Search Results
Investigation of Persistent HIV Immune Stimulation in Lymphoid Tissues During Therapy as a Cause of Sustained Immune Activation
• Age >/= 18 years of age
• HIV infection
• Receiving an ART regimen
• Able to provide written voluntary consent before performance of any study related procedure.
• BMI >/= 30
• Currently taking anticoagulant blood thinners such as warfarin, enoxaparin, heparin
• Pregnant or breastfeeding
• Adults lacking capacity to consent and/or adults with diminished capacity to consent, including, but not limited to, those with acute medical conditions, psychiatric disorders, neurologic disorders, developmental disorders, and behavioral disorders.
• More than 3 pervious lymph node biopsies for the main study. No more than 2 lymph nodes for the sub-study.
Algorithms for programming DBS systems for ET
This study seeks to leverage subject-specific computational models that can predict neural activation of axonal pathways adjacent to the active electrode(s) and implicated in the therapeutic mechanisms of Vim-DBS to in turn guide clinicians with which stimulation settings are likely to be the most therapeutic on tremorous activity.
• diagnosis of ET
• medication-refractory tremor
• VIM-DBS implant (unilateral or bilateral)
• 7T MRI pre-operative scan under Dr. Harel's IRB (institutional review board) protocol (#1210M22183)
• Post-operative CT scan
• history of musculoskeletal disorders that affect movement of the limbs
• other significant neurological disorder
• prior history of stereotactic neurosurgery (other than VIM-DBS surgery)
• pregnancy
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation
This is an early study of a new drug, MRTX849, to treat certain solid tumors that have not responded to usual treatment. The tumor must have a KRAS G12C mutation. We are testing the drug to see if it is effective in treating the cancer and what side effects occur.
• Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
• Unresectable or metastatic disease
• Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
• Adequate organ function
• History of intestinal disease or major gastric surgery or inability to swallow oral medications
• Other active cancer
Synergistic Enteral Regimen for Treatment of the Gangliosidoses (SYNER-G) (Syner-G)
The Syner-G regimen research study seeks to evaluate the use of a combination of a medication called miglustat and a ketogenic diet for treatment of the gangliosidoses to learn if this combination will provide improved clinical outcomes compared to what we currently know about the natural course of the disease.
• Subjects must have a documented infantile or juvenile gangliosidosis disease.
• Age: 17 years or less at time of enrollment
• Subjects and their caregivers must be willing to work with a ketogenic diet team for management of the subject's ketogenic diet.
• A desire to not participate
• Patients who are older than 17 years will not be enrolled in this study.
• Children with severe renal impairment will not be enrolled in this study.
• Post-pubertal females who are pregnant, or who are unwilling to use highly-effective methods to prevent pregnancy, will be excluded from this study.
• Breast-feeding females will be excluded from this study.
• Subjects who have an allergy to miglustat or any of the components within the drug product will be excluded from this study.
Psychological Factors Influencing Voice Outcomes: Impacts in Gender Diverse Adults
This study will measure the relationship between voice-related quality of life and psychosocial distress in transgender and gender diverse patients with a voice concern. Participants participate in an semi-structured interview to characterize their voice-related experiences and the role of voice-related perceived control related to their voice concerns.
Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System
• patients scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated
• Emergent procedures will be excluded
• Procedures performed outside of regular Monday to Friday working hours will be excluded
• Inability to provide their own consent
QuitGuide for American Indians: Aims 2 & 3
This is a study to develop a test a culturally-tailored version of the smoking cessation phone app, QuitGuide. Aim 2 will enroll two waves of participants to use the tailored version. Aim 3 will then randomize participants to use either the tailored version or the standard, publicly-available version.
• American Indian person based on self-report
• Age ≥ 18 years
• Interested in quitting smoking
• Smoke ≥ 3 commercial tobacco cigarette per day (CPD) in the past 30 days o Use of other commercial tobacco products (e.g., e-cigarettes) is permitted if they report cigarettes being their primary product
• Smartphone ownership with the ability to download applications and sufficient data to complete research procedures
• Aim 2 • Does not speak or read English
• Aim 3
• Participation in Aim 2
• New or change in pharmacotherapy for smoking cessation (includes: nicotine gum, patch, lozenge, inhaler OR medications Chantix/Wellbtrutin/Zyban/Bupropion) in past month
• Does not speak or read English
A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults with Spinal Cord Injury
Almost 300,000 Americans with a spinal cord injury or disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function, which can compromise functional independence and quality of life. The purpose of this study is to find better treatment options for improving sensation and movement after SCI/D.
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes. Participants must be 30-70 years old, have a BMI of 35.0-50.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.
• Age 30 to 70 years at eligibility visit.
• Diagnosed with NASH with a total NAS ≥ 4 including a ballooning, or diagnosed with T2DM or prediabetes, HbA1c< 9%
• Body Mass Index (BMI): 35.0-50.0 kg/m2 at eligibility visit.
• Willingness to accept random assignment to either treatment group.
• All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all participants enrolled in the study
• Expect to live or work within approximately two-hours traveling time from the study clinic for the duration of the one-year trial.
• Evidence of liver fat present in the baseline MR images
• Suitable for liver biopsy using the percutaneous approach
• Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).
• Written informed consent.
• Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
• Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
• Pulmonary embolus or thrombophlebitis in the past six months.
• Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
• Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy.
• Serum creatinine >1.5 mg/dL.
• Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome, or alkaline phosphatase or ALT or AST greater than 2.5x the upper limit of normal. Elevated INR..
• Alcohol intake more than one drink or >20 grams per day
• History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.
• Gastric or duodenal ulcer in the past six months.
• History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).
• Previous organ transplantation.
• Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
• Currently pregnant or nursing, or planning to become pregnant in the next two years.
• History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
• Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
• Brief psychological evaluation recommendation that individual not continue in the study.
• Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
• Serum c-peptide <1.0 ng/ml post prandial.
• Exclusions may also be made at the discretion of the attending physician or the eligibility committee.
• Contraindication to MRI scanning. MRI contraindications are assessed during initial eligibility review as well as on the day of scanning using the CMRR standard safety screening form.
• Individuals that require the trans-jugular approach for liver biopsy
• History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus. Any history of dysphagia.
• NAS fibrosis score > 3
Biomarkers of Exposure and Effect in SREC Users
The purpose of this study is to better understand how switching from smoking to the use of electronic cigarettes (e-cigarettes) may change users’ exposures to various harmful chemicals. Your participation will also help us to understand how nicotine that is present in e-cigarettes is taken in and modified by your body.
• Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine;
• Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product;
• Biochemically confirmed regular smoking status by a NicAlert test level of 6;
• Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group);
• No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
• Subjects are in good physical health (no unstable medical condition);
• Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse);
• Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes;
• Women who are not pregnant or nursing or planning to become pregnant;
• Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products).
• Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes;
• Currently using nicotine replacement or other tobacco cessation products;
• Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
• Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional);
• Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional);
• Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
• Blood alcohol test > 0.01 (g/dL) as measured by a breath sample at screening (participants failing the breath alcohol screen will be allowed to re-screen once;
• Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Failing temperature strip for the sample. Marijuana will be tested for, but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once;
• Pregnant or breastfeeding;
• Failure to agree to take adequate protection to avoid becoming pregnant during the study;
• Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
• Systolic BP greater than or equal to 160 mm/hg
• Diastolic BP greater than or equal to 100 mm/hg
• Systolic BP below 90 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Diastolic BP below 50 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Heart rate greater than or equal to 105 bpm
• Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Expired air carbon monoxide (CO) level greater than 80 ppm;
• Self-reported allergies to propylene glycol or vegetable glycerin;
• Adverse reactions when previously using electronic cigarettes;
• Household member enrolled in the study concurrently;
• Unable to read for comprehension or completion of study documents;
• Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits.
MT2017-28 The Head Start 4 Protocol - Newly Diagnosed Children (less than 10 years old) with Medulloblastoma and Other Central Nervous System Embryonal Tumors: Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation with Either Single Cycle (Low Risk Patients) or Randomization (High Risk Patients) to Either Single-Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy with Autologous Hematopoietic Progenitor Cell Rescue Added Title: Neuroanatomical, Cognitive and Family Aspects to Recovery from a Brain Tumor
• Patients 10 years of age at the time of definitive confirmatory eligible histologic or cytologic diagnosis of eligible CNS tumor (brain or spinal cord)
• Patients may not have received irradiation or chemotherapy (except corticosteroids)
• Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord
• Medulloblastoma
• Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis
• Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis
• Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection
• CNS Embryonal Tumors:
• Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes (ETMR, including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNS embryonal tumor, not otherwise specified.
• Must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (MRI of brain, performed with and without gadolinium contrast, and MRI of total spine, performed with gadolinium contrast) and lumbar CSF cytological examination
• Patients must have adequate organ functions at the time of registration:
• Liver: bilirubin less than 1.5 mg/dL (except for patients with Gilbert's Syndrome of indirect hyperbilirubinemia) and transaminases [SGPT or ALT, and SGOT or AST] less than 2.5 (two and a half) times the upper limits of institutional normal.
• Renal: Creatinine clearance and/or glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m² within 21 days of protocol therapy.
• Bone Marrow Function:
• Peripheral absolute phagocyte count (APC) > 1000/ µL. APC = numbers of banded neutrophils + segmented neutrophils + metamyelocytes + monocytes + eosinophils Please note, if institution reports differential as a percentage, then APC = [percentage of banded neutrophils + segmented neutrophils+ metamyelocytes+monocytes+eosinophils] x total white cell count.
• Platelet Count > 100,000/µL (transfusion independent)
• Hemoglobin > 8 gm/dL (may have received RBC transfusions).
• Patients older than 10 years of age at time of diagnosis
• Following diagnoses are not eligible for study enrollment: CNS atypical teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of the brain or spinal cord; all choroid plexus carcinomas; all high-grade glial and glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas, granulocytic sarcomas).
• Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for this study.
Combined Cortical and Striatal Stimulation for Re-Regulating Circuits of Obsessive-Compulsive Disorder
The goal of this study is to provide therapy to patients with severe, treatment-refractory obsessive-compulsive disorder (OCD) by stimulating in two separate, but related, brain regions, the dorsolateral prefrontal cortex (dlPFC) and the ventral anterior limb of the internal capsule and adjacent ventral striatum (VC/VS) with the Medtronic Percept deep brain stimulation (DBS) system. While providing this DBS therapy, use of this recording-capable device will allow collection of data about brain activity in these two regions. This data will enable researchers to further elucidate the exact mechanisms of DBS therapy, as well as the neuropathophyisiology of OCD. This study aims to 1) gather evidence for corticostriatal changes in OCD in response to acute and chronic VC/VS DBS treatment and 2) specifically disrupt or enhance synchrony in the cortico-striato-thalamo-cortical (CSTC) circuit.
• OCD, diagnosed by Structured Clinical Interview for DSM-5 (SCID-5), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 28.
• Persistence of severe symptoms and impairment for five or more years despite: i. at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (may use any serotonin or serotonin-norepinephrine inhibitors, but must include a trial of clomipramine) alone or in combination with ii. adequate behavior therapy (≥20 sessions of expert exposure and response prevention; At least 20 sessions of behavioral therapy must be attempted), and iii. augmentation of one of the selective SRIs with a neuroleptic or clonazepam.
• Age between 21 and 65 years.
• Able to understand and comply with instructions.
• Able to give fully informed, written consent in the judgment of the site Consent Monitor.
• Either drug free or on a stable drug regimen for at least 6 weeks.
• Good general health.
• A family member or significant other, in contact with the patient every 1-3 days, is available and willing to communicate with the research team if the patient's clinical status worsens, and if necessary to accompany patients to study visits.
• The local referring psychiatrist is willing to provide ongoing care during and after the trial.
• Patient is aware of, able to adhere to, and willing to tolerate the frequency of visits associated with adjustment of the dual-stimulation configuration and/or collection of brain recordings. This will usually mean limitation to patients who live close to the study site.
• Platelet count greater than 125,000 per cubic millimeter and a PT and PTT within normal limits.
• Current or past psychotic disorder.
• Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WAIS) or cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably, as determined by the consent monitor and the site psychiatrist. A questionnaire assessing consent comprehension will be used with all study subjects, to ensure that they understand the key procedures of the study, and its risks and benefits. An independent monitor will administer that questionnaire.
• A clinical history of bipolar mood disorder. We will not exclude substance-induced mania or hypomania. In our prior studies, a history of induced hypomanic symptoms did not predict DBS-related hypomania.
• Any current clinically significant neurological disorder or medical illness affecting brain function, other than tic disorders or Tourette syndrome.
• Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
• Any labeled DBS contraindication and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
• Current or unstably remitted substance abuse, dependence, or a positive urine toxicology screen.
• Pregnancy and women of childbearing age not using effective contraception.
• Unable to adhere to operational and administrative study requirements (in the investigators' judgment).
• Clinical history of severe personality disorder.
• Imminent risk of suicide or an inability to control suicide attempts (in the investigators' judgment). History of serious suicidal behavior or one or more interrupted suicide attempts with potential lethality judged to result in serious injury or death.
• Diagnosis of body dysmorphic or hoarding disorder.
• Evidence of dementia or other significant cognitive impairment on neuropsychological evaluation or through cognitive screening (MOCA).
A novel Peptamen-based enteral nutrition protocol for treatment of Crohn s disease A Pilot Trial
The purpose of this study is to evaluate the therapeutic feasibility of a Peptamen-based, oral nutrition dietary regimen for treatment of adult Crohn’s disease. Specifically we are evaluating if consuming 80-100% of caloric needs from Peptamen 1.5 for 4 weeks is feasible for the potential future use therapeutically in adult Crohn’s disease.
Site for ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
We are continuing to study the SARS-CoV-2 coronavirus and the evolving new variants. We are looking at drugs that have Food and Drug Administration (FDA) approval for other uses. The goal is to determine if these drugs can make participants who get the coronavirus feel better faster and reduce death and hospitalizations.
• Completed Informed Consent
• Age ≥ 30 years old
• Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
• Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
• Prior diagnosis of COVID-19 infection (> 10 days from screening)
• Current or recent (within 10 days of screening) hospitalization
• Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo
• Known contraindication(s) to study drug including prohibited concomitant medications
Hair Research Regarding the Venus Glow Device and Scalp Microbiome
The scalp microbiome is made up of bacteria, viruses, and fungi that live on the scalp, and it is an important part of overall scalp health. The purpose of this research study is to test if cleansing the scalp with the Venus Glow™ changes the composition of the scalp microbiome and improves scalp health.
Mapping Chemical and Microbiological Heterogeneity Throughout Explanted Lung Specimens
We propose to study explanted tissue of patients that are scheduled to undergo single or double lung transplant surgery as a late-stage disease therapeutic strategy. The primary endpoint will be to characterize the composition of the bacterial community in the lung. The secondary endpoint will be to describe bacterial gene expression in the lower airways.
• diagnosis of cystic fibrosis
• eligible for lung transplantation
• exhausted other available therapies without success
• informed consent
• there are no exclusion criteria
Improving PCP's ability to communicate about racism
The goal of this study is to improve doctor-patient communication for African Americans at risk for cardiovascular disease. We are looking for African Americans willing to share their thoughts on talking to White doctors about how racism may be affecting their health. Participants will be asked to take part in a focus group via Zoom.
• Black/African American male
• Ages 40-56
• Born in the USA
• Lives in the USA
• Has at least one Black grandparent born in the USA
• Diagnosed with Cardiovascular Disease (CVD) OR has CVD risk factors
• Has seen a doctor for any reason within the last 2 years
• Has Internet access and device with Zoom capabilities
• Identifies as Hispanic
Assistive Technology and Functional Outcomes Following Spinal Cord Injury
The purpose of this study is to begin to build empirical evidence needed to support adequate funding of assistive technology (AT) for both veterans and civilians with SCI. Information gathered from this mixed-methods investigation will be used as a foundation to develop population-specific tailored information and interventions to improve access to and utilization of AT.
• You are between 18 and 65 years of age
• You are living with tetraplegia (C7 or higher) and have limited hand function
• You are greater than 1-year post-spinal cord injury
• You are fluent in English
• Spinal cord disorder (e.g., ALS, MS, transverse myelitis, Guillain-Barre)
• SCI without neurologic impairment (i.e., ASIA Impairment Scale E ? normal motor and sensory function)
• Severe cognitive impairment
• Active military personnel
COG AGCT1532 - A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors
This trial is an open label, randomized, stratified 2-arm Australian-led multicenter phase 3 clinical trial undertaken in two stages. Participants (age >= 11 years and <= 45 years) with intermediate and poor-risk metastatic germ cell tumors will be randomized into either a “standard BEP” group or “accelerated BEP” group. Participants will be assigned to the two treatment arms in a 1:1 ratio and evaluated weekly, and then for 5 years after completing the study to assess the long-term effects of the chemotherapy. Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.
Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI (The ACT Trial)
This study will be a multi-site, single-blinded, randomized controlled trial (RCT) that will screen older adults with mild cognitive impairment (MCI) using 4 steps (over the phone, in-person interview including informed consent, medical verification, exercise stress test/magnetic resonance imaging [MRI]). We will enroll 128 participants (target 96 completers, assuming 25% attrition rate at 6 months). After baseline assessment, participants will be enrolled and randomized within age (65-74 years of age or ≥75 years of age) and study site (Minnesota or Rochester) strata centrally at the University of Minnesota (UMN) to one of four groups: ACT, cycling only, SOP only, or control with equal allocation and using a randomization scheme generated by our UMN biostatistician (CI: Vock). Group allocations will be concealed to all investigators and data collectors. The interventions will last for 6 months with 12-month follow-up. Outcomes include: 1) cognition: composite measures of executive function and episodic memory, 2) AD signature cortical thickness: composite using structural magnetic resonance imaging (MRI), 3) functional connectivity in DMN: resting-state using functional MRI (fMRI), 4) aerobic fitness, and 5) clinical and pathological AD conversion. Cognition and aerobic fitness will be assessed at baseline, 3, 6, 12, and 18 months; AD conversion at 6, 12, and 18 months; and AD signature cortical thickness and DMN at baseline, 6, 12, and 18 months. PIs Yu and Lin have developed and tested strategies in their preliminary studies to successfully ensure the protection of human participants.
COG ALTE2031 - StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention among Adolescent and Young Adult Childhood Cancer Survivors
The study objectives are to compare the effect of 2 different physical activity programs on physical activity levels in adolescents and young adults who received and completed treatment for cancer and to measure lab tests associated with heart health and information collected from surveys to learn how changes in physical activity levels affect health and quality of life in participants.
• First diagnosis of malignant neoplasm (International Classification of Diseases for Oncology [ICD-O] behavior code of "3") in first and continuous remission at the time of enrollment
• Curative cancer treatment must have included chemotherapy (including cellular therapy) and/or radiation (including radioactive iodine)
• Note: Childrens Oncology Group (COG) therapeutic trial participation is not required
• All cancer treatment must have been completed within 3-36 calendar months prior to enrollment
• Patients must have a life expectancy of > 1 year
• Self-report of < 420 minutes of moderate-to-vigorous physical activity per week as assessed via the study-specific Physical Activity Worksheet
• Note: See COG Study Web Page for the Godin-Shephard Leisure Time Physical Activity Questionnaire or link to online calculator
• Ambulatory and no known medical contraindications to increasing physical activity
• Note: Patients with amputation, rotationplasty, or other prothesis are not automatically excluded as long as they are ambulatory and have no known medical contraindications to increasing physical activity and all other eligibility criteria are satisfied
• No known significant physical or cognitive impairment that would prevent use of the electronic devices used for the protocol intervention (e.g. Fitbit, smartphone, tablet, or computer)
• Able to read and write English
• Note: For patients < 18 years, consenting parent/legal guardian does not have to be able to read and write English
• All patients and/or their parents or legal guardians must sign a written informed consent
• Note: Informed consent may be obtained electronically/online if allowed by local site policy and Institutional Review Board (IRB)/Research Ethics Board (REB) of record
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
• Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded
• Note: Pregnancy status can be established by clinical history with patient. Post-menarchal female patients are eligible as long as they agree to use an effective contraceptive method (including abstinence) during study participation
• Patients with previous hematopoietic stem cell transplant (HSCT) are excluded
• Note: Patients with previous autologous HSCT, chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate as long as all other eligibility criteria are satisfied
MT2013-06C : Treatment of graft Failure after HSCT
• Patients with primary or secondary graft failure, as defined below, may receive a second transplant:
• Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42 following the first transplant.
• Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10^9/L without recovery.
• Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.
• Recipients should have acceptable organ function defined as:
• Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
• Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal
• Cardiac: left ventricular ejection fraction > 40%
• Uncontrolled infection at the time of transplant.
• Patients with Fanconi Anemia or other DNA breakage syndromes.
Early identification of right ventricular dysfunction and failure in cardiothoracic and liver surgical patients
This is prospective, non-interventional, observational study. The main purpose of this study is to develop an algorithm for the early detection of RV dysfunction/failure. The algorithm will be based on the RV pressure waveform gradients (the difference between early right ventricular diastolic pressure and end right ventricular diastolic pressure), RV end-diastolic pressure, and RV contractility (dpdt) and validated through associated clinical measures including perioperative mean arterial blood pressure, advanced hemodynamic measures like cardiac output, stroke volume and systemic vascular resistance, perioperative cerebral oximetry (a measure of cerebral perfusion), intraoperative transesophageal echocardiography and clinical outcomes. These associations will be used to train multiple mathematical models to discriminate between patients with and without RV dysfunction/failure as a primary endpoint. Examining the association between the slope of the diastolic right ventricular waveform (RV end-diastolic pressure, and RV contractility) and perioperative hemodynamics, TEE, cerebral saturation and clinical outcomes will allow us to estimate the specificity and sensitivity of our model.
MT2013-34C: Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia: Standard of Care Considerations
• Aged 0 - 70 years
• Acceptable hematopoeitic stem cell donor
• Dyskeratosis Congenita (DC) with evidence of BM failure defined as:
• requirement for red blood cell and/or platelet transfusions or
• requirement for G-CSF or GM-CSF or erythropoietin or
• refractory cytopenias having one of the following three
• platelets <50,000/uL or transfusion dependent
• absolute neutrophil count <500/uL without hematopoietic growth factor support
• hemoglobin <9g/uL or transfusion dependent
• Diagnosis of DC with a triad of mucocutaneous features:
• oral leukoplakia
• nail dystrophy
• abnormal reticular skin hyperpigmentation, or
• Diagnosis of DC with one of the following:
• short telomeres (under a research study)
• mutation in telomerase holoenzyme (DKC1, TERT, TERC, NOP10, NHP2, TCAB1)
• mutation in shelterin complex (TINF2)
• mutation in telomere-capping complex (CTC1)
• Severe Aplastic Anemia (SAA) primary transplant with evidence of BM failure:
• Refractory cytopenia defined by bone marrow cellularity <50% (with < 30% residual hematopoietic cells)
• Diagnosis of SAA with refractory cytopenias having one of the following three:
• platelets <20,000/uL or transfusion dependent
• absolute neutrophil count <500/uL without hematopoietic growth factor support
• absolute reticulocyte count <20,000/uL
• Severe Aplastic Anemia (SAA) requiring a 2nd transplant
• Graft failure as defined by blood/marrow chimerism of < 5%
• Early myelodysplastic features
• With or without clonal cytogenetic abnormalities
• Adequate organ function defined as:
• cardiac: left ventricular ejection fraction ≥ 35% with no evidence of decompensated heart failure
• pulmonary: DLCO ≥30% predicted, no supplemental oxygen requirement
• renal: Glomerular filtration rate (GFR) ≥30% predicted
• Voluntary written consent
• Acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
• Pregnant or lactating
• Uncontrolled infection
• Prior radiation therapy (applies to SAA patients only)
• Diagnosis of Fanconi anemia based on DEB
• Diagnosis of dyskeratosis congenita with advanced MDS or acute myeloid leukemia with >30% blasts
A Randomized Trial of Intra-Portal Alone Versus Intra- and Extra- Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis (iSite)
One treatment for certain types of chronic pancreatitis is total pancreatectomy with islet autotransplantation (TPIAT). In this procedure, the pancreas is removed (eliminating the source of the pain) and the islets, which produce insulin and other important hormones, are taken from the pancreas and transplanted in to the liver. This is a small study to evaluate a new procedure for transplanting some islets to a new location in the body.
• Age 18-68
• Scheduled for total pancreatectomy and IAT at U of MN. All patients who are approved for pancreatectomy and IAT at U of MN are reviewed by a multi-disciplinary committee including surgeons, gastroenterologists specializing in pancreatic disease, a pain specialist psychologist, and endocrinologist to confirm the diagnosis of chronic pancreatitis and candidate suitability for surgery.
• Able to provide informed consent
• Pre-Existing diabetes mellitus fasting blood glucose>115mg/dl, or hemoglobin A1c level >6.0% because these are all evidence of inadequate beta-cello mass.
• Use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, or amylin.
• ALT or AST>2.5 times the upper limit of normal (ULN). Bilirubin>ULN, unless due to benign diagnosis such as Gilbert's.
• Any of the following hematologic abnormalities: server anemia (hemoglobin <10 g/dL), thrombocytopenia (<150/mm3), or neutropenia(<1.0 x 109/L).
• Current use or expected use of oral or injected corticosteroids, or any mediation likely to affect glucose tolerance. However, use of hydrocortisone for physiologic replacement, or use of any topical, inhaled or intranasal glucocorticoid is permitted.
• Current or expected use of any other immunosuppressive agent.
• Known coagulopathy, or need for anticoagulant therapy preoperatively (coumadin, enoxaparin), or any history of pulmonary embolism.
• For females, plans to become pregnant or unwillingness to use birth control for the study duration.
• Inability to comply with the study protocol.
• Untreated psychiatric illness that may interfere with ability to give informed consent, or other developmental delay or neurocognitive disorder that impairs with a patient's ability to consent on their own behalf.
• Any other medical condition that , in the opinion of the investigator, may interfere wit the patient's ability to successfully and safely complete the trial.
Artificial Urinary Sphincter Clinical Outcomes (AUSCO)
The study objective is to evaluate the AMS 800 Artificial Urinary Sphincter™ (AUS) in men with primary stress urinary incontinence as measured by pad weight tests. The AMS 800 Artificial Urinary Sphincter is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. Treatment success defined as ≥ 50% reduction in 24-hour pad weight test from baseline at 12 months post device activation.
• Male
• ≥ 18 years of age
• Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
• Demonstrates primary stress urinary incontinence
• Positive screening 24-hour pad weight test (≥100 grams)
• Experiences at least 3 incontinence episodes per day during baseline diary or presents with continuous incontinence
• Negative urine culture
• Willing and able to undergo surgical implantation of the AUS device
• Willing and able to comply with the follow-up requirements
• Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
• Willing and able to sign the informed consent
• Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
• Primary urgency incontinence
• Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
• Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
• Known urogenital malignancy other than previously treated prostate cancer
• Recurrent prostate cancer that is expected to require intervention during the study follow-up period
• History of recurrent bladder stones within the past 12 months prior to signing the informed consent
• Neurogenic bladder
• Need for intermittent catheterization
• Known history of bleeding diathesis or coagulopathy
• Immunosuppressed or on medical therapy which would impact the immune system
• Uncontrolled diabetes, defined as (HbA1c>10)
• Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent
• Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted
• Undergone bulking procedure within 6 months of the baseline assessment
• Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
• Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract
• Irresolvable detrusor hyperreflexia or bladder instability
• Currently enrolled or plans to enroll in another device or drug clinical trial
• Currently using an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use at least 4 weeks prior to baseline assessment
• Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device)
• Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)
The role of cytomegalovirus and inflammation on patient symptoms and outcomes in ovarian cancer
The central research idea for this award is that CMV reactivation is an unrecognized complicating factor in the treatment of ovarian cancer. Based on preliminary data, our hypotheses are: a) ovarian cancer patients with elevated biomarkers of CMV report greater fatigue and poorer quality of life; b) CMV and inflammation (C-reactive protein; CRP) levels in ovarian cancer patients are higher post-chemotherapy than baseline; c) ovarian cancer patients who experience increases in CMV and/or CRP report greater fatigue and poorer quality of life; d) ovarian cancer patients who experience increases in CMV and CRP will have shorter recurrence-free and overall survival. We propose the following specific aims and studies to address these research questions: Aim 1: Determine the relationship between CMV and ovarian cancer patient-reported symptoms post-treatment. A cross-sectional study of 200 women with ovarian cancer within two years of completing first line chemotherapy will be recruited for a one-time blood draw and survey. We will assess CMV status by measuring IgG serology and CMV DNA levels in serum (indicative of active infection/reactivation) and determine their relationship with patient-reported symptoms including fatigue and quality of life. Aim 2: Characterize the changes in CMV and CRP levels following chemotherapy and their association with patient symptoms and outcomes. A prospective study of 150 women with newly diagnosed ovarian cancer will evaluate the association between serum CMV IgG, CRP IgG, and CMV DNA levels and patient-reported symptoms, recurrence-free and overall survival. Planned blood samples include before, after and 6 months post-chemotherapy completion with planned surveys and clinical follow-up at least every six months for five years.
• Age ≥18
• Ability to read and write in English
• women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer
• Treatment plan includes chemotherapy
• Able to provide written voluntary consent before performance of any study related procedure.
• Cohort 1 only: within 2 years of completing initial chemotherapy treatment
• Cohort 2 only: prior to starting chemotherapy
• Inability to provide informed written consent
• Previous exposure to chemotherapy
• Life expectancy < 3 months or in hospice care or nursing home
HPS-4/TIMI 65/ORION-4: A Double-blind Randomized Placebo-controlled Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Atherosclerotic Cardiovascular Disease
The HPS-4/TIMI 65/ORION-4 study aims to provide evidence about both the efficacy and safety of inclisiran. It is intended to be conducted at approximately 150 clinical sites in Europe (primarily in the UK) and North America. Approximately 15,000 participants aged 55 years or older with pre-existing atherosclerotic cardiovascular disease will be randomized between inclisiran sodium 300 mg and matching placebo (given by subcutaneous injection on the day of randomization, at 3 months and then every 6-months) in a 1:1 ratio for a planned median duration of about 5 years. Consistent with relevant guideline recommendations for people with vascular disease, it is intended that participants be on intensive background LDL-lowering therapy (for example, atorvastatin 40 or 80 mg daily, simvastatin 40 or 80 mg daily, or rosuvastatin 20 or 40 mg daily) at screening. In order to achieve a target LDL cholesterol reduction of at least 1.2 mmol/l [45 mg/dL], it is intended to recruit a study population with a mean LDL cholesterol of at least 2.6 mmol/l [100mg/dL] at baseline.
CHEC-OB-17: CHaractErizing CFTR Modulated Changes in Sweat Chloride and their Association with Clinical Outcomes
Cystic fibrosis (CF) is caused by gene mutations leading to absence or dysfunction of the cystic fibrosis transmembrane conductance regulator (CFTR) protein which functions as a chloride channel in epithelial cells lining the respiratory tract, gastrointestinal system and sweat glands. Over the past several years, CFTR modulators (small molecule therapies that improve activity of the CFTR protein) have been shown in large clinical trials to improve clinical outcomes in people with CF resulting in the FDA approval of the modulators ivacaftor and lumacaftor/ivacaftor. In clinical trials, SC measurements emerged as an important marker of CFTR activity. The CHEC-SC study is looking at SC levels in people with CF who are currently being treated with CFTR modulator therapies. This study is being done to answer the following questions: • Why do different CF patients have larger or smaller reductions in sweat chloride after treatment with CFTR modulator therapy? • Does the sweat chloride value achieved after treatment with CFTR modulator therapy impact long-term health outcomes in people with CF?
Effect of sensory perturbations on motor control
A general objective of this research is to improve our understanding of the effect of sensory feedback on movement, and to determine how cortical lateralization affects motor behavior in neurologically intact individuals. We will determine differences in motor control in the left and right hands under visual perturbations, in terms of muscle activity and several kinematic measures. “Visual perturbations”, in the context of this study, refer to an unexpected change in the visual field.