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NCT ID: NCT03832998 Recruiting - Migraine Clinical Trials

Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

OASIS(CM)
Start date: September 5, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study hypothesis is that in pediatric participants with chronic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).

NCT ID: NCT03821935 Recruiting - Clinical trials for Advanced Solid Tumors Cancer

Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors

Start date: February 21, 2019
Phase: Phase 1
Study type: Interventional

The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.

NCT ID: NCT03817398 Recruiting - Clinical trials for Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive

Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia

Start date: November 8, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.

NCT ID: NCT03794531 Recruiting - Obesity Clinical Trials

Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico

PROSPECT
Start date: March 1, 2019
Phase:
Study type: Observational

The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,000 adults (30-75 years) in PR recruited with a community-wide sampling strategy, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.

NCT ID: NCT03785249 Recruiting - Metastatic Cancer Clinical Trials

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

Start date: December 26, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.

NCT ID: NCT03778229 Recruiting - Carcinoma Clinical Trials

Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib

SAVANNAH
Start date: January 9, 2019
Phase: Phase 2
Study type: Interventional

This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib

NCT ID: NCT03723928 Recruiting - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer

Start date: September 17, 2018
Phase: N/A
Study type: Interventional

This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.

NCT ID: NCT03717246 Recruiting - Sleep Clinical Trials

A Sleep Hygiene Intervention to Improve Sleep Quality in Urban, Latino Middle School Children - Phase 2

Start date: February 12, 2021
Phase: N/A
Study type: Interventional

Sleep is essential for children's daytime functioning and health. Poorer sleep hygiene can negatively affect sleep outcomes in children. Urban Latino children are at greater risk for poor sleep hygiene and poor quality sleep due to exposure to higher levels of urban and cultural stressors. This project aims to refine and test a novel school-based intervention to improve sleep hygiene and in turn, sleep quality in urban Latino middle school children. An existing sleep hygiene intervention that has been shown to improve sleep in urban children will be culturally and contextually tailored and has the potential to exert greater improvements in sleep hygiene and sleep outcomes for this high-risk group.

NCT ID: NCT03711032 Recruiting - Clinical trials for High-risk Non-muscle Invasive Bladder Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

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

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

NCT ID: NCT03635788 Recruiting - HIV Infections Clinical Trials

The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE

Start date: March 28, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).