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NCT ID: NCT04179175 Active, not recruiting - Clinical trials for Hidradenitis Suppurativa

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this extension study is to evaluate maintenance of HiSCR response in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).

NCT ID: NCT04160130 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)

RHEIA
Start date: November 29, 2019
Phase: N/A
Study type: Interventional

Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female patients with severe symptomatic aortic stenosis. Patients will be randomized 1:1 to receive either TAVI or SAVR aortic valve replacement. For TAVI procedure, Edwards SAPIEN 3 THV system Model 9600 TFX (20, 23, 26 and 29 mm) or SAPIEN 3 Ultra THV system Model 9750 TFX (20, 23, 26) with the associated transfemoral delivery systems will be sued, for SAVR any commercially available surgical bioprosthetic valve. Patients will undergo the following visits: Screening, Procedure, Post Procedure, Discharge, 30 day, 6 months (telephone contact) and 1 year.

NCT ID: NCT04157153 Active, not recruiting - Clinical trials for Coronary Artery Disease

First in Men Study: BIOMAG-I

Start date: April 27, 2020
Phase: N/A
Study type: Interventional

A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.

NCT ID: NCT04153149 Active, not recruiting - Clinical trials for Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Start date: November 26, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in patients with ATTR amyloidosis with cardiomyopathy.

NCT ID: NCT04139538 Active, not recruiting - Oral Microbiome Clinical Trials

Microbiome and Immunogenity of Saliva During Orthodontic Therapy

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

There are two essential ways of treatment in the field of orthodontics. The fixed appliance treatment with self-ligating or conventional brackets and treatment with aligners. Fixed orthodontic treatment has been the optional therapy for decades. Due to an increasing demand of patients for a more aesthetic treatment, the number of aligner treatments multiplied over the last years. Within the last years, a crucial role of oral microbiome in the maintenance of oral health was largely appreciated. However, to date there is no data on the effect of different orthodontic treatments on the oral microbiome. The aim of the research project is the prospective comparison of the oral microbiome in saliva of adult patients treated with Invisalign® aligners or metal brackets. We plan to include a sample of twenty healthy individuals. Half of the participants will receive aligner treatment with Invisalign® and half metal brackets. Saliva will be collected before, 3 and 6 months after the beginning of the orthodontic therapy via a stimulated a saliva collection. The 16S rDNA genes will be amplified and sequenced with Illumina MiSeq® System. Probing depth, bleeding on probing and Plaque Index will be evaluated over time and correlated with changes of the oral microbiome.

NCT ID: NCT04138277 Active, not recruiting - Clinical trials for Pompe Disease (Late-onset)

A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With LOPD

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

This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.

NCT ID: NCT04136171 Active, not recruiting - Clinical trials for Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Start date: March 13, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com.

NCT ID: NCT04133909 Active, not recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level

MATINEE
Start date: October 30, 2019
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.

NCT ID: NCT04130191 Active, not recruiting - Clinical trials for Hereditary Angioedema (HAE)

A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II

ENABLE
Start date: December 11, 2019
Phase:
Study type: Observational

The main aim of this study is to compare the number of HAE attacks occuring in persons using lanadelumab with the number of HAE attacks before lanadelumab treatment was started. Data from participants who start the study after 1 March 2021, will be collected for 24 months; data from all other participants (who started the study before 1 March 2021) will be collected for 36 months. Participants will report information in a smartphone application at study start and for the next 3 months and then every 6 months until the study ends; data will also be collected by the study doctor during routine clinic visits

NCT ID: NCT04129502 Active, not recruiting - Clinical trials for Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Start date: January 10, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group. Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.