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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.
Sayeed Ikramuddin
Male or Female
18 Years and over
N/A
STUDY00014879
STUDY00014879
Inclusion Criteria:
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.
Exclusion Criteria:
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 Behavioral: Lifestyle Modification Counseling, Procedure: Vertical Sleeve Gastrectomy
Digestive & Liver Health
Bariatric Surgery, NASH, VSG, Clinics and Surgery Center (CSC)
A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment
This is a minimal risk, prospective, non-randomized, open label, multi-center study designed to assess the performance of the PrevisEA device in the prediction of GII. MH4 levels recorded by the device at 12 hours after placement of the device will provide a prediction of no GII development or GII development within 10 days after the procedure and is based on a previously optimized and validated MH4 cutoff level. PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel obstruction. GII is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. For subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later. The device is considered non-significant risk (NSR). The device does not inform medical decisions in this study. Researchers will be blinded to results of the device during this study.
Wolfgang Gaertner, MD
Male or Female
18 Years and over
N/A
STUDY00012967
STUDY00012967
Inclusion Criteria:
Age ≥ 18 and ≤ 90 years
Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:
Segmental ileocolic resection with or without diversion
Segmental colon resection with or without diversion
Segmental coloproctectomy with or without diversion
Low anterior resection with or without diversion
Abdominoperineal resection
Total abdominal colectomy with or without diversion
Proctocolectomy with or without end ileostomy or diversion
Closure of end colostomy (Hartmann's reversal)
Exclusion Criteria:
Allergies to any of the device components (i.e., adhesive)
Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.)
Patients undergoing:
Small bowel resection without colonic resection
Transanal proctectomy without transabdominal approach
Perineal proctosigmoidectomy
Closure of loop colostomy or ileostomy
Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection Device: PrevisEA device
Digestive & Liver Health
Clinics and Surgery Center (CSC)
Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma: Big Ten Cancer Research Consortium BTCRC-HN17-111
We are looking at the effectiveness of adding an immunotherapy drug, pembrolizumab, to usual treatment for people who have salivary gland cancer that can’t be treated with surgery or radiation. The cancer must be androgen receptor positive.
Manish Patel
All
18 Years to old
Phase 2
STUDY00004710
STUDY00004710
Inclusion Criteria:
Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
Locally advanced, recurrent, or metastatic salivary gland carcinoma that is not amenable to curative surgery or radiation
ECOG Performance Status of 0 or 1 within 28 days prior to registration.
Local, pathologic testing of androgen receptor-positive salivary gland carcinoma will be performed as standard of care. Archival tissue must be available for central confirmation of androgen receptor-positive disease and for correlative studies. AR positivity will be defined according to IHC staining of tumor tissue with at least 20% of tumor staining positive with moderate intensity (1+ or greater).
Measurable disease according to RECIST v1.1 for solid tumors within 28 days prior to registration.
For patients who have been treated with prior therapy, patients must have documented progression of disease on their prior therapy for entry into the study.
Patients with prior chemotherapy, radiation, or surgery as part of curative intent therapy are allowed. Any number of prior lines of systemic therapy is permitted for entry into this study so long as prior therapy did not include anti-androgen therapy or immune checkpoint blockade.
If prior cancer treatment, the subject must have recovered from toxic effects of prior cancer treatment (other than alopecia) to ≤ Grade 1.
Adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
Absolute neutrophil count (ANC) ≥1500/µL
Platelets ≥100,000/µL
Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
Creatinine (Cr) OR Measured or calculated creatinine clearance (GFR can also be used in place of Cr or creatinine clearance) ≤1.5 × ULN OR
≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) o International normalized ratio (INR) OR prothrombin time (PT) & aPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
A male participant must agree to use contraception during the treatment period and for at least 8 months after the last dose of study treatment and refrain from donating sperm during this period.
Females of childbearing potential must have a negative serum pregnancy test within 72 hours prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
Females of childbearing potential and males with partners of childbearing potential must be willing to abstain from heterosexual activity or to use a highly effect form of contraception from the time of informed consent until 8 months after treatment discontinuation.
As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
Exclusion Criteria:
Women of childbearing age with a positive serum pregnancy test within 72 hours prior to study registration.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
Has received prior androgen deprivation therapy including orchiectomy, gonadotropin-releasing hormone (GnRH) agonists/antagonists, androgen receptor blocker, abiraterone, or enzalutamide.
Has received prior systemic anti-cancer therapy including investigational agents within 14 days prior to registration.
Has had an allogenic tissue or solid organ transplant.
Has received prior palliative radiotherapy within 7 days of start of study treatment. Participants must have recovered from all radiation-related toxicities and require less than 10mg of prednisone (or equivalent corticosteroid) daily.
Has received a live vaccine or live-attenuated vaccine within 28 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast ductal carcinoma in situ, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 14 days by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
Has ≥Grade 3 hypersensitivity to pembrolizumab and/or any of its excipients.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy.
Has a known history of Human Immunodeficiency Virus (HIV).
Has a known history of active TB (Bacillus Tuberculosis).
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. Drug: Goserelin Acetate, Drug: Pembrolizumab
Salivary Gland Carcinoma
Clinics and Surgery Center (CSC)
COG ACNS1833 - A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
The overall goal of this phase 3 non-inferiority study is to assess if selumetinib works as well as the standard treatment using carboplatin and vincristine (called CV) for subjects with low-grade glioma (LGG).
Christopher Moertel, MD
All
2 Years to 21 Years old
Phase 3
STUDY00009277
STUDY00009277
Inclusion Criteria:
Patients must be >= 2 years and =< 21 years at the time of enrollment
Patients must have a body surface area (BSA) of >= 0.5 m^2 at enrollment
Patients must have non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1 (NCT02402244) and that has not been treated with any modality besides surgery. Note: Patients may be newly-diagnosed OR previously diagnosed, and there is no required time frame between biopsy/surgery and treatment initiation.
Patients with residual tumor after resection or progressive tumor after initial diagnosis (with or without surgery) who have not received treatment (chemotherapy and/or radiation) are eligible
Patients must have two-dimensional measurable tumor >= 1 cm^2 to be eligible
Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma
Patients with metastatic disease or multiple independent primary LGG are eligible
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows (performed within 7 days prior to enrollment):
Age: Maximum Serum Creatinine (mg/dL)
2 to < 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female)
6 to < 10 years: 1 mg/dL (male); 1 mg/dL (female)
10 to < 13 years: 1.2 mg/dL (male); 1.2 mg/dL (female)
13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
>= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL)
Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (performed within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L
Albumin >= 2 g/dL (performed within 7 days prior to enrollment)
Left ventricular ejection fraction (LVEF) >= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (performed within 4 weeks prior to enrollment)
Corrected QT (QTc) interval =< 450 msec by electrocardiography (EKG) (performed within 4 weeks prior to enrollment)
Absolute neutrophil count >= 1,000/uL (unsupported) (performed within 7 days prior to enrollment)
Platelets >= 100,000/uL (unsupported) (performed within 7 days prior to enrollment)
Hemoglobin >= 8 g/dL (may be supported) (performed within 7 days prior to enrollment)
Patients with a known seizure disorder should be stable and should not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment
Patients 2-17 years of age must have a blood pressure that is =< 95th percentile for age, height, and gender at the time of enrollment (with or without the use of anti-hypertensive medications)
Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications)
Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension
All patients must have ophthalmology toxicity assessments performed within 4 weeks prior to enrollment
For all patients, a magnetic resonance imaging (MRI) of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 4 weeks prior to enrollment
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
Patients must have the ability to swallow whole capsules
All patients have signed an appropriate consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form (if applicable)
All patients and/or their parents or legal guardians must sign a written informed consent
All patients have been consented and enrolled on APEC14B1 (NCT02402244) followed by enrollment on the ACNS1833 Pre-Enrollment Eligibility Screening (Step 0) on the same day to complete the Rapid Central Review
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted
Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible
Patients with diffuse intrinsic pontine tumors as seen on MRI (> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals grade I/II histology
Patients may not be receiving any other investigational agents
Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment
Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible
Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
Lactating females who plan to breastfeed their infants are not eligible
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 12 weeks after stopping study therapy are not eligible.
Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo
Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented
Symptomatic heart failure
New York Health Association (NYHA) class II-IV prior or current cardiomyopathy
Severe valvular heart disease
History of atrial fibrillation
Current or past history of central serous retinopathy
Current or past history of retinal vein occlusion or retinal detachment
Patients with uncontrolled glaucoma
If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or ULN adjusted by age are not eligible
Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E
Surgery within 2 weeks prior to enrollment, with the exception of surgical biopsy, placement of a vascular access device or cerebral spinal fluid (CSF) diverting procedure such as endoscopic third ventriculostomy (ETV) and ventriculoperitoneal (VP) shunt.
Note: Patients must have healed from any prior surgery
Patients who have an uncontrolled infection are not eligible Procedure: Biospecimen Collection, Drug: Carboplatin, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Selumetinib Sulfate, Drug: Vincristine Sulfate
Low Grade Astrocytoma, Low Grade Glioma, Metastatic Low Grade Astrocytoma, Metastatic Low Grade Glioma
MT2020-21: A PHASE 1,OPEN-LABEL,DOSE ESCALATING STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND CLINICAL ACTIVITY OF THE COMBINATION OF CLBR001, AN ENGINEERED AUTOLOGOUS T-CELL PRODUCT, AND SWI019,AN ANTIBODY-BASED BIOLOGIC, IN PATIENTS WITH RELAPSED/REFRACTORY B-CELL MALIGNANCIES
This study is designed to assess the safety and tolerability of the combination of CLBR001 and SWI019 in patients with B cell malignancies who are refractory or unresponsive to salvage therapy or who cannot be considered for or have progressed after autologous hematopoietic cell transplantation.
Joseph Maakaron
All
18 Years and over
Phase 1
STUDY00011917
STUDY00011917
Inclusion Criteria:
Patients with relapsed / refractory previously treated B cell malignancies (according to the World Health Organization classification; 2017)
Patients must have received adequate prior therapy including at least two lines of prior therapies including anthracycline or bendamustine-containing chemotherapy, anti-CD20 (cluster of differentiation antigen 20) therapies and/or Brutton's tyrosine kinase (BTK) inhibitors
Patients treated with prior CD19 targeted molecules (e.g., Blincyto) must have confirmed CD19+ disease
Patients must be ineligible for allogeneic stem cell transplant (SCT)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Estimated life expectancy of ≥ 12 weeks from the first day of SWI019 dose administered
Willing to undergo pre- and post-treatment core needle biopsy
Adequate hematological, renal, pulmonary, cardiac, and liver function
Resolved adverse events of any prior therapy to either baseline or CTCAE Grade ≤1
Women of childbearing potential, a negative pregnancy test and must agree to practice effective birth control
Men sexually active with female partners of child bearing potential must agree to practice effective contraception
Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures
Exclusion Criteria:
Patients diagnosed with certain disease histologies including pediatric lymphomas/leukemias, monoclonal gammopathy of undetermined significance (MGUS), T-cell histiocyte large B cell lymphoma
Pregnant or lactating women
Active bacterial, viral, and fungal infections
History of allogeneic stem cell transplantation
Treatment with any prior lentiviral or retroviral based CAR-T
Patients receiving live (attenuated) vaccines within 4 weeks of screening visit or need for live vaccine on study
Patients with known active central nervous system (CNS) disease. Patients with prior CNS disease that has been effectively treated may be eligible
History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction, unstable angina or other significant cardiac disease within 6 months of screening
Involvement of cardiac tissue by lymphoma
Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP)
HIV-1 and HIV-2 antibody positive patients Combination Product: CLBR001 and SWI019
Cancer
Clinics and Surgery Center (CSC)
A dimensional approach to perinatal mania and psychosis (BUMPP)
The overall goal of the BUMPP study is to improve our understanding of a range of moods, feelings, and thoughts that women can experience during pregnancy and soon after they give birth. This study will examine how these moods, feelings, and thoughts are related to changes in hormonal and immune health that women experience during and after pregnancy, and to mother-baby relationships and infant development in the early postpartum months.
Megan Gunnar
Female
18 Years and over
STUDY00013892
STUDY00013892
Inclusion Criteria:
• 18 years or older
• 35 weeks pregnant or less carrying only one baby (not twins or triplets)
• first time giving birth
• can speak, read & write English
Exclusion Criteria:
• any major medical health condition like a heart, kidney, or liver disease or HIV
• currently taking corticosteroids, progesterone, or immunosuppressive medications that might impact the samples we are taking in this study
• regularly using alcohol, tobacco, or recreational drugs (such as marijuana or prescription drugs for non-medical reasons) during pregnancy (regularly means more than a few times total, such as on a monthly, weekly, or daily basis)
Other: Observation Group
Women's Health
Pregnancy
INHALE-1: A 26-week Primary Treatment Phase, with 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza? Versus Rapid-acting Insulin Analog Injections, Both in Combination with a Basal Insulin, in Pediatric Subjects with Type 1 or Type 2 Diabetes Mellitus (INHALE-1)
To assess the safety of Afrezza in a pediatric population when compared to the usual standard of care insulin.
Muna Sunni
Male or Female
up to 18 Years old
Phase 3
STUDY00016428
STUDY00016428
Inclusion Criteria:
Assent from the pediatric subject, as appropriate, and fully informed consent from the parent(s) or legal guardian, as required by both state and federal laws and the local Institutional Review Board (IRB)
Subjects ≥4 and <18 years of age
Clinical diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) per the Investigator and have been using insulin for at least 6 months for T1DM, or at least 3 months for T2DM
Treatment with basal-bolus insulin therapy delivered by multiple daily injections for at least 2 weeks
Bolus insulins are restricted to the RAAs insulin lispro, insulin aspart or insulin glulisine, including biosimilar products
Basal insulins are restricted to insulin glargine, insulin degludec or insulin detemir, including biosimilar products
Access to stable WiFi connection
HbA1c ≥7.0% and ≤11%
Average prandial dose of insulin ≥2 units per meal
Utilized CGM for ≥70% of the time over a consecutive 14-day period preceding randomization
Exclusion Criteria:
History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements
Recent history of asthma (defined as using any medications to treat within the last year), any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease
History of serious complications of diabetes (e.g., active proliferative retinopathy or symptomatic autonomic neuropathy), or likely need for specific treatment for diabetic retinopathy (laser photocoagulation, vitrectomy, other) in the next year
FEV1 and FEV1/forced vital capacity (FVC) ≤80% of predicted Global Lung Function Initiative (GLI) value
Inability to achieve an acceptable FEV1 and FVC reading for subjects ≥8 years of age would make the subject ineligible
For subjects <8 years of age who are unable to achieve an acceptable FVC reading, FEV1 only may be assessed; inability to achieve an acceptable FEV1 would make the subject ineligible
Respiratory tract infection within 14 days before screening (subject may return 14 days after resolution of symptoms for rescreening)
Inability or unwillingness to perform study procedures
Exposure to any investigational product(s), including drugs or devices, in the past 30 days
Any disease other than diabetes or exposure to any medication that, in the judgment of the Investigator, may impact glucose metabolism and current or anticipated acute uses of glucocorticoids or weight loss medications, with the exception of metformin and/or GLP-1 agonists (if GLP-1 agonists used for at least the 3 months prior to enrollment) in subjects with T2DM
Use of antiadrenergic drugs (e.g., clonidine)
Any concurrent illness (other than diabetes mellitus) not controlled by a stable therapeutic regimen
Current uncontrolled eating disorder (e.g., anorexia or bulimia nervosa)
Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the Investigator or the Sponsor, would make the subject an unsuitable candidate for participation in the study
Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) for the preceding 6 months and/or positive urine cotinine test
Female subject who is pregnant, breast-feeding, intends to become pregnant, or is of child-bearing potential, sexually active and not using adequate contraceptive methods as required by local regulation or practice
An event of severe hypoglycemia, as judged by the Investigator, within the last 90 days prior to screening
An episode of DKA requiring hospitalization within the last 90 days prior to screening Biological: Afrezza, Biological: Basal Insulin, Biological: Rapid-acting Insulin Analog
Diabetes & Endocrine
diabetes, insulin, type 1 diabetes, type 2 diabetes
Assessment of bimodal stimulation device compliance and satisfaction in individuals with tinnitus
Tinnitus or 'ringing in the ears' is a neurological condition affecting brain signals. Around 10-15% of the global population is affected by tinnitus. Many of those living with tinnitus report feeling distressed bytheir symptoms and a negative effect on their quality of life. Unfortunately, there are fewreliable treatment options for people with tinnitus. This study expands on research that found a noninvasive therapy combining audio and tongue stimulation to reduce the severity of tinnitus symptoms. The development of a treatment for tinnitus would meet an unmet need and advance care for military personnel, Veterans and the public. This study involves the use of an investigational device, which means that it has not been approved yet by the FDA for reducing tinnitus symptoms. The device we will use in this study is approved for use in Europe. In Europe, it is fitted in a clinical setting, and patient’s pure-tone audiometric thresholds (hearing ability) need to be obtained by a hearing specialist. Those audiometric hearing thresholds are then used to set up the sound stimuli to a comfortable audible level above the patient's hearing threshold. Adjustments to the device are also completed in a clinical setting. For this pilot study, the researchers want to assess if they can streamline the process of using the device by allowing patients to adjust their own sound stimuli levels within a safe range. This study will also have virtual follow-up assessments, reducing the burden for in person visits that are currently used for the approved device use. We want to know if patients will follow instructions reliably in regards to the use of the device and adjustments, and also if they remain satisfied when the in person clinical burdens are removed.
Meredith Adams
Male or Female
18 Years and over
STUDY00015524
STUDY00015524
Inclusion Criteria:
• 18 years and over at time of consent
• Ability to read and understand English
• Willing and able to provide and understand informed consent
• Willing to commit to the full duration of the investigation
• Subjective tinnitus
• Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent
• Baseline THI score from 38 to 76
• Hearing loss condition
• Low hearing loss group (minimum n=4)
• High hearing loss group (minimum n=4)
• Access to reliable internet connection and device to complete virtual video visits and electronic surveys
Exclusion Criteria:
• Subjective tinnitus, where pulsatility is the dominant feature
• Objective tinnitus
• Middle ear pathology in either ear including documented/known conductive hearing loss >= 20 dB at three adjacent frequencies or if a diagnosis of a tympanic membrane perforation or other middle ear pathology has been rendered, if there is an indwelling pressure equalization tube by patient report, or if middle ear surgery has been performed.
• Began wearing hearing aids within the past 3 months
• Hearing loss greater than 90 dB HL in the set 250, 500, 1k Hz
• Health care provider has rendered a diagnosis of Meniere?s disease or other disorder with fluctuating hearing loss
• A diagnosis of hyperacusis, misophonia or hypersensitivity to loud noises has been rendered
• History of auditory hallucinations
• Tumor on the hearing or balance nervous systems
• Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
• Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments.
• Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments.
• Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments.
• Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)
• Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)
• Participant with a pacemaker or other electro-active implanted device
• Participant previously diagnosed with psychosis or schizophrenia
• Participants diagnosed with Burning Mouth Syndrome
• A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
• Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus
• Inability to physically or comprehensively use the device
• Oral piercings that cannot or will not be removed
• Current or previous involvement in medico-legal cases
• Pregnancy per patient report
• Prisoner
• PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.
Ear, Nose & Throat
audiology, bimodal stimulation, ear, hearing, lenire, tinnitus, neuromod
SKOAP: A Sequenced-Strategy for Improving Outcomes in people with knee OsteoArthritis Pain (SKOAP)
There is an urgent public health need to reduce our reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare recommended treatments to reduce pain and functional limitations in KOA and identify clinical and patient-level factors associated with treatment response. These results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-opioid alternatives.
Clarence Shannon
All
18 Years to old
Phase 3
STUDY00010620
STUDY00010620
Inclusion Criteria:
Meets American College of Rheumatology Classification criteria for knee osteoarthritis
Exclusion Criteria:
Any inability to complete study procedures, including, but not limited to inadequate resources to mitigate low English language literacy
Unstable medical condition that presents as an absolute or relative contraindication for participation (e.g., unstable angina, poorly controlled diabetes mellitus, end stage renal failure, automated implantable cardioverter-defibrillator that cannot be disabled before RFA).
Severe untreated bleeding disorder (anticoagulants may be continued during phase II treatments in most patients)
Severe vision or hearing impairment or serious cognitive impairment that could interfere with consent or outcome assessment
Poorly controlled serious psychiatric condition
Active substance abuse
Scheduled joint replacement on the affected knee
History of unilateral total knee arthroplasty (TKA) with complaints of KOA pain limited to the operated knee
Ulcers or an open wound in the region of the index knee Other: Best Practices, Drug: Duloxetine, Combination Product: Intra-Articular Injection, Procedure: Nerve Procedure with long acting blocks, Procedure: Nerve Procedure with nerve ablation, Behavioral: Pain Coping Skills Training
Knee Osteoarthrosis
A Parallel-group, Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas (POPLAR-NF2)
This study will investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutations. This study is a parallel-group, two-staged, Phase 2/3, randomized, multi-center study with two cohorts: Cohort A followed by Cohort B. The purpose of Cohort A is to provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas, and provide guidance for the correct dose, population, sample size, and endpoint for the confirmatory part of the study (Cohort B). Additional goals for Cohort A are to assess effects of food on drug absorption. The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas.
Christopher Moertel, MD
All
12 Years to old
Phase 2/Phase 3
STUDY00015488
STUDY00015488
Inclusion Criteria:
≥12 years of age and weighing at least 40 kg
Progressive meningioma that is amenable to volumetric analysis
Has either 1) sporadic meningioma with confirmed NF2 mutation; or, 2) confirmed diagnosis of NF2 disease (revised Manchester criteria); or, 3) at least one NF2-related tumor (with pathogenic germline or proven mosaic NF2 variant)
Adequate bone marrow function
Has provided written informed consent/assent to participate in the study
Exclusion Criteria:
Progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months.
Received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 6 months prior to screening.
Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening.
History of an active malignancy within the previous 3 years except for localized cancers that are considered cured, and, in the opinion of the investigator, present a low risk of recurrence.
Received another investigational drug within 30 days prior to screening
Pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dose of IMP. Drug: Placebo, Drug: REC-2282
Neurofibromatosis Type 2
Neurofibromatosis Type 2, Neurofibromatosis Type II
Bupropion for the Prevention of Postpartum Smoking Relapse
Sharon Allen, PhD
Female
18 Years to 40 Years old
Phase 4
STUDY00007684
STUDY00007684
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
Telehealth Patient Monitoring Tool for Airway Stenosis
The purpose of this study is to implement personalized medical services via a telehealth monitoring home system for a pilot cohort of patients with airway stenosis.
Raluca Gray
Male or Female
18 Years and over
STUDY00016867
STUDY00016867
Inclusion Criteria:
• At least 18 years old
• Diagnosis of airway stenosis
• Subglottic stenosis
• Post-operative subglottic stenosis
• Tracheal stenosis
• Tracheal stenosis after procedure
• History of tracheal stenosis
• Able to read and speak English proficiently
Exclusion Criteria:
• People who have more than one level airway stenosis (supraglottic stenosis, glottic stenosis, bronchial stenosis, tracheobronchomalacia)
• Dependent on a Tracheotomy
• People who have additional Pulmonary diseases such as COPD and asthma
• People who have Neurological diseases that affect breathing
Breathing, Lung & Sleep Health, Ear, Nose & Throat
Airway Stenosis, Subglottic stenosis, Post-operative subglottic stenosis, Tracheal stenosis, larynx, Clinics and Surgery Center (CSC)
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.
Emily Greengard
All
to 50 Years old
Phase 3
STUDY00016802
STUDY00016802
Inclusion Criteria:
Patients must be < 50 years at the time of enrollment.
Patients must have =< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being >= 3 mm and all of which must be =< 3 cm size.
Note: Patient must have eligibility confirmed by rapid central imaging review.
Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
Patients must have a histological diagnosis of osteosarcoma.
Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
Newly diagnosed patients must be receiving systemic therapy considered by the treating physician as at least equivalent to methotrexate, doxorubicin and cisplatin (MAP) at the time of enrollment on this study.
Patients at time of 1st recurrence must have previously completed initial systemic therapy for their primary tumor, considered by the treating physician as at least equivalent to MAP.
Exclusion Criteria:
Patients with unresectable primary tumor.
Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
Patients with pleural or mediastinal based metastatic lesions, or with pleural effusion.
Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
Patients with evidence of extrapulmonary metastatic disease.
Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
All patients and/or their parents or legal guardians must sign a written informed consent.
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met. Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Questionnaire Administration, Procedure: Thoracoscopy, Procedure: Thoracotomy
Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
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.
Irina Stepanov
Male or Female
18 Years and over
Phase 1
STUDY00002033
STUDY00002033
Inclusion Criteria:
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).
Exclusion Criteria:
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. Drug: Nicotine Mini-Lozenge, Drug: Standardized Research E-cigarette (SREC)
Prevention & Wellness
Neoadjuvant therapy for patients with high risk stage III melanoma: a pilot clinical trial (NeoACTIVATE)
To estimate the percentage of patients with stage III BRAFm melanoma that achieves a pathologic complete response after 12 weeks of neoadjuvant vemurafenib/cobimetinib/atezolizumab. To estimate the percentage of patients with stage III BRAFwt melanoma that achieves a pathologic complete response after 12 weeks of neoadjuvant cobimetinib/atezolizumab. Adjuvant phase primary objectives: To assess recurrence-free survival (RFS) in patients with stage III BRAFm melanoma after neoadjuvant vemurafenib/cobimetinib/atezolizumab, surgery, and adjuvant atezolizumab. To assess RFS in patients with stage III BRAFwt melanoma after neoadjuvant cobimetinib/atezolizumab, surgery, and adjuvant atezolizumab.
Evidio Domingo Musibay
All
18 Years to old
Phase 2
STUDY00004666
STUDY00004666
Inclusion Criteria:
PRE-REGISTRATION: Age >= 18 years
PRE-REGISTRATION: High-risk stage III melanoma, defined as (any of the following):
Recurrent nodal metastasis, or
Clinically detectable nodal metastasis, or
Metastatic involvement of more than one nodal basin
NOTE: For the purpose of pre-registration, high-risk stage III melanoma is defined based on clinical and imaging assessment (positron emission tomography/computed tomography [PET/CT], CT, or magnetic resonance imaging [MRI]). Histologic confirmation of nodal metastatic disease is not needed at the time of pre-registration, provided there is histologic confirmation of primary melanoma or a prior lymph node metastasis.
PRE-REGISTRATION: Willing to submit archival tissue from a lymph node biopsy or undergo a needle biopsy (with clip placement) for BRAF testing and for research purposes.
PRE-REGISTRATION: Willing to forego anticancer treatments or investigational agents during pre-registration period.
PRE-REGISTRATION: The following laboratory values obtained =< 28 days prior to pre-registration:
Only for patients receiving therapeutic anticoagulation: stable anticoagulant regimen and stable international normalized ratio (INR).
REGISTRATION: Histologic confirmation of stage III melanoma, as defined by the American Joint Committee on Cancer, 8th revised edition.
REGISTRATION: Arms A and B only: Documentation of BRAFV600 mutation status in melanoma tumor tissue (archival or newly obtained) through use of a Clinical Laboratory Improvement Amendments (CLIA)-approved clinical mutation test.
REGISTRATION: Surgically resectable disease, as determined by a melanoma surgical oncologist.
REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
REGISTRATION: Life expectancy >= 26 weeks.
REGISTRATION: Absolute neutrophil count (ANC) >= 1500/mm^3 obtained =< 14 days prior to registration.
REGISTRATION: Platelet count >= 100,000/mm^3 obtained =< 14 days prior to registration.
REGISTRATION: Hemoglobin >= 9.0 g/dL obtained =< 14 days prior to registration.
REGISTRATION: Direct bilirubin =< institutional upper limit of normal (ULN) obtained =< 14 days prior to registration.
REGISTRATION: Aspartate transaminase (AST) and alanine transaminase (ALT) =< 2 x ULN obtained =< 14 days prior to registration.
REGISTRATION: Alkaline phosphatase < 2.5 x ULN obtained =< 14 days prior to registration.
REGISTRATION: Creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 45 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockcroft-Gault glomerular filtration rate estimation obtained =< 14 days prior to registration.
REGISTRATION: Arms A and B only: Left ventricular ejection fraction (LVEF) >= 50% or institutional lower limit of normal (LLN) =< 6 months prior to registration.
REGISTRATION: Arms A and B only: Average corrected QT interval (QTc) =< 450 ms on triplicate 12 lead electrocardiography (ECG) =< 28 days prior to registration.
NOTE: QTc intervals will be corrected using Fridericia's formula.
REGISTRATION: Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only.
REGISTRATION: For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of study treatment.
REGISTRATION: For persons able to father a child: agreement to remain abstinent (refrain from heterosexual intercourse with a person of childbearing potential) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 6 months after the last dose of study treatment.
REGISTRATION: Provide written informed consent.
REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
REGISTRATION: Willing to provide tissue, blood, and stool samples for correlative research purposes.
REGISTRATION: Arm C Only: Negative serology for acute Epstein-Barr virus (EBV) infection (negative EBV viral capsid antigen [VCA] immunoglobulin M [IgM]).
Exclusion Criteria:
PRE-REGISTRATION: Prior systemic anti-cancer therapy for melanoma (e.g., chemotherapy, hormonal therapy, targeted therapy, immunotherapy including anti-PD-1, anti-PDL1 agents, or other biologic therapies), with the following exceptions: adjuvant treatment with interferon, IL-2, granulocyte-macrophage colony-stimulating factor (GM-CSF) or vaccine therapies are allowed, if discontinued >= 28 days prior to pre-registration.
PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
PRE-REGISTRATION: For patients with concurrent diagnosis of primary melanoma with nodal involvement, major surgical procedure other than lymph node biopsy or wide local excision of primary melanoma =< 4 weeks prior to pre-registration, or anticipation of need for a major surgical procedure for reasons other than melanoma during the course of the study.
PRE-REGISTRATION: For patients with nodal recurrence, surgical procedure or anti-cancer therapy for this recurrence (other than lymph node biopsy) or anticipation of need for a major surgical procedure for reasons other than melanoma during the course of the study.
PRE-REGISTRATION: Prior radiotherapy for melanoma.
PRE-REGISTRATION: History of non-nodal melanoma metastasis or central nervous system (CNS) lesion(s) proven or clinically suspected to be metastasis.
PRE-REGISTRATION: Active malignancy (other than melanoma) or malignancy =< 3 years prior to pre-registration.
NOTE: Exceptions: Asymptomatic papillary thyroid cancer (not requiring treatment), resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC), resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, non-muscle-invasive bladder cancer, Stage I uterine cancer, or other curatively treated malignancies from which the patient has been disease-free for at least 3 years prior to pre registration.
PRE-REGISTRATION: Prior allogeneic stem cell or solid organ transplantation.
PRE-REGISTRATION: History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
PRE-REGISTRATION: History of autoimmune disease requiring systemic immunosuppressive or immune-modulatory therapy =< 5 years prior to pre-registration.
NOTE: Exceptions are allowed for hypothyroidism on thyroid replacement therapy; or Type 1 diabetes on insulin regimen.
PRE-REGISTRATION: Active psoriasis requiring therapy (systemic or topical).
PRE-REGISTRATION: Known clinically significant liver disease, including alcoholism, cirrhosis, fatty liver, and other inherited liver disease as well as active viral disease.
PRE-REGISTRATION: Arms A and B only: History of or evidence of retinal pathology on ophthalmologic examination including but not limited to:
Neurosensory retinal detachment
Central serous chorioretinopathy
Retinal vein occlusion (RVO)
Neovascular macular degeneration
PRE-REGISTRATION: Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
PRE-REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection (including but not limited to tuberculosis)
Clinically significant cardiac dysfunction including:
Symptomatic congestive heart failure defined as New York Heart Association class II or higher
Unstable angina pectoris or new-onset angina =< 3 months prior to pre-registration
Unstable cardiac arrhythmia
Myocardial infarction =< 3 months prior to pre-registration
Congenital long QT syndrome
Clinically significant stroke, reversible ischemic neurological defect, or transient ischemic attack =< 6 months prior to pre-registration
Any grade 3 hemorrhage or bleeding event =< 4 weeks prior to pre-registration
Uncontrolled diabetes or symptomatic hyperglycemia
Psychiatric illness/social situations that, in the judgement of the investigator, would: a) limit compliance with study requirements, or b) make the patient inappropriate for entry into this study, or c) interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
PRE-REGISTRATION: Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells (example [ex]: recombinant follicle-stimulating hormone [FSH]).
PRE-REGISTRATION: Known hypersensitivity to any components of the atezolizumab (all arms), tiragolumab (Arm C only), cobimetinib (Arms A and B only), or vemurafenib (Arms A and B only) formulations.
PRE-REGISTRATION: History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
REGISTRATION: Received anticancer treatments or investigational agents during pre-registration period.
REGISTRATION: Clinically suspected non-nodal metastatic melanoma.
REGISTRATION: Arm A only: For BRAF-mutant patients only: anticipated use of any concomitant medication =< 7 days prior to registration that is known to cause QT prolongation (which may lead to torsade de pointes).
REGISTRATION: Arms A and B only: History of malabsorption or other clinically significant metabolic dysfunction that may interfere with absorption of oral study treatment or inability or unwillingness to swallow oral medication.
REGISTRATION: Signs or symptoms of infection or has received antibiotics =< 14 days prior to registration.
NOTE: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
REGISTRATION: Any of the following because this study involves investigational agents whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
Pregnant persons
Nursing persons
Persons of childbearing potential who are unwilling to employ adequate contraception
REGISTRATION: Treatment with a live, attenuated vaccine =< 4 weeks prior to registration, or anticipation of need for such a vaccine during the course of the study.
REGISTRATION: Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)-alpha agents) =< 2 weeks prior to registration, or anticipation of need for systemic immunosuppressive medication during the course of the study.
NOTE: Patients who have received acute, low-dose systemic steroids (=< 10 mg/day oral prednisone or equivalent) prior to registration or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
NOTE: The use of inhaled corticosteroids for chronic obstructive pulmonary disease or asthma, mineralocorticoids (e.g., fludrocortisone), or low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
REGISTRATION: Requirement for concomitant therapy or food that is prohibited during the study.
REGISTRATION: Arms A and B only: Inability to abstain from alcohol during neoadjuvant phase.
REGISTRATION: Arm C only: Known Epstein-Barr virus (EBV) infection.
NOTE: Patients with symptoms such as splenomegaly, fever, sore throat, non-malignant cervical lymphadenopathy, and/or tonsillar exudate, should undergo an EBV polymerase chain reaction (PCR) test to screen for acute infection or suspected chronic active infection. Patients with a positive EBV PCR test are excluded. Drug: Atezolizumab, Drug: Cobimetinib, Biological: Tiragolumab, Drug: Vemurafenib
Clinical Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8
Clinics and Surgery Center (CSC)
Diaphragmatic Breathing Exercises for post-COVID-19 Diaphragmatic Dysfunction (DD)
Our overarching hypothesis is that there is significant diaphragmatic dysfunction following the PASC patient population following COVID-19 infection irrespective of severity of the disease. Given the significant number of PASC patients who experience shortness of breathlessness and chest tightness, we extrapolate that the diaphragm is impacted by the SARS CoV-2 virus leading to the shortness of breath and chest tightness. Our intervention will be targeting the diaphragmatic dysfunction by breathing retraining exercises and manual therapy. Our long-term goal is to develop a precision-based approach to manage PASC supported by restorative, safe and inexpensive interventions that can impact the trajectory of PASC, and panel of predictors of improved clinical outcomes.
Farha Ikramuddin
Male or Female
18 Years and over
STUDY00017641
STUDY00017641
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet the following criteria:
a) Male or female age 18 and above
b) PCR positive 4 weeks prior to the development of the PASC symptoms
c) new diagnosis of PASC (defined as new-onset symptoms of fatigue, shortness of breath, chest tightness or persistence of symptoms 4 weeks following a positive PCR test for COVID-19)
d) patients did not need hospitalization of 5 days or more and did not need ICU admission via chart review or history taking.
e) nose breathers as reported by patient at the time of screening by history taking
f) symptoms should include shortness of breath/chest tightness/fatigue
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
a) pre-existing lung disease such as COPD, IPF, Asthma, Exercise induced Asthma, Lung cancer, or history of Lung transplant
b) history of current smoking and pack years of 10
c) history of coronary artery disease
d) general anxiety disorder
e) unable to have full range of motion of the shoulders
f) stable dose of antidepressants prior to covid-19 infection
g) Pregnant women/fetuses/neonates via self-report.
h) non-English speakers
i) patients with previously diagnosed severe cognitive deficits such as dementia, developmental defects, those with acute medical conditions, psychiatric disorders such as schizophrenia, mania, and psychosis, neurologic disorders such as stroke, Parkinson?s disease and Multiple sclerosis
j) unable to read
k) Individual or group with a serious health condition for which there are no satisfactory standard treatments Respiratory System
The TrialNet Natural History Study of the Development of Type 1 Diabetes
Antoinette Moran
All
30 Months to 45 Years old
0305M47349
0305M47349
Inclusion Criteria:
Individuals 2.5 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
Individuals 2.5-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
Individuals 2.5-45 years old without a type 1 diabetes proband, who are known to have 1 or more islet antibody are eligible for screening if needed to determine eligibility for a clinical trial to delay or prevent disease progression.
Exclusion Criteria:
To be eligible a person must not:
Have diabetes already
Have a previous history of being treated with insulin or oral diabetes medications.
Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
Have any known serious diseases Diabetes Mellitus, Type 1
"at risk" for developing type 1 diabetes, T1DM, T1D, juvenile diabetes, Type 1 Diabetes TrialNet, TrialNet
MT2021-03: A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (BEAT-MS)
Adam Carpenter
All
18 Years to 55 Years old
Phase 3
STUDY00007288
STUDY00007288
Inclusion Criteria:
Participant(s) must meet all of the following criteria to be eligible for this study:
Diagnosis of Multiple Sclerosis (MS) according to the 2017 McDonald Criteria
(Kurtzke) Expanded Disability Status Scale (EDSS) ≤ 6.0 at the time of randomization (Day 0)
T2 abnormalities on brain Magnetic Resonance Imaging (MRI) that fulfill the 2017 McDonald MRI criteria for dissemination in space
--A detailed MRI report or MRI images must be available for review by the site neurology investigator.
Highly active treatment-resistant relapsing MS, defined as ≥ 2 episodes of disease activity in the 36 months prior to the screening visit (Visit -2). The two disease activity episodes will be a clinical MS relapse or MRI evidence of MS disease activity and must meet all the criteria as described below:
At least one episode of disease activity must occur following ≥ 1 month of treatment with an oral DMT approved by the FDA or MHRA for the treatment of relapsing MS, or a monoclonal antibody, specifically: dimethyl fumarate (Tecfidera®), diroximel fumarate, teriflunomide (Aubagio®), cladribine (Mavenclad®), daclizumab (Zinbryta®), siponimod (Mayzent®), ozanimod, fingolimod (Gilenya®), rituximab (Rituxan®), ocrelizumab (Ocrevus®), natalizumab (Tysabri®), alemtuzumab (Campath®, Lemtrada®), or ofatumumab (Arzerra®), and
At least one episode of disease activity must have occurred within the 12 months prior to the screening visit (Visit -2), and
At least one episode of disease activity must be a clinical MS relapse (see item c.i. below). The other episode(s) must occur at least one month before or after the onset of the clinical MS relapse, and must be either another clinical
MS relapse or MRI evidence of disease activity (see item d.ii. below):
i. Clinical MS relapse must be confirmed by a neurologist's assessment and documented contemporaneously in the medical record. If the clinical MS relapse is not documented in the medical record, it must be approved by the study adjudication committee, and
ii. MRI evidence of disease activity must include ≥ 2 unique active lesions on a brain or spinal cord MRI. A detailed MRI report or MRI images must be available for review by the site neurology investigator. A unique active lesion is defined as either of the following:
A gadolinium-enhancing lesion, or
A new non-enhancing T2 lesion compared to a reference scan obtained not more than 24 months prior to the screening visit (Visit -2).
Candidacy for treatment with at least one of the following high efficacy DMTs:
Cladribine, natalizumab, alemtuzumab, ocrelizumab, rituximab, and ofatumumab (after approval by the FDA for relapsing MS). Candidacy for treatment for each DMT is defined as meeting all of the following:
No prior disease activity with the candidate DMT, and
No contraindication to the candidate DMT, and
No treatment with the candidate DMT in the 12 months prior to screening.
Completion of SARS-CoV-2 vaccination series ≥ 14 days prior to randomization (Day 0).
Positive for VZV antibodies, or completion of at least one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least 4 weeks prior to randomization (Day 0).
Insurance or public funding approval for MS treatment with at least one candidate DMT, and
Ability to comply with study procedures and provide informed consent, in the opinion of the investigator.
Exclusion Criteria:
Subject(s) who meet any of the following criteria will not be eligible for this study:
Diagnosis of primary progressive Multiple Sclerosis (MS) according to the 2017 McDonald criteria
History of neuromyelitis optica or anti-myelin oligodendrocyte glycoprotein (anti-MOG) antibodies associated encephalomyelitis
Prior treatment with an investigational agent within 3 months or 5 half-lives, whichever is longer. Agents authorized by the FDA or MHRA for prevention or treatment of SARS-CoV-2 are not considered investigational.
Either of the following within one month prior to randomization (Day 0):
Onset of acute MS relapse, or
Treatment with intravenous methylprednisolone 1000 mg/day for 3 days or equivalent.
Initiation of natalizumab, alemtuzumab, ocrelizumab, or rituximab between screening visit (Visit -2) and randomization (Day 0)
Brain MRI or Cerebrospinal fluid (CSF) examination indicating a diagnosis of progressive multifocal leukoencephalopathy (PML)
History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS)
Presence of unexplained cytopenia, polycythemia, thrombocythemia or leukocytosis
History of sickle cell anemia or other hemoglobinopathy
Evidence of past or current hepatitis B or hepatitis C infection, including treated hepatitis B or hepatitis C
-Note: Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past infection.
Presence or history of mild to severe cirrhosis
Hepatic disease with the presence of either of the following:
Total bilirubin ≥ 1.5 times the upper limit of normal (ULN) or total bilirubin
• 0 times the ULN in the presence of Gilbert's syndrome, or Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2.0 times the ULN. Positive SARS-CoV-2 PCR test, or alternative nucleic acid amplification test (NAAT) per institutional standards, within 14 days prior to randomization (Day 0). Evidence of HIV infection Positive QuantiFERON - TB Gold, TB Gold Plus, or T-SPOT®.TB test results (e.g., blood test results. Purified Protein Derivative (PPD) tuberculin test may be substituted for QuantiFERON - TB Gold, TB Gold Plus, or T-SPOT®.TB test results. Active viral, bacterial, endoparasitic, or opportunistic infections Active invasive fungal infection Hospitalization for treatment of infections or parenteral (IV or IM) antibacterials, antivirals, antifungals, or antiparasitic agents within the 30 days prior to randomization (Day 0) unless clearance is obtained from an Infectious Disease specialist Receipt of live or live-attenuated vaccines within 6 weeks of randomization (Day 0) Presence or history of clinically significant cardiac disease including: Arrhythmia requiring treatment with any antiarrhythmia therapy, with the exception of low dose beta blocker for intermittent premature ventricular contractions Coronary artery disease with a documented diagnosis of either: Chronic exertional angina, or Signs or symptoms of congestive heart failure. Evidence of heart valve disease, including any of the following: Moderate to severe valve stenosis or insufficiency, Symptomatic mitral valve prolapse, or Presence of prosthetic mitral or aortic valve. Left ventricular ejection fraction (LVEF) < 50% Impaired renal function defined as Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula Forced expiratory volume in one second (FEV1) <70% predicted (no bronchodilator) Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for Hgb) < 70% predicted Poorly controlled diabetes mellitus, defined as HbA1c >8% History of malignancy, with the exception of adequately treated localized basal cell or squamous skin cancer, or carcinoma in situ of the cervix. -Note:Malignancies for which the participant is judged to be cured prior to randomization (Day 0) will be considered on an individual basis by the study adjudication committee. Presence or history of any moderate to severe rheumatologic autoimmune disease requiring treatment, including but not limited to the following: systemic lupus erythematous systemic sclerosis rheumatoid arthritis Sjögren's syndrome polymyositis dermatomyositis mixed connective tissue disease polymyalgia rheumatica polychondritis sarcoidosis vasculitis syndromes, or unspecified collagen vascular disease. Presence of active peptic ulcer disease, defined as endoscopic or radiologic diagnosis of gastric or duodenal ulcer Prior history of AHSCT Prior history of solid organ transplantation Positive pregnancy test or breast-feeding Inability or unwillingness to use effective means of birth control Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy Psychiatric illness, mental deficiency, or cognitive dysfunction severe enough to interfere with compliance or informed consent History of hypersensitivity to mouse, rabbit, or Escherichia coli-derived proteins Any metallic material or electronic device in the body, or condition that precludes the participant from undergoing MRI with gadolinium administration Presence or history of ischemic cerebrovascular disorders, including but not limited to transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage Presence or history of other neurological disorders, including but not limited to: central nervous system (CNS) or spinal cord tumor metabolic or infectious cause of myelopathy genetically-inherited progressive CNS disorder CNS sarcoidosis, or systemic autoimmune disorders potentially causing progressive neurologic disease or affecting ability to perform the study assessments. Presence of any medical comorbidity that the investigator determines will significantly increase the risk of treatment mortality, or Presence of any other concomitant medical condition that the investigator deems incompatible with trial participation.
Procedure: Autologous Hematopoietic Stem Cell Transplantation, Biological: Best Available Therapy (BAT)
Rare Diseases
Clinics and Surgery Center (CSC)
Topical cannabidiol (CBD) for the treatment of chemotherapy-induced peripheral neuropathy: a randomized placebo-controlled pilot trial
This study is a pilot study that will randomize 40 participants with chemotherapy-induced peripheral neuropathy to receive, for 14 days, either a CBD cream or a placebo. Participants initially receiving the placebo will cross over to receive the CBD cream, while those receiving the CBD creams will cross over to receive the placebo, for 14 days. This cross-over will allow all participants to eventually receive the CBD cream and will allow the study team to determine whether any benefit derived from a CBD preparation will diminish or persist after the CBD preparation is stopped.
Anastas Provatas
All
18 Years to old
Pilot
STUDY00017595
STUDY00017595
Inclusion Criteria:
Age >= 18 years
English speaking
Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy
At least 4 out of 10 severity of neuropathy pain and/or tingling
Stable for at least 7 days prior to registration on medications for neuropathy, if any are being used
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
NOTE: If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Able to provide written informed consent
Ability to complete questionnaire(s) by themselves or with assistance
No evidence of residual cancer
Platelet count > 100,000/mm^3 (following completion of chemotherapy)
Absolute neutrophil count (ANC) >= 1,000/mm^3 (following completion of chemotherapy)
Hemoglobin > 11 g/dL (following completion of chemotherapy)
Serum transaminase (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) =< 1.2 x upper limit of normal (ULN) (following completion of chemotherapy)
Alkaline phosphatase =< 1.2 x ULN (following completion of chemotherapy)
Serum creatinine =< 1.2 x ULN (following completion of chemotherapy)
Exclusion Criteria:
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
Pregnant persons
Nursing persons
Persons of childbearing potential who are unwilling to employ adequate contraception
Any medical condition that would prohibit use of a topical cream (skin infection or open wound in the area of the neuropathy)
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Pre-existing neuropathy prior to chemotherapy that would confuse the issue of CIPN
Currently on chemotherapy or received chemotherapy treatment within the prior 3 months
Use of other cannabis products within 30 days prior to registration
History of allergy to cannabis products Drug: Cannabidiol, Drug: Placebo Administration, Other: Quality-of-Life Assessment, Other: Questionnaire Administration
Chemotherapy-Induced Peripheral Neuropathy, Malignant Solid Neoplasm
Creativity Camp Study
This study pursues the question of whether deep engagement in creative activities may benefit adolescents with depression symptoms by introducing a more flexible way of thinking, helping adolescents recognize and foster their own creative talents, and (ultimately) developing more positive views of themselves and their futures.
Kathryn Cullen
Male or Female
up to 18 Years old
STUDY00014280
STUDY00014280
Inclusion Criteria:
• age 12-17
• experiencing depressive symptoms
Exclusion Criteria:
• significant medical conditions that would interfere with participation
• current active suicidal ideation and refusal to adhere to safety plan
Children's Health, Mental Health & Addiction
Adolescents, Camp, Creativity, Depression, Diversity, Flexibility, Summer
Assessing Movement Disorder Patients
Patients with movement disorders, for example Parkinson’s disease (PD), essential tremor (ET) and dystonia, will be assessed using appropriate clinical and (sensor) quantified measures in order to obtain quantitative and qualitative data that is not consistently obtained in clinical exams. This data will aid in assessing trends and outcomes in motor and non-motor signs, side effects and symptoms that correlate with deep brain stimulation (DBS) lead location, stimulation parameters, and other variables, for those that have received this treatment, in order to inform neurosurgical and neurological practices aimed at optimizing treatment and therapy for movement disorders. For those patients that have received DBS lead implant(s), this study will include the analysis of patient’s clinical and/or research-related intraoperative neurophysiological recordings collected during the microelectrode recording portion of the DBS lead implant surgery. Additionally, researchers may analyze trends and outcomes by gathering data from retrospective and prospective chart review.
Jerrold Vitek
All
10 Years to old
STUDY00007781
STUDY00007781
Inclusion Criteria:
Diagnosis or suspected diagnosis of Parkinson's disease, Essential Tremor, or Dystonia
Aged: 10+
Exclusion Criteria:
History of dementia
Patients with post-operative complications or adverse effects that affect patient safety or confound the experiment will be excluded from further study.
Pregnant women
Lactating women Movement Disorders
Clinics and Surgery Center (CSC)
Real-Time Feedback (RTFB) to Improve Colonoscopy
To test whether real-time feedback during the withdrawal phase of colonoscopy improves quality of colonoscopy and the adenoma detection rate.
Piet de Groen
All
18 Years and over
N/A
STUDY00007271
STUDY00007271
Inclusion Criteria:
• Any endoscopist willing to parcipate and performing routine colonscopy
Exclusion Criteria:
• No exclusion criteria
Device: AI program for colonoscopy
Digestive & Liver Health
Clinics and Surgery Center (CSC)
Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M;(ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant
The study hypothesis is that the administration of Viralym-M to patients with virus-associated HC will demonstrate superiority for the time to resolution of HC (as measured by resolution of macroscopic hematuria) compared to patients treated with placebo. The primary hypothesis will be tested in patients with BKV viruria to demonstrate superiority over placebo in this population (BK Intent-to-Treat [ITT] Population). A supplementary analysis will be conducted in all patients with any viral-associated HC (BKV, JCV, AdV, EBV, CMV, and/or HHV-6) in order to evaluate efficacy in this broader population (ITT Population). Further detail is provided in the statistical section below and will be described in the Statistical Analysis Plan (SAP).
Jo-Anne Young, MD
All
Not specified
Phase 3
STUDY00011838
STUDY00011838
Key Inclusion Criteria
Participants must meet all of the following criteria in order to be eligible to participate in the study:
Male or female ≥1 year of age.
Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.
Diagnosed with HC based on the following criteria (all 3 criteria must be met):
Clinical signs and/or symptoms of cystitis.
Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available.
Key Exclusion Criteria
Participants who meet any of the following criteria will be excluded from participation in the study:
Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
Evidence of active Grade >2 acute graft versus host disease (GVHD).
Uncontrolled or progressive bacterial or fungal infections.
Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
Pregnant or lactating or planning to become pregnant.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Biological: Placebo, Biological: Posoleucel (ALVR105)
Cancer, Infectious Diseases
Clinics and Surgery Center (CSC)
A Phase II Multicenter, Randomized, Double-Blind, 12-Week Treatment, 3-Arm, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of RO7017773 in Participants Aged 15 to 45 Years with Autism Spectrum Disorder (ASD)
Suma Jacob
All
15 Years to 45 Years old
Phase 2
STUDY00010423
STUDY00010423
Inclusion Criteria
Male and female participants with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Wechsler Abbreviated Scale of Intelligence (WASI-II) >/= 50 at screening or within the last 12 months prior to screening
ASD or Autism diagnosis confirmed by Autism Diagnostic Observation Schedule (ADOS-2)
Body mass index within the range of 18.5 to 40 kg/m2
Female Participants: is eligible if she is not pregnant, not breastfeeding, and women of childbearing potential (WOCBP), who agree to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 28 days after the last dose of study drug
Language, hearing, and vision compatible with the study measurements as judged by the Investigator
Allowed existing treatment regimens should be stable for 8 weeks prior to screening. Investigator expects stability of these treatments and behavioral interventions for the duration of the study
In the Investigator's opinion, able to participate and deemed appropriate for participation in the study, capable of following the study SoA and able to comply with the study restrictions
In the Investigator's opinion, participation in the study or discontinuation of prohibited medication will not pose undue risks
Exclusion Criteria
Neurologic/Psychiatric Conditions:
Non-verbal individuals
Presence of chromosome 15q11.2 q13.1 duplication syndrome (Dup15q syndrome), known "syndromic" forms of ASD (confirmed per genetic results available at screening): fragile X syndrome, Prader Willi syndrome, Rett's syndrome, tuberous sclerosis, and Angelman syndrome, as well as genetic alterations strongly associated with ASD per genetic results available at screening affecting the following genes: CHD8, ANDP, SHANK3
Medical history of alcohol and/or substance abuse/dependence in the last 12 months or positive test for drugs of abuse at screening
Initiation of a major change in psychosocial intervention within 6 weeks prior to screening. Minor changes in ongoing treatment are not considered major changes
Clinically significant psychiatric and/or neurological disorder that may interfere with the safety or efficacy endpoints
Risk of suicidal behavior in the opinion of a certified clinician or as evidenced by a "yes" to questions 4 and/or 5 of Columbia-Suicide-Severity Rating Scale (C-SSRS) taken at screening and baseline with respect to the last 12 months, or any suicide attempt in the past 5 years
Unstable epilepsy/seizure disorder within the past 6 months or changes in anticonvulsive therapy within the last 6 months
Other Conditions:
Medical history of malignancy if not considered cured or if occurred within the last 3 years with the exception of fully excised non-melanoma skin cancers or in-situ carcinoma of the cervix that has been successfully treated
Concomitant disease, condition or treatment which would either interfere with the conduct of the study or pose an unacceptable risk to the participant in the opinion of the Investigator Prior/Concomitant Therapy
Use of prohibited medications or herbal remedies within 6 weeks or 5 half-lives (t1/2) prior to randomization
Prior/Concurrent Clinical Study Experience:
Donation or loss of blood over 500 mL in adults and 250 mL in adolescents within 3 months prior to randomization
Participation in an investigational drug study within 1 month or 5 times the t1/2 of the investigational molecule prior to randomization or participation in a study testing an investigational medical device within 1 month prior to randomization or if the device is still active Diagnostic Assessments
Confirmed clinically significant abnormality in hematological, chemistry or coagulation laboratory parameters
Positive test result at screening for hepatitis B surface antigen, hepatitis C virus (HCV, untreated), or human immunodeficiency virus (HIV)-1 and -2. HCV participants who have been successfully treated and who test negative for HCV RNA, may be considered eligible for entry into the study
Other Exculsions:
Uncorrected hypokalemia or hypomagnesaemia
Drug: Placebo, Drug: RO7017773
Autism Spectrum Disorder (ASD)
Study of Nutraceutical Intervention with High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, type 1 (NF1)
This is a single center, open label, Phase I clinical trial of bioactive curcumin with high phenolic extra virgin olive oil (HP-EVOO) to treat cutaneous neurofibromas (cNF) in Neurofibromatosis, type 1 (NF1) patients (aged 18 years or older).
Christopher Moertel, MD
All
18 Years to old
Phase 1
STUDY00014832
STUDY00014832
Inclusion Criteria:
NF1 diagnosis based on NIH Consensus Conference Criteria and/or genetic testing
Measurable cutaneous neurofibromas (cNFs) with or without plexiform NF
Aged 18 years or older at the time of written consent
Voluntary signed written consent obtained before the performance of any study-related procedure not part of normal medical care
Exclusion Criteria:
Concurrent treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation
Conditions requiring systemic immunosuppression
Swallowing difficulties or strong gag reflex which may interfere with study compliance
Any comorbidities that may affect study participation in the judgement of enrolling investigator
Psychiatric illness, cognitive challenges, social situations, or other circumstances that would limit compliance with study requirements, per judgment of the enrolling investigator
Treatment with high phenolic olive oil or curcumin within six months of study entry
Known pregnancy or anticipated conception during the 1 year study period Dietary Supplement: curcumin, high phenolic extra virgin olive oil (HP-EVOO)
Rare Diseases
Hepatic Energy Fluxes, NASH, and Vertical Sleeve Gastrectomy
Hepatic Energy Fluxes
Sayeed Ikramuddin
All
40 Years to 67 Years old
N/A
STUDY00006269
STUDY00006269
Inclusion Criteria:
Age 18 to 67 years at eligible visit
Diagnosed with NASH with a total NAS ≥ 3 including a ballooning score of at least 1, or non-NASH/NAFLD with a total NAS ≤3, or Diagnosed with T2DM or prediabetes, HbA1c< 8% , or CAP score greater than or equal to 248 on Fibroscan
Body Mass Index (BMI) 30.0-55.0 kg/m2 at eligibility visit
Willingness to accept surgical intervention after an individual seminar session
All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all patients enrolled in the study
Expect to live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial
Willingness to comply with the follow-up protocol and successful completion of the run-in
Written informed consent
Suitable for liver biopsy using the percutaneous approach
Vulnerable populations will not be targeted for inclusion, but those noted in section 9.1 may be allowed to participate provided they met all of the inclusion and none of the exclusion criteria.
Exclusion Criteria:
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.
Cardiac stress test indicating that surgery or IMM would not be safe.
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 2.5 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, or cirrhosis
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.
Depression A CESD score more than 17 and a psychologist determination that the patient is not a good fit for surgery.
Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
12-lead EKG indicating that surgery would not be safe.
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 by MR technologists on the day of scanning using a standard safety screening form.
History of endoscopy demonstrating esophagitis or Barretts changes in the esophagus. Any history of dysphagia.
Treatment with drugs associated with nonalcoholic fatty liver disease (amiodarone, methotrexate, oral glucocorticoids at doses greater than 5 mg/day, tamoxifen, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, valproic acid) for more than 4 weeks within the last 2 months prior to the initial screening.
Treatment with pioglitazone or high-dose vitamin E (>400 IU/day) within the last 2 months prior to the initial screening. Procedure: Vertical Sleeve Gastrectomy (VSG)
NASH - Nonalcoholic Steatohepatitis, NAS, Overweight or Obesity, Weight Loss, Bariatric Surgery Candidate
Clinics and Surgery Center (CSC)
MT2018-46: Longterm Follow-up of Subjects with Cerebral Adrenoleukodystrophy who were Treated with Lenti-D Drug Product
Paul Orchard
Male
to 17 Years old
STUDY00005330
STUDY00005330
Inclusion Criteria:
Provision of written informed consent for this study by the participant or participant's parent(s)/ legal guardian(s) and written informed assent by participant, if applicable
Have received eli-cel in a parent clinical study
Exclusion Criteria:
There are no exclusion criteria for this study Genetic: Lenti-D Drug Product
Cerebral Adrenoleukodystrophy (CALD), Adrenoleukodystrophy (ALD), X-Linked Adrenoleukodystrophy (X-ALD)
Adrenoleukodystrophy, X-linked Adrenoleukodystrophy, Hematopoietic Stem Cells
Scapular Mechanisms of Movement-Related Shoulder Dysfunction
The purpose of the study is to detect subgroups of shoulder movement abnormalities in individuals with shoulder pain. The study is a comparative, cross sectional design. A clinical exam will be used to identify subgroups of subjects with specific movement abnormalities. These individuals' joint movements will be recorded utilizing dynamic fluoroscopy (x-ray) images to determine if there are distinct verifiable movement distinctions
Paula Ludewig
Male or Female
18 Years and over
1603M85761
1603M85761
Inclusion Criteria:
Ages 18-60 with shoulder pain
Exclusion Criteria:
History of shoulder surgery or traumatic injury Bone, Joint & Muscle
motion analysis, pain, physical therapy, rehabilitation, shoulder
Geniculate Artery Embolization
This is a single center phase I and II study which is designed to initially assess the safety, and later the efficacy of geniculate artery embolization in reducing pain compared to a control group undergoing only conservative presurgical management. This study will consist of two phases, each with a 1 month preprocedural evaluation, day of treatment and 30 day follow up period for the first 10 participants and 6 month for the remaining 40 participants. 10 participants will be enrolled for the first phase, and 40 participants will be enrolled for the second phase at the University of Minnesota Medical Center. Enrollment is expected to take up to 6 months for each phase of the study. The collection of data will be accomplished by utilizing a clinical research team that will assess the efficacy and safety. Efficacy assessments will include; Joint injection intervals, MRI, X-ray, joint aspiration / serologies and patient questionnaires evaluating joint pain. Safety assessments include participant and investigator reported adverse events, vital signs, (blood pressure, heart rate, temperature), and physical exam.
Reza Talaie
All
40 Years to 70 Years old
N/A
STUDY00006202
STUDY00006202
Inclusion Criteria:
Unilaterally dominant symptomatic osteoarthritis (bilateral radiographic OA will not exclude)
Patients who are symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or 0-1 intra-articular injections of the affected knee)
Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
Patients who are willing to comply with the protocol requirements and willing to undergo non-contrast MRI 1-30 days prior to procedure and at 12 months following procedure
Patients who are willing to comply with regular follow up during the 12 month follow-up period
Patients who have been evaluated by an orthopaedic surgeon or sports medicine provider and deemed to not be a current candidate for partial or total knee arthroplasty. These patients do, however, need to be considered a potential candidate for partial or total knee as an end point following the natural history of osteoarthritis.
Patients with WOMAC Score >=6 in at least 2 categories
Exclusion Criteria:
Patients with a weight >250 pounds
Patients with advanced peripheral arterial disease (resting ABI <= 0.9)
Patients with known significant peripheral arterial disease precluding common femoral catheterization
Patients who do smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
Patients with diabetes who have a hemoglobin A1C of >9%
Patients who have undergone previous lower extremity embolization
Patients with uncontrolled emotional disorders per patient medical history
Patients with chronic pain syndrome or currently under a pain contract
Patients with anatomic variants involving the lower extremities which would increase the risk of non-target embolization
Patients with renal insufficiency based on an estimated GFR<45 ml/min who are not already on hemodialysis.
Patients with an abnormal INR (>1.5).
Patients with a platelet count <50x109/L.
Patients who are currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
Patients with a known severe allergy to iodine which cannot be adequately pre-medicated
Patients who are pregnant or intend to become pregnant within 6 months of the procedure
Patients with a contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl
Patients with a life expectancy <60 months
Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
Patients with contraindications to medical and physical rehabilitative treatments of OA
Patients with known advanced atherosclerosis
Patients with known current or previous lower extremity fistula
Patients with rheumatoid arthritis or seronegative arthropathies
Patients with prior ipsilateral knee surgery.
Patients with WOMAC Pain Scale < 6
Patients having received more than one steroid injection in the affected joint or an injection in the affected joint within 3 months of screening Device: Geniculate Artery Embolization
Osteo Arthritis Knee, Arthritis, Osteoarthritis, Osteoarthritis, Knee
Clinics and Surgery Center (CSC)
A Phase 2 Open-label, Dose Escalation Study of HST5040 in Subjects with Propionic or Methylmalonic Acidemia Followed by a 6-Month, Randomized, Double-blind, Placebo-controlled, 2-period Crossover and an Open-label, Long-term Extension (HERO)
Phase 2 Open-label, Dose Escalation Study Followed by a 6-Month, Randomized, Double-blind, Placebo-controlled, 2-period Crossover and an Open-label, Long-term Extension
Sue Berry
All
up to 18 Years old
Phase 2
STUDY00010175
STUDY00010175
Inclusion Criteria:
Confirmed diagnosis of symptomatic PA or MMA (Mutase)
Ages ≥ 2 years old.
History of Inadequate metabolic control while receiving standard of care (SoC).
Plasma MCA concentration > 3x upper limit of normal of the reference range at screening.
Stable supplementation dose of carnitine for at least 1 week prior to the entry in the study.
Exclusion Criteria:
Moderate-to-severely impaired cardiac function with LVEF < 45% by ECHO.
Clinically significant arrhythmia by Holter monitor.
QTcF > 450 msec
Moderate to severe chronic kidney disease with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2.
Exposure to any investigational therapy, apart for a COVID-19 vaccine, within the past 6 months prior to study entry.
Exposure to gene therapy for PA or MMA at any time prior to study entry.
History of organ transplantation (Part A and B only)
History of severe allergic or anaphylactic reactions to any of the components of HST5040. Drug: HST5040, Drug: Placebo
Children's Health, Rare Diseases
Clinics and Surgery Center (CSC)