers' profile with the CPAP treatment. Methodology: Open-label, parallel, prospective, randomized and controlled trial including normotensive patients diagnosed with severe SAHS without significant somnolence. 64 patients with dipper circadian pattern will be included and will be randomized to receive CPAP (32) or conservative treatment (32). ABPM and blood sample collection will be performed at the beginning of the study and at 3 months.