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387 Study Matches

Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) and Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF)

This study is a randomized, double-blind, parallel-group, placebo-controlled, multicenter, event-driven Phase 3 study with independently adjudicated clinical outcome assessments.

Tamas Alexy
Phase III
This study is NOT accepting healthy volunteers
NCT04435626
STUDY00010807
Heart Failure
Heart Failure with Preserved Ejection Fraction,, Mineralocorticoid receptor antagonist (MRA), Clinics and Surgery Center (CSC)
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MT2019-09: A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCR alpha beta +/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Blood and Marrow Transplant Consortium (PBMTC) PIDTC CSIDE Protocol (CSIDE)

To determine the incidence of humoral immune reconstitution by 2 years post-transplant in 2 SCID cohorts (IL2RG/JAK3, RAG1/RAG2) undergoing alternative donor HCT by randomized assignment to a busulfan preparative regimen targeted at cumulative area-under-the-curve (cAUC) exposure of 25-35 mg*h/L vs 55-65 mg*h/ L.

Christen Ebens
All
up to 2 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03619551
STUDY00006513
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Inclusion Criteria:

• Infants with SCID, either typical or leaky or Omenn syndrome.
• Typical SCID is defined as either of the following
• Absence or very low number of T cells (CD3+ T cells <300/microliter AND no or very low T cell function (<10% of lower limit of normal) as measured by response to phytohemagglutinin OR
• Presence of maternally derived T cells
• Leaky SCID is defined as the following • Absence of maternally derived T cells • AND either one or both of the following (i, ii): i) <50% of lower limit of normal T cell function as measured by response to PHA OR <30% of lower limit of normal T cell function as measured by response to CD3 ii) Absent or <10% of lower limit of normal proliferative responses to candida and tetanus toxoid antigens (must document post vaccination or exposure for this criterion to apply) • AND at least two of the following (i through iii): i) CD3 T cells < 1500/microliter ii) >80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative AND/OR >50% of CD3+ or CD4+ T cells express HLA-DR (at < 4 years of age) AND/OR are oligoclonal T iii) Low TRECs and/or the percentage of CD4+/45RA+/CD31+ or CD4+/45RA+/CD62L+ cells is below the lower level of normal.
• Omenn syndrome • Generalized skin rash
• Maternal lymphocytes tested for and not detected.
• >80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative AND/OR >50% of CD3+ or CD4+ T cells express HLA-DR (<2 years of age)
• Absent or low (up to 30% lower limit of normal (LLN)) T cell proliferation to antigens (Candida, tetanus) to which the patient has been exposed IF: Proliferation to antigen was not performed, but at least 4 of the following 8 supportive criteria, at least one of which must be among those marked with an asterisk (*) below are present, the patient is eligible as Omenn Syndrome.
• Hepatomegaly
• Splenomegaly
• Lymphadenopathy
• Elevated IgE
• Elevated absolute eosinophil count
• *Oligoclonal T cells measured by CDR3 length or flow cytometry (upload report)
• *Proliferation to PHA is reduced to < 50% of lower limit of normal (LLN) or SI < 30
• *Low TRECs and/or percentage of CD4+/RA+ CD31+ or CD4+/RA+ CD62L+ cells below the lower level of normal
• Documented mutation in one of the following SCID-related genes a. Cytokine receptor defects (IL2RG, JAK3) b. T cell receptor rearrangement defects (RAG1, RAG2) 3. No available genotypically matched related donor (sibling) 4. Availability of a suitable donor and graft source
• Haploidentical related mobilized peripheral blood cells
• 9/10 or 10/10 allele matched (HLA-A, -B, -C, -DRB1, -DQB1) volunteer unrelated donor mobilized peripheral blood cells 5. Age 0 to 2 years at enrollment Note: to ensure appropriate hepatic metabolism, age at time of busulfan start: For IL2RG/JAK3: 8 weeks For RAG1/RAG2: 12 weeks
• Adequate organ function defined as:
• Cardiac: Left ventricular ejection fraction (LVEF) at rest ≥ 40% or, shortening fraction (SF) ≥ 26% by echocardiogram.
• Hepatic: Total bilirubin < 3.0 x the upper limit of normal (ULN) for age (patients who have been diagnosed with Gilbert's Disease are allowed to exceed this limit) and AST and ALT < 5.0 x ULN for age.
• Renal: GFR estimated by the updated Schwartz formula ≥ 90 mL/min/1.73 m2. If the estimated GFR is < 90 mL/min/1.73 m2, then renal function must be measured by 24-hour creatinine clearance or nuclear GFR, and must be > 50 mL/min/1.73 m2.
• Pulmonary No need for supplemental oxygen and O2 saturation > 92% on room air at sea level (with lower levels allowed at higher elevations per established center standard of care).
Exclusion Criteria:

• Presence of any serious life-threatening or opportunistic infection at time of enrollment and prior to the initiation of the preparative regimen. Serious infections as defined below that occur after enrollment must be reported immediately to the Study Coordinating Center, and enrollment will be put on hold until the infection resolves. Ideally enrolled subjects will not have had any infection. If patients have experienced infections, these must have resolved by the following definitions: a. Bacterial i. Positive culture from a sterile site (e.g. blood, CSF, etc.): Repeat culture(s) from same site must be negative and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). ii. Tissue-based clinical infection (e.g. cellulitis): Complete resolution of clinical signs (e.g. erythema, tenderness, etc.) and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). iii. Pneumonia, organism not identified by bronchoalveolar lavage: Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.) and patient has completed appropriate course of antibacterial therapy (typically at least 10 days). If possible, radiographic resolution should also be demonstrated. b. Fungal i. Positive culture from a sterile site (e.g. blood, CSF, etc.): Repeat culture(s) from same site is negative and patient has completed appropriate course of antifungal therapy (typically at least 14 days). The patient may be continued on antifungal prophylaxis following completion of the treatment course. c. Pneumocystis i. Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.) and patient has completed appropriate course of therapy (typically at least 21 days). If possible, radiographic resolution should also be demonstrated. The patient may be continued on prophylaxis following completion of the treatment course. d. Viral i. Viral PCRs from previously documented sites (blood, nasopharynx, CSF) must be re-tested and are negative. ii. If re-sampling a site is not clinically feasible (i.e. BAL fluid): Complete resolution of clinical signs (e.g. tachypnea, oxygen requirement, etc.). If possible, radiographic resolution should also be demonstrated.
• Patients with HIV or HTLV I/II infection will be excluded.
Drug: Busulfan, Device: Cell processing for TCRαβ+/CD19+ depletion
SCID
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MT2020-39: AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter, Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab at 3 Different Doses in Patients with Recurrent of Refractory Active Chronic Graft Versus Host Disease who have Received at least 2 Lines of Systemic Therapy (AGAVE-201)

The purpose of this study is to compare how well axatilimab helps cGVHD at different dose levels and to find out whether there are side effects from its use.

Shernan Holtan
All
2 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04710576
STUDY00011666
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Inclusion Criteria:

• Participants must be 2 years of age or older, at the time of signing the informed consent.
• Participants who are allogeneic hematopoietic stem cell transplantation (HSCT) recipients with active cGVHD requiring systemic immune suppression. Active cGVHD is defined as the presence of signs and symptoms of cGVHD per 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.
• Participants with refractory or recurrent active cGVHD despite at least 2 lines of systemic therapy.
• Refractory disease defined as meeting any of the following criteria:
• The development of 1 or more new sites of disease while being treated for cGVHD.
• Progression of existing sites of disease despite at least 1 month of standard or investigation therapy for cGVHD.
• Participants who have not achieved a response within 3 months on their prior therapy for cGVHD and for whom the treating physician believes a new systemic therapy is required.
• Recurrent cGVHD is active, symptomatic disease (after an initial response to prior therapy) as defined, based on the NIH 2014 consensus criteria, by organ-specific or global assessment or for which the physician believes that a new line of systemic therapy is required.
• Participants may have persistent, active acute and cGVHD manifestations (overlap syndrome), as defined by 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.
• Karnofsky Performance Scale of ≥60 (if aged 16 years or older); Lansky Performance Score of ≥60 (if aged <16 years)
• Adequate organ and bone marrow functions evaluated during the 14 days prior to randomization.
• Creatinine clearance (CrCl) ≥30 milliliter/minute/1.73 square meter based on the Cockcroft-Gault formula in adult participants and Schwartz formula in pediatric participants.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Concomitant use a of systemic corticosteroid is allowed but not required. Topical and inhaled corticosteroid agents are allowed. If a participant is taking corticosteroids at study randomization, they must be on a stable dose of corticosteroids for at least 2 weeks prior to Cycle 1 Day 1.
• Concomitant use of CNI or sirolimus is allowed but not required.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol. A parent/guardian should provide consent for pediatric participants unable to provide consent themselves; in addition, where applicable pediatric participants should sign their own assent form.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
• Has acute GVHD without manifestations of cGVHD.
• Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
• History of acute or chronic pancreatitis.
• History of myositis.
• History or other evidence of severe illness, uncontrolled infection or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study.
• Participants with acquired immune deficiency syndrome (AIDS).
• Hepatitis B (defined as hepatitis B virus [HBV] surface antigen positive and HBV core antibody positive, with positive HBV deoxyribonucleic acid [DNA], or HBV positive core antibody alone with positive HBV DNA. Hepatitis C (defined as positive hepatitis C [HCV] antibody with positive HCV ribonucleic acid [RNA]).
• Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of randomization, unless previously treated with curative intent and approved by Sponsor's Medical Monitor (for example, completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection).
• Female participant who is pregnant or breastfeeding.
• Previous exposure to CSF1-R targeted therapies.
• Taking agents for treatment of cGVHD other than corticosteroids and either a CNI or sirolimus is prohibited.
• For approved or commonly used agents, other than corticosteroids, CNI and sirolimus, a washout of 2 weeks or 5 half-lives, whichever is shorter, is required at study enrollment.
• Receiving another investigational treatment within 28 days of randomization.
• Participants should not be participating in any other interventional study. Pediatric participants are encouraged to also participate in the ongoing developmental studies of the Pediatric cGVHD Symptom Scale (PCSS).
Drug: Axatilimab
Chronic Graft-versus-host-disease
cGVHD, AGAVE-201, GVHD, graft versus host disease, graft-versus-host-disease, Clinics and Surgery Center (CSC)
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A Phase 2/3, Two-Part, Open-Label, Dose Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 months to < 12 Years of Age (mRNA-1273-P204) - COVID-19

The Sponsor of this study, ModernaTX, is studying the mRNA-1273 vaccine for the prevention of COVID-19 in children. This study is being conducted to learn about the safety, any side effects, and how your child’s body responds to the study vaccine (the “immune response”).

Shane McAllister
Phase II/III
This study is also accepting healthy volunteers
NCT04796896
STUDY00012613
SARS-CoV-2
COVID-19, COVID-19 Vaccine, Coronavirus, Messenger RNA, Moderna, SARS-CoV-2, SARS-CoV-2 Vaccine, Virus Diseases, mRNA-1273, mRNA-1273 vaccine
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A Safety and Pharmacokinetic Study of Single Agent REGN2810 in Pediatric Patients with Relapsed or Refractory Solid or Central Nervous System (CNS) Tumors and a Safety and Efficacy Trial of REGN2810 in Combination with Radiotherapy in Pediatric Patients with Newly Diagnosed Diffuse Intrinsic Pontine Glioma, Newly Diagnosed High-Grade Glioma, or Recurrent High-Grade Glioma (PNOC013)

Phase I will include children 0 years of age to <18 years of age with recurrent or refractory solid or CNS tumors. Efficacy Phase will include children and young adults ≥3 years of age and <25 years of age with newly diagnosed diffuse intrinsic pontine glioma (DIPG), newly diagnosed high-grade glioma (HGG), or recurrent HGG.

Christopher Moertel, MD
All
up to 25 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03690869
STUDY00004561
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Key
Inclusion Criteria:

• Age 0 to <18 years of age (Phase 1)
• Age ≥3 and ≤25 years of age (Efficacy Phase)
• Karnofsky performance status ≥50 (patients >16 years) or Lansky performance status ≥50 (patients ≤ 16 years)
• Life expectancy >8 weeks
• Adequate Bone Marrow Function
• Adequate Renal Function
• Adequate Liver Function
• Adequate Neurologic Function Key
Exclusion Criteria:

• Patients with bulky metastatic disease of the CNS causing Uncal herniation or symptomatic midline shift, significant, symptomatic mass effect, or uncontrolled neurological symptoms such as seizures or altered mental status
• Patients with metastatic spine disease and gliomatosis as documented by diffuse involvement of >2 lobes
• Patients who are receiving any other investigational anticancer agent(s)
• Patients on greater than dexamethasone 0.1 mg/kg/day (maximum 4 mg/day) or equivalent dose in alternate corticosteroid, or actively undergoing corticosteroid dose escalation in the last 7 days
• Patients with a history of allogeneic stem cell transplant
• Prior treatment with an agent that blocks the PD-1/PD-L1/PD-L2 pathway Note: Other protocol-defined Inclusion/Exclusion criteria apply
Drug: cemiplimab (monotherapy), Drug: cemiplimab (maintenance), Radiation: Conventional or hypofractionated, Radiation: Re-irradiation
Relapsed Solid Tumor, Refractory Solid Tumor, Relapsed Central Nervous System Tumor, Refractory Central Nervous System Tumor, Diffuse Intrinsic Pontine Glioma, High Grade Glioma
Newly Diagnosed, Recurrent, Refractory
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Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents with Severe Obesity

In this study we want to find out more about weight loss and how diet and medications can affect weight loss. This study will last for up to 58 weeks. There are two phases to the study: - A weight loss phase with prescribe meals that lasts 6 weeks. - A study medication/placebo phase that lasts up 52 weeks. You will not know if you are receiving the medication or the placebo.

Aaron Kelly
All
12 Years to 18 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04298203
STUDY00008743
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Inclusion Criteria:

• Severe obesity (BMI >/= 120% of the 95th percentile or BMI >/= 35 kg/m2)
• Age 12 to < 18 years of age at enrollment (screening) and Tanner stage >/= 2 - Female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial
Exclusion Criteria:

• Diabetes (type 1 or 2)
• Current or recent (< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
• Previous metabolic/bariatric surgery
• Current use of a stimulant medication
• History of glaucoma
• Current or recent (<14 days) use of monoamine oxidase inhibitor
• Known hypersensitivity to sympathomimetic amines
• Any history of treatment with growth hormone
• Any history of bulimia nervosa
• Major psychiatric disorder as determined by the local medical monitor
• Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression
• Any history of active suicide attempt
• History of suicidal ideation or self-harm within the previous 30 days
• PHQ-9 score >15
• Current pregnancy or plans to become pregnant during study participation
• Current tobacco use
• ALT or AST >/= 3 times the upper limit of normal
• Bicarbonate <18 mmol/L
• Creatinine > 1.2 mg/dL
• Any history of seizures
• Uncontrolled hypertension as determined by the local medical monitor
• History of structural heart defect or clinically significant arrhythmia
• Diagnosed monogenic obesity
• Any history of cholelithiasis
• Any history of nephrolithiasis
• Clinically diagnosed hyperthyroidism
• Untreated thyroid disorder
• Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol
Drug: Phentermine-Topiramate, Dietary Supplement: Meal Replacement Therapy, Other: Placebo
Obesity
Childhood, Adolescent, Clinics and Surgery Center (CSC)
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Use of 31P MRS to Assess the Effect of Nicotinamide Riboside on Brain NAD+ in Athletes with Football-Related Concussion (TRMC-004)

This study is being conducted at Mayo Clinic; the University of Minnesota site is responsible for the MRI portion of the study.

Xiao-Hong Zhu
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT02721537
1603M85902
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Inclusion Criteria:

• Adult current and former (within 2 years) collegiate athletes (football, rugby, soccer, hockey, and volleyball)
• Body mass index (estimated based on height and weight) from 23 to 37
• Willing to provide informed consent, ingest test substance, and provide blood specimens
• Willing to comply with study instructions and maintain current level of physical activity throughout the study
Exclusion Criteria:

• History of loss of consciousness of more than 5 minutes
• Contraindications to Magnetic Resonance Imaging (MRI), such as implanted medical devices, metal objects, or pacemakers
• History of epilepsy
• History of more than 3 concussions
• History of headache preceding a concussion
• History of depression preceding a concussion
• History of developmental delays or Attention Deficit Hyperactivity Disorder (ADHD)
• History of post-traumatic seizures
• History of complex spine and/or skull trauma
Dietary Supplement: Nicotinamide Riboside, Other: Matching placebo
Concussion, Mild
Brain Nicotinamide Adenine Dinucleotide (NAD+), Adenosine Triphosphate (ATP) Depletion, Polyadenosine Diphosphate-Ribosepolymerase (PARP) Activation
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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
This study is NOT accepting healthy volunteers
NCT03793478
STUDY00005937
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Inclusion Criteria:

• Has diagnosis of AML according to the World Health Organization (WHO) 2008 classification with ≥5% blasts in bone marrow, with or without extramedullary disease
• Is 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 study drug or cytarabine, whichever is later
• If female of child-bearing potential, tests negative for pregnancy and agrees not to breast feed
• 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
• Meets protocol-specified guidelines before inclusion in the continuation therapy phase
Exclusion Criteria:

• Has been diagnosed with isolated central nervous system relapse, certain kinds of leukemia, 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: Quizartinib, Drug: Intrathecal (IT) triple chemotherapy prophylaxis, Drug: Fludarabine, Drug: Cytarabine, Drug: Etoposide
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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Randomization of Cytarabine Monotherapy Versus Standard-of-Care Vinblastine/Prednisone For Frontline Treatment of Langerhans Cell Histiocytosis (TXCH LCH0115)

The purpose of this research study is to compare previously used vinblastine/prednisone to single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study called a positron emission tomography (PET) scan to more accurately assess areas of LCH involvement not otherwise seen in other imaging studies as well as response to therapy. We also want to identify if genetic and other biomarkers (special proteins in patient's blood and in patient's cancer) relate to the response of patients LCH to study treatment.

Lucie Turcotte
Phase III
This study is NOT accepting healthy volunteers
NCT02670707
STUDY00008859
Langerhans Cell Histiocytosis
Langerhans Cell Histiocytosis (LCH), cytarabine, prednisone, vinblastine
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Vibrotactile stimulation of the larynx to treat unexplained chronic cough

This is a study of adults with unexplained chronic cough between 18-80 years old. This study is trying to determine whether a noninvasive vibrotactile stimulation device can help reduce cough symptoms.

Stephanie Misono
18 Years and over
Pilot
This study is NOT accepting healthy volunteers
ENT-2020-28903
STUDY00012174
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Inclusion Criteria:
- Adults aged 18-80 - >8 weeks of non-productive cough - Cough visual analogue scale (VAS): Rating of 40 or greater on a 0-100 cough severity scale - CXR or chest CT negative (collected as part of routine clinical care); no time limit on imaging (if available) - Clinical impression that untreated or inadequately treated gastroesophageal, pulmonary, and/or sinonasal source is not primary cough etiology - Ability to provide informed consent and independently complete questionnaires - Ability to read and speak English
Exclusion Criteria:
- Current or recent (quit < 3 months ago) smoking - Known currently infectious cause for cough (e.g., TB, pertussis, COVID) - History of known or suspected aspiration pneumonia - Neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA) - Untreated carotid disease - Electronic implants (e.g., pacemaker) - Specific medication use conditions, including: - Taking ACE-inhibitors - Around the clock use of benzodiazepines - Anticipate new medications targeting cough during the period of the study - If on neuromodulators and/or opioids, anticipate change in dose during the period of the study - Currently doing speech therapy for cough - BMI > 30 (for transmission of VTS through soft tissue) - Contraindications to safe VTS device use, including: - Allergy to adhesives - Unable to manipulate device - Recent intubation/neck surgery (within 8 weeks) - Drug/alcohol dependency or abuse - Pregnant - No regular access to wifi internet
Breathing, Lung & Sleep Health, Ear, Nose & Throat
Clinics and Surgery Center (CSC), chronic cough, cough, larynx, vibrotactile stimulation
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Vibrotactile stimulation of the larynx to treat unexplained chronic cough

This is a study of adults with unexplained chronic cough between 18-80 years old. This study is trying to determine whether a noninvasive vibrotactile stimulation device can help reduce cough symptoms.

Stephanie Misono
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05273190
STUDY00012174
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Inclusion Criteria:
- Adults aged 18-80 - >8 weeks of non-productive cough - Cough visual analogue scale (VAS): Rating of 40 or greater on a 0-100 cough severity scale - CXR or chest CT negative (collected as part of routine clinical care); no time limit on imaging (if available) - Clinical impression that untreated or inadequately treated gastroesophageal, pulmonary, and/or sinonasal source is not primary cough etiology - Ability to provide informed consent and independently complete questionnaires - Ability to read and speak English
Exclusion Criteria:
- Current or recent (quit < 3 months ago) smoking - Known currently infectious cause for cough (e.g., TB, pertussis, COVID) - History of known or suspected aspiration pneumonia - Neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA) - Untreated carotid disease - Electronic implants (e.g., pacemaker) - Specific medication use conditions, including: - Taking ACE-inhibitors - Around the clock use of benzodiazepines - Anticipate new medications targeting cough during the period of the study - If on neuromodulators and/or opioids, anticipate change in dose during the period of the study - Currently doing speech therapy for cough - BMI > 30 (for transmission of VTS through soft tissue) - Contraindications to safe VTS device use, including: - Allergy to adhesives - Unable to manipulate device - Recent intubation/neck surgery (within 8 weeks) - Drug/alcohol dependency or abuse - Pregnant - No regular access to wifi internet
Device: Vibrotactile Stimulation
Breathing, Lung & Sleep Health, Ear, Nose & Throat, Cough
Chronic cough, Clinics and Surgery Center (CSC), chronic cough, cough, larynx, vibrotactile stimulation
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RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with Crohn s disease: The OPTIMIZE Trial

The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.

Byron Vaughn
18 Years and over
Phase IV
This study is NOT accepting healthy volunteers
NCT04835506
STUDY00013632
Crohn Disease, Digestive & Liver Health
Clinics and Surgery Center (CSC)
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Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (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.

All
12 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT05130866
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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: REC-2282, Drug: Placebo
Neurofibromatosis Type 2
Neurofibromatosis Type 2, Neurofibromatosis Type II
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A closed-loop assessment and treatment platform for unipolar depression and anxiety

This study is a validation study to evaluate the acceptability and feasibility of the closed-loop strategy employing the mobile mental health application with the target population to prepare for a large-scale efficacy trial in adults with MDD, depression and/or anxiety.

Gamze Camsari
All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02948036
STUDY00004179
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Inclusion Criteria:

• Participant must be 18 to 60 years of age.
• Participant must score ≥ 9 on the Patient Health Questionnaire-9 (PHQ-9).
• Participant taking antidepressants or engaged in psychotherapy will not be excluded. If potential participants are currently prescribed psychotropic medication, they must be on a clinically stable medication regimen for ≥ 6 weeks prior to screening, based on self-report or as verified by medical health records, when available and authorized.
• Participant must be a fluent English speaker.
• Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer as required to complete study activities.
• Participant must have access to wireless Internet connectivity.
• Participant must be willing to communicate with study staff via email.
Exclusion Criteria:

• Participant with unstable and/or untreated conditions that may affect cognition, including untreated substance abuse/dependence disorders, unmanaged cardiovascular disease, endocrine or neurologic disorder, epilepsy, brain injury, hospitalization within 6-weeks of enrollment, ongoing chemotherapy or other cancer treatment (e.g., radiation) .
• Participant with history or current DSM-5 diagnosis of psychosis, such as schizophrenia, schizoaffective disorder, delusion disorder, psychotic disorder NOS, bipolar disorder, substance abuse (<1 year), and/or mood congruent or mood incongruent psychotic features or disorders.
• Participant has a history or current diagnosis of dementia and/or scores less than a 14 (75%) on the UBACC.
• Participant with active suicidal ideations or behaviors within 2 months of screening.
• Participant that shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit. Such participants will have that visit re-scheduled; participants with this problem occurring more than once may be excluded and dropped at the discretion of the Principal Investigators.
• Participant has problems performing assessments or comprehending or following spoken instructions, or those with behaviors during screening or baseline visits that, in the judgment of the screening staff, are likely to present significant problems for the staff conducting assessments.
• Participant is enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable..
• Participant is using computer-based cognitive training programs or has used it within a month of the consent date.
Other: Mobile-device, plasticity-based adaptive cognitive treatment
Major Depressive Disorder
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ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation

We are doing this study to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for 2.5 to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Daniel Duprez
Phase III
This study is NOT accepting healthy volunteers
NCT05021835
STUDY00013843
Cardiovascular Risk, Chronic Kidney Disease, Inflammation
Clinics and Surgery Center (CSC)
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Neural Correlates of the Shift in Social Buffering of Social Evaluative Threat

This study is one of three studies on an NIH-funded project addressing the effectiveness of parents in buffering children and adolescents from the physiological and brain responses to stress. This study uses MRI scanning to measure the brain response to social evaluative stress (giving a speech and doing math problems in front of a panel of judges) as well as the impact of the presence of various social partners (no one, researcher, or parent) in buffering the physiological and brain responses to social evaluative stress.

All
11 Years to 14 Years old
N/A
This study is also accepting healthy volunteers
NCT04211155
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Inclusion Criteria:

• sufficient vision to complete assent and study procedures
• sufficient hearing to complete assent and study procedures
• sufficient language skills to provide verbal and written assent
Exclusion Criteria:

• Premature birth (less than 37 weeks)
• congenital and/or chromosomal disorders (e.g. cerebral palsy, FAS, mental retardation, Turner Syndrome, Down Syndrome, Fragile X)
• Autism Spectrum Disorders
• history of serious medical illness (e.g., cancer, organ transplant)
• youth taking systemic glucocorticoids
• youth taking beta-adrenergic medications
• diagnoses of psychiatric illness, seizure disorder or other neurological disorders
• contraindications for MRI (implanted medical device; presence of non-removal metal in or on the body, including piercings, orthodontic braces or certain permanent retainers)
• known pregnancy
• tattoos
• history of significant claustrophobia
Other: Questionnaires, Other: MRI
Social Stress, Adolescent Behavior
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Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

This study will enroll adults who are currently in a methadone treatment program and clinically stable in a randomized, double-blind, transcranial direct current stimulation (tDCS) intervention (active or sham) trial study. The primary study aim seeks to examine whether pairing non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) with cognitive training, as a therapeutic intervention can enhance cognition and reduce relapse rates in opioid use disorder. The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder.

All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04495673
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Inclusion Criteria:

• Current diagnosis of opioid use disorder
• Enrolled in a methadone treatment program for at least 2 months in Hennepin Healthcare and be clinically stable.
• Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for opioid use disorder
• Participants may have current comorbid drug use, but their primary substance use disorder diagnosis must to be based on opioid use.
• Participants must have the intention to remain in the methadone treatment program until the end of the intervention portion of the study.
Exclusion Criteria:

• Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
• Head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
• Any contraindications for tDCS or MRI scanning (tDCS contraindication: actively receiving treatment for seizures or epilepsy; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
• Current active psychosis or mania
• Presence of a condition that would render study measures difficult or impossible to administer or interpret (e.g. current mania, active psychosis)
• Primary current substance use disorder diagnosis on a substance other than opioid except for caffeine or nicotine
• Current stimulant use disorder (need to be free of stimulant use for at least 1 month)
• History of electroconvulsive therapy or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies
• incarceration
Device: Transcranial Direct Current Stimulation (tDCS), Device: Sham Transcranial Direct Current Stimulation (tDCS), Behavioral: Cognitive Training
Opioid-Related Disorders, Heroin Dependence, Morphine Dependence
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A randomized double-blind, placebo-controlled, multicenter;trial assessing the impact of lipoprotein (a) lowering with;TQJ230 on major cardiovascular events in patients with;established cardiovascular disease (HORIZON)

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a). The primary objectives of this study is to demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) ≥ 70 mg/dL) and/or 2) in a sub-population with established CVD and Lp(a) ≥ 90 mg/dL.

Daniel Duprez
18 Years and over
Phase III
This study is NOT accepting healthy volunteers
NCT04023552
STUDY00011204
Cardiovascular Disease and Lipoprotein(a)
Lipoprotein(a), Lp(a),CVD, myocardial infarction, PAD,Stroke, Pelacarsen, Clinics and Surgery Center (CSC)
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A multiple ascending dose trial investigating safety, tolerability, and pharmacokinetics of NNC0361-0041 administered subcutaneously to patients with type 1 diabetes mellitus (TOPPLE T1D)

This study is looking at 48 adult patients that have been diagnosed with type 1 diabetes within the past 4 years and giving them subcutaneous injections weekly of NNC0361-0041 plasmid to assess the safety and tolerability. This is a phase1 study that will enrolled over a 28 week period.

Antoinette Moran
All
18 Years to 45 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT04279613
STUDY00011044
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Inclusion Criteria:

• Willing to provide Informed Consent
• Participants must live in a location with rapid access to emergency medical services
• Age 18-45 years (both inclusive) at the time of signing informed consent
• Must have a diagnosis of T1D for less than 48 months at randomization
• Must have at least one diabetes-related autoantibody present (GAD65A; mIAA, if obtained within 10 days of the onset of insulin therapy; IA-2A; ICA; or ZnT8A)
• Must have stimulated C-peptide levels greater than or equal to 0.2 pmol/ml measured during an MMTT conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization
• Be willing to comply with intensive diabetes management
• HbA1c ≤8.5% at screening
• Subjects who are CMV and/or EBV seronegative at screening must be CMV and/or EBV PCR negative within 37 days of randomization and may not have had signs or symptoms of a CMV and/or EBV compatible illness lasting longer than 7 days within 37 days of randomization
• Be up to date on recommended immunizations
• Be at least 6 weeks from last live immunization
• Be at least 4 weeks from killed vaccine other than flu vaccine
• Participants are required to receive killed influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available
• Be willing and medically acceptable to postpone live vaccines during the treatment period and for 3 months following last dose of study drug
• If participant is female with reproductive potential, she must have a negative pregnancy test at screening and be willing to avoid pregnancy using a highly effective contraceptive method for the 12 months of the study
• Males of reproductive age must use adequate contraceptive method during the treatment phase and for 3 months following last dose of study drug
• Participants are required to receive an authorized non-live COVID-19 vaccination and be fully vaccinated, including eligible boosters as indicated, at least two weeks prior to randomization.
Exclusion Criteria:
Potential participants must not meet any of the following exclusion criteria:
• One or more screening laboratory values as stated
• Leukocytes < 3,000/μL
• Neutrophils <1,500 /μL
• Lymphocytes <800 /μL
• Platelets <100,000 /μL
• Haemoglobin <6.2 mmol/L (10.0 g/dL)
• Potassium >5.5 mmol/L or <3.0 mmol/L
• Sodium >150mmol/L or < 130mmol/L
• AST or ALT ≥2.5 times the upper limits of normal
• Bilirubin ≥ 1.5 times upper limit of normal
• Glomerular Filtration Rate (eGFR) value of eGFR < 60 ml/min/1.73 m2 as defined by KDIGO 2012 (43)
• Any other laboratory abnormality that might, in the judgment of the investigator, place the subject at unacceptable risk for participation in this trial
• Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening
• Use of other immunosuppressive agents including chronic use of systemic steroids. Topical products are acceptable (nasal, conjunctival, skin)
• Have active signs or symptoms of acute infection at the time of randomization
• Have current, confirmed COVID-19 infection
• Chronic active infection other than localized skin infections
• Have evidence of prior or current tuberculosis infection as assessed by PPD, interferon gamma release assay or by history
• Have evidence of current or past HIV, Hepatitis B infection
• Have evidence of active Hepatitis C infection
• Vaccination with a live virus within the last 6 weeks and killed vaccine within 4 weeks (except 2 weeks for flu vaccine)
• Be currently pregnant or lactating, or anticipate getting pregnant within the one-year study period.
• Have severe obesity: adults BMI ≥ 40
• Have a history of malignancies
• Untreated hypothyroidism or active Graves' disease
• History of severe reaction to prior vaccination
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days after last blood draw (or 5 half-lives of investigational drug, whichever is greater) before screening, or currently enrolled in any other clinical trial
• Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the trial
• Supine blood pressure at screening outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic. To exclude white-coat nervousness a single repeat measurement is allowed
• Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk
• Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
Drug: NNC0361-0041, Other: Placebo
Type I Diabetes
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Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT)

This is a cross-sectional, non-therapeutic study in a cohort of retinoblastoma patients. The study will estimate the prevalence of specific late effects and SMN, assess for predictors of these late effects and SMN, and identify factors predictive of these late effects and SMN, and identify factors predictive of decreased HRQoL.

Joseph Neglia, M.D.
NA
This study is also accepting healthy volunteers
NCT03932786
STUDY00004765
Biological Sibling, Cancer Survivor, Intraocular Retinoblastoma, Retinoblastoma, Unilateral Retinoblastoma
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Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics

The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.

Christine Conelea
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT04578912
STUDY00010519
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Inclusion Criteria:
-- 12-21 years old -- right-handed -- able to undergo MRI -- currently experiencing chronic motor and/or vocal tics
Exclusion Criteria:
-- currently receiving therapy focused on tics -- currently taking neuroleptic/antipsychotic medications
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT), Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Continuous Theta Burst Stimulation (cTBS)
Brain & Nervous System, Children's Health, Mental Health & Addiction, Tic Disorders, Tics, Tic, Motor, Tic Disorder, Childhood, Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence
CBIT, TMS, Tourette's, neurodevelopmental disorders, tics, transcranial magnetic stimulation
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Neural mechanisms of early visual dysfunction in psychosis

This study was reviewed as a JIT under STUDY00006280. This submission will complete the initial IRB review process. We propose to study visual perception in PwP as a window into deviant neural processing. This allows us to use well-developed paradigms from animal models, and to translate directly from basic neuroscience to a clinical population.

Michael-Paul Schallmo
18 Years and over
NA
This study is also accepting healthy volunteers
PSYCH-2019-28336
STUDY00007958
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Inclusion Criteria:
18-60 years old; Normal or corrected-to-normal vision; Current diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria:
Claustrophobia; Current substance dependence (besides nicotine); Any vision anomaly (e.g. strabismus/crossed eyes, lazy eye, color blindness); Current or past diagnosis of bipolar I disorder
Brain & Nervous System, Vision & Eyes
EEG, MRI, neuroscience, psychosis, vision
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COG AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

Peter Gordon
All
1 Year to 24 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03959085
STUDY00008473
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Inclusion Criteria:

• B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol.
• APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.
• White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):
• Age 1-9.99 years: WBC >= 50,000/uL
• Age 10-24.99 years: Any WBC
• Age 1-9.99 years: WBC < 50,000/uL with:
• Testicular leukemia
• CNS leukemia (CNS3)
• Steroid pretreatment.
• White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):
• Age 1-24.99 years: any WBC.
• Patient has newly diagnosed B-ALL or MPAL (by World Health Organization [WHO] 2016 criteria) with > 25% blasts on a bone marrow (BM) aspirate;
• OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;
• OR A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.
• Patient has newly diagnosed B-LLy Murphy stages III or IV.
• Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.
• Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.
• All patients and/or their parents or legal guardians must sign a written informed consent.
• All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.
Exclusion Criteria:

• Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group).
• With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.
• Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
• Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells.
• Patients with acute undifferentiated leukemia (AUL) are not eligible.
• For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply:
• T-lymphoblastic lymphoma.
• Morphologically unclassifiable lymphoma.
• Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.
• Patients with known Charcot-Marie-Tooth disease.
• Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.
• Patients requiring radiation at diagnosis.
• 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 women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
• Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.
Drug: Calaspargase Pegol-mknl, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: Daunorubicin Hydrochloride, Drug: Dexamethasone, Drug: Doxorubicin Hydrochloride, Biological: Inotuzumab Ozogamicin, Drug: Leucovorin Calcium, Drug: Mercaptopurine, Drug: Methotrexate, Drug: Pegaspargase, Drug: Prednisolone, Other: Questionnaire Administration, Radiation: Radiation Therapy, Radiation: Radiation Therapy, Drug: Thioguanine, Drug: Vincristine Sulfate
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
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Effect and safety of liraglutide 3.0 mg on weight management in children with obesity aged 6 to < 12 years: 56-week, double-blind, randomised, placebo-controlled trial

This study will compare the effect of liraglutide 3.0 mg subcutaneous once daily versus liraglutide placebo on weight management in children aged 6 to <12 years with placebo. The study will also compare the effect of liraglutide 3.0 mg s.c. once daily versus placebo in children aged t to 12 years with obesity on cardiovascular risk factors and metabolism.

Claudia Fox
Phase III
This study is NOT accepting healthy volunteers
NCT04678323
STUDY00011812
Obesity, Childhood
Obesity
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MT2020-27: Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to Tisagenlecleucel (Kymriah) Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

This purpose of this study is to identify a safe dose level for the study drug, E7777, when given with standard tisagenlecleucel therapy (also known by its brand name, Kymriah, is an immunotherapy that is made from the participants own blood cells) in participants with Diffuse Large B-Cell Lymphoma (DLBCL). Up to three dose levels of E7777 will be tested.

Veronika Bachanova, MD
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04855253
STUDY00011895
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Inclusion Criteria:

• Diagnosis of a relapse or refractory (r/r) large B cell lymphoma, for which treatment with Kymriah is planned, including:
• diffuse large B-cell lymphoma (DLBCL) not otherwise specified,
• high grade B-cell lymphoma
• DLBCL arising from follicular lymphoma
• Considered at high risk for progression after CAR-T therapy by meeting one or more of the following factors:
• refractory to last line of therapy
• myc over expression >40% in any prior biopsy
• ≥2 sites of extranodal disease
• Received two or more lines of systemic therapy
• Has secured insurance coverage for Kymriah administration either in the outpatient or inpatient setting.
• Age 18 years or older at the time of signing consent.
• ECOG performance status of 0, 1, or 2
• Adequate bone marrow reserve defined as:
• Absolute neutrophil count (ANC) > 1,000/mm^3
• Platelets ≥ 50,000/mm^3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided) Bone marrow involvement at disease assessment is an exclusion as these patients are at an increased risk of severe CRS and/or neurotoxicity
• Adequate organ function at enrollment and within 14 days of planned E7777 treatment including:
• renal function: eGFR ≥ 50 mL/min/1.73 m^2
• liver function: ALT ≤ 3 times the upper limit of normal (ULN) for age, AST ≤ 3 times the ULN, total bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN (if liver is involved by lymphoma, the exception are allowed upon approval of PI)
• albumin ≥ 3.0 g/dl
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea (CTCAE v5) and pulse oxygenation SpO2 > 91% on room air. Pulmonary function tests within 28 days of enrollment: >50% corrected DLCO and FEV1
• Hemodynamically stable and LVEF ≥ 50% confirmed by echocardiogram or MUGA
• Life expectancy ≥12 weeks in the opinion of the enrolling investigator as documented in the medical record
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use birth control for at least 30 days after study treatment or at least at least 4 months after the final dose of CY, whichever is longer Female participants: Two forms of birth control, one of which must be a barrier method, for example: use of intrauterine device (IUD) or oral contraceptives, plus a barrier method such as a condom, diaphragm or cervical cap Male participants: If possible to father a child (unless a successful vasectomy with confirmed azoospermia) participant and female partner, must use adequate contraception
• Written voluntary consent prior to the performance of any research related tests or procedures
Exclusion Criteria:

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
• Known bone marrow involvement, if history of bone marrow involvement must have a BM biopsy to rule-out current involvement
• Prior allogeneic transplant
• Ocular disease or complaints visual acuity impairment, color or shape distortion, or blurred vision - potential participants are required to have an ophthalmological examine as part of screening
• Known CNS involvement by malignancy - if clinically suspicious, must be ruled-out by examination of cerebrospinal fluid (CSF) by flow cytometry
• Uncontrolled active hepatitis B or hepatitis C
• Active or inactive HIV infection
• Untreated active bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to enrollment)
• History of heart failure or pulmonary edema, evidence of pleural effusion or active lower extremity edema
• Uncontrolled unstable angina and/or myocardial infarction within 3 months of enrollment
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
Drug: E7777
DLBCL, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, DLBCL Arising From Follicular Lymphoma
Clinics and Surgery Center (CSC)
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An Assessment of the Biological and Clinical Effects of Palbociclib (PD 0332991) with Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Patients with Premenopausal Estrogen-Receptor Positive/ HER2-Negative Primary Breast Cancer

This cross-sectional study will use different modes of survey administration to examine how the level of harm patients sustain due to a medical error or adverse event influences Minnesota physicians' willingness to disclose them to patients and/or their families. A random sample of 8,000 currently licensed physicians will be selected from the state licensure database to participate in this study.

Phase II
This study is NOT accepting healthy volunteers
NCT03628066
STUDY00000971
Breast Cancer
Estrogen-Receptor Positive, Goserelin, HER2-Negative, Ki67, Letrozole, Neoadjuvant, Oncotype DX Breast Recurrence Score, Open-Label, Ovarian Suppression, Palbociclib, Premenopausal, Primary
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Targeting individual alpha frequencies to enhance perceptual timing

Study of transcranial alternating current stimulation (tACS) in participants with a diagnosis of psychosis and healthy controls.

Ian Ramsay
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT04856657
STUDY00012304
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Inclusion Criteria:
Symptoms of psychosis or healthy adult without a mental health condition 18-64
Exclusion Criteria:
Not actively suicidal Clinically stable (stable medication and no recent hospitalizations) No history of seizures, epilepsy, brain surgery No eczema on scalp
Device: Transcranial alternating current stimulation
Psychosis, Schizophrenia, Schizo Affective Disorder, Mental Health & Addiction
tacs, neuromodulation, psychosis, schizophrenia, Healthy Participants, Psychosis, Schizoaffective Disorder, Schizophrenia
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Autonomic regulation of blood pressure in premature and early menopausal women

The goal of this study is to learn more about the effects of menopause on women's blood pressure and heart health. We are looking for women between the ages of 35 and 70 years to participate in the study. Participants may be pre- or postmenopausal; we are specifically interested in evaluating the influence of premature (< age 40 years) and early (< age 46 years) menopause.

Manda Keller-Ross
Female
35 Years to 70 Years old
This study is also accepting healthy volunteers
NCT04439370
STUDY00004979
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Inclusion Criteria:

• Aged 35-49 or 50-70 years of age who experienced premature (<40) or early (≤45) menopause
• Premenopausal 35-49 years of age
• Typical-age menopause (i.e., after 45 years of age), who are between 50-70 years old
• Menopause will be confirmed by subject report of amenorrhea for 12 months and serum FSH of >30 mIU/mL
Exclusion Criteria:

• Current nicotine/tobacco use within the past six months
• Are diabetic or asthmatic
• Have diagnosed significant carotid stenosis
• Have a history of significant autonomic dysfunction, heart disease, respiratory disease or a severe neurologic condition such as stroke or traumatic brain injury.
• Have existing metabolic or endocrine abnormities
• Take any heart/blood pressure medications that are determined to interfere with study outcomes
• IF the participant is premenopausal AND currently taking OC or other exogenous steroids that are determined to interfere with study outcomes
• Females who classify as having early or premature menopause AND are not willing to discontinue OC or MHT in order to complete the study
• Are pregnant or breastfeeding
Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA), Diagnostic Test: Baroreflex sensitivity testing, Diagnostic Test: Sympathoexcitatory Maneuvers, Diagnostic Test: Blood tests
Hypertension, Menopause, Premature, Menopause, Blood Pressure
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Stress Response and Opioid Dysfunction in Nicotine Dependence

This study includes healthy adults between 18-70 years old who are either non-smokers or cigarette smokers interested in quitting. The purpose of this study is to learn more about how people respond to stress and to taking one dose of a widely and safely used drug called naltrexone as well as to learn about how these responses relate to whether or not someone smokes, smoking cessation, and smoking relapse.

Mustafa al'Absi
18 Years and over
NA
This study is NOT accepting healthy volunteers
DMED-2019-28512
STUDY00008687
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Inclusion Criteria:

• Live in Minnesota.
• Between 18-70 years old.
• Generally healthy.
• Want to quit using tobacco and nicotine.
• Are willing to attend up to 11 online (videoconference) study visits over a period of approximately 4 months (though you may be asked to complete the last visits over a period of up to 1 year).
Exclusion Criteria:

• Do not live in Minnesota.
• Not between 18-70 years old.
• Not willing to attend to up to 11 online (videoconference) study visits over a period of approximately 4 months.
Heart & Vascular, Mental Health & Addiction, Prevention & Wellness
cigarette, nicotine, quit smoking, smoker, smoking, smoking cessation, stress, tobacco
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Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients undergoing Sevoflurane Anesthesia

Study is to investigate the relationship between Bispectral Index (BIS) values including EEG profile and anesthetic agents in the pediatric population.

Benjamin Kloesel
up to 18 Years old
Pivotal
ANES-2021-30290
STUDY00014663
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Inclusion Criteria:
-Pediatric Subjects aged: 4 years to 18 years scheduled for procedures with sedation where the process of assessment will not interfere with the procedure, progress, or patient care
Exclusion Criteria:
-severe contact allergies -Known neurological disorder -Severe developmental delay -Airway abnormalities -Pregnancy -Taking psychoactive medications
• Taking any medications that may have an impact on the Central Nervous System
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