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436 Study Matches

A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT) (VICTORION-2P)

CKJX839B12302 is a pivotal, randomized, double-blind, placebo controlled, multicenter Phase III trial, designed at assessing the benefits of inclisiran sodium 300 mg s.c., administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in addition to well-tolerated high-intensity statin therapy, on major adverse cardiovascular events (3P-MACE defined as first occurrence of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke), in a secondary prevention cohort of atherosclerotic cardiovascular disease (ASCVD) participants with a LDL-C ≥1.8 mmol/L (70 mg/dL).

Daniel Duprez
All
40 Years to old
Phase III
STUDY00015316
STUDY00015316
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Inclusion Criteria:
Fasting LDL-C ≥ 70 mg/dL at randomization visit Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD Established CV disease defined as ANY of the following three conditions Spontaneous Myocardial infarction ≥ 4 weeks from screening visit History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.
Exclusion Criteria:
Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 weeks before screening visit Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit Heart failure NYHA class III or IV Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.
Drug: Inclisiran sodium 300 mg, Drug: Placebo
Atherosclerotic Cardiovascular Disease
Clinics and Surgery Center (CSC)
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A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.

Boris Winterhoff
All
18 Years to old
Phase 1
STUDY00014893
STUDY00014893
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Inclusion Criteria:
Advanced solid tumor Measurable disease, per RECIST v1.1 Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Adequate organ function
Exclusion Criteria:
Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23 Progressive or symptomatic brain metastases Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection History of significant cardiac disease History of myelodysplastic syndrome (MDS) or AML History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded If female, is pregnant or breastfeeding
Drug: TORL-1-23
Advanced Solid Tumor, Ovarian Cancer, Endometrial Cancer, NSCLC
Clinics and Surgery Center (CSC)
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The role of cytomegalovirus and inflammation on patient symptoms and outcomes in ovarian cancer

The central research idea for this award is that CMV reactivation is an unrecognized complicating factor in the treatment of ovarian cancer. Based on preliminary data, our hypotheses are: a) ovarian cancer patients with elevated biomarkers of CMV report greater fatigue and poorer quality of life; b) CMV and inflammation (C-reactive protein; CRP) levels in ovarian cancer patients are higher post-chemotherapy than baseline; c) ovarian cancer patients who experience increases in CMV and/or CRP report greater fatigue and poorer quality of life; d) ovarian cancer patients who experience increases in CMV and CRP will have shorter recurrence-free and overall survival. We propose the following specific aims and studies to address these research questions: Aim 1: Determine the relationship between CMV and ovarian cancer patient-reported symptoms post-treatment. A cross-sectional study of 200 women with ovarian cancer within two years of completing first line chemotherapy will be recruited for a one-time blood draw and survey. We will assess CMV status by measuring IgG serology and CMV DNA levels in serum (indicative of active infection/reactivation) and determine their relationship with patient-reported symptoms including fatigue and quality of life. Aim 2: Characterize the changes in CMV and CRP levels following chemotherapy and their association with patient symptoms and outcomes. A prospective study of 150 women with newly diagnosed ovarian cancer will evaluate the association between serum CMV IgG, CRP IgG, and CMV DNA levels and patient-reported symptoms, recurrence-free and overall survival. Planned blood samples include before, after and 6 months post-chemotherapy completion with planned surveys and clinical follow-up at least every six months for five years.

Rachel Vogel
Female
18 Years to old
STUDY00005451
STUDY00005451
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Inclusion Criteria:
Age ≥18 Ability to read and write in English women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer Treatment plan includes chemotherapy Able to provide written voluntary consent before performance of any study related procedure. Cohort 1 only: within 2 years of completing initial chemotherapy treatment Cohort 2 only: prior to starting chemotherapy
Exclusion Criteria:
Inability to provide informed written consent Previous exposure to chemotherapy Life expectancy < 3 months or in hospice care or nursing home
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Clinics and Surgery Center (CSC)
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MT2021-01: PTCy + Sirolimus/VIC-1911 as GVHD prophylaxis in myeloablative PBSC transplantation

The primary objective of this study is to determine the optimal dose of VIC-1911 when given in combination with standard immunosuppressive therapy in adult patients undergoing myeloablative stem cell transplantation.

Shernan Holtan
All
18 Years to old
Phase 1/Phase 2
STUDY00015049
STUDY00015049
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Inclusion Criteria:
Diagnosis of acute leukemia in complete remission, or myelodysplasia with <5% blasts, or myeloproliferative neoplasm/myelofibrosis with <5% marrow or circulating blasts chemosensitive Hodgkin or non-Hodgkin lymphoma Age 18 years or older Performance status of ≥ 80% Karnofsky Adequate organ function within 28 days of study registration defined as: left ventricular ejection fraction ≥ 45% pulmonary function with FEV1, FVC, and DLCO ≥ 50% predicted AST and ALT < 2 times upper limit of normal Total bilirubin <1.5 times the upper limit of normal. If the patient is suspected of having Gilbert syndrome, they require prior approval of the medical monitor creatinine clearance ≥ 50cc/min no active/uncontrolled infection negative HIV, HBV and HCV ferritin < 2000 ng/ml Patients able to tolerate oral medication Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment through 60 days after the last treatment of VIC-1911 or sirolimus Able to provide written voluntary consent prior to the performance of any research related tests or procedures
Exclusion Criteria:
HCT-CI > 4 or unable to receive myeloablative TBI Use of planned post-transplant maintenance therapy to begin prior to day +75. Patients may receive standard of care maintenance therapies starting at day +75 or later Patients with a history of hypersensitivity to any of the investigational products Pregnant or breastfeeding as agents used in this study are Pregnancy Category o C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations, and Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 28 days of study registration. Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 60 days after the last treatment of VIC-1911 or sirolimus
Drug: VIC- 1911
Acute Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm, Lymphoma
Clinics and Surgery Center (CSC)
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MT2021-36: A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML) (VIALE-T) (VIALE-T)

Part 1 Primary: To determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in AML subjects when given as maintenance therapy following allogeneic SCT. Part 2 primary: 1. To determine the efficacy of venetoclax in combination with azacitidine to improve RFS in AML subjects compared to BSC when given as maintenance therapy following allogeneic SCT

Mark Juckett
All
12 Years to old
Phase III
STUDY00014681
STUDY00014681
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Inclusion Criteria:
Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2. Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 45 days. Blast percentage in bone marrow before transplant must be < 10%. Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant. Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol. Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40.
Exclusion Criteria:
History of disease progression during prior treatment with venetoclax. History of any other malignancy within 2 years prior to study entry, except for: Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; Myelodysplastic Syndrome, Myeloproliferative neoplasm (only allowed if it transformed to AML and AML should be the indication for marrow transplantation). Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.
Drug: Azacitidine, Other: Best Supportive Care (BSC), Drug: Venetoclax
Acute Myeloid Leukemia (AML), Cancer
Clinics and Surgery Center (CSC)
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Assessments of sound perception and brain activation in response to paired sound and electrical stimulation of surface ear regions

The purpose of this scientific study is to systematically investigate sound perception and brain activation effects in response to paired non-invasive electrical stimulation of surface ear regions and sound stimulation. Stimulation of non-auditory peripheral nerves including trigeminal, vagus, and other somatosensory nerves, when combined with sound stimulation, can activate and alter neural patterns in the central auditory nervous system. For future research, the ability to demonstrate systematic changes in sound perception and brain activity (i.e., auditory plasticity) using this bimodal stimulation approach could open opportunities for applying this method to improving hearing capabilities associated with deficits or helping with hearing disorders such as tinnitus. The sound perception and brain activation effects will be assessed in this study using multiple psychoacoustical and electrophysiological techniques.

Hubert Lim
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00016992
STUDY00016992
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Inclusion Criteria:
Normal Hearing or hearing loss With or without tinnitus Not users of Cochlear Implant or hearing aids
Ear, Nose & Throat
hearing loss, tinnitus, auditory plasticity, neuromodulation, transcutaneous electrical stimulation
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Identifying hearing loss through neural responses to engaging stories

This research study will develop an efficient electroencephalographic (EEG) method that uses narrated stories to identify frequency-specific hearing loss.

Melissa Polonenko
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00017008
STUDY00017008
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Inclusion Criteria:

• Group 1: Adults aged 18-70 years, normal hearing, no history of neurological problems or ANSD
• Group 2: Adults aged 18-70 years, hearing loss with thresholds better than 70 dB HL, no history of neurological problems or ANSD, doesn?t wear a cochlear implant
Exclusion Criteria:

• Neurological problems
• ANSD
• Wears a cochlear implant
Ear, Nose & Throat
Hearing, Hearing loss, Listening, electrophysiology
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A Phase 1b/2 Study of Abemaciclib in Combination with Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors and Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients with Relapsed/Refractory Neuroblastoma (Part C). Protocol Number: I3Y-MC-JPCS

The study's purpose is to see if the drug abemaciclib is safe and effective in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult participants with relapsed/refractory solid tumors.

Emily Greengard
All
to 21 Years old
Phase 1/Phase 2
STUDY00013998
STUDY00013998
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Inclusion Criteria:
Parts A and B only: Participants must be less than or equal to (≤)18 years of age. Body weight greater than or equal to (≥)10 kilograms and body surface area (BSA) ≥0.5 -- Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies. For sites that are actively enrolling Parts B and C, participants with neuroblastoma who are eligible for Part C will be excluded from Part B unless approved by Lilly CRP/CRS. Part C only: Participants must be less than (<) 21 years of age. Participants have a BSA ≥0.3 m². Participants with first relapse/refractory neuroblastoma. All Parts Participants must have measurable or evaluable disease by RECIST v1.1 or RANO. A Lansky score ≥50 for participants <16 years of age or Karnofsky score ≥50 for participants ≥16 years of age. Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment. Able to swallow. Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study drug. Females of reproductive potential must have negative urine or serum pregnancy test at baseline (within 7 days prior to starting treatment). Female participants of reproductive potential must agree to use highly effective contraceptive precautions during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib. For other study drugs, highly effective contraceptive precautions (and avoiding sperm donation) must be used according to their label. Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment. Caregivers and participants willing to make themselves available for the duration of the trial.
Exclusion Criteria:
Received allogenic bone marrow or solid organ transplant. Received live vaccination. Intolerability or hypersensitivity to any of the study treatments or its components. Diagnosed and/or treated additional malignancy within 3 years prior to enrollment that may affect the interpretation of results, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers. Pregnant or breastfeeding. Active systemic infections or viral load. Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study. Parts A and C only: Have a bowel obstruction. Prior treatment with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) or strong inhibitors of uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) if the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug. Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor. Part C only: Received prior systemic therapy for relapsed/refractory neuroblastoma. Currently enrolled in any other clinical study involving an investigational product or non-approved use of a drug or device. Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
Drug: Abemaciclib, Drug: Dinutuximab, Drug: GM-CSF, Drug: Irinotecan, Drug: Temozolomide
Relapsed Solid Tumor, Refractory Solid Tumor
Recurrent neuroblastoma, CDK4, CDK6, Ewing's sarcoma, Neuroblastoma, Malignant rhabdoid tumor, Rhabdomyosarcoma, Osteosarcoma, Brain tumor, Glioblastoma, Malignant glioma, Diffuse intrinsic pontine glioma, Medulloblastoma, Ependymoma, Solid tumor, High-grade glioma
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A Phase 1/2, Multi-Center, Dose-Escalating Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Quizartinib Administered in Combination with Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to < 18 Years (and Young Adults Aged up to 21 Years) with FLT3-ITD Mutations (Protocol Number: AC220-A-U202/ADVL1822)

This is an open-label, multi-center, single arm, Phase 1/2 study to evaluate the safety, PK, PD, and efficacy of quizartinib administered in combination with fludarabine and cytarabine (FLA) (Re-Induction Cycles 1 and 2) chemotherapy for re-induction, with optional consolidation chemotherapy, and as a single agent continuation therapy (after optional, but strongly encouraged, HSCT per standard of care), in pediatric relapsed/refractory AML subjects aged ≥1 month old to <18 years old (and young adults up to 21 years old) with FLT3-ITD mutations.

Emily Greengard
All
1 Month to 21 Years old
Phase 1/Phase 2
STUDY00005937
STUDY00005937
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Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for enrollment into the study: Has diagnosis of AML according to the World Health Organization (WHO) 2008 classification with ≥5% blasts in bone marrow, with or without extramedullary disease In first relapse or refractory to first-line high-dose chemotherapy with no more than 1 attempt (1 to 2 cycles of induction chemotherapy) at remission induction - prior HSCT is permitted Has presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood as defined in the protocol Is between 1 month and 21 years of age at the time the Informed Consent/Assent form is signed Has protocol-defined adequate performance status score Has fully recovered from the acute clinically significant toxicity effects of all prior chemotherapy, immunotherapy, or radiotherapy, per protocol guidelines Has protocol-defined adequate renal, hepatic and cardiac functions If of reproductive potential, is permanently sterile or agrees to use highly effective birth control upon enrollment, during the period of therapy, and for 6 months following the last dose of quizartinib, etoposide, fludarabine, methotrexate, or cytarabine, whichever is later If female of child-bearing potential, tests negative for pregnancy and agrees not to breast feed Male participants must be surgically sterile or willing to use highly effective birth control during the treatment period, and for 6 months following the last dose of quizartinib, etoposide, fludarabine, methotrexate, or cytarabine, whichever is later. Participant/legal representative is capable of understanding the investigational nature of the study, potential risks, and benefits, and the patient (and/or legal representative) signs a written assent/informed consent
Exclusion Criteria:
Participants who meet any of the following criteria will be disqualified from entering the study: Has been diagnosed with isolated central nervous system relapse, acute promyelocytic leukemia (APL), juvenile myelomonocytic leukemia, French-American-British classification M3 or WHO classification of APL with translocation, or with myeloid proliferations related to Down syndrome Has uncontrolled or pre-defined significant cardiovascular disease as detailed in the protocol Has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient must be off vasopressors and have negative blood cultures for at least 48 hours prior to the start of systematic protocol therapy. Has known active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C) Has known history of human immunodeficiency virus (HIV) Has history of hypersensitivity to any of the study medications or their excipients Is receiving or is anticipated to receive concomitant chemotherapy, radiation, or immunotherapy other than as specified in the protocol Has any significant concurrent disease, illness, psychiatric disorder or social issue that would compromise subject safety or compliance, interfere with consent/assent, study participation, follow up, or interpretation of study results Is currently participating in another investigative interventional procedure (observational or long-term interventional follow-up is allowed) Is otherwise considered inappropriate for the study by the Investigator
Drug: Cytarabine, Drug: Etoposide, Drug: Fludarabine, Drug: Intrathecal (IT) triple chemotherapy prophylaxis, Drug: Quizartinib
Acute Myeloid Leukemia
Acute myeloid leukemia recurrent, Relapsed or refractory, FMS-like tyrosine kinase 3 positive, Cancer of the blood, AML, FLT3-ITD mutation
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QuitGuide for American Indians: Aims 2 & 3

This is a study to develop a test a culturally-tailored version of the smoking cessation phone app, QuitGuide. Aim 2 will enroll two waves of participants to use the tailored version. Aim 3 will then randomize participants to use either the tailored version or the standard, publicly-available version.

Dana Carroll
All
18 Years to old
N/A
STUDY00016190
STUDY00016190
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Inclusion Criteria:
American Indian person based on self-report Age ≥ 18 years Interested in quitting smoking Smoke ≥ 3 commercial tobacco cigarette per day (CPD) in the past 30 days o Use of other commercial tobacco products (e.g., e-cigarettes) is permitted if they report cigarettes being their primary product Smartphone ownership with the ability to download applications and sufficient data to complete research procedures
Exclusion Criteria:
Aim 2 • Does not speak or read English Aim 3 Participation in Aim 2 New or change in pharmacotherapy for smoking cessation (includes: nicotine gum, patch, lozenge, inhaler OR medications Chantix/Wellbtrutin/Zyban/Bupropion) in past month Does not speak or read English
Behavioral: Standard QuitGuide app, Behavioral: Tailored QuitGuide app
Tobacco Use, Tobacco Use Disorder
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A randomized phase II trial of adjuvant Pembrolizumab versus observation following curative resection for stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm: Big Ten Cancer Research Consortium BTCRC-LUN18-153

The primary objective is to evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves disease free survival compared with observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size, regardless of PD-L1 TPS score.

Amit Kulkarni
All
18 Years to old
Phase 2
STUDY00010745
STUDY00010745
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Inclusion Criteria:
The participant (or legally acceptable representative if applicable) must provide written informed consent for the study. The participant may also provide consent for future unspecified research samples. However, the participant may participate in the study without participating in the future unspecified research sample collection. NOTE: Initial informed consent will remain valid throughout the 12-week period between surgical resection and study registration unless, in the opinion of the treating investigator, the participant experiences a significant change in medical or mental status. Males and females age ≥ 18 years at the time of consent. ECOG Performance Status of 0-1 within 28 days prior to registration. Patients must have undergone complete surgical resection of their stage I NSCLC between 4-12 weeks prior to registration and have negative surgical margins (R0). NOTE: Both squamous and non-squamous histologies are allowed into the study. Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus "non-squamous histology". NOTE: Staging will be according to the AJCC 8th edition. Pathological tumor size must be 1.0 - 4.0 cm in greatest dimension. NOTE: According to AJCC 8th edition, subjects with lepidic predominant adenocarcinoma should be staged based on their invasive tumor size and not their total tumor size (i.e., subjects with lepidic predominant tumors whose invasive tumor size is less than 1 cm are not eligible, even if their total tumor size is 1.0 cm or greater). Surgery for this lung cancer must be completed at least 28 days prior to registration. Must have either previous NGS and PD-L1 results available using the Dako 22C3 antibody or have archival tissue of surgical specimen from current diagnosis available to perform analyses. If prior PD-L1 results with Dako 22C3 antibody are not available from a CLIA-accredited laboratory, subjects must be able to provide 5 x 5µm unstained slides for prospective analysis to be used for stratification. If NGS results are not available, subjects must be able to provide at least 10 x 10µm unstained and 1 x 4µm H&E slides from current diagnosis for future NGS and/or other genetic analyses. Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration. Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. For subjects randomized to the pembrolizumab arm: If there is > 72 hours between the screening test and C1D1, another pregnancy test (urine or serum) must be performed and must be negative before the subject may start C1D1. NOTE: Females are considered of childbearing potential unless: they are postmenopausal; are surgically sterile; or they have a congenital or acquired condition that prevents childbearing. See Section 5.1.4 for definitions. NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who is using a highly effective contraceptive method (failure rate of <1% per year), or is abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) during the intervention period and for at least 120 days after the last dose of study drug. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study drug. See contraceptive guidance in Section 5.1.4 of the protocol. 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:
Current lung cancer is <1 cm or > 4 cm in size or is stage II, III, or IV. Patients with tumors that are known to harbor actionable EGFR mutations. Prior chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer. Has a known active additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma in situ, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 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, OX-40, CD137). Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. 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 randomization. Has had an allogenic tissue/solid organ transplant. Has severe hypersensitivity (≥Grade 3) 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., thyroxine, 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). Note: HIV testing is not required unless mandated by local health authority. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: Hepatitis B and Hepatitis C testing is not required unless mandated by local health authority. Has active TB (Bacillus Tuberculosis) infection. 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: Pembrolizumab
NSCLC, Stage I
Clinics and Surgery Center (CSC)
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Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

We are studying women who have triple negative or HER2 positive breast cancer and have received chemotherapy before surgery. We will do a breast MRI, with or without a biopsy, to see if results can predict if the cancer is completely gone.

Todd Tuttle, MD
Female
18 Years to old
STUDY00006873
STUDY00006873
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Inclusion Criteria:
Biopsy proven triple negative (TN) (ER-/PR-/HER2-) or HER2 positive (ERany/PRany/HER2+) breast cancer for which neoadjuvant chemotherapy is planned A biopsy clip placed at the time of diagnostic biopsy 18 years of age or older Must be able to read and write in English due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation Able to provide written consent prior to any research related activities
Exclusion Criteria:
Stage IV breast cancer T4 breast cancer Previous ipsilateral breast cancer Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery
Radiation: Standard Trimodality Breast Imaging
TN ER-/PR-/HER2- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, ERany/PRany/HER2+ Breast Cancer
Breast Cancer
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A MULTI-CENTER STUDY OF NON-INVASIVE COLORECTAL CANCER EVALUATION IN CYSTIC FIBROSIS (NICE-CF) (NICE-CF)

This multi-center study will compare multi-target DNA and quantitative FIT stool-based testing to colonoscopy in individuals with Cystic Fibrosis (CF) undergoing colon cancer screening with colonoscopy. The primary endpoint is detection of any adenomas, including advanced adenomas and CRC.

Shahnaz Sultan
All
30 Years to 75 Years old
STUDY00015837
STUDY00015837
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Inclusion Criteria:
Adults eligible for routine colon cancer screening: Adults with CF ages 40 - 75 years of age without history of transplant, or adults with CF age 30 - 75 who have had a transplant Cystic Fibrosis diagnosis, defined by a sweat chloride test result ≥ 60 mmol/L (may be of historic value), and/or documented CF-causing CFTR mutations and clinical features of CF Capable of understanding the purposes and risks of the study in English or Spanish and willing to participate and sign informed consent Referred for screening or surveillance colonoscopy for CRC (current standard of care) and willing to undergo colonoscopy and stool testing Able to access the Internet to complete self-administered surveys
Exclusion Criteria:
Any condition that, in the opinion of the site PI, introduces undue risk by participating in this study Incapable of understanding the purposes of the study or informed consent for any reason Pregnancy Active inflammatory bowel disease as defined by a prior diagnosis of Crohn's Disease or Ulcerative Colitis, based on both clinical and histopathologic findings and the individual currently on medical therapy for Crohn's disease or Ulcerative Colitis. Personal history of colon cancer diagnosis and treatment within 5 years of enrollment Symptoms that merit colonoscopy for diagnostic purposes rather than as screening for CRC
Procedure: Stool tests
Rare Diseases
Clinics and Surgery Center (CSC)
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MT2020-08 A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 in subjects with Relapsed/Refractory Non-Hodgkin Lymphoma and r/r B-cell Acute Lymphoblastic Leukemia

To evaluate the safety and tolerability of PBCAR0191 in subjects with r/r B-ALL and r/r NHL and find an appropriate dose to optimize safety and efficacy. To evaluate the clinical benefit of PBCAR0191 in subjects with r/r B-ALL and r/r NHL. To evaluate the clinical activity of PBCAR0191 in subjects with r/r B-ALL and r/r NHL.

Joseph Maakaron
All
18 Years to old
Phase 1/Phase 2
STUDY00009953
STUDY00009953
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Key Inclusion Criteria* Criteria for B-ALL: Subject has unequivocal r/r CD19+ B-ALL that has been confirmed by morphology, flow cytometry, or a validated minimal residual disease assay. Subjects with Philadelphia chromosome positive disease can be eligible if they are intolerant to tyrosine kinase inhibitor therapy or if they have r/r disease. Criteria for NHL: Subject has unequivocal aggressive CD19+ r/r B-cell NHL that is confirmed by archived tumor biopsy tissue from last relapse after CD19-directed therapy and corresponding pathology report. Alternatively, if at least 1 tumor involved site is accessible at time of Screening, the subject's diagnosis is confirmed by pretreatment biopsy (excisional when possible) or by flow cytometry of fine needle aspirate. If a subject never had a CR, a sample from the most recent biopsy is acceptable. NHL subtypes included but are not limited to: Diffuse large B-cell lymphoma (DLBCL) including Richter's transformation FL including Grade 3 or transformed FL High-grade B-cell lymphoma Primary mediastinal lymphoma Subject has measurable or detectable (for example positron emission tomography-positive) disease according to the Lugano Classification. Subject must have received at least 2 prior chemotherapy-containing regimens, consistent with standard of care treatment guidance (e.g., NCCN), unless no second line therapy of known benefit exists for a given subject. Other than those specifically prohibited, other therapies are allowed until 7 days prior to initiation of LD. In that case, all Screening safety laboratories and disease assessments must be performed after the last dose of prior therapy. For Richter's transformation, only 1 prior line of therapy is required for the DLBCL component. Subject has received no more than 7 systemic lines of anti-cancer therapy for the disease under study. Subjects previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product. Expansion cohort only: Subjects must have received autologous CD19-directed CAR T therapy and demonstrated clinical response to the treatment at Day 28 or later, followed by relapse. Criteria for both B-ALL and NHL: Eastern Cooperative Oncology Group performance status score of 0 or 1. An estimated life expectancy of at least 12 weeks according to the investigator's judgment. Seronegative for human immunodeficiency virus antibody (i.e., intact immune function). Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as: Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2 (calculated using the CKD-EPI equation [Levey et al, 2009]). If there is a concern that eGFR calculation is not an accurate reflection of renal function, a 24-hour urine collection for creatinine clearance may be used at the investigator's discretion. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels both ≤3 times of upper limit of normal (ULN), unless there is suspected disease in the liver. Total bilirubin <2.0 mg/dL, except in subjects with Gilbert's syndrome. Platelet count ≥50,000/μL and absolute neutrophil count of ≥1000/ μL. Platelet transfusions within 14 days of screening are not allowed except for subjects in B-ALL disease cohort with extensive bone marrow disease burden, in which case adequate bone marrow recovery after prior treatment is required to be documented. C-reactive protein (CRP) <2x ULN; subjects with CRP elevation within 2x ULN, ruling out infectious cause will be required. Left ventricular ejection fraction >45% as assessed by echocardiogram (ECHO) or multiple gated acquisition scan performed within 1 month before starting lymphodepleting chemotherapy. ECHO results performed within 6 months before Screening and at least 28 days after the last cancer treatment may be acceptable if the subject has not received any treatment with cardiotoxicity risks. No clinically significant evidence of pericardial effusion or pleural effusion causing clinical symptoms and needing immediate intervention, based on the investigator's opinion. Any known effusion must be stable without need for drainage within 2 weeks of enrollment. No clinically significant renal/pulmonary comorbidities. Baseline oxygen saturation >92% on room air. Key Exclusion Criteria* Criteria for B-ALL: Burkitt cell (L3 ALL) or mixed-lineage acute leukemia. No active central nervous system (CNS) disease. Subjects with a history of CNS involvement must have a documented CR on at least 2 imaging studies at least 3 months apart (with no masses in parenchyma and no ocular involvement) and a negative cerebrospinal fluid cytology on at least 2 evaluations (one evaluation may be during the Screening Period and the other must be at least 3 months prior). Criteria for NHL: No prior or active CNS disease. Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression. Active hemolytic anemia. Criteria for B-ALL and NHL: Subject has had a malignancy, besides the malignancies of inclusion (B-ALL or NHL), that in the investigator's opinion, has a high risk of relapse in the next 2 years. In the case of Richter's transformation, subjects may be enrolled with ongoing chronic lymphocytic leukemia/small lymphocytic lymphoma. Uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection that has not resolved and does require therapeutic anti-microbial medications at least 7 days prior to LD. Subjects with elevated CRP must undergo infectious disease workup and the recommendations discussed with medical monitor to be considered on an individual basis. The CRP must be trending toward the normal range for the laboratory with the exception when it's deemed related to the underlying malignancy. Any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease). Active hepatitis B or hepatitis C confirmed by PCR. Subject positive for inactive hepatitis B is allowed to enroll if on prophylactic treatment. Subject is seropositive for hepatitis B antigen with confirmation. If confirmatory tests are negative, the subject can be enrolled. Subject is seropositive for hepatitis C antibody unless antigen negative. If hepatitis C antibody test is positive, the subject must be tested for the presence of RNA by reverse transcription PCR and be hepatitis C virus-RNA negative. Any known uncontrolled cardiovascular disease at the time of Screening that, in the investigator's opinion, renders the subject ineligible, including but not limited to: Active ventricular or atrial dysrhythmia ≥ Grade 2, bradycardia ≥ Grade 2. Myocardial infarction within 6 months before Screening. Pulmonary embolism, deep vein thrombosis, or any other significant coagulopathy including disseminated intravascular coagulation. History of hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening. In case of hypertensive crisis caused by omission of well-established treatment regimen, transient and promptly stabilized, enrollment must be discussed and agreed upon with sponsor and medical monitor. History of severe immediate hypersensitivity reaction to any of the agents used in this study. Presence of a CNS disorder that, in the opinion of the investigator, renders the subject ineligible for treatment. Abnormal findings during the Screening Period or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety. History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or any other known bone marrow failure syndrome. Active uncontrolled autoimmune disease requiring active immunosuppression at the time of Screening (excluding subjects needing steroids for physiologic replacement). Subject has received stem cell transplant within 90 days before Screening. Subject has active GvHD symptoms. Subject has received systemic biologic agent for treatment of disease under study within 28 days of LD or other systemic anti-cancer therapy within 10 days of LD Note: this criterion does not apply if the subject has clear evidence of disease progression after such an agent has been administered and all AEs have resolved to a Grade 2 or less in severity. This should be discussed with the medical monitor for confirmation. Participation in noninterventional registries or epidemiological studies is not excluded. Radiotherapy within 4 weeks before Screening should be discussed with monitor and determined on a case-by-case basis. Presence of pleural/peritoneal/pericardial catheter, as well as biliary and ureteral stents (does not apply to intravenous lines). Subject has received live vaccine within 4 weeks before Screening. Non-live virus vaccines are not excluded. Subject has received CD19-directed therapy other than autologous CD19-directed CAR T therapy within 90 days of the anticipated start date of LD. Additional criteria apply
Drug: Cyclophosphamide, Drug: Fludarabine, Genetic: PBCAR0191
Non-Hodgkin Lymphoma, B-cell Acute Lymphoblastic Leukemia
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Targeting Family Meal Quality and Quantity to Reduce Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback

The proposed study is an individual three-arm randomized controlled tiled aimed at utilizing state-of-the-art intervention methods to examine whether increasing the quality and the quantity of family meals reduces childhood obesity.

Jerica Berge
Male or Female
up to 18 Years old
NA
This study is also accepting healthy volunteers
STUDY00000706
STUDY00000706
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Inclusion Criteria:
Child 5-10 years old; Have a sibling who lives in the home with the child; Live in the Metro area; Speaks English or Spanish
Behavioral: Ecological Momentary Intervention, Behavioral: Feedback on Video-recorded Family Meals, Behavioral: In-home Visits and Food Preparation Activities, Behavioral: Maintenance
Children's Health
family, family meals, nutrition, primary care
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Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.

Colum MacKinnon
All
18 Years to 89 Years old
N/A
1608M93561
1608M93561
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Inclusion Criteria:
diagnosis of idiopathic PD have undergone neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN) Existing 7T brain imagery
Exclusion Criteria:
history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs other significant neurological disorder history of dementia or cognitive impairment as found with UBACC (or MacCAT-CR) post-operative complications or adverse effects
Device: Deep Brain Stimulation
Parkinson's Disease
Clinics and Surgery Center (CSC)
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A Prospective Study of Acute Flaccid Myelitis (AFM) to Define Natural History, Risk Factors, and Pathogenetic Mechanisms

The overall objective of the study is to create a biorepository of specimens and associated clinical and outcome data for use in future studies of AFM, including virologic or immunologic assessments.

Mark Schleiss
Male or Female
up to 18 Years old
This study is also accepting healthy volunteers
STUDY00008961
STUDY00008961
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Inclusion Criteria:

• Experiencing flaccid limb weakness involving one or more limbs with diagnosis of suspected Acute Flaccid Myelitis (AFM)
• Weakness started less than 30 days ago
• Child weighs at least 7.8 kg
• Had or will have a MRI of the spinal cord
• For " Healthy Household Comparators": lived in the same home as the child who is thought to have AFM (within the past 30 days) and weight at least 6.0 kg
Exclusion Criteria:

• Known condition other than AFM causing the flaccid limb weakness
Bone, Joint & Muscle, Rare Diseases
Acute Flaccid Myelitis (AFM)
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Advancing Liver Therapeutic Approaches (ALTA). The ALTA Consortium Study Group for the management of portal hypertension A 5-year longitudinal observational study of patients with cirrhosis undergoing TIPS placement

ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.

Nicholas Lim
All
18 Years to old
STUDY00014403
STUDY00014403
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Inclusion Criteria:
Subjects over the age of 18 able to provide consent or have a legally authorized consent in the event the subject is unable to consent due to a transient clinical condition Subject scheduled to undergo a TIPS procedure
Exclusion Criteria:
Minors under the age of 18 at the time of enrollment Prisoners Pregnant Women Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care
Cirrhosis, Liver, Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Clinics and Surgery Center (CSC)
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A RANDOMIZED PHASE III TRIAL OF OLANZAPINE VERSUS MEGESTROL ACETATE FOR CANCER-ASSOCIATED ANOREXIA (ALLIANCE A222004)

To determine whether olanzapine leads to greater appetite improvement from baseline in cancer patients suffering from anorexia compared to megestrol acetate using the 0-10 numerical rating scale (NRS).

Arjun Gupta
Male or Female
18 Years and over
STUDY00014956
STUDY00014956
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Inclusion Criteria:

• Diagnosis of advanced cancer
• Patient-reported 2-month weight loss of at least 5 pounds (2.3 kilograms) and/or physician-estimated caloric intake of less than 20 calories/kilogram of body weight per day
• The patient must perceive loss of appetite and/or weight as a problem; and have an appetite score of 4 or worse on the "Please rate your appetite?." question that requires a patient response on a 0-10 numeric rating scale
• Not receiving ongoing tube feedings or parenteral nutrition at the time of registration
Exclusion Criteria:

• Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
• Patients who cannot swallow oral formulations of the agents
Drug: Megestrol Acetate, Drug: Olanzapine, Other: Questionnaire Administration
Cancer
Clinics and Surgery Center (CSC)
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MT2017-17: T cell receptor Alpha/Beta T Cell Depleted Hematopoietic Cell Transplantation in Patients with Fanconi Anemia (FA)

The primary objective is to determine the incidence of grade II-IV acute graft versus host disease (GVHD) by Day 100 using an alpha/beta T cell depleted peripheral blood stem cells (PBSC) and without routine GVHD prophylaxis.

Margaret MacMillan, MD
All
to 65 Years old
STUDY00003182
STUDY00003182
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Patient Selection:
Inclusion Criteria:
Diagnosis of Fanconi anemia Less than 65 years of age Karnofsky performance status of ≥ 70% or, for children < 16 years of age, Lansky Play Score ≥ 50 Presence of at least one of the following risk factors: Severe aplastic anemia (SAA) defined as: Aplastic anemia is defined as having at least one of the following when not receiving growth factors or transfusions: platelet count <20 x 109/L absolute neutrophil count of <5 x 108/L hemoglobin <8 g/dL Myelodysplastic syndrome (MDS) or acute leukemia High risk genotype Adequate organ function defined as: Bilirubin, AST or ALT, ALP <5 x normal, Cardiac: left ventricle ejection fraction (LEFV) ≥45% by ECHO Pulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note. Identification of a suitable donor for peripheral blood cells per match criteria found in Section 5. Females of childbearing potential and males with partners of child-bearing potential must agree to use of contraception for the duration of treatment and 4 months after the transplant Able to provide written voluntary consent prior to the performance of any research related tests or procedures with parental/guardian consent for minor (and assent as appropriate)
Exclusion Criteria:
Pregnant or breastfeeding as the treatment used in this study are Pregnancy Category D. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days of study registration Active, uncontrolled infection within 1 week prior to starting study therapy Malignant solid tumor cancer within previous 2 years Donor Selection (Inclusion Criteria): meets one of the following match criteria: an HLA-A, B, DRB1 matched sibling donor (matched sibling) an HLA-A, B, DRB1 matched related donor (other than sibling) a related donor mismatched at 1 HLA-A, B, C and DRB1 antigen 7-8/8 HLA-A,B,C,DRB1 allele matched unrelated donor per current institutional guidelines Patients and donors are typed for HLA-A and B using serological or molecular techniques and for DRB1 using high resolution molecular typing. If a donor has been selected on the basis of HLA-A, B, C and DRB1 typing as above, preference will be made for donors matched at the HLA-C locus. Body weight of at least 40 kilograms and at least 12 years of age Willing and able to undergo mobilized peripheral blood apheresis In general good health as determined by the medical provider Adequate organ function defined as: Hematologic: hemoglobin, WBC, platelet within 10% of upper and lower limit of normal range of test (gender based for hemoglobin) Hepatic: ALT < 2 x upper limit of normal Renal: serum creatinine < 1.8 mg/dl Performance of a donor infectious disease screen panel including CMV Antibody, Hepatitis B Surface Antigen, Hepatitis B Core Antibody, Hepatitis C Antibody, HIV 1/2 Antibody, HTLVA 1/2 Antibody, Treponema, and Trypanosoma Cruzi (T. Cruzi) plus HBV, HCV, WNV, HIV by nucleic acid testing (NAT); and screening for evidence of and risks factors for infection with Zika virus, or per current standard institutional donor screen - must be negative for HIV and active hepatitis B Not pregnant - females of childbearing potential must have a negative pregnancy test within 7 days of mobilization start Voluntary written consent (parent/guardian and minor assent, if < 18 years) prior to the performance of any research related procedure
Drug: Busulfan, Drug: Cyclophosphamide (CY) (Plan 1), Drug: Cyclophosphamide (CY) (Plan 2), Device: Donor mobilized PBSC infusion, Drug: Fludarabine (FLU), Drug: G-CSF, Drug: Methylprednisolone (MP), Drug: Rituximab, Drug: Total Body Irradiation (TBI) (Plan 1)
Fanconi Anemia, Myelodysplastic Syndromes, Severe Aplastic Anemia
Clinics and Surgery Center (CSC)
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R01HL153613: Comprehensive Proteomic Classifier for the Molecular Characterization of Pulmonary Sarcoidosis

This study proposes to collect lung fluid to identify potential biomarkers associated with pulmonary sarcoidosis, and to compare those with healthy controls.

Maneesh Bhargava
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00013734
STUDY00013734
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Inclusion Criteria:

• Age 18-80
• Those living with Sarcoidosis: Contact umnsarc@umn.edu for inclusion/exclusion criteria
Exclusion Criteria:

• History/Current use of cigarette, e-cigarette, vaping or marijuana smoking
• History/Current use of nicotine products
• Presence of underlying chronic condition
• Inability to undergo procedure using IV sedation
• Weight < 110 lbs. & BMI > 35 kg/m2
• Pregnant and/or breast feeding
• History/Current use of chronic immunosuppressive medications
• Those living with Sarcoidosis: Contact umnsarc@umn.edu for inclusion/exclusion criteria
Breathing, Lung & Sleep Health, Respiratory System
Sarcoid, Lung, Pulmonary, Sarcoidosis, Clinics and Surgery Center (CSC)
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RPC01-3202: INDUCTION STUDY #2 - A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN S DISEASE

This is a Phase 3, randomized, double-blind, placebo-controlled study to determine the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active CD, defined as a CDAI score ≥ 220 to ≤ 450. Approximately 600 subjects with active clinical symptoms and mucosal inflammation will be randomized in a 2:1 ratio to receive either ozanimod or placebo. Subjects will be stratified by prior biologic use and corticosteroid use at baseline. Approximately 50% of subjects with a history of treatment with marketed biologic agents (eg, TNF antagonists, anti-IL-12/23 and anti-integrin therapy) will be recruited. This limit will ensure the enrollment of subjects who have failed or been intolerant to corticosteroids or immunomodulators but never failed a TNF antagonist.

Eugenia Shmidt
All
18 Years to 75 Years old
Phase 3
STUDY00003227
STUDY00003227
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
Crohn's disease for ≥ 3 months on endoscopy and on histological exam Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450 Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)
Exclusion Criteria:
Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention Extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition Current stoma, ileal-anal pouch anastomosis, or fistula Other protocol-defined inclusion/exclusion criteria apply
Drug: Ozanimod, Other: Placebo
Digestive & Liver Health
inflammatory bowel disease, Clinics and Surgery Center (CSC)
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Plasticity of motor systems in early stage Parkinson's disease

The purpose of this project is to provide new knowledge of the relationship between structural and functional changes in cortico-basal ganglia pathways and the severity of motor and non-motor deficits in humans with PD.

Colum MacKinnon
Male or Female
18 Years and over
This study is also accepting healthy volunteers
STUDY00008043
STUDY00008043
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Inclusion Criteria:
Inclusion Criteria For PD Group:
• Diagnosis of Parkinson's disease
• Not taking medication to treat Parkinson's
• Age: 21-75 years.
• Able to walk independently Inclusion Criteria For Control Subject Group:
• Age and sex matched to participants with PD.
• Able to walk independently
Exclusion Criteria:
Exclusion criteria for PD group:
• Dementia diagnosis
• History of musculoskeletal disorders
• History of bipolar disorder, post-traumatic stress disorder or major depressive disorder.
• Other significant neurological disorders that may affect participation or performance in the study.
• Implanted DBS or other neurosurgeries to treat PD.
• Pregnant women.
• History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
• Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
• Pacemaker or any implanted device
• History of surgery on blood vessels, brain, or heart
• Unexplained, recurring headaches or concussion within the last six months
• Severe hearing impairment Exclusion Criteria for Control subject Group:
• Same as exclusion criteria of PD group
Diagnostic Test: Neuroimaging, Diagnostic Test: Quantitative assessments
Brain & Nervous System
Parkinson
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Web-based Automated Imaging Differentiation of Parkinsonism

The purpose of this study is to test the performance of the wAID-P across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.

Paul Tuite
Male or Female
18 Years and over
STUDY00012513
STUDY00012513
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Inclusion Criteria:

• Adults 40-80 years old
• Diagnosed with progressive supranuclear palsy or multiple system atrophy
Exclusion Criteria:

• People who have an implanted electrical device such as a cardiac pacemaker, ICD or neurostimulator, or a metal aneurysm clip.
• History of metalworking involving cutting processes such as grinding, filing, shaving, and threading
• People who are claustrophobic
• Women who are pregnant or breast feeding
Brain & Nervous System
Neurological Disorder, Movement Disorder, Progressive Supranuclear Palsy, Multiple System Atrophy, Clinics and Surgery Center (CSC)
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MT2014-10C : Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders

Ashish Gupta
All
to 55 Years old
N/A
1407M52125
1407M52125
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Inclusion Criteria:
Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated Acceptable stem cell source identified Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score) Creatinine <2.0 mg/dl for adults or glomerular filtration rate > 50 ml/min for children Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase <5 times the upper limit of institutional normal Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%
Exclusion Criteria:
active, uncontrolled infection pregnant or breastfeeding HIV positive
Drug: Myeloablative Preparative Regimen, Drug: Reduced Intensity Preparative Regimen, Drug: Reduced Toxicity Ablative Regimen
Sickle Cell Disease, Transfusion Dependent Alpha- or Beta- Thalassemia, Diamond Blackfan Anemia, Paroxysmal Nocturnal Hemoglobinuria, Glanzmann Thrombasthenia, Severe Congenital Neutropenia, Shwachman-Diamond Syndrome, Non-Malignant Hematologic Disorders
Clinics and Surgery Center (CSC)
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A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

The purpose of this trial is to evaluate the efficacy, safety, and tolerability of BI 1015550 9 mg bid and 18 mg bid compared to placebo in patients with progressive fibrosing ILDs in addition to patient’s standard of care over the course of at least 52 weeks. New treatments with better tolerability are needed for patients with ILDs to further reduce the decline in lung function and improve quality of life. Based on its anti-inflammatory and antifibrotic properties and the preliminary clinical evidence described, BI 1015550 may provide an additional treatment option to patients with progressive pulmonary fibrosis irrespective of concomitant treatment with standard of care.

Hyun Kim
All
18 Years to old
STUDY00016654
STUDY00016654
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Inclusion criteria Patients ≥18 years old at the time of signed informed consent. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed). Patients may be either: on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. (*stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks) not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1. DLCO corrected for Hemoglobin (Hb) [Visit 1] ≥25% and <90% predicted of normal at Visit 1. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. Of note, oral hormonal contraceptives are not considered a highly effective method due to potential drug-drug interactions. Patients treated with permitted immunosuppressive agents for an underlying systemic disease (e.g. Methotrexate (MTX), Azathioprine (AZA)) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period. Exclusion criteria Relevant airways obstruction (prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) <0.7) at Visit 1 In the opinion of the Investigator, other clinically significant pulmonary abnormalities. Acute Interstitial Lung Disease (ILD) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined). Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis. Patients having developed ILD due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection/coronavirus disease 2019 (COVID-19) within 12 months of screening (based on investigators judgement). Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix. Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) >2.5 x upper limit of normal (ULN) or total Bilirubin >1.5 x ULN at Visit 1. Further exclusion criteria apply.
Drug: BI 1015550, Drug: Placebo
Lung Diseases, Interstitial
Clinics and Surgery Center (CSC)
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COG ARST2031: A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)

his phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. Cyclophosphamide is in a class of medications called alkylating agents. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work by slowing or stopping the growth of cancer cells in the body. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.

Emily Greengard
All
to 50 Years old
STUDY00017650
STUDY00017650
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Inclusion Criteria:
Patients must be =< 50 years of age at the time of enrollment Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification are eligible to enroll on the study based upon stage, group, and age, as below. FOXO1 fusion status must be determined by week 4 (day 28) of therapy. RMS types included under embryonal RMS (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) Classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Classification of alveolar RMS (ARMS) in the 2020 WHO Classification is the same as in the ICR and includes classic and solid variants ERMS Stage 4, group IV, >= 10 years of age ARMS Stage 4, group IV Patients will be eligible to remain on protocol therapy based upon stage, group, and age Bone marrow metastatic disease is based on morphologic evidence of RMS based on hematoxylin and eosin (H&E) stains. In the absence of morphologic evidence of marrow involvement on H&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study 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 (must be performed within 7 days prior to enrollment): Age; Maximum serum creatinine (mg/dL) 1 month to < 6 months; 0.4 mg/dL (male); 0.4 mg/dL (female) 6 months to < 1 year; 0.5 mg/dL (male); 0.5 mg/dL (female) 1 to < 2 years; 0.6 mg/dL (male); 0.6 mg/dL (female) 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 (must be performed within 7 days prior to enrollment) If there is evidence of biliary obstruction by tumor, then total bilirubin must be < 3 x ULN for age 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
Exclusion Criteria:
Patients with evidence of uncontrolled infection are not eligible RMS that is considered a second malignancy and previous cancer(s) that were treated with chemotherapy and/or radiation. Surgical resection alone of previous cancer(s) is allowed Patients with central nervous system involvement of RMS as defined below: Malignant cells detected in cerebrospinal fluid Intra-parenchymal brain metastasis separate and distinct from primary tumor (i.e., direct extension from parameningeal primary tumors is allowed). Diffuse leptomeningeal disease Patients who have received any chemotherapy (excluding steroids) and/or radiation therapy for RMS prior to enrollment. Note: the following exception: Patients requiring emergency radiation therapy for RMS. These patients are eligible, provided they are consented to ARST2031 prior to administration of radiation Note: Patients who have received or are receiving chemotherapy or radiation for non-malignant conditions (e.g. autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy Vincristine and vinorelbine are sensitive substrates of CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment Female patients who are pregnant 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 Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Procedure: Bone Scan, Procedure: Computed Tomography, Drug: Cyclophosphamide, Biological: Dactinomycin, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Radiation: Radiation Therapy, Drug: Vincristine Sulfate, Drug: Vinorelbine Tartrate, Procedure: X-Ray Imaging
Alveolar Rhabdomyosarcoma, Botryoid-Type Embryonal Rhabdomyosarcoma, Embryonal Rhabdomyosarcoma, Metastatic Embryonal Rhabdomyosarcoma, Metastatic Rhabdomyosarcoma, Solid Alveolar Rhabdomyosarcoma, Spindle Cell Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma
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DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Compare overall survival for subjects treated with docetaxel versus subjects treated with docetaxel plus radium-223.

Gautam Jha
Male
18 Years to old
Phase 3
STUDY00011960
STUDY00011960
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Inclusion Criteria:
Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. Males 18 years of age and above Histological or cytological proof of prostate cancer Documented progressive mCRPC based on at least one of the following criteria: PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL. Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan. Two or more bone lesions ECOG 0- 1 Normal organ function with acceptable initial laboratory values within 14 days of randomization: Albumin > 30 g/L ANC ≥ 1.5 x 10^9/L Hemoglobin ≥ 10 g/dL Platelet count ≥ 100 x 10^9/L Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN) Bilirubin ≤ ULN (unless documented Gilbert's disease) SGOT (AST) ≤ 1.5 x ULN SGPT (ALT) ≤ 1.5 x ULN WBC count ≥ 3 x 10^9/L Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent. Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy. All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less. Willing and able to comply with the protocol, including follow-up visits and examinations
Exclusion Criteria:
Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization. Received external beam radiotherapy within the 4 weeks prior to randomization. Has an immediate need for external beam radiotherapy. Has received any systemic bone-seeking radiopharmaceutical in the past. Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel. Has received four or more systemic anticancer regimens for mCRPC. Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines. Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation. Has received blood transfusions or growth factors within the last 4 weeks prior to randomization. Symptomatic nodal disease (i.e., scrotal, penile, or leg edema). Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization. Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms. Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years. Has imminent or established cord compression based on clinical findings and/or MRI. Known bone marrow dysplasia Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to: Uncontrolled infection NYHA III or IV heart failure Crohn's disease or those with ulcerative colitis who have not undergone a colectomy Known active infection with HIV, Hepatitis B or Hepatitis C
Drug: Docetaxel 60 mg/m2, Drug: Docetaxel 75 mg/m2, Drug: Radium-223
Prostate Cancer
Clinics and Surgery Center (CSC)
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A Phase I/II, Multicenter, Open-Label, Single-Dose, Dose-Ranging Study to Assess the Safety and Tolerability of ST-920, a AAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects with Fabry Disease

Chester Whitley, MD, PhD
All
18 Years to old
Phase 1/Phase 2
STUDY00007094
STUDY00007094
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Inclusion Criteria:
≥ 18 years of age Documented diagnosis of Fabry disease One or more of the following symptoms: i) cornea verticillata, ii) acroparesthesia, iii) anhidrosis, iv) angiokeratoma Subject must be fully vaccinated (as per the Centers for Disease Control and Prevention (CDC) definition in the US and as per local guidelines in other countries) for COVID-19 at least one month prior to dosing Additional
Inclusion Criteria:
Renal Cohort: Screening eGFR value between 40-90 mL/min/1.73 m² Linear negative eGFR slope (estimated from at least 3 serum creatinine values within 18 months, including the value obtained during screening visit) of ≥ 2 mL/min/1.73m²/year Cardiac Cohort: • Left ventricular hypertrophy (LVH) in 2D echocardiography or CMR defined as an end diastolic septum and posterior wall thickness ≥12 mm with no other explanation for LVH, OR presentation with cardiac changes indicative of disease progression such as decreased global longitudinal strain on 2D strain echocardiography or low native T1 mapping on CMR
Exclusion Criteria:
Neutralizing antibodies to AAV6 eGFR < 40 ml/min/1.73m2 New York Heart Association Class III or higher Active infection with hepatitis A, B or C, HIV or TB History of liver disease such as clinically significant steatosis, fibrosis, non-alcoholic steatohepatitis (NASH) and cirrhosis, biliary disease within 6 months of informed consent; except for Gilbert's syndrome Elevated circulating serum AFP Recent or recurrent hypersensitivity response to ERT within within 6 months prior to consent Current or history of systemic (IV or oral) immunomodulatory agents, or biologics or steroid use in the past 6 months prior to consent (topical treatment and inhaled allowed). Contraindication to use of corticosteroids History of malignancy except for non-melanoma skin cancer and localized prostate cancer treated with curative intent Recent history of alcohol or substance abuse Participation in investigational interventional drug or medical device study throughout the duration of this study and within previous 3 months prior to consent Prior treatment with a gene therapy product Known hypersensitivity to components of ST-920 formulation Any other reason that, in the opinion of the Site Investigator or Medical Monitor, would render the subject unsuitable for participation in the study including but not limited to risk of COVID-19 infection Additional exclusion criteria for: Renal cohort: History of renal dialysis or transplantation History of acute kidney insufficiency in the 6 months prior to screening Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy initiated within 4 weeks prior to screening or changed ACE inhibitor or ARB dose in the 4 weeks prior to screening Urine protein to creatinine ratio (UPCR) > 0.5 g/g who are not being treated with an ACE inhibitor or ARB Cardiac cohort: Significant cardiac fibrosis defined by late gadolinium enhancement on CMR Any contraindications to CMR as per local hospital/institution guidelines Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy initiated within 4 weeks prior to screening or changed ACE inhibitor or ARB dose in the 4 weeks prior to screening NYHA Class IV
Biological: ST-920
Fabry Disease
Sangamo, Rare, Lysosomal Storage Disease, Gene Therapy
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Measurement of Glucose Homeostasis in Human Brain by NMR: Effect of Recurrent Hypoglycemia on Type 1 Diabetes (Aim 2)

To measure glucose transport in the frontal cortex and hypothalamus in subjects with T1D before and after induction of impaired awareness of hypoglycemia (IAH). Kinetic parameters for glucose transport and metabolism will be measured using hyperglycemic clamps at 3T at baseline and after recurrent HG.

Elizabeth Seaquist
All
18 Years to 65 Years old
N/A
STUDY00008108
STUDY00008108
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Inclusion Criteria:
Type 1 diabetes diagnosed on clinical or laboratory grounds Diabetes duration 2 - 30 years Hemoglobin A1C <8.5%
Exclusion Criteria:
Impaired awareness of hypoglycemia as determined by the Cox and Gold questionnaires Pregnant or plan to become pregnant during the study period Uncontrolled hypertension (blood pressure > 145/95 mmHg at screening) Evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis) Proliferative retinopathy Impaired kidney function (GFR < 45) History of myocardial infarction, stroke, seizures, neurosurgical procedures, major depression requiring hospitalization within the last 5 years, arrhythmias Current substance abuse Use of drugs that can alter glucose metabolism including but not limited to glucocorticoids and niacin, and excluding insulin and glucose lowering drugs used to treat diabetes, as determined by a clinician Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs Unable to complete all study visits or procedures, as determined by the investigator
Other: Experimental hyperglycemia
Diabetes Mellitus, Type 1
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