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85 Study Matches

A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer

This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Herbert Zeh
162393
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03735680
STU-2019-0967
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Inclusion Criteria:

• Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection
• Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer
• Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.
• Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers
Exclusion Criteria:

• Histologically diagnosed by an excisional biopsy procedure
• Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible
• Life expectancy <12 weeks
• Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis
Drug: ONM-100
Prostate Cancer, Non-Small Cell Lung Cancer, Breast Cancer, Colorectal Cancer, Ovarian Cancer, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma, Breast - Female, Colon, Ovary, Prostate
UT Southwestern
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Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Suzanne Cole
42296
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03775265
STU-2019-1159
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Inclusion Criteria:

• STEP 1 REGISTRATION:
• If this will be the first patient from a registering site to receive a given RT modality (3DCRT vs. IMRT), the site must first submit pre-RT planning documents within 3 days of Step 1 registration and receive approval from Imaging and Radiation Oncology Core (IROC) before randomizing the patient to Step 2. If this will not be the first patient to receive a specific RT modality, the patient should be immediately randomized to Step 2 on the same day.
• STEP 2 RANDOMIZATION
• If patient required review of pre-RT planning, randomization must occur within 14 days of initial registration.
• Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the bladder within 120 days prior to randomization and no intervening treatment between the histologic proof and randomization. Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible. Patients with lymph nodes >= 1.0 cm in shortest cross-sectional diameter on imaging (computed tomography [CT]/magnetic resonance imaging [MRI] of abdomen and pelvis) must have a biopsy of the enlarged lymph node showing no tumor involvement within 70 days prior to randomization. These patients may be suitable for neoadjuvant chemotherapy and radical cystectomy and are eligible for this trial if they seek out a bladder sparing treatment strategy, however patients who have received prior systemic chemotherapy for bladder cancer are not eligible for the trial.
• Patients must undergo a transurethral resection of bladder tumor (TURBT) within 70 days prior to randomization. In a situation where a patient is referred from outside to the enrolling institution, patient must have a repeat office cystoscopy by the urologist who will be following the patient on the clinical trial to assess the adequacy of the prior TURBT. This cystoscopy can be performed in urologist office without general anesthesia. Patient may then undergo repeat TURBT if deemed necessary as standard of care by the treating urologist. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection. Patient must not have T4b disease
• Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease. Eligibility is based on the local radiology report.
• Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.
• Patient must be planning to receive one of the protocol specified chemotherapy regimens.
• All adverse events associated with any prior surgery and intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade =< 2 prior to randomization.
• Patients must be >= 18 years of age
• Patient may or may not be radical cystectomy candidates.
• Absolute neutrophil count (ANC) >=1,500/microliter (mcL) (within 28 days prior to randomization).
• Platelets >= 100,000/mcL (within 28 days prior to randomization).
• Hemoglobin >= 9 g/dL (within 28 days prior to randomization).
• Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) (within 28 days prior to randomization).
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x IULN (within 28 days prior to randomization).
• Patients must have adequate renal function as evidenced by calculated creatinine clearance >= 25 mL/min. The creatinine used to calculate the clearance result must have been obtained within 28 days prior to randomization.
• Patients must have Zubrod performance status =< 2.
• Patients must have a baseline electrocardiography (ECG) performed within 30 days prior to randomization.
• If patient has a known history of hepatitis B virus (HBV) or hepatitis C virus (HCV), they must meet the following criteria within 28 days prior to randomization.
• Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
• Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
• Patients who are known to be positive for human immunodeficiency virus (HIV) are eligible only if they have all of the following:
• A stable regimen of highly active anti-retroviral therapy (HAART)
• No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
• A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests within 28 days prior to randomization.
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
• Female patients of childbearing potential must have a serum pregnancy test prior to randomization. Patients must not be pregnant or nursing due to the potential teratogenic side effects of the protocol treatment. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of protocol treatment, and for 5 months (150 days) after the last dose of all study drugs. A woman is considered to be of "reproductive potential" if she has had a menses at any time in the preceding 12 consecutive months.
• Patients must be offered the opportunity to participate in specimen banking for future studies.
• Patients who can complete Patient-Reported Outcome instruments in English or Spanish must agree to complete the EORTC QLQ-C30, the EORTC QLQ-BLM30, the EPIC Bowel Assessment, and the EQ-5D-5L per protocol schedule of assessment.
• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
Exclusion Criteria:

• STEP 2 RANDOMIZATION EXCLUSION CRITERIA
• Patients must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within the previous 24 months except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy.
• Patients must not have diffuse CIS based on cystoscopy and biopsy.
• Patient must not have received any systemic chemotherapy for their bladder cancer.
• Patient must not have had prior pelvic radiation.
• Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.
• Patients must not have received any systemic therapy (including, but not limited to, interferon alfa-2b, high dose IL-2, pegylated interferon [PEG-IFN], anti-PD-1, anti-PD-L1), for non-muscle invasive bladder cancer. Prior intravesical BCG, interferon, and intravesical chemotherapy are allowed.
• Patients must not have received any of the following prohibited therapies within 28 days prior to randomization or be planning to receive any of the following prohibited therapies during protocol treatment:
• Anti-cancer systemic chemotherapy or biological therapy not specified in the protocol.
• Immunotherapy not specified in this protocol.
• Systemic or intravesical use of any non-study anti-cancer agent (investigational or non-investigational).
• Investigational agents other than atezolizumab.
• Live vaccines: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed. Prior administration of intravesical BCG is allowed.
• Glucocorticoids for any purpose other than to modulate symptoms from an event of suspected immunologic etiology. The use of physiologic doses of corticosteroids (defined as 10 mg prednisone) are acceptable, however site investigators should consult with the study chair for any dose higher than 10 mg prednisone. Dexamethasone 4 mg iv with chemotherapy to prevent nausea is allowed.
• RANKL infusion: Concurrent denosumab (which binds the cytokine RANKL) for any known indication is prohibited due to interaction with study medication.
• Patients must not have a major surgical procedure within 28 days prior to randomization. If patient had any surgical procedure then they should have recovered to full presurgical performance status and surgical adverse events should have resolved to grade =< 2. TURBT is not considered a major surgical procedure.
• Patients must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization. Exceptions:
• Patients may have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea).
• The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed. Physiological doses equivalent of 10 mg prednisone daily are allowed. Short term steroids given as antiemetic therapy, e.g. 4 mg dexamethasone or equivalent once a week, is allowed.
• Patients must not have received a live, attenuated vaccine within 4 weeks prior to randomization or anticipate that such a live, attenuated vaccine will be required while on protocol treatment and up to 5 months after the last dose of protocol treatment.
• Inactivated influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine within 4 weeks prior to randomization or while on protocol treatment and up to 5 months after the last dose of protocol treatment.
• Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
• Patients must not have clinically significant liver disease that precludes patient from treatment regimens prescribed on the study (including, but not limited to, active viral, alcoholic or other autoimmune hepatitis, cirrhosis or inherited liver disease).
• Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis.
• Patients must not have an active infection requiring oral or IV antibiotics within 14 days prior to randomization. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are not eligible. If patient develops urinary tract infection after TURBT they must have recovered from the infection prior to registration.
• Patients must not have active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, Graves' disease treated with methimazole or glomerulonephritis.
• Patient must not have a history of active tuberculosis.
• Patients must not be known to be allergic to Chinese hamster egg or ovary cell products and must not have any known major allergic reactions to any study drug.
Drug: Atezolizumab, Drug: Cisplatin, Drug: Fluorouracil, Drug: Gemcitabine, Drug: Mitomycin, Other: Quality-of-Life Assessment, Radiation: Radiation Therapy, Other: Survey Administration
Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage III Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8, Muscle Invasive Bladder Carcinoma
UT Southwestern
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Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

The primary objectives of the study by study part are: Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures, and to inform/confirm the final sample size determination for Part B. Part B: To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures. Part C: To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures. The secondary objectives of the study are: - To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE - To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses
Call 214-648-5005
studyfinder@utsouthwestern.edu
Christopher Parrish
168280
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03633617
STU-2019-0556
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Key Inclusion Criteria (Parts A & B):
• A documented diagnosis of EoE by endoscopic biopsy
• Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
• History (by patient report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening Key Exclusion Criteria (Parts A & B):
• Body weight ≤40 kg
• Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
• Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening.
• Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
• Active Helicobacter pylori infection
• History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
• Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening
• History of bleeding disorders or esophageal varices
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study Key Exclusion Criteria (Part C):
• Participants who, during Part A or Part B, developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to study drug, which in the opinion of the investigator could indicate that continued treatment with study drug may present an unreasonable risk for the participant
• Participants who became pregnant during Part A or Part B
• Participants who are prematurely discontinued from study drug due to an AE (patients who are prematurely discontinued from study drug due to lack of efficacy are eligible to enter Part C)
• Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment Note: Other inclusion/ exclusion criteria apply
Drug: Dupilumab, Drug: Placebo
Eosinophilic Esophagitis, Other
Children’s Health
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A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Muhammad Beg
125541
All
18 Years to 110 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03778957
STU-2019-1141
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Key
Inclusion Criteria:

• No evidence of extrahepatic disease
• Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
• Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
• Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
• Adequate organ and marrow function Key Exclusion Criteria
• Any history of nephrotic or nephritic syndrome
• Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction
• Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)
• History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
• Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded
Drug: Durvalumab, Drug: Bevacizumab, Other: Placebo, Procedure: Transarterial Chemoembolization (TACE)
Hepatocellular Carcinoma, Liver
Hepatocellular Carcinoma, TACE, Durvalumab, Bevacizumab, Liver Cancer
Parkland Health & Hospital System
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Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body

This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin, 5-fluorouracil, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding radiotherapy to the usual chemotherapy may work better compared to the usual chemotherapy alone in treating patients with esophageal and gastric cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Nina Sanford
181796
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04248452
STU-2020-0217
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Inclusion Criteria:

• REGISTRATION TO STEP 1
• Patient must have histologically confirmed HER2 negative metastatic esophageal or gastric adenocarcinoma (American Joint Committee on Cancer [AJCC] 8th edition)
• Patient must have oligometastatic disease at the time of registration, which is defined as the following:
• At most 3 radiologically visible metastatic lesions (not sites), in addition to the primary site. Computed tomography (CT) or magnetic resonance imaging (MRI) scans will be performed for staging purposes. Patients with oligometastatic sites that are only detected with positron emission tomography (PET)/CT will be eligible for participation, as long as radiation planning and administration is feasible after discussion with treating radiation oncologist. Malignant lymph node should be at least 1 cm in size or biopsy proven involved by disease
• Anatomically defined lymphadenopathy will be considered as 1 site of metastatic disease. For example, 2 enlarged paraaortic lymph nodes will be considered as one site, and 2 additional sites will be allowed to meet protocol definition of oligometastatic disease. However, if supraclavicular or cervical nodes are involved for distal esophageal tumors or gastric tumors, these are counted separately from intrathoracic nodes. For upper thoracic/cervical esophageal tumors, the involvement of celiac nodes are counted separately from intrathoracic nodes. Intrathoracic nodes, defined as hilar and mediastinal nodes, will be collectively counted as one
• Patients with radiologically evident peritoneal metastasis will be excluded.
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception (both double barrier contraception and birth control pills or implants) or by abstaining from sexual intercourse for at least one month after the last dose of protocol treatment and continuing for 5 months after the last dose of protocol treatment (for female patients) and for 7 months after the last dose of protocol treatment (for male patients who are sexually active with women of child bearing potential [WOCBP]). Investigators must counsel WOCBP and male patients who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained within 28 days prior to registration)
• Hemoglobin >= 8 g/dL (obtained within 28 days prior to registration)
• Platelets (PLT) >= 100 x 10^9/L (obtained within 28 days prior to registration)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x upper limit of normal (ULN) (obtained within 28 days prior to registration)
• Bilirubin =< 1.5 x institutional ULN (obtained within 28 days prior to registration)
• Serum creatinine =< 1.5 x institutional ULN (Cockcroft and Gault formula) (obtained within 28 days prior to registration)
• Albumin > 2.5 g/dL (obtained within 28 days prior to registration)
• Patient must be able to understand and willing to sign and date the written voluntary informed consent form prior to any protocol-specific procedures
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must have CD4 > 200 at the time of registration
• NOTE: HIV testing is not required for eligibility
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Patients who had prior definitive treatment for early stage EGA with either surgery or chemoradiation are eligible for participation as long as recurrent disease developed at least 6 months after completion of all prior therapies
• Any major surgery must have been completed >= 4 weeks prior to registration
• REGISTRATION TO STEP 2
• Patient must have histologically confirmed HER2 negative metastatic esophageal or gastric adenocarcinoma (AJCC 8th edition) with stable disease after about 4 months of fluorouracil, leucovorin calcium, and oxaliplatin (FOLFOX) or 6 cycles of capecitabine and oxaliplatin (CAPOX) (Step 1 treatment)
• Patient must have no evidence of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria since Step 1 registration. Patients with complete radiologic response are eligible for Step 2
• Patient must have an ECOG performance status 0-1
Exclusion Criteria:

• Patient must not have any contraindications to 5-fluorouracil (5-FU) or capecitabine, oxaliplatin
• Patient must not have any contraindications to radiation therapy based on consultation with a radiation oncologist. Formal radiation oncology evaluation will be required for eligibility purposes. Prior palliative or definitive radiation to the primary site is allowed, as long as it was completed at least 2 weeks before registration
• Women must not be pregnant or breast-feeding due to the potential harm to unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
• All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 14 days prior to registration
• A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Patient must not have had any prior treatment with 5-FU or capecitabine and/or oxaliplatin containing systemic therapy
• NOTE: Patients previously treated with radiosensitizing doses of 5-FU will be eligible for participation as long as adequate time has elapsed from past treatments
• NOTE: Patients who received systemic 5-FU or capecitabine and/or oxaliplatin as part of the treatment for their locoregional disease are eligible for participation, as long as all definitive therapy has been completed at least 6 months prior to trial enrollment
• Patients with known central nervous system (CNS) metastasis will be excluded from trial participation, regardless of the status of the CNS disease
• Patient must not have any uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patient must not have had live vaccines within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines and are not allowed
Drug: Capecitabine, Drug: Fluorouracil, Drug: Leucovorin, Drug: Leucovorin Calcium, Drug: Oxaliplatin, Radiation: Radiation Therapy
Metastatic Gastric Adenocarcinoma, Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Metastatic Esophageal Adenocarcinoma, Oligometastatic Esophageal Adenocarcinoma, Oligometastatic Gastric Adenocarcinoma, Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8, Pathologic Stage IV Gastric Cancer AJCC v8, Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8, Esophagus
UT Southwestern
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ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Baran Sumer
94227
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03769506
STU-2019-1166
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Overall
Inclusion Criteria:

• Have a histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment
• Have failed or progressed on or after at least 2 lines of therapy for squamous cell carcinoma of the head and neck, one of which must be prior systemic platinum-based chemotherapy
• Have completed prior curative radiation therapy for treatment of their head and neck region
• Have locoregional head and neck tumor site(s) that are all accessible to illumination
• Have target tumors that are clearly measurable by contract enhanced CT scan
• Have a life expectancy of > 6 months, based on Investigator judgment
• Male participants must agree to use contraception during the treatment period and for at least 6 months after the last ASP-1929 infusion
• Female patients of childbearing potential must not be pregnant or breastfeeding and agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of trial intervention and must refrain from breastfeeding for at least 2 months after the last ASP-1929 infusion
• Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Overall
Exclusion Criteria:

• Have a history of significant (> Grade 3) cetuximab infusion reactions
• Have been treated with prior systematic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or not recovered from adverse events due to a previously administered agent
• Have been treated with an anticancer monoclonal antibody therapy within 4 of trial Day 1 or have not recovered from adverse events due to previously administered agent
• Have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or have not recovered from adverse events, due to previously administered agent or intervention
• Have a present history of distant metastatic disease (M1)
• Have an active undergoing treatment or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC
• Have a tumor in enhanced CT or MRI scan invading a major blood vessel, unless the vessel has been embolized, stented or surgically ligated to prevent potential bleeding from a blood vessel
• Have impaired hepatic function
• Have impaired renal function
• Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with trial requirements
• Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment
Combination Product: ASP-1929 Photoimmunotherapy, Drug: Physician's Choice SOC
Head and Neck Cancer, Esophagus, Larynx, Lip, Oral Cavity and Pharynx
Rakuten Medical, ASP-1929, PIT, Photoimmunotherapy, HNC, HNSCC, Head and neck
UT Southwestern
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Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis (AlcHepNet)

This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mack Mitchell
124226
All
21 Years to 65 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04072822
STU-2019-1368
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Inclusion Criteria 1. AH, as defined by the NIAAA pan-consortia for AH6: 1. Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to screening visit 2. Regular consumption of alcohol with an intake of > 40 gm daily or >280gm weekly on average for women and > 60 gm daily or >420gm weekly on average for men for 6 months or more, with less than 8 weeks of abstinence before onset of jaundice 3. AST > 50 IU/l 4. AST:ALT > 1.5 and both values < 400 IU/l 5. and/or histological evidence of AH* 2. MELD 20-35 on day of randomization.
• In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST < 50 IU/L or > 400 IU/L, AST/ALT ratio < 1.5), antinuclear antibody > 1:160 or SMA > 1:80, a standard of care liver biopsy may be performed during current hospital admission to confirm AH and exclude competing etiologies 17 Exclusion Criteria 1. MELD SCORE <20 or > 35 2. Active sepsis (positive blood or ascitic cultures) with Systemic Inflammatory Response Syndrome (SIRS) or hemodynamic compromise requiring intravenous pressors to maintain tissue perfusion 3. Pneumonia as evidenced by radiological exam 4. Multi-organ failure 5. Renal failure defined by GFR <50 mL/min. 6. Clinically active C. diff infection 7. History of imaging of the liver (ultrasound, computerized tomography or magnetic resonance) showing other causes of jaundice 8. History of other liver diseases including hepatitis B (positive HBsAg or HBV DNA), hepatitis C (positive HCV RNA), autoimmune hepatitis, Wilson disease, genetic \hemochromatosis, alpha1-antitrypsin deficiency or strong suspicion of Drug Induced Liver Injury (DILI) 9. History of HIV infection (positive HIV RNA or on treatment for HIV infection) 10. History or presence of cancer (including hepatocellular carcinoma) other than non- melanoma skin cancer 11. History of other significant medical problems such as autoimmune diseases, severe asthma, psoriasis, Inflammatory Bowel Disease (IBD), etc. that might require immunosuppressive treatments 12. Pregnancy or breastfeeding 13. Prior exposure to experimental therapies in last 3 months 14. Prior exposure to systemic corticosteroid (glucocorticoid) or immunosuppressive therapy for more than 4 days within previous 30 days 15. Need for inotropic pressor support to maintain perfusion to critical organs within prior 48 hours before randomization and initiation of experimental treatment 16. Clinically significant pancreatitis- abdominal pain, elevated lipase (> 3 X ULN) and at least edema of pancreas with fat-stranding on CT scan 17. Total WBC count > 30,000/mm3 18. Known allergy or intolerance to therapeutic agents to be tested 19. Inability to voluntarily obtain informed consent from participant or guardian 20. Perceived inability to follow study procedures and comply with protocol 21. Platelet count < 50,000 k/cumm. 22. Positive PCR test for COVID -19 within 7 days prior to the baseline day 0 visit *Positive test is exclusionary only during screening period. If a patient tests positive any time after baseline randomization, a positive PCR test for COVID-19 will be considered as a SAE.
Drug: Anakinra and Zinc, Drug: Prednisone, Drug: Placebos
Alcoholic Hepatitis, Liver
Parkland Health & Hospital System
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An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
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Amal Aqul
103693
All
1 Year to 18 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04185363
STU-2019-1663
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Key
Inclusion Criteria:
1. Provide informed consent and assent (as applicable) per Institutional Review Board/Ethics Committee (IRB/EC) 2. Completion of study MRX-502
Exclusion Criteria:
1. Any female who is pregnant or lactating or who is planning to become pregnant 2. Administration of prohibited medication between the MRX-502 EOT visit and the MRX 503 Baseline Visit (Day 0) 3. History of non-compliance in study MRX-502, non-adherence to medical regimens, unreliability, mental instability or incompetence that could compromise the validity of informed consent or lead to non-adherence with the study protocol based on Investigator judgment 4. Experienced an adverse event (AE) or serious adverse event (SAE) related to maralixibat during the MRX-502 study that led to permanent discontinuation of the subject from maralixibat 5. Any other conditions or laboratory abnormalities that, in the opinion of the Investigator or Sponsor Medical Monitor, may compromise the safety of the subject, or interfere with the subject participating in or completing the study
Drug: Maralixibat
Progressive Familial Intrahepatic Cholestasis (PFIC), Liver
Cholestasis, Maralixibat, Mutation, PFIC, PFIC2, Bile Duct Diseases, Liver Diseases, Biliary Tract Diseases, Digestive System Diseases, Pediatric
Children’s Health
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A 5-year Longitudinal Observational Study of the Natural History and Management of Patients With HCC

TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual clinical practice. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.
Call 214-648-5005
studyfinder@utsouthwestern.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02954094
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Inclusion Criteria:
1. Male or female patients, age ≥18 years 2. Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)
Exclusion Criteria:
1. Inability to provide written informed consent
Hepatocellular Cancer
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ENhancing Recovery in CHildren Undergoing Surgery (ENRICH-US)

Initiated in the 1990s, perioperative Enhanced Recovery Protocols (ERPs) have progressively gained traction in a wide range of adult surgical disciplines and have decreased hospital length of stay (LOS), in-hospital costs, complications, and result in a markedly improved patient care experience that mitigates the physiologic stress of surgery and hastens recovery. Implementation of ERPs in pediatric surgery is lagging and concerted efforts to demonstrate both clinical effectiveness and to examine obstacles to implementation are needed. Specifically, pediatric patients with inflammatory bowel disease (IBD) undergoing elective abdominal surgery represent an ideal population in which to study the implementation of ERPs. Almost one third of patients with Crohn's disease (CD) and a quarter of patients with Ulcerative Colitis (UC) present before age 20. Up to three-quarters of CD patients require GI surgery for medically refractory disease and all patients with UC require colectomy to either manage severe disease or to mitigate cancer risks. Over the past four years, investigators modified existing adult ERPs to meet the needs of pediatric patients undergoing elective GI surgery. Based on the positive results of a pilot study, the investigators propose to conduct a multicenter, prospective, pragmatic, study using a stepped-wedge, cluster, randomized controlled trial design to evaluate the effectiveness of ERPs while assessing implementation fidelity, sustainability, and site-specific adaptations. The cluster randomized trial design is ideally suited for this type of pragmatic intervention implementation. The National Implementation Research Network's five Active Implementation Frameworks (AIFs), which identifies competency, organization, and leadership as drivers of implementation, empowers team collaboration, and facilitates rapid-cycle evaluation, will be used to optimize implementation. The investigators propose to conduct the ENhancing Recovery In CHildren Undergoing Surgery (ENRICH-US) Study in 18 US hospitals participating in the Pediatric Surgical Research Collaborative (PedSRC) by implementing and evaluating the effectiveness of the Pediatric ERP in GI Surgery on clinical outcomes for pediatric IBD patients and by measuring by fidelity and sustainability of the intervention while identifying organizational, leadership, and competency-based drivers of improved ERP implementation and sustainability.
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David Schindel
69697
All
10 Years to 18 Years old
N/A
This study is also accepting healthy volunteers
NCT04060303
STU-2020-0137
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Inclusion Criteria:

• Pediatric patients ages 10-18
• Clinical diagnosis of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
• Undergoing elective gastrointestinal/colorectal surgical procedures
Exclusion Criteria:

• Children undergoing emergent/urgent gastrointestinal/colorectal surgical procedures
• Patients/families who cannot read and write English or Spanish
Procedure: Perioperative surgical care
Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease
Pediatric Surgery, Implementation, Quality Improvement, Enhanced Recovery Protocols
Children’s Health
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ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)

studyfinder@utsouthwestern.edu
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT04752358
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Key
Inclusion Criteria:

• Age ≥18 and <75 years
• Diagnosis of Esophageal cancer or Esophagogastric junction cancer.
• Previously received for advanced or metastatic disease.
• Measurable disease according to RECIST v1.1.
• HLA-A*02 positive
• Tumor shows MAGE-A4 expression confirmed by central laboratory.
• ECOG Performance Status of 0 or1.
• Left ventricular ejection fraction (LVEF) ≥50%. Note: other protocol defined Inclusion criteria may apply Key exclusion criteria 1. Positive for any HLA-A*02 allele other than: one of the inclusion alleles 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study 3. Active autoimmune or immune mediated disease 4. Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases 5. Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease 6. Uncontrolled intercurrent illness 7. Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus 8. Pregnant or breastfeeding Note: other protocol defined Inclusion/Exclusion criteria may apply.
Genetic: Autologous genetically modified ADP-A2M4CD8 cells
Esophageal Cancer, Esophagogastric Junction Cancer
Cell Therapy, T Cell Therapy, SPEAR T Cell, MAGE-A4, Immuno-oncology, Metastatic, Esophagogastric Junction, Esophageal Cancer
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Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection

The purpose of this study is to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old with immunotolerant chronic hepatitis B.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Norberto Rodriguez-Baez
50856
All
3 Years to 18 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT01368497
STU 042011-031
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Inclusion Criteria:

• Enrolled in & completed the baseline evaluation in NCT01263600 OR completed necessary components of NCT01263600 baseline evaluation by the end of the baseline visit.
• 3 to <18 years at time of randomization (day 0).
• Documented chronic HBV infection as evidenced by detection of HBsAg in serum for ≥ 24 weeks prior to baseline OR positive HBsAg and negative anti-HBc IgM within 24 weeks of baseline visit.
• Presence of HBeAg in serum at the last screening visit within 6 weeks of baseline visit.
• Serum HBV DNA level >10^7 IU/mL on at least 2 occasions at least 12 weeks apart during the 52 weeks before baseline visit. The HBV DNA levels must be within 6 weeks of baseline visit.
• ALT ≤60 U/l in males or ≤40 U/l in females, measured on at least 2 occasions, at screening (within 6 weeks prior to baseline visit) & at least 12 weeks prior to the screening visit & within the 52 weeks prior to baseline visit.
• Compensated liver disease, with normal total bilirubin (except if Gilbert's syndrome), direct bilirubin ≤0.5 mg/dL, INR ≤1.5, and serum albumin ≥3.5 g/dL.
• Creatinine clearance 90 ml/min.
• Absence of hepatocellular carcinoma on liver ultrasound in the past 48 weeks. Exclusion criteria:
• Presence of infection with HCV-RNA or anti-HCV, anti-HDV, or HIV at screening.
• Presence of another cause of liver disease or HCC (serum alpha-fetoprotein >50ng /ml).
• Evidence of decompensated liver disease (Childs B-C).
• History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
• Females who are pregnant or breastfeeding.
• Adolescent females unwilling or unable to use an acceptable method of contraception if sexually active during the treatment period.
• Children currently breastfeeding while their mother is taking lamivudine, or those who were exposed to lamivudine for ≥24 weeks via maternal lamivudine treatment during pregnancy and/or while breastfeeding.
• Previous liver or other organ transplantation including engrafted bone marrow transplant.
• Hematological abnormalities during the screening period that contraindicate full dosing with study drugs, e.g absolute neutrophil count < 1.5 x 10^9 cells/L or platelet count < 120 x 10^9 cells/L.
• Known allergy to study drugs; peginterferon alfa-2a or entecavir.
• Treatment with systemic acyclovir or famciclovir within the previous 6 months.
• Need for ongoing use of any antivirals with activity against HBV during the course of the study or history of receiving treatment for HBV.
• Any use of illegal drugs OR use of alcoholic beverages which in the opinion of a study physician is sufficient to prevent adequate compliance with study procedures or increase the risk of pancreatitis or hepatotoxicity.
• History of immunologically mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).
• History or other evidence of bleeding from esophageal varices or consistent with decompensated liver disease.
• History or other evidence of chronic pulmonary disease associated with functional limitation.
• History of significant cardiovascular diseases.
• History of a severe seizure disorder or current anticonvulsant use.
• History or other evidence of severe retinopathy.
• History of thyroid disease poorly controlled on prescribed medications. Participants with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded.
• Concomitant use or use during ≤ 6 months prior to the first dose of study drug of anti-neoplastic, immunosuppressive, nephrotoxic or hepatotoxic medication, methadone, theophylline or medications that may affect renal excretion or hepatic metabolism are not permitted.
• Concomitant use of complementary or alternative medications purported to have antiviral activity.
• A participant may not be co-enrolled in another clinical trial where an investigational drug is administered.
• Any other condition or situation that in the opinion of a study physician would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the study.
Drug: Entecavir and peginterferon
Hepatitis B
Children’s Health
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A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFL or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients with NAFL or NASH within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.
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studyfinder@utsouthwestern.edu
Sarah Barlow
86752
All
2 Years and over
This study is NOT accepting healthy volunteers
NCT02815891
STU 042018-018
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Inclusion Criteria:
1. Adults and children (age 2 or older) being managed or treated for nonalcoholic fatty liver disease. Diagnosis is based on the clinical judgement of the care provider.
Exclusion Criteria:
1. Inability to provide informed assent/consent.
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver, Liver
Children’s Health
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Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

studyfinder@utsouthwestern.edu
All
12 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04991935
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Inclusion Criteria:

• Previously participated in prior clinical study CC-93538-EE-001 and either:
• completed both the Induction and Maintenance phases; or
• completed the Induction Phase, however, did not qualify for the Maintenance Phase, including having a severe eosinophilic esophagitis (EoE) flare requiring endoscopic intervention or rescue therapy.
• Demonstrated compliance with required investigational product dosing during the prior study.
• Did not permanently discontinue investigational product in the prior study and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing.
• Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.
Exclusion Criteria:

• Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study.
• Active Helicobacter pylori infection or esophageal varices.
• Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study.
• Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study.
• Received an investigational product, other than that administered in CC-93538-EE-001, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19). Those vaccinated with an investigational COVID-19 vaccine during CC-93538-EE-001 are not eligible, unless allowed following a discussion with the Clinical Trial Physician.
• Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study.
• Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic or psychiatric illness that could compromise the participant's ability to accurately document symptoms of EoE; newly diagnosed malignancy, lymphoproliferative disease, or clinically significant laboratory abnormality).
• Active or ongoing infections including parasitic/helminthic infections, viral hepatitis, tuberculosis, or HIV.
• Has had idiopathic anaphylaxis or major immunologic reaction to an immunoglobulin-G containing agent; or any known hypersensitivity to any ingredient in CC-93538.
• Females who are pregnant or lactating.
Drug: CC-93538
Eosinophilic Esophagitis
Eosinophilic Esophagitis, CC-93538, RPC4046, Adult, Adolescent, Gastrointestinal Diseases, Esophagitis, Gastroenteritis, Eosinophils, Eosinophilia, Esophageal Diseases, Allergic Diseases, Antibody, Monoclonal, Hypersensitivity, Immunologic factors, Physiological Effects of Drugs
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A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis

This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
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studyfinder@utsouthwestern.edu
Marlyn Mayo
14698
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02932449
STU 032017-093
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Inclusion Criteria:

• Adult patients (age 18 or older) being treated or managed for PBC
Exclusion Criteria:

• Inability to provide written informed consent
• Simultaneous enrollment in another prospective registry or clinical trial or study where PBC treatment outcomes are reported, except where approved or conducted as an adjunct project of TARGET-PBC
Biliary Cirrhosis, Primary, Liver
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Effect of Fatty Liver on TCA Cycle Flux and the Pentose Phosphate Pathway (HPFFF)

The investigators plan to evaluate sensitivity and specificity of HP 13C-pyruvate as an imaging agent for detection of altered PDH flux in fatty liver.
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Craig Malloy
14563
All
18 Years to 99 Years old
Early Phase 1
This study is also accepting healthy volunteers
NCT03480594
STU 082017-019
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Inclusion Criteria:

• Ages 18 to 99 years.
• All races, ethnicities and gender identification may be included. Subjects must meet all of the inclusion and exclusion criteria to be included in the study.
• Either fatty liver diagnosis (defined as >5.6% fat content in the liver) or healthy control
• While all races and ethnicities will be included, subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included.
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion Criteria:
Fatty Liver Subjects
• No subjects taking hypoglycemic agents or insulin will be enrolled. There is no exclusion based on fasting glucose.
• Subjects with major mental health conditions such as schizophrenia and bipolar disorder that would limit compliance with study requirements will not participate. In general, subjects with any form of medical instability such as seizure disorders, significant COPD, significant asthma, left ventricular dysfunction will not participate.
• Medications for control of hypercholesterolemia, hypertriglyceridemia or hyperglycemia. Healthy Control Subjects
• Liver disease or other chronic illness
• Diagnosis of type I or type II diabetes
• No subjects taking hypoglycemic agents or insulin will be enrolled. There is no exclusion based on fasting glucose.
• A potential subject with any major medical, surgical or psychiatric condition will not participate. These conditions include but are not limited to thyroid disease, chronic metabolic illness, known vascular disease, current cancer diagnosis and/or treatment.
• Subjects with major mental health conditions such as schizophrenia and bipolar disorder that would limit compliance with study requirements will not participate. In general, subjects with any form of medical instability such as seizure disorders, significant COPD, significant asthma, left ventricular dysfunction will not participate.
• Medications for control of hypercholesterolemia, hypertriglyceridemia or hyperglycemia. All Subjects
• No prior hepato-biliary surgery.
• Donated blood within the prior 4 weeks.
• Consume more than 10 grams of ethanol per day.
• Cirrhosis or any form of viral hepatitis.
• Prior documented hepatic reaction to drugs with a known hepatotoxicity profile such as isoniazid, methotrexate, phenytoin, propylthiouracil, valproate, etc.
• Pregnant/Lactating
• Receiving any other investigational agents.
• Any contraindication noted on the UTSWMC MRI Screening Form including implants contraindicated at 3T, pacemakers, Implantable Cardioverter Defibrillators (ICD), etc., and significant claustrophobia.
Drug: Hyperpolarized [13C] Pyruvate Injection
Fatty Liver
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Social & Contextual Impact on Children Undergoing Liver Transplantation (SOCIAL-TX)

studyfinder@utsouthwestern.edu
All
up to 70 Years old
This study is NOT accepting healthy volunteers
NCT04551742
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Inclusion Criteria:
Caregivers/parents of children with the following criteria will be approached for inclusion in this study:
• Children <18 years of age at the time of transplant
• Undergoing liver transplantation
• Guardian's consent, child assent (in accordance with each institution's IRB policies)
• Consents to enrollment in SPLIT
Exclusion Criteria:
Caregivers/parents of children undergoing liver transplantation will be excluded it:
• Caregiver unwilling or unable to complete the survey
• Child is a ward of the state (e.g., foster care) since present circumstances may not be reflective of child's past or future circumstances
• Non-English, non-Spanish speakers
• Non-US residents
• Declined participation in SPLIT Inclusion Criteria for Interview Portion of the Study:
• Participants who have completed the questionnaire OR
• Medical team member involved in the care of children undergoing liver transplant (e.g., physician, nurse, social worker)
Liver Diseases, Liver Transplantation
Pediatric, Health services research, Social determinants of health
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A Multi-Center Trial to Study Acute Liver Failure in Adults (ALFSG)

The purpose of this study is to collect clinical and epidemiological data as well as serum, plasma, urine, tissue and DNA samples on individuals who have acute liver failure and on individuals who have acute liver injury, a less severe group of patients who have coagulopathy but do not reach the threshold of encephalopathy.
Call 214-648-5005
studyfinder@utsouthwestern.edu
William Lee
14217
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT00518440
STU 062010-126
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ALF
Inclusion Criteria:

• Written Informed consent from patient's next of kin
• Altered mentation of any degree (encephalopathy)
• Evidence of moderately severe coagulopathy (INR ≥ 1.5)
• A presumed acute illness onset of less than 26 weeks
• The NIH guidelines on the inclusion of women and minorities as subjects in clinical research will be observed ALF
Exclusion Criteria:

• Cirrhosis patients
• Alcohol induced liver failure
• Known pre-existing chronic liver disease ALI
Inclusion Criteria:
Acetaminophen (APAP) etiology: acute illness < 2 wks
• INR ≥ 2.0, ALT ≥ 10X ULN Non-acetaminophen etiology: acute illness < 26 wks
• INR≥ 2.0, ALT≥ 10X ULN, TBili ≥ 3 mg/dl ALI
Exclusion Criteria:
• Altered mentation of any degree (encephalopathy)
Acute Liver Failure, Fulminant Hepatic Failure, Acute Liver Injury, Liver
Liver disease, Liver injury
Parkland Health & Hospital System
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Alcoholic Hepatitis Network Observational Study

The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, and stool samples (e.g., biological samples) and personal health information from you to use in future research studies related to alcoholic hepatitis or other diseases. Part of your blood sample will be used to extract your DNA. DNA is the genetic material that gives us unique characteristics. We are doing this research study because we are trying to find out more about how and why illnesses related to alcoholic hepatitis or other diseases occur in people. To do this, we will study the biological samples and personal health information from healthy and sick people. A "biological sample" is usually blood, but can be any body fluid. "Personal Health Information" includes such items as your name, age, gender, race, and/or your medical information. It can also include data from measurements and tests that you had while participating in another research study or that were done during the course of your regular medical care or doctor visits.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mack Mitchell
124226
All
21 Years and over
This study is also accepting healthy volunteers
NCT03850899
STU-2019-0472
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CASES: Heavy drinkers with alcoholic hepatitis Inclusion criteria 1. A clinical diagnosis of alcoholic hepatitis 2. Serum total bilirubin >3 mg/dL 3. Subject or guardian ability to understand and willingness to provide written consent 4. Age greater or equal to 21 years 5. Re-enrolment of an alcoholic hepatitis donor is permissible up to 4 times if the donor presents with a new episode of alcoholic hepatitis 24 weeks or longer after the most recent enrolment in the study Exclusion criteria 1. Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis 2. (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.)Pregnant or breast feeding Based on the judgment of the investigator, subject is not capable of understanding or complying with the study requirements. CONTROLS: Heavy drinkers without significant liver disease Inclusion criteria 1. History of chronic alcohol consumption sufficient to cause liver damage. Generally, this is considered to be >40 g/day or >280g/week on average for women and >60 g/day or >420 g/week on average for men, for many years (usually decades). Judgement about chronic alcohol consumption will be made by the site investigator. 2. Subject or guardian ability to understand and willingness to provide written consent 3. Age greater or equal to 21 years Exclusion criteria 1. Past evidence of alcoholic liver disease, defined as a bilirubin > 2.0 mg/dL, an AST > 1.5 ULN, and any hospital admission for liver disease, or the presence of esophageal varices or ascites (at any time in the past). 2. Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.) 3. Alcohol intake at less than 40 g/day or 280g/week on average for women and 60 g/day or 420 g/week on average for men for longer than the past 28 days 4. If liver stiffness has been assessed within the prior 90 days, then stiffness suggesting fibrosis of F1 or greater is excluded. For Fibroscan, this is a fibrosis score >7.0 kPa. 5. Pregnant or breast feeding 6. Any of the following laboratory abnormalities within 90 days prior to signing the consent. 1. Total bilirubin: >ULN* 2. INR: > 1.4 5 *Individuals with a diagnosis of Gilbert's can have total bilirubin up to 3.0 mg/dL and still be eligible for participation. Healthy Controls Inclusion criteria 1. AUDIT-C scores of <4 for men and <3 for women (signifying no alcohol misuse) 2. Abstinent (consumption of less than one standard drink/week) during the 6 months prior to enrolment 3. Ability to understand and willingness to provide written consent. Exclusion criteria 1. Clinical history or laboratory evidence of liver disease including alcoholic liver disease, NAFLD, hemochromatosis, alcoholic hepatitis, autoimmune liver disease, Wilson disease, hepatitis C, or hepatitis B. 2. Presence of diabetes (requiring treatment with oral agents or insulin). 3. Significant heart disease (prior history of heart disease, other than hypertension) 4. Chronic lung disease (requiring chronic treatment) 5. Immune related conditions (such as Crohn's disease, rheumatoid arthritis, ulcerative colitis, systemic lupus erythematosus, severe psoriasis, etc.) 6. Known infection with HIV 7. Presumed infection, or use of antibiotics or other medications (e.g., corticosteroids) that would affect immune function, within the past 14 days 8. BMI>35 9. Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment 10. Pregnant or breast feeding 11. Any of the following laboratory abnormalities within 90 days prior to signing the consent. 1. Hemoglobin: <10 g/dL 2. Conjugated bilirubin: > ULN 3. INR: > 1.4 4. AST: >40 IU/mL 5. ALT: >40 IU/mL 12. Based on the judgment of the investigator, subject is not capable of complying with the study requirements
Alcoholic Hepatitis, Liver
Parkland Health & Hospital System
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Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair (TT TEF)

This trial will compare the effectiveness of two common surgical practices for Type C esophageal atresia repair: esophageal atresia (EA) with distal tracheoesophageal fistula (TEF). Infants with EA/TEF requiring surgical intervention will be recruited. Subjects will be randomized to either repair with or without transanstomotic tube (TT) during esophageal anastomosis creation. Primary outcome is symptomatic anastomotic stricture development requiring dilation within 12 months.
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Samir Pandya
177098
All
up to 6 Months old
Phase 4
This study is NOT accepting healthy volunteers
NCT03730454
STU-2020-1118
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Inclusion Criteria:

• Infants diagnosed with type C esophageal atresia: proximal esophageal atresia and distal tracheoesophageal fistula
• Primary repair of the esophageal atresia within the first six months of life
• Minimum follow up of 1 year (12 months)
Exclusion Criteria:

• Other types of esophageal atresia without esophageal anastomosis creation
• Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations
Device: Transanastomotic Tube (5FR), Other: No Transanastomotic Tube
Esophageal Atresia, Esophagus, Tracheoesophageal Fistula
Children’s Health
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Alcohol Induced de Novo Lipogenesis in Women

The study is cross-sectional is design. In the first Aim of this study, 5 women and 5 men will be asked to consume 2g/kg of [2H]water (a.k.a. deuterium oxide or heavy water) which incorporates 2H tracers into newly synthesized fatty acids and triglycerides. Deuterated water is not radioactive and has a long history of application in human studies. Researchers will collect blood samples 2 hours before and 5 hours after the participants consume 20 grams of alcohol as vodka to measure alcohol induced hepatic de novo lipogenesis (DNL) in both men in women. In addition, for Aim 2 researchers will recruit an additional 10 women who will be randomized into one of two groups who will consume a beverage containing vodka and sucrose, or sucrose alone. Aim 2 will be identical to the experimental scheme in Aim 2 in order to determine if sucrose enhances the effects of vodka on hepatic DNL.
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Justin Fletcher
157755
All
21 Years to 45 Years old
N/A
This study is also accepting healthy volunteers
NCT04829110
STU-2021-0246
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Inclusion Criteria:

• Male or Female
• Ages 21
•45
• Healthy
• Light to moderate alcohol consumption (≤1 drink a day (~14g) in women and ≤2 drinks a day (~28 g) in men)
• BMI between 18.5-29.9
• Normal Nutritional Status
• Ability to speak and understand English
Exclusion Criteria:

• BMI >29.9
• Comorbid conditions
• Any regular medications, except Oral Contraceptives
• Pregnant or Breastfeeding
• Regular exercise above activities of daily living
Other: ETOH, Other: Sucrose
Liver Metabolism
UT Southwestern
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13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF (ALFSG-MBT)

The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the outcome of patients diagnosed with severe acute liver injury that is not related to acetaminophen overdose or acute liver failure who meet inclusion/exclusion criteria. Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin solution (test substrate). The Breath Test will be performed up to five times during the study period on all enrolled patients. The first Breath Test will be performed upon admission into the study (Day 1) and repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the improvement or deterioration in liver metabolic function about improvement or deterioration in liver metabolic function. If an enrolled non-APAP ALI or ALF patient receives a liver transplant, is discharged /transferred from the hospital or dies prior to Day 7, additional Breath Tests will not be performed. Patients will be contacted for the Day 21 follow up (21 days after enrollment into the trial) to determine spontaneous survival, transplantation and occurrence of serious adverse events since the patient's last study treatment.
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William Lee
14217
All
18 Years to 80 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT02786836
STU 122015-008
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Inclusion Criteria:
1. Adult men or women (18-80 years of age) 2. Severe acute liver injury not related to acetaminophen overdose: INR ≥2.0; no evidence of HE 3. Acute liver failure: INR ≥1.5; presence of any degree of HE 4. Duration of illness <26 weeks 5. Enrolled into the ALFSG Registry. 6. Written informed consent from the patient or patient's legally authorized representative or family member as defined in the Federal Register Number 21 Congressional Federal Register (CFR)50.3(m)
Exclusion Criteria:
1. Evidence of pre-existing chronic liver disease 2. Pre-existing New York Heart Association stage III/IV heart failure 3. Evidence of pre-existing chronic renal failure 4. Chronic hemodialysis prior to hospital admission 5. Evidence of cirrhosis (unless clinically acute Wilson disease or autoimmune non-APAP ALI or ALF) 6. Severe obstructive lung disease (FEV1 <50% of predicted on previous spirometry) 7. Severe shock, defined as mean arterial pressure (MAP) <70 mmHg despite >15 µg/kg/min dopamine, >0.1 µg/kg/min epinephrine, or >0.1 norepinephrine µg/kg/min 8. Extensive small bowel resection (>50 cm) 9. Any evidence of upper GI bleeding at enrollment requiring intervention (endoscopy or red blood cell (RBC) transfusion specifically for upper GI bleeding) 10. Liver transplantation (LT) prior to enrollment. (Note: Listing for LT does not preclude participation in the trial.) 11. Pregnancy or breastfeeding women (Note: Pregnancy related non-APAP ALI or ALF may be considered for entry following the delivery of the baby and assuming the mother does not wish to breastfeed or collect breast milk during the study period.) 12. Allergic to acetaminophen (such as Tylenol® or any other acetaminophen-containing medications) 13. Participation in other clinical studies evaluating other experimental treatments or procedures. (Note: Participation in observatory studies is not an exclusion.) 14. Patients in whom enteral drugs or fluids are contra-indicated or the patient either does not have an appropriately placed naso-enteric/orogastric tube in situ or cannot tolerate taking the drug preparation orally (200 ml) 15. Budd-Chiari Syndrome 16. Non-APAP ALI or ALF caused by malignancy 17. Moderate and severe adult respiratory distress syndrome (ARDS), as defined by Berlin Criteria. 18. Subjects who have received amiodarone in the 30 days prior to study enrollment 19. Consumption of any food or beverage that contains caffeine in the 24 hours prior to enrollment 20. Consumption of any of the following drugs that may interfere with the metabolism of 13C-Methacetin in the 48 hours prior to study enrollment including: allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, disulfiram, Echinacea, enoxacin, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives 21. Consumption of alcohol in the 24 hours prior to enrollment 22. Smoking cigarettes in the 8 hours prior to enrollment.
Drug: 13C-Methacetin
Acute Liver Failure
acute liver failure, methacetin, breath test, severe acute liver injury, hepatic encephalopathy, ALFSG Registry, acetaminophen toxicity
UT Southwestern
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Neuromodulation for Accidental Bowel Leakage (NOTABLe)

This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women. The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.
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David Rahn
49553
Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03278613
STU 122017-009
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Inclusion Criteria:

• Women ≥ 18 years of age
• FI symptoms ≥ 3 months
• Baseline St. Mark's score of ≥ 12
• Attended ≥ 2 supervised PMT for ABL
• Intolerance, unwillingness, or inadequate response to constipating medications
• Current negative colon cancer screening based on the USPSTF's recommendation for colorectal cancer screening (2016)
Exclusion Criteria:

• Previous PTNS treatment
• History of uncontrolled diarrhea in the past 3 months (usual or most common stool type over the preceding 3 months of 7 on the Bristol Stool Form Scale)
• History of severe constipation in the past 3 months (usual or most common stool type over the preceding 3 months of 1 on the Bristol Stool Form Scale)
• History of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis, but does not include irritable bowel disease)
• Unrepaired rectovaginal fistula/chronic 4th degree laceration
• Full thickness rectal prolapse
• History of congenital anorectal malformation
• History of bowel resection surgery for any indication
• Minor anal procedures within 6 months for treatment of ABL (injection of bulking agent or radiofrequency energy) or ligation of hemorrhoids
• Prior pelvic or abdominal radiation
• Diagnosis of cancer of the descending colon or anus
• Diagnosis of cancer in the region where the PTNS or sham needles or surface electrodes would be placed
• Pacemaker, implantable defibrillator
• Current use of Interstim sacral nerve stimulator or TENS in the pelvic region, back, or legs
• Clinically significant neurological disorders known to affect anal continence
• Coagulopathy
• Severe peripheral edema preventing accurate placement of PTNS needles
• Chronic swollen, infected, inflamed skin or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins) in the region where the PTNS or sham needles or surface electrodes would be placed
• Metal implant in foot/toes near TENS electrode location
• Marked sensory deficit (numbness) of feet or ankles in the region where the PTNS or sham needles or surface electrodes would be placed
• Childbirth within the last 3 months
• Pregnant or planning to become pregnant during the study duration 1 year; a urine pregnancy test will be performed and must be negative by the first intervention visit if the participant is of childbearing potential
• Unwilling to use acceptable form of contraceptive if the participant is of childbearing potential
• Participation in another intervention trial impacting bowel function
• Inability to provide informed consent, complete questionnaires independently, or to attend intervention sessions
• Unable or unwilling to complete the bowel diary in Run-In Phase (valid diary defined as data from ≥ 10 of 14 days with minimum of 3 consecutive days per week)
• Unwilling to download bowel diary app onto smartphone if the participant owns a smartphone
• Visual impairment prohibiting reading the paper diary, the smart phone screen
• Unable to speak, read, or write in English or Spanish at a basic level
Device: ES-130
Fecal Incontinence, Bowel Incontinence
Parkland Health & Hospital System
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Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT)

studyfinder@utsouthwestern.edu
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04737187
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Inclusion Criteria:
1. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded). 2. RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy. 3. Has received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen. 4. Has measurable or non-measurable disease as defined by RECIST version 1.1 5. Is able to swallow oral tablets. 6. Estimated life expectancy ≥12 weeks. 7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
Exclusion Criteria:
1. More than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer. 2. Pregnancy, lactating female or possibility of becoming pregnant during the study. 3. Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization. 4. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation). 5. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease. 6. Has severe or uncontrolled active acute or chronic infection. 7. Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension. 8. Known Hepatitis B or Hepatitis C Virus infection. 9. Known carriers of HIV antibodies. 10. Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia. 11. Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization. 12. Treatment with any of the following within the specified time frame prior to randomization:
• major surgery within 4 weeks prior to randomisation (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may require major surgery during the study
• Prior radiotherapy if completed less than 4 weeks before randomisation, except if provided as a short course for symptoms palliation only.
• Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks prior to randomization 13. Other clinically significant medical conditions. 14. Other malignancies.
Drug: Trifluridine/Tipiracil, Drug: Bevacizumab
Refractory Metastatic Colorectal Cancer
trifluridine/tipiracil, TAS102, bevacizumab, avastin, RAS status (wild type, mutant)
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RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

studyfinder@utsouthwestern.edu
All
18 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04620733
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Inclusion Criteria:
1. Must have given written informed consent (signed and dated) and any authorizations required by local law 2. 18 to 75 years old (inclusive) 3. Male or female with a definitive diagnosis of PBC 4. UDCA for the past 12 months (stable dose for >3 months prior to screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to screening) 5. Laboratory parameters measured by the Central Laboratory at screening: 1. ALP ≥1.67× ULN 2. Aspartate aminotransferase (AST) ≤3× ULN 3. ALT ≤3× ULN 4. Total bilirubin ≤2× ULN 5. Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2 (calculated by the Modification of Diet in Renal Disease study equation) 6. International normalized ratio (INR) below 1.1× ULN For subjects on anticoagulation therapy, INR must be maintained in the range required for prophylaxis for their specific disease. 7. Platelet count ≥100×103/µL 6. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
Exclusion Criteria:
1. Advanced PBC as defined by the Rotterdam criteria (albumin below the lower limit of normal AND total bilirubin above 1.0× ULN) 2. Clinically important hepatic decompensation, including the history of liver transplantation, current placement on liver transplantation list, or current Model for End-Stage Liver Disease (MELD) score ≥12, complications of portal hypertension and / or cirrhosis with complications, including history or presence of spontaneous bacterial peritonitis, hepatocellular carcinoma, or hepatorenal syndrome 3. History or presence of other concomitant chronic liver diseases (for example, AIH, PSC, NASH, alcoholic liver disease, hepatitis B, hepatitis C, etc.) 4. Known history of human immunodeficiency virus (HIV) or positive antibody test at screening 5. Clinically important alcohol consumption 6. History of malignancy diagnosed or treated, actively or within 2 years, or ongoing evaluation for malignancy; localized treatment of squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ is allowed if appropriately treated prior to screening. 7. Treatment with obeticholic acid (OCA) or fibrates (eg, bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) 3 months prior to screening 8. Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (>2 weeks) during 2 months prior to screening 9. Treatment with anti-pruritic drugs (eg, cholestyramine, naltrexone, rifampicin, sertraline, or any experimental approach) must be on a stable dose within 1 month prior to screening 10. Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening 11. For females, pregnancy or breastfeeding 12. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the investigator 13. Immunosuppressant therapies 14. Other medications that effect liver or GI functions
Drug: Seladelpar 10 mg, Drug: Placebo, Drug: Seladelpar 5 mg
Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC), PBC
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