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99 Study Matches

Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)

The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age (adolescents); Age Group 2: From 2 to <12 years of age (children); and Age Group 3: From birth to <2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (~100 days) post-transplant, with doses based on body weight and age.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Paul Sue
157043
All
up to 17 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03940586
STU-2018-0279
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Inclusion Criteria:

• All participants 12 to <18 years old must have documented positive CMV serostatus (CMV IgG seropositive) for the recipient (R+). Participants from birth to <12 years old must have documented positive CMV serostatus (CMV IgG seropositive) for the recipient (R+) and/or the donor (D+) and the time of screening.
• Is the recipient of a first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant).
• Has undetectable CMV DNA from a plasma or whole blood sample collected within 5 days prior to enrollment.
• Is within 28 days post-HSCT at the time of enrollment.
• Females are not pregnant, not breastfeeding,and is not a woman of childbearing potential (WOCBP); or is a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 28 days after the last dose of study intervention.
• Participants from 2 to <18 years of age must not be on concomitant Cyclosporin A (CsA), and must be able to take LET tablets or the oral granules (either by mouth or via G tube/NG tube), provided the participant does not have a condition that may interfere with the absorption of oral medication (e.g. vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment until the intensive PK sampling is completed in these participants
Exclusion Criteria:

• Has received a previous allogeneic HSCT (Note: receipt of a previous autologous HSCT is acceptable).
• Has a history of CMV end-organ disease within 6 months prior to enrollment.
• Has evidence of CMV viremia at any time from either signing of the ICF or the HSCT procedure, whichever is earlier, until the time of enrollment.
• Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations.
• Has severe hepatic insufficiency within 5 days prior to enrollment.
• Is on hemodialysis or has end-stage renal impairment.
• Has both moderate hepatic insufficiency and moderate-to-severe renal insufficiency.
• Has an uncontrolled infection on the day of enrollment.
• Requires mechanical ventilation or is hemodynamically unstable at the time of enrollment.
• Has a documented positive result for a human immunodeficiency virus antibody (HIVAb) test at any time prior to enrollment, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollment.
• Has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g. lymphomas).
• Has a preexisting cardiac condition a) for which the patient is currently being treated or b) which required hospitalization within the last 6 months or c) that may be expected to recur during the course of the trial.
• Has received within 7 days prior to screening any of the following: ganciclovir; valganciclovir; foscarnet; acyclovir; valacyclovir; famciclovir.
• Has received within 30 days prior to screening of any of the following: cidofovir; CMV immunoglobulin; any investigational CMV antiviral agent/biologic therapy; Rifampin and other strong inducers (such as phenytoin, carbamazepine, St John's wort (Hypericum perforatum), rifabutin and phenobarbital) and moderate inducers such as nafcillin, thioridazine, modafinil and bosentan.
• Has received LET at any time prior to enrollment in this study.
• Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5X half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing in this study.
• Has previously participated in this study or any other study involving LET.
• Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
• Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 28 days after the last dose of study intervention.
• Is expecting to donate eggs starting from the time of consent through 28 days after the last dose of study intervention.
• Has clinically relevant drug or alcohol abuse within 12 months of screening that may interfere with participant treatment, assessment, or compliance with the protocol, as assessed by the investigator.
Drug: Letermovir oral granules, Drug: Letermovir tablet, Drug: Letermovir intravenous
Lymphoma, Multiple Myeloma, Cytomegalovirus (CMV) Infection, Brain and Nervous System, Eye and Orbit, Colon, Esophagus, Kidney, Liver, Lung/Thoracic, Other Respiratory and Intrathoracic Organs, Leukemia, Other, Leukemia, Not Otherwise Specified, Lymphoid Leukemia, Myeloid and Monocytic Leukemia, Non-Hodgkins Lymphoma, Other Hematopoietic, Small Intestine, Unknown Sites
Parkland Health & Hospital System
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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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A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric subjects with advanced or metastatic malignancies harboring ALK, ROS1, or NTRK1-3 alterations.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Tanya Watt
128737
All
up to 25 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04094610
STU-2019-1268
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Key
Inclusion Criteria:
1. Documented genetic ALK, ROS1, or NTRK1-3 alteration (point mutation, fusion, amplification) as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required. 2. Age <12 years. 3. Prior cytotoxic chemotherapy is allowed. 4. Prior immunotherapy is allowed. 5. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1. 6. All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology Criteria (RANO) criteria at time of enrollment. 7. Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 14 days prior to enrollment. 8. Subjects must have a Lansky (< 16 years) or Karnofsky (≥ 16 years) score of at least 50. 9. Life expectancy greater than or equal to 12 weeks. 10. Adequate hematologic, renal and hepatic function. Phase 2
Inclusion Criteria:
1. Age 12 to <25 years 2. Cohort Specific
Inclusion Criteria:

• Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve;
• Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated;
• Cohort 3: subjects with tumors or ALCL characterized by other ALK/ROS1/NTRK alterations or NTRK fusions without centrally confirmed measurable disease or not otherwise eligible for Cohort 1 or 2. 3. Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment. Key Exclusion Criteria (Phase 1 and Phase 2): 1. Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only. 2. Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery. 3. Known active infections (bacterial, fungal, viral including HIV positivity). 4. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption. 5. Any of the following cardiac criteria:
• Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) > 470 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value
• Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec)
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval 6. Peripheral neuropathy of CTCAE ≥grade 2. 7. Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
Drug: Oral repotrectinib (TPX-0005)
Lymphoma, Locally Advanced Solid Tumors, Metastatic Solid Tumors, Primary CNS Tumors, Breast - Female, Breast - Male, Colon, Kidney, Lung/Thoracic, Rectum, Thyroid, Urinary Bladder, Soft Tissue
ALK, ROS1, NTRK1-3, Primary CNS tumor, anaplastic large cell lymphoma, metastatic solid tumor, advanced solid tumor, sarcoma, infantile fibrosarcoma, glioblastoma, soft tissue schwannoma, solitary fibrous tumor, glioma, inflammatory myofibroblastic tumor, pediatric
Parkland Health & Hospital System
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AcceleRET Lung Study of Pralsetinib for 1L RET Fusion-positive, Metastatic NSCLC

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcome when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for patients with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Patients who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Jonathan Dowell
11902
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04222972
STU-2020-0283
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Main inclusion criteria:
• Patient is ≥18 years of age
• Patient has pathologically confirmed, definitively diagnosed, advanced (not able to be treated with surgery or radiotherapy) or metastatic NSCLC and has not been treated with systemic anticancer therapy for metastatic disease.
• Patient must have a documented RET-fusion
• Patient has measurable disease based on RECIST 1.1 as determined by the local site Investigator/radiology assessment.
• Patient has an ECOG PS of 0-1.
• Patient should not have received any prior anticancer therapy for metastatic disease.
• Patients can have received previous anticancer therapy (except a selective RET inhibitor) in the neoadjuvant or adjuvant setting but must have experienced an interval of at least ≥ 6 months from completion of therapy to recurrence.
• Patients that received previous immune checkpoint inhibitors in the adjuvant or consolidation following chemoradiation are not allowed to receive pembrolizumab if randomized in Arm B
• Patient is an appropriate candidate for and agrees to receive 1 of the Investigator choice platinum-based chemotherapy regimens if randomized to Arm B.
• Patient provides signed informed consent to participate in the study. Main exclusion criteria:
• Patient's tumor has any additional known primary driver alterations other than RET, such as targetable mutations of EGFR, ALK, ROS1, MET, and BRAF. Investigators should discuss enrollment with Sponsor designee regarding co-mutations.
• Patient previously received treatment with a selective RET inhibitor.
• Patient received radiotherapy or radiosurgery to any site within 14 days before randomization or more than 30 Gy of radiotherapy to the lung in the 6 months before randomization.
• Patient has a presence of Grade 2 or worse interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis within 28 days before randomization.
• Patient has CNS metastases or a primary CNS tumor that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease. If a patient requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks before Cycle 1 Day 1.
Drug: Pralsetinib, Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed, Drug: Pembrolizumab, Drug: Gemcitabine
Carcinoma, Non-Small-Cell Lung, Carcinoma, Neoplasms by Site, Neoplasms, Head and Neck Neoplasms, Carcinoma, Bronchogenic, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms, Nerve Tissue, Lung Diseases, Respiratory Tract Disease, Lung/Thoracic, RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Bronchial Diseases, Adenocarcinoma, Neoplasms by Histologic Type, Neoplasms, Germ Cell and Embryonal
Advanced Non-Small Cell Lung Cancer, RET Lung, RET Mutation, RET Alteration, RET Positive, RET Inhibitor, RET Altered, RET Rearrangement, RET NSCLC, RET-Rearranged NSCLC, RET Fusion, RET Fusion Lung Cancer, M918T, TRIM33-RET, Lung Cancer Mutation, BLU 667, Pralsetinib, RET Tyrosine Kinase, RET Gene Mutation, RET Kinase, Advanced Lung Cancer, Metastatic Lung Cancer, KIF5B-RET, CCDC6-RET
UT Southwestern
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VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors

A more recent competing technology for implementing the DIBH technique is real-time surface photogrammetry using the AlignRT system (Vision RT Ltd., London, UK). AlignRT system use non-ionization near infrared light to track patient surface motion. The system has one projector projecting near infrared optical pattern on patient surface. The optical pattern is imaged by optical cameras (two per pod) at ~25 Hz. The user selects a region-of-interest (ROI) on the surface and the software calculates and displays the real-time position in six degrees (3 translations and 3 rotations) in real-time. Once the patient has matched the pre-determined DIBH position (within threshold accuracy), the radiation beam is enabled to be turned on for treatment.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Xuejun Gu
133029
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04686500
STU 022017-075
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Inclusion Criteria:
1. Patients must be willing and capable to provide informed consent to participate in the protocol. 2. Patient with presumed pulmonary function capable of holding breath for at least 30 seconds
•later to be confirmed. 3. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and until study imaging is complete. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 3.1 A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 3.2 Patients must be compliant to all required pretreatment evaluations
Exclusion Criteria:
1. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus 2. Patients are not compliant to all required pretreatment evaluations
Device: Tidal volume measured by spirometer and DIBH surface from CT image
Thoracic Cancer, Liver, Lung/Thoracic, Abdominal Cancer
UT Southwestern; Children’s Health
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JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Corey Kershaw
113967
All
40 Years to 80 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03538301
STU 042018-023
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Inclusion Criteria:

• Forced vital capacity (FVC) ≥ 45% of predicted.
• Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin ≥ 30% of predicted value
• Ratio of forced expiratory volume in 1 second (FEV1) to FVC ≥ 0.70.
Exclusion Criteria:

• Best, acceptable FVC from separate screening spirometry that differ by ≥ 200 mL.
• Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months before screening.
• Anticipated to receive a lung transplant during the subject's participation in the study.
• Active smoker or smoking cessation within 12 weeks before screening.
• Malignancy within the last 5 years, with the exception of curable cancer that has received adequate treatment.
• Evidence of any unstable or untreated, clinically significant disease or condition that, in the opinion of the Investigator, might confound the interpretation of the study or place the subject at increased risk.
• Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is longer) before screening
• Participation in an investigational study with the last dose of investigational product occurring within 8 weeks or 5 half-lives (whichever is longer) before screening.
• Pregnant or breastfeeding.
• Medical history of infection with HIV, hepatitis B, or hepatitis C.
• History of alcohol abuse and/or dependence within the last 2 years.
• History within the last 2 years of significant mental illness, or physical dependence on any opioid or illicit drugs. Other protocol defined inclusion/exclusion criteria could apply.
Drug: ND-L02-s0201, Drug: ND-L02-s0201, Other: Other: Placebo
Idiopathic Pulmonary Fibrosis
UT Southwestern
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Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts (ECP)

The primary aims of this study is to determine the efficacy and tolerability of Extracorporeal Photopheresis (ECP) for the treatment of either refractory (240) or newly diagnosed (739) Bronchiolitis Obliterans Syndrome (BOS) in patients after lung transplantation.In compliance with the Centers for Medicare and Medicaid Services' (CMS) Coverage with Evidence Development (CED) decision, the study will collect specified demographic, comorbidity, treatment, and outcome data exclusively for Medicare beneficiaries who are treated with Extracorporeal Photopheresis for either refractory or New Bronchiolitis Obliterans Syndrome .
Call 214-648-5005
studyfinder@utsouthwestern.edu
Nicole De Simone
41037
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02181257
STU-2018-0362
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INCLUSION Criteria for REFRACTORY BOS 1. Age (18 years old or older). 2. Medicare-eligible (i.e., patients with both Part A and Part B) status 3. Lung transplant recipient (combined organ transplant recipients, e.g. heart-lung or liver-lung recipients, are eligible). 4. Patients with a diagnosis of BOS using at least two laboratory based FEV1 values obtained at least three weeks apart that are both at least 20% lower than baseline FEV1 using the International Society for Heart and Lung Transplantation (ISHLT) definition (The average of the two highest FEV1 measurements obtained at least 3 weeks apart after transplantation). 5. Refractory BOS defined as ongoing decline in FEV1 despite at least one of the following treatments: azithromycin, high-dose steroid, anti-thymocyte globulin, total lymphoid irradiation, sirolimus, or everolimus. 6. At minimum five recorded FEV1 measurements obtained at intervals of at least two weeks apart, over the 6 months preceding study enrollment, of which one FEV1 must be within two weeks prior to enrollment. 7. History of frequent spirometry monitoring defined as having had regular FEV1 measurements during the preceding four months prior to enrollment with no time interval between FEV1 measurements that exceeds 8 weeks. 8. A documented clinical assessment including a physical assessment and Complete Blood Count (CBC) with White Blood Cell Count (WBC) within two weeks prior to enrollment. INCLUSION criteria for NEWLY Diagnosed BOS 1. Age (18 years old or older) 2. Medicare-eligible status (i.e., patients with both Part A and Part B) 3. Lung transplant recipient (combined organ transplant recipients, e.g. heart-lung or liver-lung recipients, are eligible). 4. History of close FEV1 monitoring prior to diagnosis of new BOS defined as having had either of the two monitoring approaches: Frequent laboratory based spirometry defined as having had regular FEV1 measurements during the preceding six months prior to diagnosis of new BOS with no time interval between FEV1 measurements that exceeds 8 weeks. Frequent Home Spirometry through a Standardized Home Spirometry Method: this Method is currently IRB approved and will be utilized to meet this close monitoring enrollment criteria. 5. Diagnosis of new BOS (i.e., "new BOS" is defined as within six weeks of enrollment) based on laboratory-based spirometric FEV1 measurements obtained on at least two separate occasions (i.e., at least 3 weeks apart) that have declined by more than 20% from post-transplant baseline values (i.e., using ISHLT definition). Inherent to the diagnosis of new BOS is the exclusion of other potential causes of allograft dysfunction such as acute rejection, respiratory tract infection, and airway anastomotic complications. Thus, sites are encouraged to conduct appropriate evaluation for declining allograft function including bronchoscopy with bronchoalveolar lavage (BAL) and lung biopsies if clinically appropriate to exclude other potential causes of allograft dysfunction. 6. Achievement of a statistically significant rate of decline in lung function (FEV1) at the diagnosis of new BOS per the criteria in Section 3.6 as assessed by the following criteria: For patients who are monitored with laboratory based spirometry, at least five recorded FEV1 measurements obtained at intervals of at least two weeks apart, over the 6 months preceding study enrollment accompanied by a statistically significant (p<0.05) rate of decline of FEV1 that exceeds 30 mL/month; or For patients who are monitored with home Spirometry, the Standardized Home Spirometry Method will define the specific criteria that will be used for these patients. 7. Documented clinical assessment including a physical assessment and a CBC with WBC within two weeks prior to enrollment. EXCLUSION Criteria (Subjects meeting any one of these criteria will be excluded) 1. Current participation in another clinical treatment trial with an investigational agent. 2. Any condition that may interfere with the subject's ability to perform pulmonary function testing. 3. Known allergy or hypersensitivity to pharmacologic agents used during ECP 4. Any condition that would significantly affect the participant's ability to adhere to the protocol, affect interpretation of the study results, or put the participant at unacceptable risk for study-related complications as judged by the referring clinician. This may include a) patients with a specific acute contraindication to receiving ECP due to any acute condition such as new or evolving myocardial infarction or central nervous system disorder, hemodynamic instability or hypovolemia, acute bleeding, respiratory distress; or b) patients with lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, albinism, or other dermatologic or ocular condition that contraindicates the use of methoxsalen or markedly enhances photosensitivity in the investigator's judgment. 5. Aphakia or absence of ocular lenses 6. Pregnancy (positive pregnancy test
•a urine or blood pregnancy test must be obtained within 2 weeks prior to enrollment in women of childbearing potential) 7. Inability to provide informed consent or to comply with study treatments or assessments (e.g. due to cognitive impairment or geographic distance) 8. Recent (i.e., within 2 weeks prior to enrollment) leukopenia (white blood cell count < 3,000 K/cumm) 9. Patients whose decline in lung function (FEV1) is related to either Restrictive Chronic Lung Allograft Dysfunction (CLAD) or other causes that do not represent BOS such as pneumonia, heart failure, etc. For patients under review for eligibility for ECP for refractory BOS: 10. The most recent FEV1 < 900 mL 11. Rate of FEV1 decline within the last 6 months > 300 mL/month. For patients under review for eligibility for RCT: 12. any patient who at least one year after transplant is treated with either lymphocyte depleting therapy or with an escalated dose of steroids (i.e., prednisone greater than 30 mg/day) for more than one month for an acute decline in lung function that is suspected to be secondary to acute cellular rejection.
Combination Product: Extracorporeal Photopheresis (ECP)
Bronchiolitis Obliterans Syndrome (BOS)
Bronchiolitis Obliterans Syndrome, Lung Transplantation, Extracorporeal Photopheresis, Methoxsalen
UT Southwestern
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Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea

The objective of this study is to evaluate Lung Doppler signals (LDS) among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to discriminate ADHF causing dyspnea from any other cause i.e., non-ADHF causes of dyspnea.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Deborah Diercks
152662
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03998410
STU-2019-0989
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Inclusion Criteria:

• Age ≥ 18 years
• Patients with acute onset dyspnea (defined as shortness of breath (SOB) at rest or on exertion) and diagnostic uncertainty of etiology where heart failure is in consideration.
• Patients designated to undergo chest X-ray as part of standard of care assessment.
Exclusion Criteria:

• Obvious trauma contributing to dyspnea
• Inability to provide written informed consent
• Not speaking English or Spanish
• Right-sided lobectomy
• Patients with implanted ventricular assist device
• Patient is unable to undergo the TPD test
• Patient is already enrolled in a clinical study with experimental medications
Device: Lung Doppler Signals
ADHF, Lung/Thoracic
ADHF Dyspnea ED
Children’s Health
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Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy (SIMPLIFY)

Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating CF, it is still largely unknown whether or not other chronic therapies can be safely stopped. The SIMPLIFY study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline or Pulmozyme® (dornase alfa) in those people that are also taking Trikafta™. Trikafta (elexacaftor/tezacaftor/ivacaftor) is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up Trikafta work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function. Inhaled hypertonic saline and Pulmozyme (dornase alfa) also improve clearance of mucus from the lungs to support lung function and have been available to people with CF for many years. Both therapies are considered to be relatively burdensome and it is not known whether either therapy can improve or maintain lung function above what is already gained through Trikafta use. The goal of the SIMPLIFY study is to get information about whether or not it is safe to stop either inhaled hypertonic saline or Pulmozyme (dornase alfa) by testing if there is a change in lung function in subjects with cystic fibrosis (CF) who are assigned to stop their chronic medication (either hypertonic saline or Pulmozyme) as compared to those who are assigned to keep taking their medication while continuing to take Trikafta.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
12 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04378153
STU-2020-0246
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Inclusion Criteria:

• Diagnosis of CF.
• Age ≥ 12 years at the Screening Visit.
• Forced expiratory volume in 1 second (FEV1) ≥ 70 % predicted at the Screening Visit if < 18 years old, and ≥ 60 % predicted at Screening Visit if ≥ 18 years old.
• Clinically stable with no significant changes in health status within the 7 days prior to and including the Screening Visit.
• Current treatment with elexacaftor/tezacaftor/ivacaftor (ETI) for at least the 90 days prior to and including the Screening Visit and willing to continue daily use for the duration of the study.
• Currently taking hypertonic saline (at least 3%) and/or dornase alfa for at least the 90 days prior to and including the Screening Visit and willing to continue daily use for the 2-week screening period.
Exclusion Criteria:

• Active smoking or vaping.
• Use of an investigational drug within 28 days prior to and including the Screening Visit.
• Changes to chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, aztreonam lysine) within 28 days prior to and including the Screening Visit. This includes new airway clearance routines.
• Acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 7 days prior to and including the Screening Visit.
• Chronic use of systemic corticosteroids at a dose equivalent to ≥ 10mg per day of prednisone within 28 days prior to and including the Screening Visit.
• Antibiotic treatment for nontuberculous mycobacteria (NTM) within 28 days prior to and including the Screening Visit.
Other: Discontinuation of hypertonic saline (HS), Other: Continuation of hypertonic saline (HS), Other: Discontinuation of dornase alfa (dnase), Other: Continuation of dornase alfa (dnase)
Cystic Fibrosis
Cystic Fibrosis, CF, Withdrawal, Trikafta, hypertonic saline, dornase alfa, pulmozyme
UT Southwestern; Parkland Health & Hospital System
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Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary Fibrosis

This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis
Call 214-648-5005
studyfinder@utsouthwestern.edu
John Fitzgerald
12247
All
40 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03955146
STU-2019-0797
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Key
Inclusion Criteria:
1. Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018) within the past 7 years prior to study participation. 2. HRCT scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing. 3. FVCpp value ≥50% and ≤80%. 4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥30% and ≤90%. 5. Not currently receiving treatment for IPF with an approved therapy (i.e., pirfenidone or nintedanib) for any reason, including prior intolerance to an approved IPF therapy. Key
Exclusion Criteria:
1. Previous exposure to pamrevlumab. 2. Evidence of significant obstructive lung disease. 3. Female subjects who are pregnant or nursing. 4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study. 5. Interstitial lung disease other than IPF. 6. Sustained improvement in the severity of IPF. 7. Other types of respiratory diseases including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall. 8. Certain medical conditions, including recent (e.g. MI/stroke, or severe chronic heart failure or pulmonary hypertension, or cancers. 9. Acute IPF exacerbation during Screening or Randomization. 10. Recent use of any investigational drugs or unapproved therapies, or approved or participation in any clinical trial. 11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
Drug: Pamrevlumab, Drug: Placebo
Idiopathic Pulmonary Fibrosis, Lung/Thoracic
Idiopathic Pulmonary Fibrosis, IPF, Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Lung Fibrosis
UT Southwestern
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Hydrocortisone for BPD

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.
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studyfinder@utsouthwestern.edu
Roy Heyne
13172
All
up to 30 Weeks old
Phase 3
This study is NOT accepting healthy volunteers
NCT01353313
STU 082017-069
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Inclusion Criteria:

• infants <30 weeks estimated gestational age
• inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age
• have received at least 7days of mechanical ventilation;
• are receiving mechanical ventilation through an endotracheal tube .
Exclusion Criteria:

• Major congenital anomalies
• Decision to limit support
• Indomethacin or ibuprofen treatment within 48 hours of study drug
• Previous corticosteroid treatment for BPD
• Received hydrocortisone for 14 or more cumulative days
• Received hydrocortisone within 7 days of study entry
Drug: Hydrocortisone, Drug: Placebo
Infant, Newborn, Bronchopulmonary Dysplasia, Infant, Small for Gestational Age, Infant, Premature, Infant, Very Low Birth Weight, Lung/Thoracic
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Intubation, Neurodevelopmental impairment
Children’s Health; Parkland Health & Hospital System
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Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome (SiVent)

A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease the number of days they require invasive mechanical ventilation.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Joseph Minei
14988
All
18 Years to 89 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02582957
STU 102015-009
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Inclusion Criteria:
Patients in an intensive care unit (ICU) as a result of injuries resulting from penetrating or non-penetrating trauma who are intubated and receiving invasive mechanical ventilation who also have one or more of the following: 1. Traumatic brain injury 2. > 1 long bone fractures 3. Shock on arrival in the Emergency Department (systolic BP < 90 mmHg) 4. Lung contusion 5. Receipt of > 6 units of blood
Exclusion Criteria:
1. Inability to obtain consent from the patient or his/her legally authorized representative (LAR) 2. Unwillingness of the treating physician to use sigh ventilation as all treating physicians must have equipoise with respect to the intervention 3. Age limitations per Institutional Review Board regulations 4. Undergoing invasive mechanical ventilation for > 24 hours, excluding any time during which the patient was being ventilated in the operating room, CT or IR, as this could represent too long a delay in instituting the intervention for it to have a chance of being effective 5. Presence of malignancy or other irreversible disease or condition for which the six month mortality is estimated to exceed 50% (e.g., chronic liver disease with a Child-Pugh Score of 10-15, malignancy refractory to treatment) as this could affect the clinical course and cloud interpretation of the endpoints 6. Women who are pregnant (negative pregnancy tests required on women of child-bearing age) per Human Subjects regulations 7. Prisoners, per Human Subjects regulations 8. Neurological condition that could impair spontaneous ventilation (e.g., C5 or higher spinal cord injury as this could affect the clinical course and cloud interpretation of the ventilator-free day endpoint 9. Lack of availability of Dräger Evita Infinity V500 ventilator as this is the only ventilator capable of delivering sigh breaths as described in the protocol 10. Burns > 40% of body surface area as this could affect the clinical course and cloud interpretation of the endpoints 11. Treating physicians being unwilling to use low VT ventilation strategy when ARDS is diagnosed as low VT ventilation is now considered standard of care for patients with ARDS. 12. Moribund, not expected to survive 24 hours as this could affect the clinical course and cloud interpretation of the endpoints13. Treating physician's decision to use airway pressure release ventilation (APRV). 13. Patient not expected to require mechanical ventilation > 24 hours (e.g., intubated for alcohol intoxication rather than pulmonary problem).
Other: Sigh breaths
Acute Respiratory Distress Syndrome
ARDS, Shock Lung, Acute Chest Syndrome, Respiratory Distress Syndrome, Adult, Respiratory insufficiency, Trauma
Children’s Health
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STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) (STAR-TER)

To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis.
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studyfinder@utsouthwestern.edu
Preeti Sharma
117060
All
2 Years to 45 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03489629
STU 022018-089
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Inclusion Criteria:
1. Male or female ≥ 2 and ≤ 45 years of age at the Screening Visit. 2. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria: 1. sweat chloride ≥ 60 milliequivalents/liter by quantitative pilocarpine iontophoresis test (QPIT) 2. two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene 3. abnormal nasal potential difference(NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV) 3. First OR early MRSA colonization defined as: 1. First MRSA colonization: first documented isolation of MRSA from respiratory tract occurred ≤ 6 months prior to screening 2. Early MRSA colonization: MRSA was previously isolated from the respiratory tract ≤ 2 times over the past 3.5 years, but this was followed by at least 1 year of documented negative cultures for MRSA 4. MRSA is available to the central laboratory
•either the incident MRSA isolate from the clinic visit or the subject is MRSA positive at the screening visit 5. Clinically stable with no significant changes in health status within the 14 days prior to screening 6. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Exclusion Criteria:
1. Received antibiotics with activity against MRSA within 28 days prior to screening 2. Use of an investigational agent within 28 days prior to screening 3. For subjects ≥ 6 years of age: FEV1 at screening < 25% of predicted for age based on the Wang (males < 18 years, females < 16 years) or Hankinson (males ≥ 18 years, females ≥ 16 years) standardized equations 4. MRSA from the screening culture or the most recent clinical care visit within 6 months prior to screening resistant to TMP/SMX 5. History of intolerance to topical chlorhexidine or mupirocin 6. History of intolerance to both TMP/SMX and minocycline 7. < 8 years of age and allergic or intolerant to TMP/SMX 8. ≥ 8 years of age and allergic or intolerant to TMP/SMX and MRSA isolate (from screening or clinical care visit)is resistant to minocycline 9. For females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception through Day 42 of the study 10. Subjects with history of abnormal renal function will need screening labs showing normal function Abnormal renal function is defined as estimated creatinine clearance <50 mL/min using the: 1. Bedside Schwartz Equation for subjects <18 years of age, and 2. Levey Glomerular filtration rate (GFR) Equation for subjects ≥ 18 years of age. 11. Subjects with a history of abnormal liver function will need to have screening labs showing normal transaminases. Liver dysfunction is defined as ≥3x upper limit of normal (ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT) or abnormal synthetic function 12. History of solid organ or hematological transplantation 13. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Drug: Trimethoprim Sulfamethoxazole (TMP/SMX), Drug: Minocycline, Drug: Mupirocin, Drug: Chlorhexidine Gluconate, Behavioral: Environmental Decontamination
Cystic Fibrosis
Methicillin-resistant Staphylococcus aureus (MRSA), Early infection, Treatment, Forced Expiratory Volume in 1 Second (FEV1)
Parkland Health & Hospital System
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Safety and Durability of Sirolimus for Treatment of LAM (MIDAS)

The MIDAS study aims to follow LAM patients who are currently taking, have previously failed or been intolerant of, or may (at some time in the future) take mTOR inhibitors (sirolimus or everolimus) as part of their clinical care. Adult female TSC patients may also enroll, with or without lung cysts.
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studyfinder@utsouthwestern.edu
Carlos Girod
30441
Female
18 Years and over
This study is NOT accepting healthy volunteers
NCT02432560
STU 022017-055
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Inclusion Criteria:

• Female, age 18 or over
• Diagnosis of LAM
• Signed and dated informed consent
• On chronic therapy, newly treated or may be considered for therapy with mTOR inhibitors or previously intolerant of or having failed mTOR inhibitor therapy
Exclusion Criteria:

• Inability to attend at least one RLD Clinic visit per year
• Inability to give informed consent
• Inability or unwillingness to perform pulmonary function testing
Drug: Sirolimus, Drug: Everolimus
Lymphangioleiomyomatosis, Lung/Thoracic
Lymphangioleiomyomatosis, LAM, rare lung, Rare Lung Disease
UT Southwestern
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A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Sonja Bartolome
115047
All
18 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03626688
STU 062018-068
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Inclusion Criteria:
1. At least 18 years of age. 2. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. 3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 4. Primary diagnosis of symptomatic PAH 5. Has had a right heart catheterization (RHC) performed at or within 3 years of Screening (RHC will be performed during Screening if not available) that is consistent with the diagnosis of PAH 6. Has WHO/ NYHA functional class II to IV symptoms. 7. If on PAH-specific background oral therapy, subject is on stable therapy with either an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Subjects may be naïve to PAH-specific treatment. 8. Has a 6MWD of ≥150 meters.
Exclusion Criteria:
1. For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell count <200/mm3 within 90 days of Baseline. 2. Must not have 3 or more left ventricular dysfunction risk factors as defined in the study protocol. 3. Has evidence of more than mild lung disease on PFTs performed within 180 days prior to, or during Screening. 4. Has evidence of thromboembolic disease as determined by a V/Q lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH. 5. Current diagnosis of uncontrolled sleep apnea as defined by the Investigator. 6. Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec and female subjects with a QTcF >470 msec on ECG measured at Screening or Baseline in subjects without evidence of intraventricular conduction delay (IVCD). In the presence of IVCD, subjects will be excluded if the QTcF >500 msec for both males and females. 7. Severe chronic liver disease (ie, Child-Pugh C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy). 8. Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). 9. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times the upper limit of normal (ULN) or total bilirubin ≥2 × ULN at Screening. 10. Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL or requiring dialysis at Screening. 11. Hemoglobin concentration <9 g/dL at Screening. 12. Subjects treated with an IV or SC prostacyclin pathway agent (eg, epoprostenol, treprostinil, or iloprost) at any time prior to Baseline (use in vasoreactive testing is permitted). 13. Subjects treated with an inhaled or oral prostacyclin pathway agent (iloprost, treprostinil, beraprost, or selexipag) that was stopped for a safety or tolerability issue. 14. Subject has pulmonary veno-occlusive disease. 15. Malignancy diagnosed and/or treated within 5 years prior to Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent. 16. Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse.
Drug: Ralinepag, Drug: Placebo
Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Cardiovascular Diseases, Hypertension, Pulmonary, PAH, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Lung Diseases, Respiratory Tract Disease, Lung/Thoracic
Prostacyclin, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Right Ventricular Function
UT Southwestern
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Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (A DUE)

Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.
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studyfinder@utsouthwestern.edu
Trushil Shah
169968
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03904693
STU-2020-0178
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Inclusion Criteria:

• Signed and dated informed consent form (ICF)
• Confirmed diagnosis of symptomatic PAH in WHO FC II or III
• Symptomatic PAH belonging to one of the following subgroups of WHO Group 1 pulmonary hypertension:
• Idiopathic
• Heritable
• Drug- or toxin-induced
• Associated with connective tissue disease, HIV infection, portal hypertension or congenital heart disease with simple systemic-to-pulmonary shunt with persistent pulmonary hypertension documented by a right heart catheterization (RHC) ≥ 1 year after surgical repair
• PAH diagnosis confirmed by hemodynamic evaluation at rest (through central reading), evaluated within 5 weeks prior to randomization:
• Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, AND
• Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg, AND
• Pulmonary vascular resistance (PVR) ≥ 3 WU (i.e., ≥ 240 dyn∙sec∙cm-5)
• Negative vasoreactivity test in idiopathic, heritable, and drug/toxin-induced PAH. (Participants for whom no vasoreactivity test was performed at diagnosis can be eligible if currently treated with PAH therapy for more than 3 months and PAH diagnosis confirmed by hemodynamic evaluation at least 3 months after introduction of their PAH therapy).
• Neither no history of PAH-specific treatment or currently receiving a stable dose of ERA or PDE-5i monotherapy for at least 3 months prior to baseline RHC, within the specified doses in the study protocol
• Subject able to perform the 6MWT with a minimum distance of 100 m and maximum distance of 450 m at Screening
• A woman of childbearing potential must:
• have negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization
• agree to undertake monthly urine pregnancy tests during the study and up to at least 30 days after study treatment discontinuation
• agree to follow the contraception scheme from Screening up to at least 30 days after study treatment discontinuation
Exclusion Criteria:

• Treatment with a soluble guanylate cyclase stimulator, L-arginine, any form of prostanoids or prostacyclin-receptor agonists (including oral, inhaled, or infused routes) in the 3-month period prior to start of treatment
• Treatment with combination therapy of ERA and PDE-5i in the 3-month period prior to start of treatment or history of intolerance to ERA and PDE-5i combination therapy
• Hypersensitivity to any of the study treatments or any excipient of their formulations
• Treatment with a strong cytochrome P450 3A4 (CYP3A4) inducer in the 1-month period prior to start of treatment
• Treatment with a strong CYP3A4 inhibitor or a moderate dual CYP3A4/CYP2C9 inhibitor or co-administration of a combination of moderate CYP3A4 and moderate CYP2C9 inhibitors in the 1-month period prior to start of treatment
• Treatment with doxazosin
• Treatment with any form of organic nitrate, either regularly or intermittently
• Diuretic treatment initiated or dose changed within 1 week prior to the RHC or start of treatment
• Treatment with another investigational drug in the 3-month period prior to start of treatment
• Body mass index (BMI) > 40 kg/m2 at Screening
• Known presence of three or more of the following risk factors for heart failure with preserved ejection fraction at Screening:
• BMI > 30 kg/m2
• Diabetes mellitus of any type
• Essential hypertension (even if well controlled)
• Coronary artery disease, i.e. history of stable angina or known more than 50% stenosis in a coronary artery or history of myocardial infarction or history of or planned coronary artery bypass grafting and/or coronary artery stenting
• Known presence of moderate or severe obstructive lung disease any time prior to Screening as specified in study protocol
• Known presence of moderate or severe restrictive lung disease any time prior to Screening as specified in study protocol
• Clinically significant aortic or mitral valve disease; pericardial constriction; restrictive or congestive left-sided cardiomyopathy; life-threatening cardiac arrhythmias; significant left ventricular dysfunction; or left ventricular outflow obstruction, in the opinion of the investigator
• Known permanent atrial fibrillation, in the opinion of the investigator
• Known or suspected uncontrolled thyroid disease (hypo- or hyperthyroidism)
• Documented pulmonary veno-occlusive disease
• Hemoglobin < 100 g/L (<10 g/dL) at Screening
• Known severe hepatic impairment as specified in study protocol
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN) at Screening
• Severe renal impairment at Screening as specified in study protocol
• Systemic hypotension at Screening or Randomization and systemic hypertension at Screening as specified in study protocol
• Acute myocardial infarction or cerebrovascular event (e.g., stroke) within the last 26 weeks prior to Screening
• Known bleeding disorder, in the opinion of the investigator
• Loss of vision in one or both eyes because of non-arteritic anterior ischemic optic neuropathy
• Hereditary degenerative retinal disorders, including retinitis pigmentosa
• Difficulty swallowing large pills/tablets that would interfere with the ability to comply with study treatment regimen
• Any planned surgical intervention (including organ transplant) during the double-blind treatment period, except minor interventions
• Exercise training program for cardiopulmonary rehabilitation in the 12-week period prior to start of treatment, or planned to be started during the double-blind period of the study
• Pregnant, planning to become pregnant or lactating
• Any known factor or disease that might interfere with treatment adherence, full participation in the study or interpretation of the results as judged by the investigator (e.g., drug or alcohol dependence etc.)
Drug: FDC macitentan/tadalafil, Drug: Macitentan 10 mg, Drug: Tadalafil 40 mg, Drug: Placebo FDC, Drug: Placebo macitentan, Drug: Placebo tadalafil
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
Pulmonary Arterial Hypertension, PAH, macitentan, tadalafil, fixed dose combination therapy
UT Southwestern
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A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions

The LTI-01-2001 study is a double-blind, placebo-controlled, Phase 2 study to evaluate LTI-01 (single-chain urokinase plasminogen activator, scuPA) in patients with infected, non-draining pleural effusions.
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Muhanned Abu-Hijleh
123140
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04159831
STU-2020-0484
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Key
Inclusion Criteria:

• Male or female ≥ 18 years of age who provide written informed consent
• Clinical presentation compatible with complicated parapneumonic pleural effusion (CPE), empyema or other type of pleural infection
• Has pleural fluid requiring drainage as determined by chest ultrasonography or by chest CT, and which is either:
• a) purulent; b) gram stain positive; c) culture positive; d) pH < 7.2; or e) glucose < 60 mg/dL (3.3 mmol/L)
• Failure to adequately drain pleural fluid ≥ 3 hours post insertion of patent chest tube within the pleural space, as evidenced by one or more of the following criteria:
• > 2 cm depth of fluid by ultrasound or CT
• < 80% drainage from chest radiograph obtained prior to chest tube insertion. Key
Exclusion Criteria:

• Current pleural infection already treated with intrapleural fibrinolytic therapy
• Evidence of ipsilateral fibrothorax (e.g. CT scan with > 0.5 cm visceral pleural thickening)
• History of multiple thoracenteses or thoracic surgical procedures within 3 months of screening
• Previous pneumonectomy on the side of the pleural effusion
• Current bilateral pleural infections
• Known non-expandable lung prior to this pleural infection
• Known or high clinical suspicion of a malignant pleural effusion
• Existing indwelling or tunneled pleural catheter
• Current infected hepatic hydrothorax or evidence of another abdominal process (e.g. pancreatic cyst or renal cyst) communicating with the pleural space
• Active bleeding, or any condition in which bleeding is either a significant risk or would be difficult to manage
• Fully anticoagulated patients on heparin, warfarin or novel oral anti-coagulants who are not able to temporarily discontinue anti-coagulants while receiving study medication and for 2 days after last dose of study medication Note: patients receiving low-molecular weight heparin for immobilization or anti-platelet agents are not excluded.
• Presence of severe metabolic derangements that would interfere with study assessments
• Systolic blood pressure >185 mmHg or diastolic blood pressure > 110 mmHg at screening
• Hemodynamically unstable and/or requires use of intravenous vasopressor therapy
• Expected survival < 3 months from a pathology other than the qualifying infected, non-draining pleural effusion (e.g. metastatic lung carcinoma)
Drug: LTI-01, Drug: Placebo
Pleural Effusion, Lung/Thoracic
UT Southwestern
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The Effects of Low Dose Ketamine on Cardiovascular Function

Low dose ketamine is used for pain management and for the treatment of anxiety and depression. Prior studies on low dose ketamine have noted short-term (minutes to hours) increases or decreases in blood pressure. Blood pressure that is too high or too low can be problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure. In fact, no prior studies have measured sympathetic nervous system activity after low dose ketamine has been given to an adult. Because sympathetic nervous system activity has a large influence on blood pressure, we need to know how exactly low dose ketamine affects these body systems. Therefore, in this research we will study how low dose ketamine affects sympathetic nervous system activity and cardiovascular function. The results from this research will inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and blood vessels.
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Craig Crandall
18601
All
18 Years to 45 Years old
Phase 1
This study is also accepting healthy volunteers
NCT04429685
STU-2019-1792
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Inclusion Criteria:

• Non-obese (body mass index less than 30 kg/m2) *alternatively, individuals will be permitted to participate if they have a body mass index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102 cm for males
• Systolic blood pressure <140 mmHg
• Diastolic blood pressure <90 mmHg
Exclusion Criteria:

• Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
• Current or previous use of anti-hypertensive medications
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Individuals with a history of drug abuse
• Individuals who have an unexplained positive urine drug screen (e.g., some agents cause false-positive results, but when the agent is abstained for hours/days/weeks, the repeated drug screen is negative. One example could be an over-the-counter supplement)
Drug: Ketamine, Drug: Saline (placebo)
Healthy
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Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

The investigators propose a one-year, repeated measures, within-subject design to examine the impact of improved caregiver depression on child asthma outcomes. A cross-lagged panel modeling (CLPM) for longitudinal data will be fit using a maximum likelihood structural equation model (SEM) in order to explore longitudinal mediation between asthma outcomes (asthma control, spirometry, quality of life (QOL)) and depressive symptoms. CLPM will test whether caregiver improvement preceded child asthma improvement, and SEM will test whether improved adherence and/or decreased child anxiety/depression mediated the effect. The investigators considered a randomized control trial, but it would not be ethically acceptable to withhold medication from caregivers diagnosed with Major Depressive Disorder (MDD) for the proposed one-year duration of the study. It is unlikely that potential participants in the study would find this acceptable. Furthermore a controlled design is not necessary since the investigators are not testing the efficacy of antidepressants for depression, but rather the impact of improvement on caregiver depression on the child.
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Edson Brown
10878
All
7 Years to 70 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT02809677
STU 022014-069
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Inclusion Criteria:

• Caregiver: Male or female, ages 18 to 70, primary asthma caregiver of the child, currently meeting criteria for Major Depressive Disorder (MDD) (based on depression symptoms for at least 2 weeks and causing clinically significant distress or impairment in social, occupational, or other important areas of functioning) based on a Structured Clinical Interview for DSM-4 (SCID) interview.
• Child: Male or female, ages 7-17 years who have a diagnosis of persistent asthma as classified by either of the following criteria:
• A. requirement for treatment with daily controller medication; or
• B. symptoms of persistent asthma in children not on a daily controller medication:
• 1. Daytime symptoms two or more days per week; or
• 2. Rescue bronchodilator use two or more times per week; or
• 3. Nocturnal symptoms two or more nights per month; or
• 4. Two or more oral steroid bursts in the last year.
Exclusion Criteria:

• Caregiver: Severe cognitive impairment that could impair their ability to provide informed consent; member of a vulnerable population (incarcerated, pregnant or breastfeeding women); women of childbearing age who will not use acceptable methods of birth control or abstinence during the study; severe psychiatric disorder in addition to MDD that should be a primary focus of treatment (e.g. severe and disabling eating or anxiety disorders); treatment refractory depression defined as failing ≥ 3 adequate trials of antidepressants (≥ 4 weeks at a therapeutic dose); electroconvulsive therapy or repeated transcranial magnetic stimulation during the current episode; depression as part of bipolar disorder or schizophrenia or schizoaffective disorder, or current depression secondary to substances or general medical condition, or with psychotic features or accompanied by severe obsessive compulsive disorder (OCD), or high risk for suicide defined by multiple recent suicide attempts (> 2 in the past year) or any attempt in the past month, or current suicidal ideation with a well-formed plan or intent.
• Child: Severe cognitive impairment that could impair their ability to provide informed consent; high risk for suicide defined by multiple recent suicide attempts (> 2 in the past year) or any attempt in the past month, or current suicidal ideation with a well-formed plan or intent; severe or life-threatening medical illness, such as other serious cardiopulmonary conditions (e.g. congenital heart disease, cystic fibrosis, alpha-1-antitrypsin disease) or cancer, which would confound the assessment of asthma, anxiety, depression or quality of life; severe psychiatric illness, such as autism, bipolar disorder, schizophrenia or current drug/alcohol abuse/dependence. If an eligible caregiver presents with more than one child meeting inclusion criteria for the study, only one child, randomly selected, will be enrolled.
Drug: Escitalopram, Drug: Venlafaxine XR, Drug: Bupropion XR, Drug: Sertraline, Drug: Mirtazapine, Drug: Buspirone, Drug: Quetiapine, Drug: Aripiprazole, Drug: Lithium
Major Depressive Disorder, Asthma
Children’s Health; Parkland Health & Hospital System
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SPI-1005 for Prevention and Treatment of Aminoglycoside Induced Ototoxicity

The primary objective of this study is to determine the safety and tolerability of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, using histories, physical exams, vital signs (VS), adverse event (AE) reporting, hematology (CBC) chemistry (Chem-20). The secondary objectives of this study are to determine the pharmacokinetics of oral SPI-1005 at 200, 400 and 600 mg BID for 21 days. Peak/trough assessments will be determined for ebselen, its major metabolite and selenium. Clinical assessments of the severity of sensorineural hearing loss, speech discrimination, vertigo severity, tinnitus severity and lung function will be made compared between treatment arms and the placebo arm of this study.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02819856
STU 052017-042
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Inclusion Criteria:

• Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary exacerbation.
• Voluntarily consent to participate in the study.
• Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
• Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or IUD in place for at least 3 months prior to study through study completion; or Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or Stable hormonal contraceptive for at least 3 months prior to study through study completion.
• Ability to perform all behavioral tests as indicated.
Exclusion Criteria:

• Current use or within 60 days prior to study enrollment the following IV ototoxic medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide).
• History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma.
• History of middle ear or inner ear surgery.
• Current conductive hearing loss or middle ear effusion.
• Significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or psychiatric disease.
• History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen.
• Participation in another investigational drug or device study within 30 days prior to study enrollment.
• Female patients who are pregnant or breastfeeding.
Drug: Placebo, Drug: SPI-1005 Ebselen 200mg Capsule x1, Drug: SPI-1005 Ebselen 200mg Capsule x2, Drug: SPI-1005 Ebselen 200mg Capsule x3
Ototoxicity, Lung/Thoracic
UT Southwestern
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Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial (PAH)

This protocol describes an open-label phase 2 clinical trial of fluoxetine in PAH looking at change in pulmonary vascular resistance (PVR) as the primary endpoint. In this open-label clinical trial, 18 patients with pulmonary arterial hypertension will be given fluoxetine for 24 weeks. A Right Heart Catheterization will be performed at baseline and 24 weeks. Change in PVR will be the primary endpoint; other hemodynamic endpoints, quality of life, QIDS-SR depression scale, functional class and six-minute walk distance will also be evaluated. Primary Hypothesis: Fluoxetine treatment for 24 weeks will lead to significantly lower pulmonary vascular resistance in 18 patients with PAH in patients treated in an open-label clinical trial.
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Kelly Chin
38273
All
16 Years to 80 Years old
Phase 2
This study is also accepting healthy volunteers
NCT03638908
STU 082013-045
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Inclusion Criteria:
1. WHO Group I PAH subtypes of idiopathic PAH and PAH associated with drugs / toxins, connective tissue disease, repaired congenital heart disease and unrepaired atrial septal defect 2. Age 16-80 3. WHO Functional Class II or III 4. Right Heart Catheterization within 3 weeks of study entry with mPAP ≥ 25 mmHg, wedge ≤ 15 mmHg, and PVR ≥ 3 Wood units. 5. Contraception use, (-) urine pregnancy test, not breast feeding (women of childbearing potential) 6. One or more approved PAH therapies for ≥ 3 months, no change in dose for 1 month (endothelin-1 antagonist, phosphodiesterase-5 inhibitor, prostacyclin / prostacyclin analog). Novel approved therapies in one of the three existing classes will also be acceptable as background therapy if they become available during the course of the study; other medication classes are excluded
Exclusion Criteria:
7. WHO Functional Class IV or listed for lung transplant 8. Moderate or greater obstructive lung disease: FEV1/FVC <70% and FEV1 <60% 9. Moderate or greater restrictive lung disease: TLC or FVC <60% (if 50-60%: OK if TLC or FVC ≥50% + PFT stable x1 year + CT with no more than mild lung disease) 10. Other cause for pulmonary hypertension: all other WHO group I diseases (including but not limited to liver disease, HIV), and WHO Groups II-V (i.e. left heart disease, lung disease, chronic PE and miscellaneous causes)24. 1. High probability VQ or positive CTA 2. Left ventricular ejection fraction <40% 11. Depression 12. Severe liver, renal or other medical or physical disease preventing completion of the study procedures 13. Use of antidepressants within 3 months
Drug: Fluoxetine
Pulmonary Arterial Hypertension, Lung/Thoracic, Heart
UT Southwestern
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Second Generation LMA Versus Endotracheal Tube in Obese Patients

This prospective, randomized, comparative study is intended to enroll a total of 148 patients with a BMI 30-49.9 kg/m2 undergoing surgery at Parkland Hospital. The efficacy and performance of a second-generation LMA will be compared to endotracheal intubation. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Tiffany Moon
66760
All
18 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03748342
STU 112017-050
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Inclusion Criteria:

• 18-80 years old
• Obese (BMI > or equal to 30 kg/m2
• Scheduled for a non-emergent surgery that requires general anesthesia (e.g., orthopedic, breast, urological, colorectal, ENT, vascular, general surgery)
• Willing and able to consent in English or Spanish
• No current history of advanced pulmonary or cardiac disease
Exclusion Criteria:

• Age less than 18 or older than 80
• BMI ≥50 or < 30 kg/m2
• Patient does not speak English or Spanish
• Expected surgical duration longer than 4 hours
• Planned postoperative ICU admission
• Patient refusal
• Monitored anesthesia care (MAC) or regional anesthesia planned
• Pregnant or nursing women
• "Stat" (emergent) cases
• Known or suspected difficult airway
• Full stomach/significant aspiration risk (gastroparesis, emergency surgery, untreated moderate to severe gastroesophageal reflux disease, hiatal hernia)
• No history of gastric surgery
• Surgery in position other than supine (e.g., Trendelenburg)
• Laparoscopic surgery
Device: Second-Generation Laryngeal Mask Airway
Obese, Endotracheal Tube, Laryngeal Mask Airway
Children’s Health
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Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil

The primary objective of this study is to evaluate the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).
Call 214-648-5005
studyfinder@utsouthwestern.edu
Trushil Shah
169968
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03992755
STU-2019-1218
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Inclusion Criteria:
1. Evidence of a personally signed and dated informed consent document exists indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. 2. Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Patient has fulfilled all entry criteria at the time of enrollment in original study with LIQ861. 4. Patient has completed the protocol defined end of study procedures or met a protocol-defined and adjudicated endpoint in the original LIQ861 study in which they were enrolled. 5. Patient, whether male or female, agrees to use a medically acceptable method of contraception throughout the entire study period from informed consent through the termination visit, if the possibility of conception exists. Eligible male and female patients must also agree not to participate in a conception process (e.g., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of LIQ861.
Exclusion Criteria:
1. Patient prematurely discontinued LIQ861 due to a drug-related AE/SAE or tolerability issue in the original LIQ861 study in which they were enrolled, or patient did not complete protocol defined study procedures at an end of study visit (not Early Termination visit) in their original LIQ861 study. 2. Patient withdrew consent during participation in another LIQ861 study. 3. Patient is a female who wishes to become pregnant or who has a positive pregnancy test on Day 1 (LTI-302 Study Initiation Visit). 4. Patient has undergone lung or heart/lung transplant or the initiation of parenteral (intravenous [IV] infusion or subcutaneous injection) therapy with a prostacyclin during the time since participation in their original LIQ861 study. 5. Any reason exists that, in the opinion of the Investigator or Medical Monitor, precludes the patient from participating in the study, e.g., any previous or intercurrent medical condition that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.
Drug: LIQ861 Inhaled Treprostinil
Primary Pulmonary Hypertension, Cardiovascular
Pulmonary Arterial Hypertension, Idiopathic Pulmonary Arterial Hypertension, Heritable Pulmonary Arterial Hypertension, Drug Induced Pulmonary Arterial Hypertension, Toxin Induced Pulmonary Arterial Hypertension, Connective tissue disease
UT Southwestern
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HFNC Initiation Flow Rate Study

The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected to take 6 months over the Winter/Spring of 2020-2021. The study is consisted of 3 arms, comparing HFNC therapy at 1 L/kg/min, 1.5 L/kg/min, and 2 L/kg/min (20 L/min max). Moderate to severe bronchiolitis is defined by RDAI of 6 or more.15 The primary outcome is treatment response to HFNC therapy defined by RDAI/Respiratory Assessment Change Score (RACS) ≥ 4 at 4 hours of therapy. Secondary outcome measures comprise of treatment failure requiring an escalation of care during the first 24 hours of HFNC therapy, duration of HFNC and simple nasal cannula therapy, duration of simple nasal cannula therapy, hospital and PICU length of stay (LOS), time to treatment failure, and adverse events.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Amy Cheng
185763
All
up to 12 Months old
N/A
This study is NOT accepting healthy volunteers
NCT04517344
STU-2020-0816
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Inclusion Criteria:

• Patients less than 12 months of age with: (1) clinical signs of bronchiolitis defined by AAP and (2) respiratory distress defined by RDAI score 6 or greater.
Exclusion Criteria:

• Infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (NIPPV) or invasive ventilation, or with congenital heart disease, immunocompromise, upper airway obstruction, chronic lung disease, bronchopulmonary dysplasia, infants on home oxygen therapy basilar skull fracture, facial traumas, craniofacial malformations, and infants admitted to the neonatal or cardiac ICUs. Patients who have received bronchodilator or steroid treatments are not excluded as previous studies have not shown these treatments to be effective in bronchiolitis management.
Other: Initial Flow Rate
Bronchiolitis
Bronchiolitis, HFNC, High Flow Nasal Cannula, Infants
Parkland Health & Hospital System
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Effects of Oral Sildenafil on Mortality in Adults With PAH (AFFILIATE)

This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.
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Kelly Chin
38273
All
18 Years to 74 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT02060487
STU 052014-027
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Inclusion Criteria:
Subjects ≥ 18 <75 years of age with any of the following conditions:
• Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
• PAH secondary to connective tissue disease
• PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window
• PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
• Functional Class II-IV; Baseline 6MWD ≥ 50 m.
Exclusion Criteria:

• Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
• History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
• History of pulmonary embolism; History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function
• No prior long term treatment with PDE-5 inhibitors
• Treatment with bosentan OR riociguat within 3 months of randomization
• Current treatment with nitrates or nitric oxide
Drug: sildenafil citrate, Drug: sildenafil citrate, Drug: sildenafil citrate
Pulmonary Arterial Hypertension
pulmonary arterial hypertension, pulmonary hypertension, PAH, sildenafil, revatio
UT Southwestern
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Multicenter Trial of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent (ALTERRA)

To demonstrate the safety and functionality of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR).
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studyfinder@utsouthwestern.edu
Thomas Zellers
18301
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT03130777
STU 082017-081
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Inclusion Criteria:
1. The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. 2. Pediatric or adult patent whose weight is ≥ 20 kg (44 lbs). 3. The patient has a dysfunctional RVOT/PV. 4. RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm and/or minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff immediately prior to Alterra Prestent insertion.
Exclusion Criteria:
1. Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics). 2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days. 3. Leukopenia (WBC < 2000 cells/μL), anemia (Hgb < 7 g/dL), thrombocytopenia (platelets < 50,000 cells/μL) or any known blood clotting disorder. 4. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
Pulmonary Disease, Congenital Heart Disease, Transpulmonary Valve Replacement, Pulmonary Stenosis, TPVR, Tetralogy of Fallot
Parkland Health & Hospital System
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The Dallas Asthma Brain and Cognition (ABC) Study

Asthma is a chronic inflammatory airway disease that leads to episodic symptom exacerbations, which exerts a substantial burden on quality of life and can influence other health domains if not adequately controlled. Asthma prevalence rates have increased in the past decade, affecting 8.4% (25.7 million people) of the United States population. The economic costs of asthma have been estimated annually with $56 billion in the US alone. Despite progress in pharmacological treatment, overall asthma control remains unsatisfactory and treatment non-adherence is extremely high. Asthma is particularly under diagnosed and understudied in aging adults. This problem will increase in coming decades given demographic trends and will disproportionally contribute to the societal and personal economic costs associated with asthma treatment and management. In the proposed 4-year project we will evaluate, in a two-session assessment recruiting a total of 126 asthma patients and 66 healthy controls aged 40-69 years, the extent to which asthma and aging are associated with changes in cognition and brain chemistry, structure, and function.
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Edson Brown
10878
All
40 Years to 69 Years old
N/A
This study is also accepting healthy volunteers
NCT03794856
STU-2018-0034
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Inclusion Criteria:

• For asthma patients: diagnosis of asthma (verified by a medical documentation) for at least 2 years; for healthy volunteers: no significant medical or psychiatric history.
• Ages 40 to 69 years old.
• Proficient in English.
• Education level of at least 10th grade level.
Exclusion Criteria:

• Treatment with oral corticosteroids in the previous 6 weeks, because of the potent effects of this drug on airway reactivity.
• Spirometry: Peak expiratory flow (PEF) below 60% of predicted.
• Diagnosis of vocal cord dysfunction (identified by abnormalities in spirometric flow-volume curves), clinically significant chronic obstructive pulmonary disease, or emphysema.
• Presence or history of medical or neurological disorder that may affect brain function and the physiological systems of interest (e.g. angina, myocardial infarction, congestive heart failure, transient ischemic attacks, cerebrovascular accidents, emphysema, or chronic obstructive pulmonary disease, history of seizures or head trauma, endocrine disorders or renal disease, chemotherapy or radiation presently or in the past 5 years, uncontrolled diabetes, blood pressure above 160/90 (self-reported or measured at session 1).
• Corrected vision poorer than 20/30 on Snellen Eye Chart.
• Presence or history of Schizophrenia, Psychosis, Dementia, Bipolar I, Bipolar II, PTSD or Acute Stress Disorder
• Current or recent history (within 1 year) of Substance Related Disorders, current recreational drug use (defined as past 30 days) or consuming more than 20 alcoholic drinks per week.
• Current treatment with anti-psychotics, sedatives, benzodiazepines with a half-life longer than 6 hours.
• Previous electroconvulsive therapy.
• Presence of history of orthopaedic circumstances and metallic inserts interfering with MR scanning (prior surgeries and/or implant pacemakers, pacemaker wires, artificial heart value, brain aneurysm surgery, middle ear implant, non-removable hearing aid or jewelry, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, artificial limb or joint, foreign metallic objects in the body such as bullets, BB's, shrapnel, or metalwork fragments, pregnancy, claustrophobia, uncontrollable shaking, or inability to lie still for one hour.
• Not proficient in English.
• In the opinion of the principal investigator, participant is otherwise unsuitable for this study.
Other: Functional and Structural Magnetic Resonance Imaging (research grade), Other: Cognitive Function Testing (non-diagnostic), Other: Asthma and Psychological Questionnaires (non-diagnostic)
Asthma
Healthy participants, Asthma, Cognitive functioning, MRI
UT Southwestern; Children’s Health
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G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2) (GOAL- e2)

The goal of this research study is to collect blood and urine samples from people who have either the R117H type of CF or the non-G551D gating type of CF to be kept for future research.We will also use some of the collected blood to measure the number of neutrophils.
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studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
6 Years and over
This study is NOT accepting healthy volunteers
NCT01521338
STU 102011-029
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Inclusion Criteria for Core Study: 1. Male or female ≥ 6 years of age at Visit 1. : 2. Must have a clinical diagnosis of cystic fibrosis and the following CFTR mutations: 1. For Cohort 1 (Closed to enrollment June 30, 2012): G551D on at least 1 allele Any known or unknown mutations allowed on second allele. 2. For Cohort 2: R117H on at least 1 allele Any known or unknown mutation on the second allele except G551D 3. For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). (Patients may enroll in the Registry at Visit 1 if not previously enrolled.) 4. Clinically stable with no significant changes in health status within the 14 days prior to Visit 1. 5. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative. Exclusion Criteria for Core Study 1. Participation in the VX-770-105, VX-770-106, VX-770-108, VX-770-110, VX-770-111, VX-770-112, or VX-770-113 study, VX-770 Extended Access Program or use of ivacaftor within 6 months prior to Visit 1. 2. Any upper or lower respiratory symptoms requiring treatment with oral, inhaled or IV antibiotics within the 2 weeks prior to Visit 1. 3. History of solid organ transplantation. 4. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
Cystic Fibrosis
Cystic Fibrosis, G551D, G551D Mutation
UT Southwestern; Parkland Health & Hospital System
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Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine

We are examining how morphine (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in our research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.
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Craig Crandall
18601
All
18 Years to 45 Years old
Phase 1/Phase 2
This study is also accepting healthy volunteers
NCT04138615
STU 092017-070
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Inclusion Criteria:

• Healthy
• Non-obese (body mass index less than 30 kg/m2)
• Body mass greater than or equal to 65 kg
Exclusion Criteria:

• Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Positive urine drug screen
• Currently taking pain modifying medication(s)
Drug: Morphine, Other: Placebo
Healthy
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A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment (SELECT)

Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in subjects with inoperable or persistent/recurrent CTEPH.
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studyfinder@utsouthwestern.edu
Trushil Shah
169968
All
18 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03689244
STU-2019-0535
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Main
Inclusion Criteria:

• Signed and dated informed consent form
• Male and female subjects from greater than or equal to (>) 18 (or the legal age of consent in the jurisdiction in which the study is taking place) and less then or equal to (<=85) years old at Screening (Visit 1)
• With established diagnosis of inoperable CTEPH (i.e., technically non-operable) or persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA), as confirmed by the corresponding adjudication committee
• With pulmonary hypertension (PH) in WHO FC I-IV.
• Subject able to perform the 6-minute walk test (6MWT) with a minimum distance of 100 m and a maximum distance of 450 m at screening visit.
• Women of childbearing potential must have a negative pregnancy test at screening and randomization and must agree to undertake monthly urine pregnancy tests, and to use a reliable method of birth control from screening visit up to at least 30 days after study treatment discontinuation. If a hormonal contraceptive is chosen it must be taken for at least 1 month prior to randomization. Main
Exclusion Criteria:

• Planned or current treatment with another investigational treatment up to 3 months prior to randomization.
• Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
• Known concomitant life-threatening disease with a life expectancy < 12 months.
• Planned balloon pulmonary angioplasty within 26 weeks after randomization.
• Change in dose or initiation of new PH-specific therapy within 90 days prior to the baseline RHC (and LHC, if needed) qualifying for enrollment for the hemodynamic cohort and within 90 days prior to randomization (Visit 2) for the non-hemodynamic cohort
• Treatment with prostacyclin (epoprostenol), prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e., selexipag) within 90 days prior to randomization (visit 2) except those given at vasodilator testing during RHC
• Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to baseline RHC (and LHC, if needed)
• Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc).
• Any other criteria as per selexipag Summary of Product Characteristics (SmPC).
• Exclusion criteria related to comorbidities: severe coronary heart disease or unstable angina as assessed by the investigator; mocardial infarction within the last 6 months prior to or during Screening; decompensated cardiac failure if not under close supervision; severe arrhythmias as assessed by the investigator; cerebrovascular events (example transient ischemic attack, stroke) within the last 3 months prior to or during screening; congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. (PH); known or suspicion of pulmonary veno-occlusive disease
Drug: Selexipag, Drug: Placebo
Chronic Thromboembolic Pulmonary Hypertension
CTEPH, selexipag
UT Southwestern
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