Search Results
Neural Mechanisms of Closed-loop Phase-locked Transcranial Magnetic Stimulation
We are investigating ways to improve methods of brain stimulation. The purpose of this study is to try a new way to deliver transcranial magnetic stimulation (TMS) to the brain. Participants will be asked to come in for three separate 4-hour research visits. Each research visit will take place approximately seven days after the previous one. During the research visits, we will put a mesh cap on the head to measure electrical activity in the brain (also known as an EEG). Once the cap is on, we will use a transcranial magnetic stimulation (TMS) device to deliver small pulses of electricity to the brain to see how it reacts to the stimulation.
• adults (Age 18 to 65) without any psychiatric diagnoses
• adults (Age 18 to 65) with depression diagnosis
• diagnosed with a psychiatric disorder other than depression
• potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
• potential contraindication to TMS (as identified by the TMS safety screener)
• any previous adverse reaction to TMS or MRI
• diagnosed with epilepsy or previously experienced a seizure
• diagnosed with a neurological condition, such as stroke or tinnitus
• experienced a head trauma that was diagnosed as concussion
• current use of or recent withdrawal from medications that can increase the risk of seizure
• currently pregnant
• any metal in the head (excluding mouth) or an implanted medical device
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics: R33 Phase
This study will look at the effects of treatment combining Comprehensive Behavioral Intervention for Tics (CBIT) and Transcranial Magnetic Stimulation (TMS) for young people who have tic disorder. Participants must be 12- 21 years old and able to have an MRI. All participants will receive 10 daily sessions of CBIT, a well-established behavioral treatment that is considered to be the first treatment for tics. Participants will also be assigned randomly (by chance) to receive TMS or a sham (treatment not delivered) just before each CBIT session. The device for TMS delivers electromagnetic stimulation to a specific area of the brain with a small coil on the scalp. The effectiveness of the CBIT for the two groups, with and without the TMS, will be compared.
• between the ages of 12 – 21
• currently experiencing chronic motor and/or vocal tics
• able to undergo MRI
• study staff will review additional exclusion criteria
• currently receiving therapy focused on tics
• currently taking neuroleptic/antipsychotic medications
Investigating Vaped Phenanthrene Biomarkers in Former Smokers
Former smokers continue to be at higher risk for developing lung cancer than non-smokers,even years after quitting. This study will look at how a specific chemical, phenanthrene, is broken down in the lungs of former smokers and non-smokers. If former smokers break down chemicals in a more harmful way, it might help explain their increased risk for lung cancer. Study participants will be asked to attend an in-person study visit to vape a small amount of phenanthrene and then collect their urine for 24 hours afterwards.
• In good health
• 21 years or older
• Previously smoked cigarettes daily for at least 10 years
• Have been completely quit for at least 1 year
• Have tried vaping at least once
• Willing to vape a study compound (does not contain nicotine)
• Current smoker
Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms: A Trial of tDCS and Cognitive Training 3-12 Months Post-mTBI
This study is looking at a new, non-invasive treatment approach for people who continue to have symptoms after a mild traumatic brain injury (such as a concussion). The treatment combines gentle brain stimulation with cognitive training exercises. The goal of the study is to see whether this combined approach can help improve thinking, memory, and overall daily functioning in individuals with persistent post-concussion symptoms. To see if you may be eligible, complete the screening form by selecting the "Visit the Study Website" button.
• ages 18-65
• has sustained a single mTBI 3-12 months prior to enrollment
• meets criteria for persistent post-concussive syndrome
• reliable access to a smartphone
• see link to clinicaltrials.gov for complete Inclusion criteria
• history of moderate/severe TBI
• significant neurological or psychiatric disorders (other than PPCS-related symptoms like mild depression/anxiety)
• contraindications to tDCS (e.g., implanted metal, skin lesions on scalp)
• see link to clinicaltrials.gov for complete Exclusion criteria
Extracellular Vesicles as Potential Biomarkers and Therapeutic Target in Gaucher Disease (Le-Na)
This is an observational study intended to generate preliminary data to understand how lysosomal dysfunction can affect the biogenesis of extracellular vesicles, its content and function. The study entails 2 visits over a 3-month period. On enrollment, participants will be scheduled for the 2 visits, during which fasting blood samples will be collected.
• ages 18 to 80
• diagnosis of Gaucher Disease
• hematological cancer or other uncontrolled medical conditions
SUSTAINED RELEASE ORAL FORMULATION FOR TREATMENT OF PARKINSON'S DISEASE
Medications used to treat Parkinson's disease will be delivered using a sachet ; placed in the oral/buccal cavity (between cheek and gum of lower jaw). This study may be a good fit for you if you are healthy, between the ages of 18 and 65, and aren’t currently taking regular medications. We expect that you will be in this research study for one visit, approximately 7 hours total. Compensation and transportation expenses will be provided.
• Normal healthy
• 18-65 years of age
• Not currently taking medications regularly
• Able to fast 6 hours, only water allowed
The Parallel Auditory Brainstem Response
This study aims to test the accuracy and speed of the pABR for future clinical use by recruiting infants and adults with a range of hearing loss profiles from normal hearing to severe loss.
• 0-5 months of age
RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/- NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA
This study compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.
• HER2 negative unresectable or metastatic adenocarcinoma of esophagus, gastroesophageal junction, or stomach
• have not received any prior treatment for this occurrence
• prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year ago
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breastfeeding
• untreated, symptomatic brain metastasis
• allogeneic tissue/organ transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
Using MRI Scans to Inform Individualized Neuromodulation Interventions in Major Depressive Disorders with and without Comorbidities
This study collects MRI brain scans before, during, and after treatment in people with depression and other mental health conditions who are receiving neuromodulation therapies. The goal is to see whether differences in brain structure can help explain why some people respond to treatment better than others.
• age 18 or older
• seeking clinical or research neuromodulation interventions for depression (with or without comorbidities)
• able to read English
• cannot complete MRI
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Obesity and Heart Failure (MARITIME-HF)
This study is being done to learn more about maridebart cafraglutide (MariTide [formerly AMG 133]) for people with heart failure (HF) and obesity in addition to their routine medical care. Participants will receive treatment with either MariTide or a placebo, which will be called a study drug. A placebo looks the same as the investigational medicine but contains no actual medicine.
• Age ≥ 18 years
• BMI ≥ 30 kg/m2 at screening
• diagnosis of heart failure
• NYHA Class II-IV
• left ventricular ejection fraction of of at least 40%
• see link to clinicaltrials.gov for complete Inclusion criteria
• Type 1 diabetes
• acute or chronic hepatitis
• history of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior, any prior suicide attempt, or history of self injury in past 5 years
• see link to clinicaltrials.gov for complete Exclusion criteria
Detecting Ovarian Cancer by Analyzing Volatile Organic Compounds (VOCs) in Human Breath
The purpose of this study is to evaluate the ability of a device (Vocxi Health’s MyBreath Print®) to capture and measure volatile organic compounds (VOCs) in breath samples from women who have a pelvic mass and will be having surgery. The ultimate goal is to develop a screening test for ovarian cancer. We expect that study will take approximately 45 minutes and breath samples will be obtained before and after surgery.
• women who have a pelvic mass and will have surgery
• diagnosis of ovarian, fallopian tube or primary peritoneal cancers or women with a non-malignant ovarian mass (excluding low malignant potential tumors)
• no prior history of cancer
• unable to tolerate normal breathing while wearing device mask
Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary symptoms of Long COVID (REVERSE-LC) (REVERSE-LC)
The purpose of this study is to understand if a drug called baricitinib can help with thinking and memory problems after COVID-19 infection for people suffering with Long COVID. Some people have thinking and memory problems along with possible difficulty breathing, a racing heart, dizziness, and/or fatigue after COVID-19 called Long COVID. This includes things like having a hard time remembering people’s names, managing money, or keeping a job. For some patients, these issues may last several years. We still do not understand why these problems happen and why they last longer in some people. This study will look at the changes in brain function, heart function, and daily activities after taking baricitinib or placebo for people who experience Long COVID.
• documented COVID infection 6 or more months prior
• clinical evidence of Long COVID such as fatigue, chills, post-exertional malaise, trouble with memory/concentration ("brain fog"), headache, dysautonomia/postural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance, chest pain, palpitations, shortness of breath, cough, fainting spells, muscle aches, joint pain, nausea, diarrhea
• symptoms must have started after January 2020 and be present for at least 6 months prior starting the study
• symptoms must be reported to have an impact on quality of life and/or everyday functioning and to be at least somewhat bothersome
• see link to clinicaltrials.gov for complete inclusion criteria
• severe cognitive, physical, or psychological disability preventing participation
• currently pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the study
• admission to an ICU for treatment of acute COVID-19 infection
• cancer diagnosis in the past 5 years
• see link to clinicaltrials.gov for complete exclusion criteria
Cervical and Endometrial Cancer Screening in Patients Seeking Gender-Affirming Hysterectomy
This study aims to quantify the rates of cervical cancer screening and endometrial sampling prior to gender-affirming hysterectomy, assess the need for these tests in TGD individuals, and explore patient-centered options for these tests.
• at least 18 years old
• able to understand, speak, read, and write in English
• have undergone hysterectomy, or plan to have a hysterectomy
• people who are transgender and gender diverse
• on the study’s community advisory board
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years& Less than 18 Years of Age with Alopecia Areata
We are conducting a research study for children ages 6-17 with patchy Alopecia Areata (AA). The purpose of this research study is to learn more about the safety, tolerability and efficacy of an investigational drug called Baricitinib. This study will compare the investigational drug to a placebo (inactive substance) to see how well the investigational drug works.
• children 6 to 18 years old
• at or above the 5th percentile of weight for age
• diagnosis of Alopecia Areata (AA) for at least 1 year
• current AA episode of at least 6 months duration with hair loss encompassing 50% or more of the scalp
• history of trial and failure with at least 1 available treatment
• history of psychological counseling related to AA
• primarily diffuse type of AA (characterized by diffuse hair shedding)
• currently experiencing other forms of alopecia including, but not limited to: trichotillomania, TE, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis)
SMART Bottle Phase II
Feeding problems are common among preterm infants. Left untreated they can cause problems that impact an infant’s ability to breathe and get the necessary nutrition they need to grow. In this study, we will learn how healthy term infants without feeding impairments feed. The SMART bottle system is made up of a disposable pressure-sensing nipple that monitors suction pressures during a feed, a wireless module that collects the measurements and sends them over Bluetooth to a tablet receiver. This system is compatible with Dr. Brown’s bottle systems. This part of the study will include 50 preterm infants.
• Infant born full term
• Infant <7 months old
• Infant receives nutrition at least partially via bottle
• Feeding impairments
• Poor weight gain
• Conditions impacting feeding
MT2020-35 - COG AAML1831 - A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations
The overall goal of this study is to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, and to find out what effects, good and/or bad, the drug gilteritinib has when given with chemotherapy to children and young adults with newly diagnosed AML and the FLT3/ITD mutation or non-ITD FLT3 activating mutations.
• patients must be less than 22 years of age at the time of study enrollment
• all patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
• patient must be newly diagnosed with de novo Acute Myeloid Leukemia (AML)
• see link to clinicaltrials.gov for additional inclusion criteria
• any concurrent malignancy
• female patients who are pregnant
• lactating females who plan to breastfeed their infants
• see link to clinicaltrials.com for additional exclusion criteria
Evaluation of Microbiota Transplant Therapy in Patients with Alopecia Areata
The purpose of this study is to determine if microbiota transplant therapy (MTT) is an effective treatment for patients with alopecia areata, alopecia totalis, and alopecia universalis. We will be testing two different ways of doing the Microbiota transplant therapy (MTT): half the people who choose to be part of this study will take antibiotics before the transplant and half will take placebo antibiotics. We will collect 5 types of samples (2 or more times during the study): blood samples, skin samples, skin swabs, hair, and fecal samples.
• 18 to 75 years of age
• moderate to severe alopecia areata with at least 30% scalp hair loss
• hair loss lasting for at least 3 months
• must be willing to stop using other types of medications to treat Alopecia Areata throughout the study
• evidence of active, ongoing regrowth of hair
• see link to clinicaltrials.gov for complete Inclusion criteria
• active medical conditions or cancer
• current gastrointestinal infection or use of antibiotics
• current treatment for gastrointestinal diagnosis or previous GI surgery (past 3 months)
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 with Recent Onsetn Stage 3 Type 1 Diabetes
The main purpose of this study is to see how safe and tolerable CNP-103 is for people with type 1 diabetes. CNP-103 is a nanoparticle (a tiny particle) containing special beta cell proteins. In each group of adults and teens, participants will be assigned by chance (like flipping a coin) to receive either CNP-103 or placebo (like CNP-103 but contains salt water). Participants will have a 66% chance of receiving CNP-103 and a 33% chance of receiving placebo. The total duration of participation from the first Screening visit until the last assessment is approximately 208 days.
• 12 to 35 years old
• women who are not pregnant or breastfeeding
• diagnosis of Type 1 Diabetes (T1D) within 180 days prior to study enrollment
• if on any medication used to treat the symptoms of T1D (e.g., corticosteroids), must be on a stable dose for at least 1 month before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• diabetic ketoacidosis (DKA) at the time of diagnosis of T1D
• see link to clinicaltrials.gov for specific criteria related to the previous use of certain drugs
MN CF Center Consent (PortCF) Cystic Fibrosis (CF) Center Program Accreditation and Funding
This retrospective, longitudinal project is to collect certain demographic and clinical health status information for entry into the CF Foundation Patient Registry (also known as PortCF). The registry has played an important role in CF research and will continue to do so. In addition, much of the same information is entered into the University of Minnesota Cystic Fibrosis Center Research Database. This patient database has been maintained since 1975.
• possible diagnosis of Cystic Fibrosis (CF) or CF-related complications
• receive care at the MN CF Center
PEPN2011 - A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating children, adolescents, and young adults with recurrent or refractory solid tumors, including lymphomas and desmoid tumors.
• 12 months to 30 years old
• patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible
• patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• pregnant or breast-feeding women
• patients who are currently receiving other anti-cancer agents
• patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant
• patients with primary brain tumors
• patients who have received a solid organ transplant
MT2023-38 Monitoring of Immune Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies
The purpose of this research is to collect and store specimens and information about the recovery of the immune system following a stem cell transplant (HCT) or immunotherapy to treat a cancer or blood disease. Samples from many people are being collected and stored so they can be used for research now and in the future.
• planning to have a Hematopoietic Cell Transplant (HCT), gene therapy or other cell therapy or immunotherapy
• allogeneic related donors
A Pilot Study of a Portable Head-Only MRI Scanner
This study is to investigate, validate and address remaining technical challenges of new imaging techniques used on a portable MRI machine. The research study consists of a one-time study visit that could last approximately 2.5 hours.
• 18 years of age or older
• able to consent for self
• free of contraindications for MRI
• currently pregnant
• extremely claustrophobic
10,000 Families Study
The purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.
• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial (PROVE)
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.
• at least 18 years old
• diagnosis of Peripheral Artery Disease (PAD) with leg symptoms
• BMI 25kg/m2 or more
• above or below knee amputation, critical limb ischemia, or wheelchair confinement
• walking is limited by a condition other than PAD
• heart attack or stroke in the past 3 months
• medical or mental health disease that will interfere with study participations (study staff will review)
• currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
• unwilling/unable to use a smart phone and unwilling to attend weekly study sessions
• unable to speak English
Save the Bottoms!!!: Assessing the Gay Male Experience with Anal Cancer Prevention Strategies
The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.
• 18 years of age or older
• AMAB (Assigned Male at Birth)
• Current resident of the U.S.
• Engage in receptive anal intercourse with male partners
• Fluent in English or Spanish
BEETroot juice to reverse functional impairment in PAD: The BEET PAD Trial (BEET PAD)
The BEET PAD Trial is a multi-centered double-blind randomized clinical trial of beetroot juice vs. placebo in 210 people with PAD. We hypothesize that by simultaneously increasing lower extremity perfusion, gastrocnemius muscle mitochondrial activity, and myofiber health and regeneration, beetroot juice will significantly improve walking performance in people with PAD. Our primary aim is to determine whether beetroot juice significantly improves six-minute walk distance at 4-month follow-up in people with PAD, compared to placebo. Preliminary evidence suggests that beetroot juice has both acute and chronic effects on walking performance in PAD. Our primary outcome will measure the combined acute and chronic effect of beetroot juice (i.e. the maximal effect) on change in 6-minute walk at 4-month follow-up. In secondary aims, we will distinguish between acute and chronic effects of beetroot juice on six-minute walk and delineate biologic pathways by which beetroot juice improves walking performance in PAD, by measuring change in gastrocnemius muscle perfusion (MRI arterial spin labeling), and gastrocnemius muscle health. We will assess the durability of beetroot juice effects on six-minute walk. Nitrate in beetroot juice is metabolized to nitrite and subsequently to NO, attaining peak nitrite levels 2.5 hours after ingestion (1). Inter-individual variability exists in the extent of metabolic conversion of nitrate to nitrite (1,2). Therefore, we will determine whether a higher peak or a greater increase in plasma nitrite at 2.5 hours after beetroot juice consumption at baseline has a greater effect on six-minute walk at 4-month follow-up, compared to a lower peak or a smaller increase, respectively. To achieve our specific aims, we will randomize 210 participants age 50 and older with PAD to one of two groups: beetroot juice vs placebo. Participants will be followed for 4.5 months.
• Diagnosis of peripheral artery disease (PAD)
• 50 years of age or older
• Above- or below-knee amputation
• Critical limb ischemia symptoms of rest pain
• Wheelchair or walker is needed to walk
• Walking is limited by a symptom other than PAD
• Current foot ulcer on bottom of foot
• Planned major surgery, coronary or leg revascularization during the next five months
• Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
• Major medical illness including lung disease requiring oxygen, Parkinson’s disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years
• Allergy to beetroot juice
• Currently consuming beetroot juice, oral nitrate or nitrite, or a beetroot supplement and/or unwilling to avoid beetroot juice during the study
• Currently eating one cup or more of beets daily
• Non-English speaking
• Participation in or completion of a clinical trial in the previous three months
• Visual impairment that limits walking ability
• Participation in a supervised treadmill exercise program in previous three months or planning to begin a supervised treadmill exercise program in the next five months
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)
Hidradenitis Suppurativa (HS) is a chronic condition that causes bumps or boils, often in the folds of armpits, chest, breasts, groin, stomach, back or sides, or buttocks. This Study is being done to compare the safety and effectiveness of a Study Drug called ruxolitinib cream with a vehicle cream for people with hidradenitis suppurative. A vehicle cream looks like the Study Cream but does not have active drug in it. Participants will be in the Study for approximately 60 weeks. This includes a 28-day screening period, 16 weeks of receiving either the Study Cream or vehicle cream, 36 weeks of receiving the Study Cream, and a 30-day follow-up.
• diagnosis of Hidradenitis Suppurativa (HS) at least 6 months before starting the study
• see link to clincialtrials.gov for complete inclusion criteria
• people who have cancer
• women who are pregnant or breastfeeding
• see link to clincialtrials.gov for complete exclusion criteria
Assessment of Breast and Nipple Sensation Following Nerve Grafting in DIEP Flap Breast Reconstruction: A Prospective Study Using Two-Point Discrimination and Semmes-Weinstein Monofilaments
This study is about quality of life and physical sensation in the nipple-areola area of people who have undergone deep inferior epigastric perforator (DIEP) flap breast reconstruction with or without nerve grafting. At the post-operative clinic visits at 3, 6, 12, and 18-months post-op, participants will have sensory assessments and be asked to complete a series of questionnaires.
• 18-90 years of age
• assigned gender of female at birth
• having a DIEP flap breast reconstruction with nerve grafting of one or both breasts
• peripheral neuropathy or sensory deficits
• having an alternative reconstruction technique or a revision
AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
• 50 years of age or younger
• have 4 or less nodules in the lung due to metastases or suspected metastases
• diagnosis of osteosarcoma
• contact study team for more detailed criteria
• pleural or mediastinal based metastatic lesions, or with pleural effusion
• large, or central tumors that require a lobectomy or pneumonectomy
MTT for H.S. Investigate whether restoring normal gut microbiome composition with cMTT influences the relative overabundance of anaerobic bacteria and microbial diversity of the skin in patients with HS
This research is being done to gain a better understanding of Hidradenitis Suppurativa (HS) and treatment with oral capsule microbiota transplant therapy (MTT) and the effects. Participants will be randomized (by chance) into 1 of 2 groups, treatment or placebo (no active ingredients) group. This study will last for up to 6 months
• at least 18 years old
• diagnosis of Hidradenitis Suppurativa (HS)
• able to speak English
• women who are of child bearing age must use a highly effective form of birth control
• must be on a stable dose of medications for at least 30 days before starting the study
• see link to clinicaltrials.gov for complete inclusion criteria
• planning on moving within 6 months from start of study
• history of anaphylactic food allergies
• women who are pregnant, breastfeeding or planning to get pregnant during the time of the study
• history of inflammatory bowel disease or extensive bowel surgery
• see link to clinicaltrials.gov for complete exclusion criteria