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366 Study Matches

PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial

More than 65% of people with lower extremity peripheral artery disease (PAD) are overweight or obese. Overweight or obese people with PAD have greater functional impairment and faster functional decline than normal weight people with PAD. Walking exercise is first line therapy to improve walking performance in PAD. However, our NHLBI-funded observational longitudinal study of functional decline in PAD showed that overweight and obese PAD participants who combined weight loss with walking exercise had significantly less functional decline than those who walked for exercise but did not lose weight. Therefore, we hypothesize that among people with PAD who are overweight or obese, a weight loss intervention combined with exercise will improve walking ability more than exercise alone. However, the effects of intentional weight loss in overweight or obese people with PAD are unknown and may not be beneficial if weight loss exacerbates PAD-related sarcopenia. Behavior change that achieves sustained weight loss is particularly challenging in older obese people with chronic disease. Therefore, among people with PAD and BMI>28 kg/m2, we will conduct a randomized clinical trial to test the hypothesis that a weight loss intervention combined with walking exercise achieves greater improvement in functional performance than exercise alone at 12-month follow-up.

Diane Treat-Jacobson
NA
This study is NOT accepting healthy volunteers
NCT04228978
STUDY00006194
Overweight or Obesity, Peripheral Artery Disease
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Bupropion for the Prevention of Postpartum Smoking Relapse

Sharon Allen, PhD
Female
18 Years to 40 Years old
Phase 4
This study is also accepting healthy volunteers
NCT04098874
STUDY00007684
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Inclusion Criteria:

• Ability to provide informed consent
• Age 18 to 40 years old
• Stable health
• 7-day point prevalence abstinence demonstrated at randomization
• Lifetime history of at least 100 cigarettes smoked
• Quit smoking during the current pregnancy
• Self-report of intention to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
• Uncomplicated delivery
• Denies plans to become pregnant again during the trial.
• Full-term delivery ≥ 37 weeks gestation
• Home within 10 days of delivery
Exclusion Criteria:

• Current use of other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
• Current use of cessation aids (e.g., varenicline, NRT)
• Current use of illicit drugs or alcohol dependence
• Current use of antidepressant medication
• Bipolar disorder, eating disorder, or psychotic disorder based on the Structured Clinical Interview
• Medications & conditions that may increase the risk of taking bupropion (e.g., current or history of pulmonary embolus, stroke, heart disease, kidney disease, glaucoma, diabetes, seizure disorder, traumatic head injury, use of medications metabolized by CYP2D6)
• Family history of seizures or seizure disorder
• Maternal use of medications that lower seizure threshold
• Newborn with an elevated risk of seizure
Drug: Bupropion Extended Release Oral Tablet, Drug: Placebo oral tablet
Postpartum Smoking Relapse
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Maternal Probiotic Supplementation for Improved Outcomes in Infants of Diabetic Mothers

This is pilot study designed to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance. The primary aim is to determine if maternal probiotic supplementation during pregnancy and lactation is associated with improved recognition memory performance in infants of diabetic mothers (IDMs). This will involve recruitment and enrollment of pregnant mothers who have been diagnosed with gestational diabetes and randomization to an intervention or control group. Women in the intervention group will receive a standardized probiotic supplement during the third trimester of pregnancy through the first month of lactation. We will compare the IDMs who are exposed to probiotics via maternal supplementation or not with respect to auditory and visual ERPs at 1 and 6 months of age to determine if probiotic supplementation is associated with improved hippocampus function in infancy. The secondary aim is to examine whether maternal probiotic supplementation during pregnancy and lactation is associated with differences in maternal milk and infant fecal microbiome signatures as well as maternal milk and infant serum inflammatory protein levels. Microbial analysis will be performed on infant stool and maternal breast milk samples at one and six months of age. Infant serum and maternal breast milk inflammatory protein levels will be measured at one and six months postpartum.

Female
21 Years to 45 Years old
N/A
This study is NOT accepting healthy volunteers
NCT05467150
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Inclusion Criteria:

• Pregnant people in their second or third trimester with a diagnosis of gestational diabetes.
• BMI 18.5-45 kg/m2 at first prenatal visit
• Age 21-45 at time of delivery
• Report social support for and intention to exclusively breastfeed for at least 3 months
• Singleton pregnancy
Exclusion Criteria:

• Alcohol consumption >1 drink per week during pregnancy/lactation
• Tobacco consumption during pregnancy/lactation
• Inability to speak/understand English
• Known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
• History of type I Diabetes
• Birthing parent currently taking over the counter probiotic preparation
Dietary Supplement: Probiotic Supplement
Infant of Diabetic Mother
infant of diabetic mother, probiotic, gut microbiome, neurodevelopment
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Maternal probiotic supplementation for improved neurodevelopmental outcomes in infants of diabetic mothers (IDMs)

This is pilot study designed to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance. The primary aim is to determine if maternal probiotic supplementation during pregnancy and lactation is associated with improved recognition memory performance in infants of diabetic mothers (IDMs). This will involve recruitment and enrollment of pregnant mothers who have been diagnosed with gestational diabetes and randomization to an intervention or control group. Women in the intervention group will receive a standardized probiotic supplement during the third trimester of pregnancy through the first month of lactation. We will compare the IDMs who are exposed to probiotics via maternal supplementation or not with respect to auditory and visual ERPs at 1 and 6 months of age to determine if probiotic supplementation is associated with improved hippocampus function in infancy. The secondary aim is to examine whether maternal probiotic supplementation during pregnancy and lactation is associated with differences in maternal milk and infant fecal microbiome signatures as well as maternal milk and infant serum inflammatory protein levels. Microbial analysis will be performed on infant stool and maternal breast milk samples at one and six months of age. Infant serum and maternal breast milk inflammatory protein levels will be measured at one and six months postpartum.

Marie Hickey
18 Years and over
Pilot
This study is also accepting healthy volunteers
PEDS-2022-29947
STUDY00016313
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Inclusion Criteria:
? Pregnant women (please see description of safeguards in Section: Vulnerable populations) in their second or third trimester with a diagnosis of gestational diabetes. Gestation is determined by either self-report of estimated delivery date, or from medical records information (last menstrual period, ultrasound dating or other sources of information on date of conception), depending on which method of recruitment is used. Screening for gestational diabetes involves a 2-step (screening test followed by a diagnostic test) approach is commonly used. A 50-g oral glucose challenge test (OGCT) is performed between 24 and 28 weeks of gestation in a non-fasting state. If the screening threshold is met or exceeded, patients receive the oral glucose tolerance test (OGTT). During the OGTT, a fasting glucose level is obtained, followed by administration of a 75-g or 100-g glucose load, then evaluation of glucose levels after 1, 2, and often 3 hours. A diagnosis of gestational diabetes is made when 2 or more glucose values fall at or above the specified glucose thresholds (ACOG 2017). ? BMI 18.5-45 kg/m2 at first prenatal visit ? Age 21-45 at time of delivery ? Pregnant women who report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior) ? Singleton pregnancy
Exclusion Criteria:
? Alcohol consumption >1 drink per week during pregnancy/lactation ? Tobacco consumption during pregnancy/lactation ? Inability to speak/understand English ? Known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding ? History of type I Diabetes ? Mothers currently taking over the counter probiotic preparation
Women's Health
women's health, pregnancy, pregnant women, gestational diabetes
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Surgical Timing and Rehabilitation for Multiple Ligament Knee Injuries: A Multicenter Integrated Clinical Trial (Protocol # PRO16090503)

Combat and sports injuries as well as automobile accidents can result in complex knee injuries involving tears of two or more major ligaments. These are referred to as multiple ligament knee injuries (or knee dislocations). Other structures like nerves, blood vessels, tendons and bones may also be injured at the same time. Due to their severity, knee dislocations are difficult to treat and problems after surgery, such as poor healing, stiffness or looseness of the knee, persistent pain, and early arthritis, can be quite common. Experts agree that surgery is necessary after a knee dislocation, but they do not agree on when to perform surgery or when rehabilitation after surgery should be started. Early surgery for knee dislocations may result in better outcomes, but may also be associated with increased joint stiffness. However, delayed surgery may be associated with the knee being too loose. The best evidence for when to start rehabilitation is based on treatment of anterior cruciate ligament (ACL) injuries in sports, where early post-op rehabilitation is the standard. However, unlike ACL surgery which typically replaces the ACL with a tendon graft, surgeons frequently sew torn ligaments back together after a knee dislocation. Therefore, rehabilitation typically involves protection of the knee by keeping weight off the leg and only allowing the knee to move a little for 6 weeks, which delays return to activity. This study is being conducted to determine when the best time to do surgery is and when to start rehabilitation after surgery for the treatment of a multiple ligament knee injury.

Jeffrey Macalena
Not specified
Phase III
This study is NOT accepting healthy volunteers
NCT03543098
STUDY00002789
Bone, Joint & Muscle, Children's Health, Knee Dislocations, Multiple Ligament Knee Injuries
Clinics and Surgery Center (CSC), Knee Dislocation, Knee Injuries, Knee Injury, Knee Surgery, Knee injury, Multiple Ligament Knee Injury, Rehabilitation
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Theta Burst Stimulation for Headaches after Traumatic Brain Injury

The primary objective of this study is to investigate the safety and efficacy of theta burst stimulation (TBS) for the management of post-traumatic headaches to improve outcomes and quality of life for individuals who have suffered a traumatic brain injury (TBI). To improve tolerability and logistical burden, we have developed a novel design whereby participants will receive three doses of TBS on alternate days of the week. This design will allow us to assess efficacy while leveraging an accelerated treatment course (nine stimulation sessions per week). We have three specific aims: Specific Aim 1. To determine the efficacy and safety of TBS for the treatment of post-traumatic headache among individuals who have sustained a mild TBI. Hypothesis 1a: TBS will be safe, well-tolerated, and reduce the number of headache days. Hypothesis 1b: TBS will improve function and quality of life outcomes. Specific Aim 2: To determine the efficacy and safety of an accelerated time-course of TBS for the management of post-traumatic headache. Hypothesis 2a: The accelerated-time course will be safe, welltolerated, and improve quality of life outcomes. Hypothesis 2b: The accelerated time-course will produce greater and faster improvement in headache symptoms than that reported in the literature for standard repetitive transcranial magnetic stimulation (rTMS) protocols. Specific Aim 3: To examine the durability of treatment response to accelerated TBS during a one-month observational period. Hypothesis 3: Accelerated TBS will result in enduring treatment response of posttraumatic headache symptoms over the follow-up period.

Cristina Albott
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT04906603
STUDY00013016
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Inclusion Criteria:
? Veterans receiving services through the MVAHCS; ? History of mild to moderate TBI according to VA/DoD Clinical Practice Guidelines (2009); ? Post-traumatic headaches defined by International Classification for Headache Diagnosis 3rd Edition (ICHD-3) guidelines with the following criteria present: o Headaches developing within seven days following trauma or injury to the head and/or neck o Headaches persisting beyond three months; ? Chronic daily headaches defined by clinical standards with the following criterion present: o 15 or more headache days per month; ? Men and women 18-75 years of age; ? Possess a smartphone and agree to use the EMA application on their personal device; ? Capable and willing to provide voluntary informed consent
Exclusion Criteria:
? History of severe TBI according to VA/DoD Clinical Practice Guidelines (2009); ? Current (within six months of enrollment) psychosis and mania; ? Current (within one month of enrollment) substance dependence: o Does not include dependence on opioids for chronic pain when the medication is taken as prescribed; ? Personal history of epilepsy or seizure disorder: o Does not include seizures therapeutically-induced by electroconvulsive therapy (ECT) or identified as a single seizure event (based on the principal investigator?s judgement); ? Metal particles in the eye or head (exclusive of the mouth) (e.g., shrapnel, fragments from welding or metalwork, etc.); ? Implanted medical device controlled by physiologic signals (e.g., pacemakers, defibrillators, etc.) or implanted medical device above the clavicle (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes, etc.); ? Significant neurological disorder/injury or abnormal structural brain imaging that would impact risk (based on the principal investigator?s judgement and research literature); ? Unstable physical disease (e.g., severe heart disease); ? Current use of medications with significant potential for lowering seizure threshold; ? Current benzodiazepine usage at a dose higher than 3mg of lorazepam or equivalent; ? ECT or cortical energy exposure within one month of enrollment (including participation in any other neuromodulation treatments or studies); ? Current (within one month of enrollment) participation in another interventional study that would impact the results of this research; ? Inadequate communication (e.g., language barrier); ? Women who are pregnant, trying to become pregnant, or breastfeeding; ? Women of childbearing age/potential who are not using a medically-accepted form of contraception when sexually active
Brain & Nervous System, Brain Injuries, Traumatic, Post-Traumatic Headache, Quality of Life, Transcranial Magnetic Stimulation
TBI, TMS, headache
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