PULMONARY EMBOLISM – THROMBUS REMOVAL WITH CATHETER-DIRECTED THERAPY: THE PE-TRACT TRIAL

Date Added
May 10th, 2023
PRO Number
Pro00127854
Researcher
Kevin Dickey

List of Studies

Keywords
Lung, Pulmonary
Summary

This is a study to determine effectiveness of using catheter directed therapy along with medical directed therapy when treating pulmonary embolism versus using medical directed therapy alone.

Institution
MUSC
Recruitment Contact
Samuel Bidwell
843-792-2305
bidwells@musc.edu

Occult Gastrointestinal Bleeding Caused by Portal Hypertensive Gastropathy in Patients with Cirrhosis

Date Added
May 11th, 2023
PRO Number
Pro00121305
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Liver, Stomach
Summary

In this study, we will recruit cirrhotic patients who are undergoing endocscopic procedures as part of their standard of care. Their endoscopies will reveal whether they have portal hypertensive gastropathy. After the procedure, we will ask the patients to provide us with a stool sample, which we will assess for occult GI bleeding. For those patients who DO NOT have occult GI bleeding, they will be contacted every 6 months for 2 years to check whether they have developed GI bleeding.

Institution
MUSC
Recruitment Contact
Sara Hatoum
843 792 0650
hatoum@musc.edu

UF-HN-004 Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma based on HPV subtype and plasma circulating free HPV DNA Level and Clearance Rate.

Date Added
May 16th, 2023
PRO Number
Pro00124145
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with Oropharyngeal Squamous Cell Carcinoma. The purpose of this research study is to determine if lower doses of radiation therapy are as effective as the standard higher doses. Participants will have tests and procedures that would be performed as part of regular care. Participants will be assigned to one of three study groups based on your risk for cancer recurrence. Depending on the group assigned, participants receive either standard dose of radiation therapy (RT), a moderately reduced dose of RT, or an extremely reduced dose of RT. During the RT treatment, participants will also receive chemotherapy. Chemotherapy will be given at the same dose used in routine care for everybody in the study. Participants will be in the study for up to 5 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLAHaploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)

Date Added
May 16th, 2023
PRO Number
Pro00128723
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer/Leukemia
Summary

This study is for patients with acute leukemia or myelodysplastic syndrome (MDS). This study is being done to help understand whether a haplo related donor or a MUD HCT for people with acute leukemia or MDS is better or if there is no difference at all.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Accelerated rTMS for Post-Stroke Apathy: Targeting Amotivation Toward Improving Whole Health and Rehabilitation Engagement

Date Added
May 16th, 2023
PRO Number
Pro00126436
Researcher
Parneet Grewal

List of Studies

Keywords
Depression, Memory Loss, Stroke, Stroke Recovery
Summary

Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of individuals with apathy. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, we are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. Our study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). Our study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.

Institution
MUSC
Recruitment Contact
Lisa McTeague
843-792-8274
mcteague@musc.edu

A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

Date Added
May 17th, 2023
PRO Number
Pro00128120
Researcher
Erin Forster

List of Studies


Keywords
Ulcerative colitis
Summary

This is a randomized, double-blind, active- and placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of induction and maintenance JNJ-78934804 therapy in participants 18 to 65 years of age (inclusive, at the time of consent), with moderately to severely active UC as determined by a modified Mayo score ≥5 and a final reported endoscopy subscore ≥2 obtained during the central review of the screening video endoscopy. Participants must also have demonstrated an inadequate initial response, loss of response, or intolerance to ≥1 approved ADT (advanced therapy inadequate responder [ADT-IR]). Overall, the study will evaluate 48 weeks of therapy with JNJ-7893480. The primary objective of the study is to evaluate the efficacy of JNJ-78934804 at Week 48
compared with each monotherapy (guselkumab alone and golimumab alone).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO)

Date Added
May 17th, 2023
PRO Number
Pro00128928
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Breast
Summary

This study is for people with low-risk HER-2 positive breast cancer. The study is being done to see if treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients who have had surgery, chemotherapy, and HER2-targeted therapy.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-7929321
hcc-clinical-trials@musc.edu

A Randomized Phase II Study Comparing Inotuzumab plus Chemotherapy versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome Negative B-Cell Acute Lymphoblastic Leukemia (ALL)

Date Added
May 18th, 2023
PRO Number
Pro00128781
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Cancer/Leukemia
Summary

This trial will enroll patients 50 years and older with acute lymphoblastic leukemia (ALL). Patients above age 50 years are not eligible for intensive chemotherapy regimens and have been shown to have worse outcomes than adolescents and young adults treated with the same chemotherapy. For instance, the 5-year survival for patients aged 55-65 years treated on an international ALL trial was 21% compared to 38% for younger patients. Similarly, the 5-year survival for patients treated at MD Anderson Cancer Center with the hyper-CVAD regimen was 30% for patients aged 40-59 years compared to 51% for those less then age 40 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843)792-9371
hcc-clinical-trials@musc.edu

A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia (ALL) in Adult

Date Added
May 18th, 2023
PRO Number
Pro00128835
Researcher
Praneeth Baratam

List of Studies

Keywords
Cancer, Cancer/Leukemia
Summary

This study is for patients who have newly diagnosed diagnosed BCR-ABL acute lymphoblastic leukemia (ALL). This study is being done to determine the effects (good or bad) of using the combination of a Tyrosine Kinase Inhibitor (TKI), steroids and blinatumomab versus treatment with steroids, Tyrosine Kinase Inhibitor (TKI) and chemotherapy. This investigational therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinatumomab.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843)792-9371
hcc-clinical-trials@musc.edu

A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)

Date Added
May 23rd, 2023
PRO Number
Pro00128352
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

The FLEX study is a randomized, blinded, and placebo-controlled study assessing the efficacy and safety of an investigational drug for adults diagnosed with Generalized Myasthenia Gravis (gGM). The injectable investigational drug is being evaluated over a 12-week induction period and a 12-week maintenance period. Based on completion of these periods and a participant's response to the investigational injection, participants may qualify to continue in a 52-week extension study of the investigational drug. If you choose to enter this study, you will participate in the study for up to approximately 84 weeks (1 ½ years) and you will be asked to attend up to 34 study visits; visits can last from 1 to 4 hours.

It is unknown at this time whether the study treatment will improve participant's health. The potential risks of this study include the possibility of infections, low albumin levels, and increases in blood cholesterol.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu



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