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NCT ID: NCT03921528 Completed - Clinical trials for Neuromuscular Diseases

An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy

TOPAZ
Start date: April 22, 2019
Phase: Phase 2
Study type: Interventional

The TOPAZ study will assess the safety and efficacy of SRK-015 in later-onset Spinal Muscular Atrophy (SMA Type 2 and Type 3) in pediatric and adult patients.

NCT ID: NCT03920293 Completed - Clinical trials for Generalized Myasthenia Gravis

Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

Start date: March 12, 2019
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

NCT ID: NCT03918980 Completed - Clinical trials for Healthy Volunteers, Atopic Diathesis and Atopic Dermatitis

Single Dose and Multiple Dose Study to Assess Safety and Tolerability of LOU064

Start date: August 18, 2016
Phase: Phase 1
Study type: Interventional

This is a 6-part first-in-human study in up to approximately 184 participants. Parts 1 to 5 is in health volunteers and part 6 is in subjects with atopic dermatitis. The purpose of this first-in-human study is to assess the safety and tolerability and pharmacokinetics (PK) of single and multiple doses of LOU064 both as once and twice daily oral administration in healthy volunteers and those with atopic diathesis or atopic dermatitis. This study will also explore the effect of food intake and different drug substance particle sizes on the in vivo disposition of LOU064 in healthy volunteers to guide dosing and formulation development for future clinical trials. The study is registered on CT.Gov with the initiation of part 6 in patients (FPFV in April 2019).

NCT ID: NCT03917745 Completed - Pregnancy Distress Clinical Trials

E-health Intervention in Women With Pregnancy Distress

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

The study aims to reduce the levels of distress (depression and anxiety) during pregnancy. The study investigates the effectiveness of an eHealth pregnancy distress-reducing mindfulness training in women with pregnancy distress.

NCT ID: NCT03913806 Completed - Soft Tissue Sarcoma Clinical Trials

FLuoresence Image Guided Surgery With A VEGF-targeted Tracer in Soft-tissue Sarcomas in Humans Approach With Bevacizumab-IRDye 800CW

FLASH
Start date: May 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

There is a need for better visualization of resection margins during surgery for soft tissue sarcoma. Optical molecular imaging of soft tissue sarcoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in soft tissue sarcoma versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling soft tissue sarcoma visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (10, 25 or 50mg) to detect soft tissue sarcoma intraoperatively.

NCT ID: NCT03912922 Completed - Clinical trials for Overweight and Obesity

SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism?

SITLESS4
Start date: December 15, 2017
Phase: N/A
Study type: Interventional

Research has shown that replacing sitting time with low intensity physical activity (such as slowly walking and standing) has beneficial effects on metabolic health, like insulin sensitivity, comparable to improvements after sitting all day in combination with 1h streneous exercise. The main objective of this study is to investigate the underlying mechanisms responsible for improved insulin sensitivity after 4 days of sitting less compared to sitting and exercise in healthy obese women. Our secondary objective is to investigate the effects of sitting less on cardio metabolic parameters.

NCT ID: NCT03912233 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis

Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).

NCT ID: NCT03911713 Completed - Cystic Fibrosis Clinical Trials

A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

Start date: April 17, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.

NCT ID: NCT03909984 Completed - Clinical trials for Epilepsy in Children

Promoting Implementation of Seizure Detection Devices in Epilepsy Care

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

This is a multicenter home-based medical device intervention study, with prospective validation of the wearable seizure detection device (Nightwatch) and retrospective validation of remote sensors (video and audio detection) in children. The investigators will also perform a feasibility and utility analysis of Nightwatch.

NCT ID: NCT03909386 Completed - Cancer Clinical Trials

Non-interventional Study on Patients With Atrial Fibrillation and Cancer

BLITZ-AFCancer
Start date: June 26, 2019
Phase:
Study type: Observational

AF and cancer frequently coexist. Since these patients are usually excluded from randomized trials, information on their management and outcome is scarce. Occurrence of relevant clinical events, such as ischemic and hemorrhagic and all-cause mortality and cardiovascular (CV) mortality occurring in patients treated or not with antithrombotic agents needs to be clarified. A prospective observational registry collecting information, in a real world setting, on the clinical profile of patients with these clinical conditions and on the use of antithrombotic drugs in patients with AF and cancer could improve our knowledge on the management of these high risk patients.