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Search Results Within Category "Diabetes & Endocrine"

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20 Study Matches

The TrialNet Natural History Study of the Development of Type 1 Diabetes

Antoinette Moran
All
30 Months to 45 Years old
N/A
This study is NOT accepting healthy volunteers
NCT00097292
0305M47349
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Inclusion Criteria:

• Individuals 2.5 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
• Individuals 2.5-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
• Individuals 2.5-45 years old without a type 1 diabetes proband, who are known to have 1 or more islet antibody are eligible for screening if needed to determine eligibility for a clinical trial to delay or prevent disease progression.
Exclusion Criteria:
To be eligible a person must not:
• Have diabetes already
• Have a previous history of being treated with insulin or oral diabetes medications.
• Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
• Have any known serious diseases
Diabetes Mellitus, Type 1
"at risk" for developing type 1 diabetes, T1DM, T1D, juvenile diabetes, Type 1 Diabetes TrialNet, TrialNet
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Longitudinal Study of Urea Cycle Disorders

This study is seeking individuals with urea cycle disorders. The study aims to perform a long-term analysis of individuals with a UCD.

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT00237315
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Inclusion Criteria:

• Diagnosis of NAGS deficiency, defined as the detection of a pathogenic mutation, and/or decreased (less than 20 % of control) NAGS enzyme activity in liver ,and/or hyperammonemia and first degree relative meets at least one of the criteria for NAGS deficiency
• Diagnosis of CPS I deficiency, defined as decreased (less than 20 % of control) CPS I enzyme activity in liver, and/or an identified pathogenic mutation, and/or hyperammonemia and first degree relative meets at least one of the criteria for CPS I deficiency
• Diagnosis of OTC deficiency, defined as the identification of a pathogenic mutation, and/or less than 20% of control of OTC activity in the liver, and/or elevated urinary orotate (greater than 20 uM/mM) in a random urine sample or after allopurinol challenge test, and/or hyperammonemia and first degree relative meets at least one of the criteria for OTC deficiency
• Diagnosis of AS deficiency (Citrullinemia), defined as a greater than or equal to 10-fold elevation of citrulline in plasma, and/or decreased AS enzyme activity in cultured skin fibroblasts or other appropriate tissue, and/or identification of a pathogenic mutation in the AS gene, and/or hyperammonemia and first degree relative meets at least one of the criteria for AS Deficiency
• Diagnosis of AL deficiency (Argininosuccinic Aciduria, ASA), defined as the presence of argininosuccinic acid in the blood or urine, and/or decreased AL enzyme activity in cultured skin fibroblasts or other appropriate tissue, and/or identification of a pathogenic mutation in the AL gene, and/or hyperammonemia and first degree relative meets at least one of the criteria for AL Deficiency
• Diagnosis of ARG deficiency (Hyperargininemia), defined as a greater than or equal to 5-fold elevated arginine levels in the blood, and/or decreased arginase enzyme levels in red blood cells or other appropriate tissue, and/or identification of a pathogenic mutation in the ARG gene, and/or hyperammonemia and first degree relative meets at least one of the criteria for ARG Deficiency
• Diagnosis of HHH Syndrome or ORNT deficiency, defined as a greater than or equal to 5-fold elevated plasma ornithine and homocitrulline levels in the urine, and/or a pathogenic mutation, and/or less than 20% residual labeled ornithine incorporation into protein in cultured fibroblasts, and/or hyperammonemia and first degree relative meets at least one of the criteria for HHH Syndrome or ORNT Deficiency
• Diagnosis of CITR deficiency (Citrullinemia Type II), defined as elevated citrulline levels in the blood and a pathogenic mutation and/or hyperammonemia and first degree relative meets criteria for CITR Deficiency
• Pending diagnosis of a UCD (UCD highly likely), defined as laboratory values highly suggestive of a UCD with symptomatic hyperammonemic episodes but without a verifiable diagnosis
Exclusion Criteria:

• Hyperammonemia caused by an organic academia, lysinuric protein intolerance, mitochondrial disorder, congenital lactic academia, fatty acid oxidation defects, or primary liver disease
• Rare and unrelated comorbidities (e.g., Down's syndrome, intraventricular hemorrhage in the newborn period, and extreme prematurity)
Brain Diseases, Metabolic, Inborn, Amino Acid Metabolism, Inborn Errors, Urea Cycle Disorders
Urea, Inherited metabolic disorders
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A Low Biologically Available Glucose and High Protein Diet for Treatment of Type 2 Diabetes Mellitus

Randomized clinical trial investigating the LoBAG diet versus a control diet for treatment of type 2 diabetes mellitus over a 3 month intervention period.

Anne Bantle
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02717078
1601M82501
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Inclusion Criteria:
18 years of age or older, Diagnosis of type 2 diabetes mellitus, Hemoglobin A1c of 7.0-9.5%, Taking no medications for diabetes or taking metformin
Exclusion Criteria:
Type 1 diabetes mellitus, Treatment with insulin, BMI < 25 kg/m^2, Change in weight of >5 lbs over the past 3 months, Estimated glomerular filtration rate (GFR) < 60 ml/minute/1.73 m^2, Urine albumin > 300 mg/g creatinine, Anemia, Pregnancy or immediate plans to become pregnant, Current breastfeeding, Use of antibiotics in the past 3 months, Some dietary restrictions
Other: Diet Therapy
Type 2 Diabetes Mellitus, Diabetes & Endocrine, Microbiota, Prevention & Wellness
Carbohydrate, Diet, Nutrition, Protein, Type 2 diabetes mellitus, dstudy, diet, carbohydrate, protein, glucose, type 2 diabetes mellitus, DSTUDY
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Measurement of Glucose Metabolism in Humans: Effect of Recurrent Hypoglycemia on Hypothalamic GABA (GABA)

The purpose of this study is to determine the effects of altered glucose metabolism on the brain. For example, patients with long duration diabetes mellitus lose their ability to secrete the hormones necessary to protect them against hypoglycemia, which may be due to alterations in glucose availability to the human brain.

All
18 Years to 65 Years old
N/A
This study is also accepting healthy volunteers
NCT02829593
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Inclusion Criteria:

• well controlled type 1 diabetes (hemoglobin A1c <7.5%)
• age 18-65
• healthy controls
Exclusion Criteria:

• history of stroke, seizures, neurosurgical procedures, or arrhythmias
• use of drugs that can alter GABA metabolism (such as benzodiazepines).
• Subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs and the absence of metallic substances in their body.
Other: hypoglycemia (low blood sugar) and MRI
Type 1 Diabetes, Healthy
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Type 1 Diabetes Extension Study (T1DES)

The primary objective of the study will be to further our understanding of the immunologic mechanisms underlying maintenance and loss of beta cell function by evaluating the relationship between longitudinal changes in beta cell function and changes over time in biomarkers known to be associated with a response to immune modulating treatments. This is meant to be a follow up study of the long term effects of participation in selected completed ITN new-onset T1D studies with immunomodulatory agents.

Antoinette Moran
All
8 Years to 35 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02734277
STUDY00001310
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Inclusion Criteria:

• Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
• Ability to sign informed consent/assent (as applicable for children).
Exclusion Criteria:

• Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or
• Inability to comply with the study visit schedule and required assessments.
Type 1 Diabetes Mellitus, T1DM, T1D
Insulin, Glucose Intolerance
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Measurement of Glucose Homeostasis in Human Brain by NMR: Effect of Recurrent Hypoglycemia on Type 1 Diabetes (Aim 1)

This study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (IAH) in type 1 diabetics (T1D) following exposure to experimental recurrent hypoglycemia (HG). To induce IAH, patients with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo three 2-hour long hypoglycemic clamps. Neurochemical profiles will be measured by high field MRS before and after induction of IAH at a fourth clamp. Participant glycemic variability for ~2 weeks and activity/sleep for ~1 week before the induction of IAH will be monitored as these factors have been shown to alter responses to HG.

Elizabeth Seaquist
All
18 Years to 65 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03410277
STUDY00002192
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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
Other: Experimental hypoglycemia
Diabetes Mellitus, Type 1
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Development of Novel Predictors of Hypoglycemia for Type 2 diabetes: Role of CGMS usage in predicting risk for hypoglycemia

Individuals who are at a greater/lower risk for hypoglycemia based on algorithms developed in STUDY00001981 will be recruited to wear a continuous glucose monitor for three months. Data from the CGM will then be used to refine predictive abilities of algorithm.

Lisa Chow
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03481530
STUDY00002113
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Inclusion Criteria:

• Type 2 Diabetes
• 18 years or older
Exclusion Criteria:

• Type 1 diabetes
• Current pregnancy or anticipation of pregnancy during study period
• At screening visit, HR> 130 or SBP>160 or DBP>100 which remains present on recheck
Device: Continuing Glucose Monitor System
Type 2 Diabetes Mellitus, Hypoglycemia
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Maternal Metabolism, Breastmilk Composition, and Transmission to Infants

This is a pilot prospective cohort study of the differences between women with and without diabetes during pregnancy in their breast milk composition (microbiome and hormone composition), and test for group differences in the relationship of breast milk composition to infant gut microbiome characteristics, weight gain, and body composition. Women with diabetes during pregnancy (N=50) will be recruited de novo in this study, while women without diabetes (N=100) already have been enrolled and have provided consent for all necessary data involved in the comparison with the diabetic women, except that the non-diabetic women have not provided consent for the meta-genomic sequencing analysis and so will provide that consent under this protocol.

Ellen Demerath
All
Not specified
Pilot
This study is also accepting healthy volunteers
NCT03522597
STUDY00002127
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Inclusion Criteria:
(For new enrollment of 50 pregnant women with gestational diabetes and their infants. Enrollment of normal weight and obese cohort comparators already accomplished under ClinicalTrial NCT03301753):
• Pregnant women
• age 21-45 at time of delivery
• report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior), and if parity >1, that they successfully breastfed after a previous pregnancy for at least 3 months
• singleton pregnancy
• known gestational diabetes Definition of Gestational Diabetes: 1) an elevated glucose challenge test >200 mg/dL or 2) two abnormal values on the glucose tolerance test according to Carpenter-Coustan criteria.
Exclusion Criteria:

• alcohol consumption >1 drink per week during pregnancy/lactation
• tobacco consumption during pregnancy/lactation,
• inability to speak/understand English
• known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding
• planned delivery at a site other than the University of Minnesota Medical Center- West Bank campus.
• preexisting diabetes
Obesity, Diabetes, Gestational
Obesity, Gestational Diabetes, Breast Milk, Microbiome, Infant Growth
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EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis

The purpose of this research study is because Cystic Fibrosis Related Diabetes (CFRD) has been identified by the cystic fibrosis (CF) community as one of the top ten priorities for CF research. We know that high blood sugars caused by not enough insulin lead to worse lung function in CF even before diabetes develops. However, we do not know which people with abnormal blood sugars will have long term problems.

Amir Moheet
All
6 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03650712
STUDY00004854
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Inclusion Criteria:

• Age >/= 6 years
• Diagnosis of cystic fibrosis
• CF patients regularly attending the CF centers
• Clinically stable in previous 3wks:
• absence of major clinical events including pulmonary exacerbations,
• no change in their habitual treatment regimen including introduction of antibiotics or steroids in the past 3 weeks
Exclusion Criteria:

• Diagnosis of type 1 diabetes, type 2 diabetes, or MODY
• Organ transplantation
• new diagnosis of CFRD in the past 6 months
• antidiabetic treatment in past 6 mos (insulin or oral hypoglycemic agents) -patients with previous CFRD diagnosis, but not currently taking insulin/glucose-lowering medications for at least 6 months should be included
• pulmonary exacerbation associated with systemic steroid requirement in the last 6 months
• on CFTR corrector less than 6 months prior to enrollment
Diagnostic Test: Oral glucose tolerance test, Diagnostic Test: Continuous glucose monitoring, Diagnostic Test: Dexa scan
Cystic Fibrosis-related Diabetes
cystic fibrosis, insulin, glucose, children, abnormal glucose tolerance, impaired glucose tolerance, indeterminate glycemia, diabetes
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HYDROXYCHLOROQUINE (HCQ) FOR PREVENTION OF ABNORMAL GLUCOSE TOLERANCE AND DIABETES IN RELATIVES AT-RISK FOR TYPE 1 DIABETES MELLITUS (Protocol TN-22) (TN-22)

The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo-controlled clinical trial. All participants will receive close monitoring for progression of T1D. Participants will receive hydroxychloroquine or placebo and close monitoring for progression to Stage 2 (abnormal glucose tolerance) or Stage 3 (clinically overt) T1D. To assess the efficacy, safety and mode of action of hydroxychloroquine to prevent progression from Stage 1 to Stage 2 or Stage 3 of T1D.

Antoinette Moran
All
3 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03428945
STUDY00004135
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Inclusion Criteria:

• Participant in TrialNet Pathway to Prevention Study (TN01)
• Age 3 years or greater at the time of randomization
• Willing to provide informed consent
• Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline
• Two or more diabetes-related autoantibodies present on two separate samples
• Weight of 12 kg or greater at screening
• If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and at each study visit
• Anticipated ability to swallow study medication.
Exclusion Criteria:

• Abnormal Glucose Tolerance or Diabetes
• History of treatment with insulin or other diabetes therapies
• Ongoing use of medications known to influence glucose tolerance
• Ongoing or anticipated future use of medications known to have untoward interactions with hydroxychloroquine
• Known hypersensitivity to 4-aminoquinoline compounds
• G6PD deficiency
• History of retinopathy
• Have an active infection at time of randomization
• Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection
• Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
• Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
• Be pregnant or breastfeeding.
Drug: Hydroxychloroquine, Drug: Placebo
Type1 Diabetes Mellitus
TrialNet
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Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes (SODAS)

All
35 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03944616
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Inclusion criteria: We will include men, women and non-binary participants with T2D, age 35 years and older, able to provide informed consent, otherwise healthy, who meet the following criteria:
• Physician diagnosed type 2 diabetes ≥ 6 months prior to screening
• HbA1c 6.5-8.5% at participant screening
• Current treatment with lifestyle changes or stable diabetes-related medication levels for the past 3 months
• Willingness to provide consent to contact treating physician and physician agreement to refrain from changing diabetes-related medications during the trial (change defined as > 2 fold change in dose of any 1 hyperglycemic agent or addition or subtraction of an agent)
• No physician-directed medication change for 3 months if prescribed medication for lipids or blood pressure
• Usual consumers of diet beverages (≥ 3 servings/ week (24 oz.) and the willingness to maintain fidelity of the intervention, and participate in all aspects of the intervention
• Not actively looking to make major lifestyle alterations during the study period with stable weight for 2 months (within 3%).
Exclusion Criteria:

• Type 1 diabetes or suspected type 1 diabetes (lean with polyuria, polydipsia, and weight loss with little response to metformin)
• "Secondary" diabetes due to specific causes (e.g. monogenic syndromes, pancreatic surgery, and pancreatitis)
• Diabetic Ketoacidosis hospitalization within last 6 months
• Severe/major hypoglycemia in the last 3 months-severe/major hypoglycemia is defined as a hypoglycemic event in which patient requires assistance of another person to manage the episode
• Glucocorticoid use (prednisone 2.5 mg/d or more or its equivalent)
• History of intolerance or allergy to diet beverages or AS or phenylketonuria
• Any condition that is known to affect the validity of the glycemic measures (Hba1c)
• Major cardiovascular disease event or surgery within past 6 months
• Gastrointestinal disease
• Renal or liver disease
• Current treatment for cancer
• Those with major surgery planned or history of bariatric surgery
• Antibiotic treatment (> 6 days) within past 6 months
• Currently pregnant (via self-report) or planning to become pregnant during study period; <1 year postpartum and breast feeding
• Current participation in another interventional clinical trial
• Previous randomization in this study,
• Heavy alcohol consumption (on average >2 drinks/day for women and >3 drinks/day for men)
• Habitual consumer of SSB ≥ 1 serving / day (8 oz.)
• Does not drink diet beverages
• BMI < 20.0 kg/m2
Behavioral: Diet Beverage, Behavioral: Water
Type 2 Diabetes
Diet beverages, diet, diabetes control, artificial sweeteners, continuous glucose monitor, gut microbiome, metabolomics
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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
This study is NOT accepting healthy volunteers
NCT04387422
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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Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial

The NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) study, referred to as Pediatric MATCH, will match targeted agents with specific molecular changes identified using genomic sequencing technologies in refractory/recurrent tumors from children and adolescents with cancer. The NCI-COG Pediatric MATCH study (APEC1621) is considered one study under one IND consisting of a Master Version Control protocol, screening protocol component and multiple subprotocol components, with each component being contained in its own separate document. Each “component” consists of the protocol document and its associated informed consent document. The Master Version Control Protocol is the overarching administrative protocol that will keep an up-to-date record of the current version of the screening protocol component and each subprotocol component of Pediatric MATCH. Since each subprotocol component operates independently from the other subprotocol components contained in Pediatric MATCH, each has its own version date. Likewise, the screening protocol component has its own version date since changes in any of the subprotocols may not require changes in the screening protocol.

Emily Greengard
All
12 Months to 21 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04284774
STUDY00001752
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Inclusion Criteria:

• Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621M based on the presence of an actionable mutation as defined in APEC1621SC
• Patients must have a body surface area >= 0.29 m^2 at enrollment
• Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible. Measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)
• Note: The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
• Elevated tumor markers in plasma or cerebral spinal fluid (CSF)
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Karnofsky >= 50 for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
• Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive.
• >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent.
• Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
• Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell infusions (with or without total body irradiation [TBI]):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
• Autologous stem cell infusion including boost infusion: >= 42 days
• Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)
• Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
• Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radio-pharmaceutical therapy
• Patients must not have received prior exposure to tipifarnib
• For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
• Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
• For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
• Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
• Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 (within 7 days prior to enrollment) or
• A serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
• Age: Maximum serum creatinine (mg/dL)
• 1 to < 2 years: male (0.6), female (0.6)
• 2 to < 6 years: male (0.8), female (0.8)
• 6 to < 10 years: male (1), female (1)
• 10 to < 13 years: male (1.2), female (1.2)
• 13 to < 16 years: male (1.5), female (1.4)
• >= 16 years: male (1.7), female (1.4)
• Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. (For the purpose of this study, the ULN for SGPT is 45 U/L.) (within 7 days prior to enrollment)
• Serum albumin >= 2 g/dL (within 7 days prior to enrollment)
• Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
• Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0) resulting from prior therapy must be =< grade 2
• Patients must be able to swallow intact tablets or crushed tablets mixed in water, orange juice, apple juice, tomato juice, ginger ale, applesauce, yogurt, protein shake, or a dietary supplement drink (such as Ensure). Percutaneous endoscopic gastrostomy (PEG)-tube or nasogastric tube administration is permitted
• All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:

• Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective contraceptive methods for the duration of study treatment. Both female subjects and male subjects with female partners of child-bearing potential must agree to use a highly effective method of contraception for 2 weeks prior to protocol therapy, during, and at least 4 weeks after last dose of tipifarnib. In addition, since tipifarnib could induce toxicity of male reproductive organs and cause impairment of fertility, sperm cryopreservation should be recommended for male subjects wishing to preserve their fertility following tipifarnib treatment
• Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Patients who are currently receiving another investigational drug are not eligible
• Patients who are currently receiving other anti-cancer agents are not eligible
• Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
• Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4/5 or UGT are not eligible. Strong inducers or inhibitors of CYP3A4/5 or UGT should be avoided from 14 days prior to the 1st dose of tipifarnib to the end of the study. In addition, patients receiving agents that are sensitive or narrow therapeutic range substrates of CYP3A4/5 are not eligible. Note: CYP3A4/5 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
• Patients with known hypersensitivity to tipifarnib or any components of the tablet are not eligible
• Patients with hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class are not eligible
• Patients who have an uncontrolled infection are not eligible
• Patients who have received a prior solid organ transplantation are not eligible
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Drug: Tipifarnib
Malignant Solid Neoplasm, Recurrent Adrenal Gland Pheochromocytoma, Recurrent Ectomesenchymoma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Kidney Wilms Tumor, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Melanoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdoid Tumor of the Kidney, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent Thyroid Gland Carcinoma, Recurrent WHO Grade 2 Glioma, Refractory Adrenal Gland Pheochromocytoma, Refractory Ependymoma, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Medulloblastoma, Refractory Melanoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdoid Tumor of the Kidney, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Refractory Thyroid Gland Carcinoma, Refractory WHO Grade 2 Glioma
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A Randomized Trial of Intra-Portal Alone Versus Intra- and Extra- Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis (iSite)

One treatment for certain types of chronic pancreatitis is total pancreatectomy with islet autotransplantation (TPIAT). In this procedure, the pancreas is removed (eliminating the source of the pain) and the islets, which produce insulin and other important hormones, are taken from the pancreas and transplanted in to the liver. This is a small study to evaluate a new procedure for transplanting some islets to a new location in the body.

Gregory Beilman
All
18 Years to 68 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03779139
STUDY00003956
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Inclusion Criteria:

• Age 18-68
• Scheduled for total pancreatectomy and IAT at U of MN. All patients who are approved for pancreatectomy and IAT at U of MN are reviewed by a multi-disciplinary committee including surgeons, gastroenterologists specializing in pancreatic disease, a pain specialist psychologist, and endocrinologist to confirm the diagnosis of chronic pancreatitis and candidate suitability for surgery.
• Able to provide informed consent
Exclusion Criteria:

• Pre-Existing diabetes mellitus fasting blood glucose>115mg/dl, or hemoglobin A1c level >6.0% because these are all evidence of inadequate beta-cello mass.
• Use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, or amylin.
• ALT or AST>2.5 times the upper limit of normal (ULN). Bilirubin>ULN, unless due to benign diagnosis such as Gilbert's.
• Any of the following hematologic abnormalities: server anemia (hemoglobin <10 g/dL), thrombocytopenia (<150/mm3), or neutropenia(<1.0 x 109/L).
• Current use or expected use of oral or injected corticosteroids, or any mediation likely to affect glucose tolerance. However, use of hydrocortisone for physiologic replacement, or use of any topical, inhaled or intranasal glucocorticoid is permitted.
• Current or expected use of any other immunosuppressive agent.
• Known coagulopathy, or need for anticoagulant therapy preoperatively (coumadin, enoxaparin), or any history of pulmonary embolism.
• For females, plans to become pregnant or unwillingness to use birth control for the study duration.
• Inability to comply with the study protocol.
• Untreated psychiatric illness that may interfere with ability to give informed consent, or other developmental delay or neurocognitive disorder that impairs with a patient's ability to consent on their own behalf.
• Any other medical condition that , in the opinion of the investigator, may interfere wit the patient's ability to successfully and safely complete the trial.
Procedure: Intrahepatic islets and islets in the omental pouch, Procedure: Intrahepatic islets alone, Other: Normal Volunteers
Chronic Pancreatitis, Diabetes Mellitus, Islet Cell Transplantation
total pancreatectomy with islet autotransplant, 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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A Phase 1/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors; Protocol Number: LOXO-RET-18036 (J2G-OX-JZJJ) (LIBRETTO-121)

This is an open-label, multi-center, Phase 1/2 study of oral LOXO-292 in pediatric patients with an activating RET alteration and an advanced solid or primary CNS tumor.

Emily Greengard
All
6 Months to 21 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03899792
STUDY00008874
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Inclusion Criteria:

• Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies
• Evidence of an activating RET gene alteration in the tumor and/or blood
• Measurable or non-measurable disease
• Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50
• Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days
• Adequate hematologic, hepatic and renal function.
• Ability to receive study drug therapy orally or via gastric access
• Willingness of men and women of reproductive potential to observe conventional and effective birth control
Exclusion Criteria:

• Major surgery within two weeks prior to planned start of LOXO-292
• Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292
• Active uncontrolled systemic bacterial, viral, fungal or parasitic infection
• Clinically significant active malabsorption syndrome
• Pregnancy or lactation
• Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292)
• Uncontrolled symptomatic hypercalcemia or hypocalcemia
• Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension
• Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s])
Drug: LOXO-292
Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer, Soft Tissue Sarcoma
Loxo, LOXO-292, KIF5B-RET, M918T, CCDC6-RET, RET-PTC1, NCOA4-RET, RET-PTC, RET-PTC3, RET-PTC4, PRKAR1A-RET, RET-PTC2, GOLGA5-RET, RET-PTC5, ERC1-RET, KTN1-RET, RET-PTC8, HOOK3-RET, PCM1-RET, TRIM24-RET, RET-PTC6, TRIM27-RET, TRIM33-RET, RET-PTC7, AKAP13-RET, FKBP15-RET, SPECC1L-RET, TBL1XR1-RET, BCR-RET, FGRF1OP-RET, RFG8-RET, RET-PTC9, ACBD5-RET, MYH13-RET, CUX1-RET, KIAA1468-RET, FRMD4A-RET, SQSTM1-RET, AFAP1L2-RET, PPFIBP2-RET, EML4-RET, PARD3-RET, G533C, C609F, C609G, C609R, C609S, C609Y, C611F, C611G, C611S, C611Y, C611W, C618F, C618R, C618S, C620F, C620R, C620S, C630R, C630Y, D631Y, C634F, C634G, C634R, C634S, C634W, C634Y, K666E, E768D, L790F, V804L, V804M, A883F, S891A, R912P, CLIP1-RET, Y806C, RET fusion, RET alteration, RET mutation, RET rearrangement, RET translocation, Neoplasms by Site, Neoplasms, Non-Small Cell Lung Cancer, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Respiratory Tract Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Medullary Thyroid Cancer, Papillary Thyroid Cancer, Thyroid Diseases, Thyroid Neoplasms, Cancer of the Thyroid, Cancer of Thyroid, Neoplasms, Thyroid, Thyroid Adenoma, Thyroid Cancer, Thyroid Carcinoma, Endocrine System Diseases, Endocrine Gland Neoplasms, Head and Neck Neoplasms, Thoracic Neoplasms, CNS tumor, Primary CNS tumor, Colonic Neoplasms, Cancer of Colon, Cancer of the Colon, Colon Cancer, Colon Neoplasms, Colonic Cancer, Neoplasms, Colonic, Malignant tumor of Breast, Mammary Cancer, Mammary Carcinoma, Human, Mammary Neoplasm, Human, Neoplasms, Breast, Tumors, Breast, Human Mammary Carcinoma, Malignant Neoplasm of Breast, Breast Carcinoma, Breast Tumors, Cancer of the Breast, Breast Neoplasms, Breast Cancer, RET Inhibitor, MTC, NSCLC, Soft tissue sarcoma, Infantile Myofibromatosis, Infantile Fibrosarcoma
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A Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients with Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease

Goldfinch Bio is developing a subtype-selective and potent transient receptor potential canonical–5 (TRPC5) channel inhibitor, GFB-887, which offers the potential for targeted disease-modifying therapy for patients with diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD).

Patrick Nachman
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04387448
STUDY00010082
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Inclusion Criteria:

• All patients:
• Male or female 18-75 years of age, of any race, at the time of signing informed consent.
• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at Screening.
• Currently receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
• For DN patients:
• Diagnosis of type 2 diabetes with glycated hemoglobin (HbA1c) level ≤11% at Screening.
• UACR ≥ 150 mg/g.
• For FSGS/TR-MCD patients:
• Diagnosis of FSGS based on either biopsy or genetic testing or TR-MCD based on biopsy.
• UPCR ≥ 1.0 g/g.
Exclusion Criteria:

• All patients:
• Evidence of another (non-DN, non-FSGS/TR-MCD, respectively) kidney disease.
• History of malignancy, unless in remission for at least 5 years other than adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer not expected to require treatment over the course of the study.
• History of any organ or bone marrow transplant, including kidney grafts.
• History of alcoholism or drug/chemical abuse within 12 months prior to Screening.
• For DN patients:
• Renal disease that requires immunosuppressive therapy (currently, or in the past).
• Body mass index (BMI) >45 kg/m2.
• For FSGS/TR-MCD patients:
• Currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors.
• Body mass index (BMI) >40 kg/m2.
• Known history of severe or chronic hepatobiliary disease.
Drug: GFB-887, Drug: Placebo
Kidney Diseases, Diabetic Nephropathies, Glomerulosclerosis, Focal Segmental, Nephrosis, Lipoid, Urologic Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases, Glomerulonephritis, Nephritis, Nephrosis
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The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults

All
30 Years to 64 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04931836
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Inclusion Criteria:

• Classified as overweight or obese with BMI 25.0-39.9 kg/m2.
• Documentation* of a prediabetes diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100-125 mg/dL, a 2-hour oral glucose tolerance test of 140-199 mg/dL, or an HbA1c level of
• 7%-6.4%76; OR a study screening lab value of HbA1C within the afore mentioned range.
• Currently engaged in <100 min/week of physical activity - confirmed by questionnaire.
• No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)78-this Questionnaire involves seven "yes" or "no" questions regarding an individual's health status, with answering "yes" to any one of these questions requiring a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention.
• No self-reported physical/mental disabilities or gastrointestinal conditions.
• No antibiotic usage within the last 45 days.
• Stable weight over the last 6 months (<10% change).
• Not currently pregnant, planning to become pregnant, or currently breastfeeding.
• Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
• Note: Documentation can include either a print out or screen shot of the lab value illustrating eligibility, along with the date of the test and the participant's name. If a hard copy is provided, the date and name will be redacted.
Exclusion Criteria:

• Self-reported use of metformin and/or other medications that could interfere with the primary outcome.
• History of bariatric surgery or a history of other medical interventions that would interfere with the primary outcome.
Behavioral: Physical Activity Intervention
Obesity, Overweight, Overweight and Obesity, PreDiabetes, Type 2 Diabetes, Type 2 Diabetes Mellitus, Type 2 Diabetes Mellitus in Obese
Microbiome, Physical Activity
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A One-Year, Multicenter, Non-Interventional, Follow-Up, Safety Study in Subjects Previously Implanted with VC-02TM Combination Product

This is a one-year follow-up study from the parent study; An Open-Label, First-in-Human, Study Evaluating the Safety, Tolerability, and Efficacy of VC-02 Combination Product in Subjects with Type 1 Diabetes Mellitus and Hypoglycemia Unawareness Once a subject completes participation in the parent study with the VC-02 implants and then has all units removed, they will be consented and enrolled into this follow-up study. Clinic visits will occur at the following time points: Day 1, Month 3, Month 6, and Month 12. Visit assessments will include an abbreviated physical exam, vital signs, ultrasound of the areas that were previously implanted, adverse event collection, and limited laboratory assessments. The primary objective is to establish the long-term safety profile of VC-02 through 12 months post-explant. The secondary objective is to evaluate glycemic control following explant.

Melena Bellin
Phase II
This study is NOT accepting healthy volunteers
NCT02939118
STUDY00003133
Type 1 Diabetes Mellitus
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Atrasentan in Patients With Proteinuric Glomerular Diseases (AFFINITY)

The purpose of the research is to find out if atrasentan delays worsening of kidney function in IgAN, FSGS, and Alport Syndrome

All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04573920
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Inclusion Criteria:

• Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts
• Age 18-70 years for patients in the DKD cohort
• Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks.
• For patients enrolling in IgAN Cohort:
• Biopsy-proven IgA nephropathy
• UPCR between 0.5 to less than 1.0 g/g
• Screening eGFR ≥ 30 mL/min/1.73 m2
• For patients enrolling in FSGS Cohort:
• Biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS
• UPCR > 1.0 g/g
• Screening eGFR ≥ 30 mL/min/1.73 m2
• Subjects receiving systemic corticosteroids or other immunosuppressants must be on a stable dose for at least 12 weeks.
• BMI ≤ 40 kg/m2
• For patients enrolling in Alport syndrome Cohort:
• Diagnosis of Alport syndrome by genetic testing
• UPCR > 0.5 g/g
• Screening eGFR ≥ 30 mL/min/1.73 m2
• For patients enrolling in DKD Cohort:
• Diagnosis of type 2 diabetes mellitus
• UACR ≥ 0.5 g/g
• Screening eGFR ≥ 45 mL/min/1.73 m2
• Receiving a stable dose of SGLT2 inhibitor for at least 12 weeks
• Willing and able to provide informed consent and comply with all study requirements
Exclusion Criteria:

• Current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy.
• History of kidney transplantation or other organ transplantation.
• Except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months.
• Blood pressure above 150 mmHg systolic or 95 mmHg diastolic as evaluated by the Investigator.
• History of heart failure or a previous hospital admission for fluid overload.
• Clinically significant history of liver disease as assessed by the Investigator.
• Hemoglobin below 9 g/dL as measured by the Investigator or blood transfusion for anemia within the past 3 months.
• Clinical diagnosis of nephrotic syndrome
• Malignancy within the past 5 years. Exception to the criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ.
• For women, pregnant, breastfeeding, or intent to become pregnant during the study.
• For men, intent to father a child or donate sperm during the study.
• Recently received an investigational agent.
• Clinically significant unstable or uncontrolled medical condition as assessed by the Investigator.
Drug: Atrasentan
IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome, Diabetic Kidney Disease, Diabetic Nephropathy Type 2, Immunoglobulin A Nephropathy
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