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NCT ID: NCT05629858 Enrolling by invitation - Obesity Clinical Trials

Time Restricted Eating for the Treatment of PCOS

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

Background: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among young women. This syndrome is a reproductive and endocrinological disorder that affects up to 18% of reproductive-aged women. To date, the only strategy shown to reverse PCOS is sustained weight loss of 5-10%. At present, daily calorie restriction (CR) is the main diet prescribed to patients with PCOS for weight loss. However, some women find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. Considering these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE significantly reduces body weight, insulin resistance, and inflammation in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS. Accordingly, this study will compare the effects of TRE vs CR in females with PCOS over 6 months on body weight, androgen markers, inflammatory markers and insulin sensitivity. Methods: A 6-month randomized, controlled, parallel-arm trial will be implemented. Females with obesity and PCOS will be randomized to 1 of 3 groups: (1) 6-h TRE (ad libitum food intake from 1-7 pm, fasting from 7pm-1pm); (2) CR (25% energy restriction daily); or (3) control group (ad libitum intake with no meal timing restrictions).

NCT ID: NCT05629338 Enrolling by invitation - Hemorrhage Clinical Trials

Ascending Dose Study of FrontlineODP™ Spray Dried Plasma

Start date: December 1, 2022
Phase: Phase 1
Study type: Interventional

This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP).

NCT ID: NCT05629065 Enrolling by invitation - Breast Cancer Clinical Trials

Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)

(PATH-SIC)
Start date: November 28, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to increase serious illness conversations (SICs) about patients goals and preferences regarding their healthcare between patients with cancer and their oncology clinicians and improved care provided near the end of life.

NCT ID: NCT05628649 Enrolling by invitation - Obesity Clinical Trials

Teaching Kitchen Multisite Trial

TKMT
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

This TK-MT is an interactive year-long program that teaches culinary skills, nutrition education, mindfulness, and stress reduction, promotes movement, and optimizes behavior change through health coaching strategies. The purpose of this study is to test whether a referral-based teaching kitchen intervention offered for 12 months in adjunct to primary care obesity management is feasible, acceptable, and effective on improving health behaviors and obesity prevention. Specifically, the primary goal of the study is to provide evidence of improved behavior change (ex: increases in cooking at home, fruit and vegetable intake, exercise, sleep, mindful activities), improved lab values (ex: fasting blood glucose, cholesterol, triglycerides, etc.), and resulting change in body weight and waist circumference measures. The hypothesis is that by participating in this novel TK-MT intervention - learning to cook healthy, delicious, inexpensive meals at home; understanding principles of good nutrition (based on the Harvard Healthy Eating Plate); incorporating exercise more effectively into daily living; reducing stress and increasing mindfulness and sleep; and, having access to principles of health coaching - in order to leverage personal motivations - can provide a platform to transform individuals and consequently their health, not only for the duration of this study (16 weeks intensive, 8 months boosters for a total of 12 months) but for their entire lives.

NCT ID: NCT05628142 Enrolling by invitation - Clinical trials for Sacroiliac Joint Disruption

Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate 6-to-12-month radiographic outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis that have already undergone treatment with the CATAMARAN SI Joint Fusion System. In addition, retrospective and prospective clinical outcomes will be evaluated.

NCT ID: NCT05627674 Enrolling by invitation - Smoking Cessation Clinical Trials

Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer Screening and Smoking Cessation Treatment

PRECISE
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

This trial tests the effects of two versions of RiskProfile, a clinically-informed and a genetically-informed version of a patient-specific risk feedback tool, in comparison to usual care, on lung cancer screening and tobacco treatment. The trial assesses the multilevel effects of these precision risk feedback tools on the likelihood of clinicians to order lung cancer screening and tobacco treatment and of their patients to utilize these cancer prevention interventions.

NCT ID: NCT05627661 Enrolling by invitation - Healthy Clinical Trials

Wearable Devices to Monitor Seizures in Autoimmune Epilepsy

Start date: October 27, 2022
Phase: N/A
Study type: Interventional

The purpose of this research is to search for reproducible changes in a wide range of physical signals, including heart rate, muscle tone and activity and EEG before and at the onset of seizures in patients with epilepsy.

NCT ID: NCT05627596 Enrolling by invitation - Cigarette Smoking Clinical Trials

Free Samples for Health

FreSH
Start date: June 12, 2023
Phase: Phase 2
Study type: Interventional

The Free Samples for Health (FreSH) study tests whether providing free samples of stop smoking medicine called nicotine replacement therapy at dental visits results in a greater number of people quitting smoking than providing a gift of equal value (an electric toothbrush).

NCT ID: NCT05626751 Enrolling by invitation - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Start date: November 4, 2022
Phase: Phase 2
Study type: Interventional

Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. 2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.

NCT ID: NCT05622799 Enrolling by invitation - Resilience Clinical Trials

Mind-Body Medicine Training for Incarcerated Men and Women

Start date: November 21, 2022
Phase: N/A
Study type: Interventional

The goal of this study is to learn about how effective a Mind-Body Medicine Training Program is for prisoners. The main questions it aims to answer are: 1. Does the training program increase resilience? 2. Does the training program reduce depression, anxiety, and/or stress? 3. Does the training program increase optimism? 4. Does the training program increase prisoners' belief that they can have better coping skills? 5. Does the training program increase a sense of meaning in life? 6. Does the training program increase a sense of life purpose? Participants will attend a 2-part mind-body medicine training program (4 days for each part) and will fill out questionnaires before the training, after the training and 6 months after the training. They will also participate in group interviews after the training and 6 months after the training.