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NCT ID: NCT03425643 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

Start date: April 24, 2018
Phase: Phase 3
Study type: Interventional

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).

NCT ID: NCT03425539 Completed - Fabry Disease Clinical Trials

Efficacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With Fabry Disease

MODIFY
Start date: June 21, 2018
Phase: Phase 3
Study type: Interventional

This study aimed to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease.

NCT ID: NCT03425253 Completed - Contour Clinical Trials

Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour

JAWLINE
Start date: February 2, 2018
Phase: Phase 4
Study type: Interventional

This study has been designed to evaluate the safety and effectiveness of sequential treatment with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the jawline.

NCT ID: NCT03424018 Active, not recruiting - Achondroplasia Clinical Trials

An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia

Start date: December 12, 2017
Phase: Phase 3
Study type: Interventional

The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia

NCT ID: NCT03424005 Recruiting - Breast Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

Morpheus-panBC
Start date: April 2, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.

NCT ID: NCT03422822 Active, not recruiting - Dermatitis, Atopic Clinical Trials

Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

JADE EXTEND
Start date: March 8, 2018
Phase: Phase 3
Study type: Interventional

B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country. The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to <18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.

NCT ID: NCT03422016 Completed - Clinical trials for Autism Spectrum Disorder

Electroretinogram in Autistic Spectrum Disorders

ERG in ASD
Start date: September 3, 2018
Phase:
Study type: Observational

This study aims to find out the incidence of a reduced light adapted electroretinogram (ERG) b-wave amplitude in children with a diagnosis of Autism Spectrum Disorders (ASD).

NCT ID: NCT03421743 Completed - Clinical trials for Mycobacterium Infections, Nontuberculous

Pilot Trial of Inhaled Molgramostim in Nontuberculous Mycobacterial (NTM) Infection

OPTIMA
Start date: March 1, 2018
Phase: Phase 2
Study type: Interventional

The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor; rhGM-CSF) in subjects with persistent pulmonary Nontuberculous Mycobacterial (NTM) infection. Subject will be treated for 24-weeks with inhaled molgramostim and will be followed up for 12-weeks after end of treatment. The primary aim of the trial is to investigate the efficacy of inhaled molgramostim on NTM sputum culture conversion to negative.

NCT ID: NCT03421366 Recruiting - Cystic Fibrosis Clinical Trials

Modified Release Posaconazole in Patients With Cystic Fibrosis

Start date: March 1, 2018
Phase:
Study type: Observational

A prospective single center observational cohort of patients with cystic fibrosis to determine whether adequate serum levels of posaconazole, after administration of the newer modified release once daily oral formulation, can be achieved.

NCT ID: NCT03420781 Terminated - Diabetes Mellitus Clinical Trials

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

Start date: January 24, 2018
Phase: Phase 3
Study type: Interventional

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.