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NCT ID: NCT03687359 Recruiting - Dermatitis Atopic Clinical Trials

Observational Evaluation of Atopic Dermatitis in Pediatric Patients

PEDISTAD
Start date: August 15, 2019
Phase:
Study type: Observational [Patient Registry]

Primary Objectives: - To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable. - To evaluate the time-course of AD and selected atopic comorbidities. Secondary Objectives: - To characterize disease burden and unmet need. - To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching). - To document the real-world effectiveness and safety of treatments.

NCT ID: NCT03656536 Recruiting - Clinical trials for Metastatic Cholangiocarcinoma

A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

FIGHT-302
Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

NCT ID: NCT03650114 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

ALITHIOS
Start date: December 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

NCT ID: NCT03612726 Recruiting - Clinical trials for Hepatocellular Carcinoma

The Overall Survival of Patients With Unresectable HCC in Real-life

Start date: July 16, 2018
Phase:
Study type: Observational

Liver cancer is the fifth most common cancer and the second most frequent cause of cancer-related death globally. Hepatocellular carcinoma represents about 90% of primary liver cancers and constitutes a major global health problem. The pattern of HCC occurrence shows a significant geographical imbalance, with the highest incidence rates in East Asia (more than 50% of the cases occurring in China). The aim of this study is to investigate the overall survival (OS) of patients diagnosed with unresectable hepatocellular carcinoma under real-world practice conditions in Asia Pacific region.

NCT ID: NCT03593759 Recruiting - Sarcoidosis Clinical Trials

Cardiac Sarcoidosis Randomized Trial

CHASM-CS-RCT
Start date: January 15, 2019
Phase: Phase 3
Study type: Interventional

Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).

NCT ID: NCT03591510 Recruiting - Clinical trials for FLT3-mutated Acute Myeloid Leukemia

A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML

Start date: March 13, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia. The study has two parts: Part 1 to define the Recommended Phase 2 Dose, and Part 2 to evaluate safety and tolerability and efficacy of midostaurin. Both parts will consist of 2 induction blocks, 3 consolidation blocks, 12 cycles of post-consolidation consisting of continuous therapy with midostaurin, and a follow-up phase.

NCT ID: NCT03555578 Recruiting - Clinical trials for Spinal and Bulbar Muscular Atrophy

Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"

Start date: November 2, 2017
Phase:
Study type: Observational

The purpose of this survey is to evaluate the long-term safety and efficacy of leuprorelin acetate injection kit 11.25 mg in patients with spinal and bulbar muscular atrophy (SBMA) in the routine clinical setting.

NCT ID: NCT03552432 Recruiting - Clinical trials for Coronary Artery Disease

The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography

ALTAIR
Start date: August 23, 2017
Phase: Phase 4
Study type: Interventional

the purpose of this study is to show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration

NCT ID: NCT03548311 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Clinical Trial of Ultra-high Dose Methylcobalamin for ALS

JETALS
Start date: November 1, 2017
Phase: Phase 3
Study type: Interventional

To examine the clinical efficacy and safety of ultra-high dose (50mg, im, twice a week) methylcobalamin in retarding the progression of symptoms in amyotrophic lateral sclerosis (ALS) patients, we enroll ALS patients diagnosed by revised-Awaji-El Escorial criteria within 12 months after the clinical onset. First they are followed for 12 weeks with Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised(ALSFRS-R) scores, and only those who exhibit drops of 1-2 points are allowed to enter into the test period. A total of 128 patients are randomized and the half having placebo. They are blindly evaluated for drops of ALSFRS-R in 16 weeks, as the primary outcome. After this, all subjects receive methylcobalamin.

NCT ID: NCT03543150 Recruiting - Dysphonia Clinical Trials

BOTOX® Drug Use Investigation (Spasmodic Dysphonia)

Start date: July 20, 2018
Phase:
Study type: Observational

This study is a drug use investigation program of BOTOX. The objective of this investigation is to collect and assess information on the safety and efficacy of BOTOX injections in subjects with a diagnosis of spasmodic dysphonia in daily clinical practice. All subjects treated with BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study. Approximately 400 subjects will be included in the study. The observation period per subject will be up to 12 months from the date of the first administration of BOTOX. The total study duration will be will be approximately 3 years from the date of approval for the indication of BOTOX for spasmodic dysphonia. BOTOX is a registered trademark of Allergan, Inc.