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NCT06376890 - Not yet recruiting

Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico

by New Mexico State University

Study Description:
Diabetes is a major health epidemic facing the United States and New Mexico. Currently, 11.6% of the US population (38.4 million) has diabetes, and 38.0% of US adults have prediabetes. It is estimated that around 70% of prediabetics will develop diabetes in their lifetime. In New Mexico, 48% of adults are at least prediabetic, and 12% of adults in southern New Mexico adults have diabetes. Moreover, major health disparities challenge the southern New Mexico region. Type 2 diabetes mellitus (T2DM) is generally linked with chronic inflammation, obesity, insulin resistance, and ultimately insulin dependence via pancreatic β-cell failure. Lessening pathological inflammation, a critically important factor that contributes to diabetes, can improve the disease. Furthermore, 89.8% of diabetics in the US are overweight or obese, this is a major risk for prediabetes and T2DM, as it causes insulin resistance and pancreatic β-cell dysfunction, Weight loss in people with T2DM and prediabetes has been demonstrated to affect glycemic control and metabolic parameters significantly. The purpose of this proposed study is to explore and establish the beneficial effects of 10 weeks of powdered chili pepper consumption on several parameters related to diabetes and prediabetes. This research will demonstrate how powdered chili pepper consumption can improve systemic inflammation, glycemic control, and body composition, and will provide valuable preliminary data for future funding to further examine these effects in Type 2 diabetics. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area that has health disparities. The first aim is to establish if 10 weeks of powdered red or green chili pepper consumption can significantly improve markers of inflammation, inflammatory capacity, and antioxidant capacity. The second aim is to establish if 10 weeks of powdered red or green chili pepper ingestion has a significant effect on resting blood glucose and insulin levels, connecting peptide (C-peptide) levels, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). The third aim is to determine whether powdered chili pepper consumption for 10 weeks improves resting body composition and metabolic rate. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area with health disparities. Overall, this study will provide valuable insight and background knowledge for the use of chili peppers for the treatment of prediabetes and the prevention of diabetes progression.
Lead Sponsor:
Drugs Studied:
Related Targets:
Primary Endpoint:
  • Concentration of resting and fasted blood glucose measured in mg/dl
  • 10 Weeks
  • Resting and fasted blood glucose will be measure at the pre- and post 10-week intervention time points. The outcome will be reported in mg/dl.

Enrollment

21

Phase

Not Applicable

Study Type

Interventional

Intervention Type

Dietary Supplement

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NCT06376877 - Not yet recruiting

Connectomic Targeted TMS Target for Refractory Anxiety

by Brigham and Women's Hospital

Study Description:
We will perform a randomized sham-controlled trial of aiTBS to an anxiosomatic circuit in patients with anxiety-related disorders (i.e., panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder). 80 participants with an anxiety-related disorder (defined below) will receive 50 active or sham TMS treatments over 5 days (following the SAINT protocol, which is FDA-cleared for MDD. The primary outcome will be the BAI, with a modified recall window to reflect the short treatment interval. Participants randomized to sham will be offered an open-label crossover extension.
Lead Sponsor:
Interventions Studied:
Primary Endpoint:
  • Beck Anxiety Inventory (BAI)
  • One week and one month after treatment
  • 21 item self-report scale that assesses anxiety symptoms, with a particular emphasis on physiological anxiety symptoms

Enrollment

80

Phase

Phase 2

Study Type

Interventional

Intervention Type

Procedure

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NCT06376864 - Active, not recruiting

Physical Activity Intervention Effects on Executive Function, Physical Activity and Sedentary Behaviour in Children

by Hong Kong Baptist University

  • Agency Class: OTHER
  • First Posted: April 19, 2024
  • Diseases Studied: Child Behavior
Study Description:
The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children.
Lead Sponsor:
Interventions Studied:
Primary Endpoint:
  • Executive function
  • baseline, 8 weeks, and 20 weeks
  • The Wisconsin Card Sorting Test (WCST): The computerized version of the WCST will be used to assess flexibility in decision making in this study. The number of total errors and perseverative errors and failure to maintain a set will be used as scores.

Enrollment

450

Phase

Not Applicable

Study Type

Interventional

Intervention Type

Behavioral

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NCT06376851 - Enrolling by invitation

AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management

by HeartFlow, Inc.

Study Description:
The objective of HeartFlow's DECIDE Registry is to collect observational data about the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA).
Lead Sponsor:
Interventions Studied:
Primary Endpoint:
  • Primary Endpoint
  • 90 Days
  • The primary endpoint of the DECIDE Registry is the change in medical management following HeartFlow AI-QCPA at 90 days compared to medical management following CCTA alone. The primary endpoint will only be assessed in patients in Group 2.

Enrollment

10000

Study Type

Observational

Intervention Type

Diagnostic Test

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NCT06376838 - Completed

To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crow's Feet

by DEXLEVO

Study Description:
This clinical study is a confirmatory clinical study to prove that the test device, DLMR01, is non-inferior to the control device, Rejuran®, in terms of temporary wrinkle improvement effect on crow's feet and safety. After applying DLMR01, a test device, and Rejuran®, a control device, respectively to wrinkles around the eyes, randomization to compare and evaluate the temporary wrinkle improvement effect and safety of the two clinical study medical devices, subject-evaluator blinding, pair matching, It was designed as a comparative clinical study.
Lead Sponsor:
Drugs Studied:
Related Targets:
Primary Endpoint:
  • Crow's Feet Grading Scale by independent evaluators after 12 weeks of using
  • independent evaluators after 12 weeks of using the investigational medical device for clinical trials.
  • The improvement in wrinkles assessed using the Crow's Feet Grading Scale[The scale grades wrinkles from 0(No wrinkles), 1(Very fine wrinkles),2(Fine wrinkles), 3(Moderate wrinkles), 4(Severe wrinkles)] by independent evaluators after 12 weeks of using the investigational medical device for clinical trials * Wrinkle improvement was evaluated before and after application of clinical study medical devices improved by at least 1 point on the Crow's Feet Grading Scale. It is defined as a case, and the wrinkle improvement rate is the number of wrinkles among the clinical study subjects that can be analyzed, and wrinkles improvement rate is defined as the percentage of wrinkles among analyzable clinical study subjects proportion of selected subjects.

Enrollment

218

Phase

Not Applicable

Study Type

Interventional

Intervention Type

Device

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NCT06376825 - Recruiting

The Efficacy and Acceptability of an Internet-Based Self-Help Program to Reduce Burnout

by Ahmet Nalbant

Study Description:
The goal of this clinical trial is to determine whether an internet-based self-help program reduces burnout in teachers. The study will also evaluate the program's acceptability which means assessing the extent to which users complete the program and find it useful. The main questions it aims to answer are: Does the program reduce the level of burnout in teachers? Does the program contribute to an increased sense of meaning for teachers? How much of the program do teachers finish?
Lead Sponsor:
Interventions Studied:
Primary Endpoint:
  • Burnout Assessment Tool
  • At baseline and after 8 weeks
  • Burnout Assessment Tool is a validated measure which evaluates to what extend people experience burnout in work place. The scale is a 5-point Likert type, meaning "1 = Never" to "5 = Always" (minimum:34 to maxiumum:150). Higher scores from the scale represent higher burnout. Turkish validity and reliability study was conducted and Cronbach's alpha value was stated as 0.95.

Enrollment

25

Phase

Not Applicable

Study Type

Interventional

Intervention Type

Behavioral

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NCT06376812 - Not yet recruiting

No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women

by The University of Texas Medical Branch, Galveston

Study Description:
This study will test the effects of a physical activity intervention among midlife Hispanic women.
Lead Sponsor:
Interventions Studied:
Primary Endpoint:
  • Days the activity monitor was worn
  • Baseline to 6-months
  • Objectively measured days the wearable activity monitor was worn during the intervention period

Enrollment

40

Phase

Not Applicable

Study Type

Interventional

Intervention Type

Behavioral

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NCT06376799 - Not yet recruiting

Which Health-care Professional(s) to Talk About Advance Care Planning ?

by University Hospital, Grenoble

Study Description:
The goal of this descriptive observational study is to evaluate the preference of French adult patients followed in the context of a oncological disease, regarding the choice of the preferred healthcare professional to discuss advance care planning. To this end, voluntary participants will be asked to indicate their preferences by answering a self-questionnaire available in electronic or paper format.
Lead Sponsor:
Interventions Studied:
Primary Endpoint:
  • Determining the healthcare professional preferred by cancer patients to talk about advance care planning
  • Six months
  • Hierarchical classification of healthcare professionals preferred by the patient via a self-questionnaire

Enrollment

240

Study Type

Observational

Intervention Type

Other

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NCT06376786 - Not yet recruiting

Italian iTTP Registry

by Fondazione Luigi Villa

Study Description:
ItaliTTP is an observational, prospective, single-arm, national, multicenter, non-pharmacological cohort study aimed at better defining and understanding the natural history, disease severity, and clinical outcomes of patients with immune-mediated thrombotic thrombocytopenic purpura (iTTP) in Italy. A minimum of 132 consecutive patients with acute iTTP (first event or relapse) will be enrolled for 3 years, with the possibility of extension, with a follow-up period of 3 years.
Lead Sponsor:
Primary Endpoint:
  • Age at onset
  • 3 years
  • Age at the first acute iTTP episode in years

Enrollment

132

Study Type

Observational

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NCT06376773 - Completed

Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping.

by Fujian Medical University

Study Description:
Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. This study aimed to identify the most effective drug therapeutics for patients with the mesenchymal subtype of gastric cancer.Based on RNA-seq transcriptome, 234 patients were divided into four molecular subtypes: mesenchymal, immunogenic, metabolic, and classic.Our analysis has revealed that, for neoadjuvant therapy in advanced gastric cancer (AGC), the mesenchymal subtype stands out as the ideal patient population benefiting from Apatinib, without a concurrent increase in postoperative complications.
Lead Sponsor:
Drugs Studied:
Related Targets:
Primary Endpoint:
  • overall survival
  • 2years
  • overall survival

Enrollment

234

Study Type

Observational

Intervention Type

Procedure

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