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NCT ID: NCT03977922 Completed - Multiple Sclerosis Clinical Trials

A Pilot Nutrition Program for Spinal Cord Injury and MS

Start date: February 28, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the feasibility of a 12-week pilot community-based nutrition program for individuals with spinal cord injury and multiple sclerosis, and to determine the effects of the nutrition program on body composition, inflammation, neuropathic pain, depression and quality of life.

NCT ID: NCT03977038 Completed - Clinical trials for Major Depressive Disorder

Investigation of the Effects of Repetitive Transcranial Magnetic Stimulation on Cognition in Depression

Start date: May 30, 2020
Phase:
Study type: Observational [Patient Registry]

According to the World Health Organization, MDD is attributed as the leading cause of disability worldwide, leaving 300 million individuals affected. Despite the efficacy of pharmacotherapy, a subset of MDD patients, classified as TRD, exhibit suboptimal response and thus require alternative treatment options such as rTMS. Emotional-laden "hot"and Neutral "cold" cognitions are shown to be dysfunctional in depression. Potential pro-cognitive effects remain inconclusive. In this study the investigators seek to investigate whether visual scanning patterns of emotionally laden images may be a biological marker and predictor of rTMS antidepressant efficacy. If so, then changes in visual scanning patterns are expected to precede clinical symptom improvement. Furthermore, changes in visual scanning patterns (which characterizes the state of hot cognition) are compared simultaneously to changes in cold cognition in order to elucidate the neural mechanisms underlying rTMS-induced changes in cognition. It is hypothesized that participants who are responders to rTMS will exhibit a decrease in the amount of time spent looking at dysphoric images will precede clinically detectable changes in mood as measured by a reduction in the scores on the 17-item Hamilton Depression Rating Scale (HDRS-17). The hypothesis for this study corresponds to the alleviation of the dysfunction within the hot cognitive system as a result of rTMS and a potential compensatory effect of cold cognition as a natural reaction of resetting the allocation of cognitive resources.

NCT ID: NCT03976375 Active, not recruiting - Clinical trials for Metastatic Non-Small Cell Lung Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)

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

This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

NCT ID: NCT03976362 Active, not recruiting - Clinical trials for Carcinoma, Squamous Cell, Non-small-cell Lung

A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)

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

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.

NCT ID: NCT03976349 Active, not recruiting - Parkinson's Disease Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease

REASON
Start date: August 12, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses of BIIB094 administered via intrathecal (IT) injection to participants with Parkinson's Disease (PD). The secondary objective of this study is to evaluate the pharmacokinetic (PK) profile of BIIB094.The study is open for PD patients with verified presence or absence of variations in the leucine-rich repeated kinase 2 (LRRK2) gene, but also for patients without any verified PD-related genetic variant.

NCT ID: NCT03976323 Active, not recruiting - Clinical trials for Carcinoma, Non-squamous Non-small-cell Lung

Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Non-squamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)

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

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).

NCT ID: NCT03976245 Recruiting - Clinical trials for Rheumatoid Arthritis

Advanced Therapeutics in Rheumatoid Arthritis (RA)

Start date: March 1, 2020
Phase: Phase 4
Study type: Interventional

This study will evaluate the retention rates of two advanced therapies, Tumour Necrosis Factor (TNF) and Janus kinase inhibitor (JAK) in the treatment of adults with Rheumatoid Arthritis (RA) over a two year period. It will also examine the ability to embed a clinical trial in a clinical situation using an electronic medical record (EMR).

NCT ID: NCT03975829 Recruiting - Glioblastoma Clinical Trials

Pediatric Long-Term Follow-up and Rollover Study

Start date: November 4, 2019
Phase: Phase 4
Study type: Interventional

A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.

NCT ID: NCT03975777 Recruiting - Clinical trials for Mitochondrial Biogenesis

Time-course of Mitochondrial Biogenic Gene and Protein Expression in Exercised Human Skeletal Muscle

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

This study examines the impact of exercise intensity on the 12-hour time-course of mitochondrial biogenic gene and protein expression in human skeletal muscle. Briefly, participants will perform two experimental sessions involving an acute bout of work-matched low- or high-intensity interval cycling exercise in a randomized crossover fashion, two weeks apart. Skeletal muscle biopsies will be obtained from the vastus lateralis (3 from each leg) before and 1, 3, 6, 9, and 12 hours post-exercise. Changes in the expression of various transcription factors and mitochondrial proteins will be examined at the mRNA and protein level to determine the time-course of changes in these factors differs between exercise protocols of different intensities.

NCT ID: NCT03975647 Recruiting - Clinical trials for HER2-positive Breast Cancer

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

Start date: October 2, 2019
Phase: Phase 3
Study type: Interventional

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.