Search Results
within category "Lung Disease & Asthma"
Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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.
• 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.
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.
• 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
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.
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.
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.
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.
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
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.
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
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.
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.
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
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)
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.
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.
Call 214-648-5005 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
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).
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.
Call 214-648-5005 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.
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.
Call 214-648-5005 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
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.
Prostacyclin, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Right Ventricular Function
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.
Call 214-648-5005 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.)
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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)
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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)
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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.
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.
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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
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
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.
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
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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
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).
Call 214-648-5005 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
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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)
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.
Call 214-648-5005 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
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.
Call 214-648-5005 studyfinder@utsouthwestern.edu
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)
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.
Call 214-648-5005 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