StudyFinder
Search Results
185 Study Matches
Use of a Cloud-connected Remote Blood Pressure Monitoring Program During the Postpartum Period for Hypertensive Women (BP-ME)
Research Nurse - Gwendoline.Helin-milgrom@PrismaHealth.org
FEMALE
18 years to 54 years old
NCT06096701
Inclusion Criteria:
* Pregnant individuals with hypertensive disorders
* Speak English
* At least 18 years old
* Medicaid coverage
* Between 20 weeks of pregnancy and 2 weeks postpartum
* Postpartum admission at Prisma Health Richland with hypertensive disorder within 2 weeks postpartum
Exclusion Criteria:
* Not planning to deliver at Prisma Health Richland
* Less than 20 weeks of pregnancy
* More than 2 weeks postpartum DEVICE: Blood pressure cuff
Hypertensive Disorder
Preeclampsia, Gestational hypertension, Eclampsia, Chronic hypertension
Registry of the Patient Experience for Carpal Tunnel Release (MISSION)
Kyle Adam - Kyle.Adams@prismahealth.org
ALL
18 years and over
NCT06071468
Inclusion Criteria 1. ≥18 years of age 2. Clinical diagnosis of unilateral or bilateral CTS 3. A clinical decision has been made to perform CTR on one or both hands 4. CTS-6 score ≥12 in the target hand(s)\* 5. Confirmatory diagnostic testing in the target hand(s)\*:
• CTR-US: Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region)
• ECTR or OCTR: Confirmatory electrodiagnostic testing 6. Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection) in the target hand(s) 7. Patient agrees to complete follow-up questionnaires over a 24-month period 8. Patient has a valid smart phone number and/or email address to receive and answer follow-up questionnaires Note: An asterisk (\*) denotes that this criterion must be applied to the target hand for unilateral CTR procedures, or to both hands for simultaneous bilateral CTR procedures.
• Patient meets any of the contraindications per Instruction For Use (IFU)
• Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.
• CTR-US: Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region)
• ECTR or OCTR: Confirmatory electrodiagnostic testing 6. Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection) in the target hand(s) 7. Patient agrees to complete follow-up questionnaires over a 24-month period 8. Patient has a valid smart phone number and/or email address to receive and answer follow-up questionnaires Note: An asterisk (\*) denotes that this criterion must be applied to the target hand for unilateral CTR procedures, or to both hands for simultaneous bilateral CTR procedures.
Exclusion Criteria:
• Patient meets any of the contraindications per Instruction For Use (IFU)
• Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.
DEVICE: UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US), PROCEDURE: Endocscopic CTR, PROCEDURE: Open CTR
Carpal Tunnel Syndrome, CTS
Ultrasound Guided Carpal Tunnel Release, CTR-US, ECTR, OCTR
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study (SAVE-FistulaS)
Kya Spann - Kya.Spann@prismahealth.org
ALL
18 years and over
NA
NCT06001827
Inclusion Criteria:
* Age of at least 18 years
* Referred for creation of a new AVF
* Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months
Exclusion Criteria:
* Planned index procedure to revise or repair an existing fistula
* Target artery inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
* Target vein inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
* Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound
* Known central venous stenosis of at least 50% on the side of surgery
* Presence of a stent or a stent graft within the access circuit
* Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation
* Known or suspected active infection at the time of surgery
* Congestive heart failure NYHA class 4
* Prior steal on the side of surgery;
* Enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study
* Life expectancy less than 12 months
* Expected to undergo kidney transplant surgery within 6 months of enrollment
* Expected to undergo home hemodialysis
* Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening
* Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study
* Unwillingness or inability to give consent and/or comply with the study follow up schedule
* Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study. DEVICE: SelfWrap Bioabsorbable Perivascular Wrap, PROCEDURE: Untreated AVF Control
Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure, ESRD, Vascular Access Complication, Renal Failure, Catheter Complications, Catheter Dysfunction, Renal Insufficiency
Vascular Surgery, Vascular Access, Nephrology, Bioabsorbable, Perivascular Wrap, External Support, Hemodialysis, Dialysis, Chronic Kidney Disease, End Stage Renal Disease, Arteriovenous Fistula, AVF
The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI
Lindsey M Bentley, RN, BSN - Lindsey.Bentley@prismahealth.org
ALL
NCT06907693
Inclusion Criteria:
* Participation in the CS1-004 clinical trial
Exclusion Criteria:
* Inability to undergo a CT pulmonary angiography scan (i.e., claustrophobia)
* Individuals who are pregnant or who become pregnant during the sub-study
* eGFR \<30 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease (MDRD)
* Allergy to Iodine contrast agents DIAGNOSTIC_TEST: CT Pulmonary Angiography Scan
Pulmonary Arterial Hypertension
FLUIDDA FRI, FRI
Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy (HYPOGRYPHE)
Karen Craver, MT, MHA - NCORP@wakehealth.edu
ALL
18 years and over
NA
NCT05703269
Inclusion Criteria:
* At least one intact brain metastasis or resection cavity ≥ 2 cm in diameter or ≥ 4 cc volume.
* Patients at initial diagnosis of brain metastases and patients with known brain metastasis treated with systemic therapy alone are eligible.
* Patients who have previously undergone SRS for brain metastases are eligible if all MRIs and DICOM-RT files from prior SRS courses are available for upload to TRIAD and there are no lesions requiring re-irradiation. Prior SRS data upload is NOT required prior to enrollment and randomization. Both SSRS and FSRS are acceptable.
* Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast-enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g., xyz/2). Alternatively, direct volumetric measurements via slice-by-slice contouring on a treatment planning software package can be used to calculate the total tumor volume.
* Any extent of non-CNS disease is allowed. There is no requirement for non-CNS disease to be controlled prior to study entry.
* For patients considered to be borderline or potentially eligible by size or volume criteria, sites have the option to send in DICOM films for central review screening.
* Age ≥ 18 years at the time of enrollment.
* Total number of brain metastases (including resection cavities) ≤ 15 on diagnostic MRI; all lesions must be amenable to SSRS and FSRS as determined by the treating radiation oncologist. Treatment must take place at a facility credentialed by the Imaging and Radiation Oncology Core (IROC) for SRS and that offers both SSRS and FSRS as treatment options.
* Total gross tumor volume must be ≤ 30 cc. Lesion volume will be approximated by measuring each lesion's three perpendicular diameters on contrast-enhanced T1 MRI and the product of those diameters will be divided by 2 (V = xyz/2). Direct volumetric measurements by contouring all lesions on all visible slices on treatment planning software is also acceptable. If there is a cavity, only gross residual disease within or adjacent to the cavity is counted toward the 30 cc total volume.
* Ability to tolerate MRI brain with gadolinium-based contrast.
* Pathologically confirmed melanoma, renal cell carcinoma, non-small cell lung cancer, small cell lung cancer, or breast cancer.
* Has received, is currently receiving, or is planned to receive immune checkpoint inhibitor therapy (defined as agent targeted to PD-1/PD-L1 axis) within 30 days of the planned first day of SSRS/FSRS. Dual ICI therapy with PD-1/PD-L1 and CTLA-4 targeted agents are allowed, but patients treated with a single agent CTLA-4 targeted agent only are ineligible.
o It is not mandatory to wait for the results of next generation sequencing (NGS) or other molecular tumor testing to determine if the patient is planned to receive ICI if the enrolling physician feels that identification of a mutation that would preclude ICI therapy (such as an EGFR mutation in a patient with NSCLC) is unlikely to be identified.
* Karnofsky Performance Status (KPS) ≥ 50. Refer to Appendix A.
* Negative serum or urine pregnancy test within 14 days of randomization for women of child-bearing potential.
* Ability to understand and the willingness to sign written informed consent.
* Patients must be able to provide informed consent.
* Must be able to speak, read and understand English or Spanish
Exclusion Criteria:
* Prior fractionated, whole, or partial brain radiation therapy. Prior fractionated SRS is acceptable.
* Prior courses of SRS for benign tumors such as meningiomas, pituitary adenomas, schwannomas may be acceptable if the treatment is \> 2cm away from the site of a metastatic lesion that would be treated on this study. The study PI or a designated co-PI must review this type of case to confirm eligibility prior to enrollment.
* Prior diagnosis ARE, including pseudoprogression or radiation necrosis/radionecrosis, or previously treated lesions being actively evaluated for possible ARE or local failure such as concerning imaging findings currently being tracked with short interval MRI.
* Leptomeningeal carcinomatosis established by lumbar puncture cytology, or MRI imaging. In the absence of a clinical indication, a lumbar puncture is not required to confirm eligibility.
* A brain metastasis that is 5 mm or less from the optic chiasm or optic nerves
* Inability to tolerate brain MRI or receive gadolinium-based contrast
* Planned or prior therapy with bevacizumab (or bevacizumab biosimilar) within 30 days of the planned first day of SRS as part of a systemic therapy regimen at study enrollment.
* Serious intercurrent illness or medical condition judged by the local investigator to compromise the patient's safety, preclude safe administration of the planned protocol treatment, or would not permit the patient to be managed according to the protocol guidelines. RADIATION: single fraction stereotactic radiosurgery (SSRS), RADIATION: fractionated stereotactic radiosurgery (FSRS)
NSCLC, Renal Cell Carcinoma, Breast Carcinoma, Melanoma, Brain Metastases, Adult, Non-small Cell Lung Cancer, SCLC, Small-cell Lung Cancer
Gamma Knife, Linear Accelerator, Immune Checkpoint Inhibitor (ICI) therapy, Stereotactic Radiosurgery (SRS), Fractionated Stereotactic Radiosurgery (FSRS), Stereotactic Radiosurgery (SSRS)