Treatment Trials

174 Clinical Trials for Various Conditions

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RECRUITING
Optimizing Body Mass Index (BMI) With TCMCB07, The Paradox Trial
Description

This is a randomized, double-blind, placebo-controlled study of B07, administered daily by subcutaneous (SC) injection, in up to 100 patients with newly diagnosed metastatic colorectal cancer. This study will evaluate different doses of B07 on weight, body composition and BMI in patients with sub-optimal BMIs (18 to ≤ 29 kg/m2). Treatment will begin on the same day as the start of cancer chemotherapy and continue during the first 28 days of cytotoxic therapy with a goal of preserving muscle and fat mass, relative to placebo control.

NOT_YET_RECRUITING
Redefining BMI: The Body, Mind, and Inflammation Trial
Description

Emerging adulthood (18-25 years of age) is a critical developmental window to promote weight management and cardiometabolic health, particularly for emerging adult women. The primary purpose of this study is to test the preliminary efficacy of the intensive lifestyle intervention for EA women in reducing adiposity, as well as improving biomarkers of inflammation and metabolic risk over 12 months compared with a traditional behavioral weight loss intervention. This treatment program will be tested in emerging adult (EA) women ages 18-25 years old with a BMI of 25-50 kg/m\^2.

UNKNOWN
BMI-Associated Labor Induction: A Prospective Trial
Description

The primary objective of this study is to determine if planned induction of labor at 39 weeks for nulliparous with pre-pregnancy BMI ≥ 35 kg/m2 reduces the incidence of cesarean section compared to expectant management

Conditions
COMPLETED
Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers
Description

The study team's research fills the gap in the obesity literature where BMI with a cut point of 35 is frequently used to show the association between BMI and metabolic syndrome biomarkers. The study team was unable to locate any papers that showed the association between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as this clinical team has presented.

Conditions
COMPLETED
Genetic Influences Between Cognitive Function and BMI
Description

In this study the investigators will interrogate an existing data set to examine whether genetic variants contribute to an inverse association between weight status and cognitive function. Investigators hypothesize that body mass index (BMI) will be inversely related to a number of variables measuring cognitive function, and that that this inverse relation will be at least partially attributable to genetic variants which influence both BMI and cognition.

Conditions
COMPLETED
Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85%
Description

We are currently experiencing an epidemic of obesity in the Pediatric Population. This epidemic affects many areas including quality of life. We have been conducting a nutrition and exercise program since 2003. We have noticed that many of the participants seem to have a better quality of life after finishing the one year program compared to when they started. We would like to objectively quantify this improvement using a validated questionnaire at the beginning and at the end of the study. Questionnaires will be given to participants and to their caretakers at the same time. There will be two groups in the study: one intervention (minimum attendance of 4 sessions) and one control group.

COMPLETED
Prospective Study of Dietary Factors, BMI, and Risk of Asthma in Children
Description

Asthma is a common illness among children in the United States. While there are many known causes of asthma, including tobacco smoke, pollen, dust, or other allergens, the exact cause of asthma in some individuals remains unknown. This study will examine the role that specific dietary factors and body mass index (BMI) play in the development of childhood asthma.

Conditions
COMPLETED
Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)
Description

This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.

Conditions
RECRUITING
Ketogenic Diet in Healthy Adults With Differing BMI
Description

The goal of this clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index (BMI) in the range for obesity. The main questions it aims to answer are: * Does the ketogenic diet cause larger increases in "bad cholesterol" (low density lipoprotein-cholesterol) in adults with a healthy BMI compared to adults with BMI in the range for obesity? * Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity? Participants will: * Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period * Visit the metabolic kitchen daily (Monday-Friday) to pick up meals * Attend 5 fasting visits at the Clinical Research Center for testing

ENROLLING_BY_INVITATION
LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40
Description

The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI \>40) obstetric patient population. The main questions it aims to answer are: * Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement? * Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.

RECRUITING
Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis
Description

The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.

RECRUITING
Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Description

Metformin is used widely in the treatment of type 2 diabetes. It has off-label indications for use in the prevention of diabetes and in hyperinsulinar obesity. In medical practices, the implementation of metformin for these off-label indications is variable, often at the level of the provider. Multiple retrospective investigations have also shown a clinical benefit in men with prostate cancer who are incidentally treated with metformin. This pragmatic study will test the feasibility of enrolling patients who have glucose intolerance (as defined by HbA1c of 5.7-6.4%) and/or who have increased BMI (BMI greater than or equal to 25 kg/m2) to a randomized pragmatic study of metformin plus lifestyle modification information versus lifestyle modification information only. For purposes of the scope of this project and the study's feasibility, this will be implemented in a group of prostate cancer patients, who may have additional benefits from metformin.

Conditions
RECRUITING
Study to Evaluate Weight Gain As Assessed by Change in BMI Z-score in Pediatric Subjects with Schizophrenia or Bipolar I Disorder
Description

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

COMPLETED
Misoprostol Dosing in BMI Greater Than 30
Description

The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.

COMPLETED
Does BMI Influence Pain Follow vNOTE Surgery
Description

Overweight and obesity are increasing dramatically worldwide and contribute substantially to the burden of morbidity and mortality. Obesity was considered in the past a relative contraindication for abdominal and pelvic laparoscopy surgeries due to the morbidity that is associated with it. Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications, including reducing post operation pain.

COMPLETED
Ultrasound High BMI Study
Description

This is a prospective experimental pilot study of full-term non-emergent obese parturients whose labor is being managed with epidural anesthesia to determine if neuraxial block placement with pre-procedure handheld ultrasound affects time to placement or number of needle passes. Approximately 25 patients, presenting for delivery at the University of Kentucky HealthCare Obstetrics Department, will be randomized to either the ultrasound or palpation group, between study approval and 31 July 2022.

COMPLETED
Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers
Description

This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects with high BMI and evidence of elevated liver fat.

COMPLETED
Impact of Age and BMI on Liver Transplant Outcomes
Description

Prospectively enrolled retrospective chart review and Liver Transplant database review to determine the modifiable and nonmodifiable risk factors specifically relating to Living Donor Liver Transplants. To observe the impact of age and BMI on graft outcomes and whether they impact the intraoperative management, post-operative length of stay, and complications.

TERMINATED
Fluid Resuscitation in Septic Shock Patients With BMI Elevation
Description

To explore the safety and feasibility of alternative fluid resuscitation strategies in obese patients with septic shock.

COMPLETED
Multiple Ascending Dose Study of HU6 in High BMI Volunteers
Description

This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of 10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon review of the safety and PK data, it may be decided to expand the current cohort size and/or dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 4 cohorts based on safety and/or PK and/or PD data, or enlist an additional cohort at a higher dose if deemed safe.

TERMINATED
Weekly Antepartum Testing in Women With BMI 30-40 and Neonatal Outcomes
Description

The purpose of study is to evaluate whether weekly antenatal testing in pregnant women with body mass index (BMI) 30-40 in the third trimester is associated with earlier delivery when compared to growth ultrasounds every 4 weeks. The investigators will also assess the differences in maternal and neonatal outcomes between the groups.

COMPLETED
The BMI Project (Body, Mind, Inflammation)
Description

Obesity and chronic inflammation influence the development and progression of many types of cancer. These conditions share several of the same causes, including physical inactivity, poor nutrition, stress, and insufficient sleep. Emerging adulthood (ages 18-25) represents an important developmental period in which to address behaviors and psychological variables that affect both weight status and inflammation. At least 40% of emerging adults have overweight/obesity, and this transition from adolescence to early adulthood is associated with significant increases in fast food consumption, decreases in physical activity, unpredictable sleep schedules, and alarmingly high rates of depression and perceived stress. Despite this high risk for obesity, very few weight loss interventions are designed specifically for emerging adults. Preliminary findings from weight loss interventions targeting this population have shown some promise, but generally produce modest outcomes with less consistent effects than programs in older adults. Depression and stress have been found to interfere with weight loss among emerging adults, and may be in part responsible for poorer outcomes. This proposal will develop and test an Integrated Lifestyle Intervention (ILI) that comprehensively addresses both psychological distress and traditional weight management targets. This novel approach has not been tested before and has the potential not only to enhance weight loss outcomes in this high risk population, but also to produce reductions in markers of inflammation beyond those achievable by weight loss alone.

COMPLETED
Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults
Description

Mask ventilation is fundamental to airway management at the start of surgical procedures requiring general anesthesia. For general anesthesia, medications are provided that affect the entire body and lead to a loss of consciousness. Medical professionals perform mask ventilation by placing a plastic mask over a subjects mouth and nose to provide enough oxygen for the placement of a breathing tube. In this study, we expect that a 45 degree rotation of the head will increase the efficiency of mask ventilation.

COMPLETED
Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss
Description

The study will assess the effect of attending to stomach-cues of hunger and fullness on body weight and any additional benefit provided by open-label placebo.

UNKNOWN
Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
Description

To assess the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by an individual with a BMI ≥ 35 on his/her day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing an individual's level of pain, mood, self-stigma and comfort with the use of a compression garment. Additionally, to assess the impact of the compression garment on activity, strength, posture and movement of an individual with a BMI ≥35 over the period of one year.

RECRUITING
ECoG BMI for Motor and Speech Control
Description

Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.

COMPLETED
Does Mindfulness Enhance BMI in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?
Description

Participants will be randomized to an evidence-based healthy lifestyle program alone or a healthy lifestyle program with mindfulness meditation added. The purpose of the study will be to determine if mindfulness improves BMI outcomes more than the program alone due to the stress-reduction benefits of mindfulness.

COMPLETED
Brief Motivational Interviewing (BMI)
Description

The goal of this research study is to determine if the utilization of brief motivational interviewing (BMI) during continuous care is superior compared to traditional oral hygiene instruction (OHI) to reduce patients' plaque score, bleeding on probing (BOP), and gingival index (GI) longitudinal. An additional goal is to investigate chairside time of implementing BMI.

COMPLETED
Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs
Description

The Tao Mask is a new novel facemask for positive pressure ventilation which has recently been demonstrated (MUSC study Pro00047645) to have superior performance to our conventional (standard) positive pressure mask in a random distribution of patients with experiences users. This additional study will extend our investigation of the new masks capabilities by studying it's performance in the morbidly obese - which are more challenging patients to ventilate by mask. Our hypothesis is that the Tao mask will be even more effective in this challenging population than in the random distribution of patients.

COMPLETED
Colonoscopy in the Prone Position for Patients With BMI Greater Than 30
Description

In the United States, colonoscopy has become the most commonly used screening test for colorectal cancer. Colonoscopy is typically performed with the patient starting in the left lateral decubitus position, however there is little data to support this practice and starting position is variable amongst individual gastroenterology physicians. The investigators plan to randomize patients with Body Mass Index \>30 that are presenting to the University of Virginia for colonoscopy to either the prone or left lateral decubitus position. The investigators will then record and compare cecal intubation times as well as amount of sedation used and complications to help determine which position is superior for this patient population.

Conditions