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NCT ID: NCT04621656 Active, not recruiting - Healthy Clinical Trials

Sugar Challenge Study

Start date: November 1, 2017
Phase:
Study type: Observational [Patient Registry]

This is a longitudinal study involving use of the January App which collects multiple data streams and employs machine learning techniques to offer personalized lifestyle recommendations and structured food and activity challenges.

NCT ID: NCT04621175 Active, not recruiting - Energy Deficit Clinical Trials

Effects of Essential Amino Acid-enriched Whey and Carbohydrate Co-ingestion on Protein Kinetics

Start date: September 9, 2020
Phase: N/A
Study type: Interventional

Previous work conducted by the Investigators demonstrates that an essential amino acid(EAA)-enriched whey protein combination format is an efficient EAA/protein format to support enhanced whole-body protein balance and sustain muscle protein synthesis compared to isonitrogenous amounts of whey alone or a mixed-macronutrient meal. However, additional work is needed to optimize the formulation to ensure the best possible muscle and whole-body anabolic responses are achieved. This includes addressing the potential value of adding non-EAA/protein components to support energy demands. Providing additional non-protein energy to an EAA-enriched whey protein formulation may reduce the proportion of exogenous amino acids directed towards energy production thereby preserving its use for muscle protein synthesis. However, whether suppressing exogenous amino acid oxidation by providing additional carbohydrate allows for a greater muscle protein synthetic stimulus during moderate energy deficit (- 30% total energy requirements) is unknown. Therefore, this study will test the effects of EAA-enriched whey protein plus carbohydrate versus EAA-enriched whey plus additional EAA using a randomized, cross-sectional longitudinal study design.

NCT ID: NCT04620681 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

CD8 Depleted, Non-engrafting, HLA Mismatched Unrelated Infusion With MDS and Secondary AML

Start date: January 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to determine the safety of an investigational treatment for myelodysplastic syndrome (MDS) after the first therapy (such as azacitidine or decitabine) stops working or after progression of MDS to acute myeloid leukemia (AML). Funding source - FDA OOPD.

NCT ID: NCT04620551 Active, not recruiting - Parkinson Disease Clinical Trials

Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease

Start date: October 21, 2020
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is a neurodegenerative disorder that leads to both motor and non-motor symptoms. Therapies have been developed that effectively target the motor symptoms. Non-motor symptoms are far more disabling for patients, precede the onset of motor symptoms by a decade, are more insidious in onset, have been less apparent to clinicians, and are less effectively treated. Sleep dysfunction is oftentimes the most burdensome of the non-motor symptoms. There are limited options for treating sleep dysfunction in PD, and the mainstay of therapy is the use of sedative-hypnotic drugs without addressing the underlying mechanisms. Patients with PD who demonstrate significant motor fluctuations and dyskinesia are considered for subthalamic nucleus (STN) deep brain stimulation (DBS) surgery. Several studies have reported that STN-DBS also provides benefit for sleep dysregulation. Additionally, local field potentials recorded from STN DBS electrodes implanted for the treatment of PD, have led to the identification of unique patterns in STN oscillatory activity that correlate with distinct sleep cycles, offering insight into sleep dysregulation. This proposal will leverage novel investigational DBS battery technology (RC+S Summit System; Medtronic) that allows the exploration of sleep biomarkers and prototyping of closed-loop stimulation algorithms, to test the hypothesis that STN contributes to the regulation and disruption of human sleep behavior and can be manipulated for therapeutic advantage. Specifically, in PD patients undergoing STN-DBS, the investigators will determine whether STN oscillations correlate with sleep stage transitions, then construct and evaluate sensing and adaptive stimulation paradigms that allow ongoing sleep-stage identification, and induce through adaptive stimulation an increase in duration of sleep stages associated with restorative sleep.

NCT ID: NCT04619797 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

SKYSCRAPER-06
Start date: December 14, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase: - Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin - Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).

NCT ID: NCT04619420 Active, not recruiting - Alzheimer Disease Clinical Trials

A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease

Autonomy
Start date: January 6, 2021
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.

NCT ID: NCT04619017 Active, not recruiting - Allergic Rhinitis Clinical Trials

Airway Immune Response to Allergens (Use Lay Language Here)

Start date: October 28, 2021
Phase: Phase 1
Study type: Interventional

Most asthma is allergic in origin. The purpose of this study is to better understand the airway immune response to inhaled allergens in order to identify factors that promote asthma.

NCT ID: NCT04619004 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer Metastatic

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

Start date: February 2, 2021
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.

NCT ID: NCT04618653 Active, not recruiting - Clinical trials for Alcohol Use Disorder (AUD)

Comprehensive Process Model of AA-related Behavior Change

Start date: September 28, 2020
Phase:
Study type: Observational

Alcoholics Anonymous (AA) is one of the most popular resources for dealing with alcohol-related problems, and 12-step therapy (TS), based upon AA doctrine and practice, is one of the prevailing alcohol treatment approaches in the United States. Two large multisite trials, one high in internal validity and the second high in external validity came to the same conclusion, TS was equally effective as more research supported therapies, and may actually be superior when total abstinence is the treatment goal. A primary objective of TS is to facilitate AA affiliation and strong evidence suggests that this aim is a major factor accounting for the effectiveness of TS. High priority has therefore been assigned to the investigation of what actually occurs in AA, with a special focus on identifying prescribed AA behaviors and processes that are predictive of drinking reduction. The guiding assumption of these efforts is that the key to improve TS is to first understand AA better. To this end, this study will generate, for the first time, a comprehensive and definitive process model of AA-related behavior change. This objective will be realized through the highly innovative use of EMA data collection among early AA affiliates. Using real-time daily data, aim 1 will determine if four MOBC identified by AA researchers (gains in social support, increased abstinence self-efficacy, spiritual practices, and negative urgency) mediate the linkage between three types of AA prescribed behaviors and drinking outcome. Noteworthy, these analyses will include the first rigorous testing of six of seven of criteria to confirm (or reject) that these four statistical mediators are MOBC. Aim 2 will investigate whether the actions of the AA active ingredients on mediators (a path) and the actions of the mediators (b path) are constant over time or, alternatively, if there are critical periods of influence. Last, aim 3 will determine if the four MOBC operate differently across distinct subpopulations. To achieve study aims, we propose a two-group randomized longitudinal study (N = 190). In one group (n = 130) we will collect 6-months of continuous EMA data, allowing us to examine near real-time associations between AA active ingredients in three domains, four MOBC, and drinking. In tandem, we will also conduct in-person interviews at baseline, 3, and 6-months. Assessment reactivity is a concern, especially so because this will be the first study to use EMA in addition to in-person interviews in AA research. We will therefore include a traditional fixed assessment group (n = 60) also interviewed at baseline, 3, and 6-months to identify potential measurement biases introduced in our innovative approach. Achievement of study aims will generate the first empirically validated AA process model that will inform TS with critical information for improving treatment outcomes.

NCT ID: NCT04618471 Active, not recruiting - Chronic Pain Clinical Trials

Paresthesia-Free Fast-Acting Subperception (FAST) Study

FAST
Start date: February 10, 2021
Phase: N/A
Study type: Interventional

Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.