MULTICENTER SINGLE-BLIND RANDOMIZED CONTROLLED TRIAL OF LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION FOR TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE IN PATIENTS REQUIRING HIATAL HERNIA REPAIR (TIF vs LNF)
A Study to Compare Safety and Effectiveness of Transoral Incisionless Fundoplication versus Laparoscopic Partial Fundoplication to Treat Gastroesophageal Reflux Disease Patients with Hiatal Hernia
•80 years of age.
- Subjects have GERD with hiatal hernia < 5 cm, and Hill grade III or IV.
- Pathologic reflux while off PPI based on Lyon criteria by either of the following:
- Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% or LA grade C or D esophagitis;
- Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B, and signed informed consent.
- Commitment to long-term study.
- Ability to give consent individually or by a legally authorized representative.
- Hiatal hernia > 5 cm.
- Evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis).
- Pregnancy (in females) at time of procedure.
- Previous anti-reflux procedure, have contraindications to the procedure will be excluded from participation.
- Subjects requiring mesh treatment at time of procedure.
- Provider discretion.
- BMI > 35.
LS1981: Phase Ib Trial of Low-Dose Selinexor (KPT-330) in Combination With Choline Salicylate (CS) for the Treatment of Patients With Non-Hodgkin Lymphoma (NHL), Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasms, or Multiple Myeloma
Low-Dose Selinexor and Choline Salicylate for the Treatment of Patients With Non-Hodgkin Lymphoma or Histiocytic/Dendritic Cell Neoplasms
- Biopsy-proven relapsed and/or refractory non-Hodgkin lymphoma or histiocytic/dendritic
cell neoplasms. Relapsed is defined as a relapse that occurred after having a response
to the last therapy that lasted > 26 weeks. Refractory is no response (stable disease
or progressive disease while on therapy) or relapse within 6 months. Refractoriness to
autologous stem cell transplant will be defined as disease progression within 52 weeks
- Most recent tumor biopsy must be < 26 weeks prior to registration
- Measurable or assessable disease: Measurable disease is defined as measurable by
computed tomography (CT) (dedicated CT or the CT portion of a positron emission
tomography [PET]/CT) or magnetic resonance imaging [MRI]: To be considered measurable,
there must be at least one lesion that has a single diameter of >= 1.5 cm. NOTE: Skin
lesions can be used if the area is >= 1.5cm in at least one diameter and photographed
with a ruler. Patients with assessable disease by PET/CT are also eligible as long as
the assessable disease is biopsy proven lymphoma
- Patients must have previously been treated with at least 2 lines of therapy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1,000/mm^3 (obtained =< 14 days prior to
- Platelet count >= 100,000/mm^3 (obtained =< 14 days prior to registration)
- Hemoglobin >= 8.5 g/dL (may be transfused to reach criteria) (obtained =< 14 days
prior to registration)
- Total bilirubin < 2 x upper limit of normal (ULN) (or total bilirubin =< 3.0 x ULN
with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert's
syndrome) (obtained =< 14 days prior to registration)
- Aspartate transaminase (AST) =< 2.5 x ULN and alanine aminotransferase (ALT) =< 2.5 x
ULN (obtained =< 14 days prior to registration)
- Calculated creatinine clearance must be >= 35 ml/min using the Cockcroft Gault formula
(obtained =< 14 days prior to registration)
- Negative pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only
- Female of childbearing potential (FCBP*) must commit to take highly effective
contraceptive precautions** without interruption during the study and continue for at
least 12 weeks after the last dose of selinexor and CS. FCBP must refrain from
breastfeeding and donating oocytes during the course of the study. Males must use an
effective barrier method of contraception without interruption during the study and
continue for at least 12 weeks after the last dose of selinexor and CS. They must
refrain from donating sperm during the study participation.
- *FCBP defined as sexually mature women who have not undergone bilateral tubal
ligation, bilateral oophorectomy, or hysterectomy; or who have not been
postmenopausal (i.e., who have not menstruated at all) for at least 1 year
- Highly effective forms of birth control are methods that achieve a failure
rate of less than 1% per year when used consistently and correctly. Highly
effective forms of birth control include: hormonal contraceptives (oral,
injectable, patch, and intrauterine devices), male partner sterilization, or
total abstinence from heterosexual intercourse, when this is the preferred
and usual lifestyle of the patient NOTE: The double-barrier method (e.g.,
synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream,
or gel), periodic abstinence (such as calendar, symptothermal,
post-ovulation), withdrawal (coitus interruptus), lactational amenorrhea
method, and spermicide-only are not acceptable as highly effective methods
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the Active Monitoring
Phase of the study)
- Willingness to provide mandatory blood specimens per protocol for Pharmacokinetics
(PKs) and banking, and mandatory tissue samples for correlative research. NOTE: If an
institution is not able to provide the tissue, it does not cause the patient to be
ineligible; however, the collection of these tissues is strongly recommended
- Any of the following because this study involves an investigational agent whose
genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
- Pregnant women
- Nursing women
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
- Patients known to have active hepatitis B, or C infection, or known to be positive for
hepatitis C virus (HCV) ribonucleic acid (RNA) or hepatitis B surface antigen (HBsAg)
(hepatitis B virus [HBV] surface antigen). Patients known to be human immunodeficiency
virus (HIV) positive, except those with CD4+ T-cell (CD4+) counts >= 350 cells/uL and
on an established antiretroviral therapy (ART) for at least twelve weeks and have an
HIV viral load less than 400 copies/mL prior to enrollment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
- Life expectancy of < 6 months
- Active gastrointestinal (GI) dysfunction interfering with the ability to swallow
tablets, or any GI dysfunction that could interfere with absorption of study treatment
- Known intolerance to or contraindications for choline salicylate therapy. Patients
with known allergy to acetylsalicylic acid (ASA) are not eligible
- Prior exposure to a selective inhibitors of nuclear export (SINE) compound, including
- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm
- Active second malignancy requiring treatment that would interfere with the assessment
of the response of the lymphoma to this protocol therapy. Patients with treated
malignancies on hormonal therapy (for example breast or prostate cancer) are eligible
- History of myocardial infarction =< 6 months, or congestive heart failure requiring
use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks
prior to registration. NOTE: Exception: patients on any BTK inhibitor (ibrutinib,
zanabrutinib, acalabrutinib, etc), or venetoclax, or corticosteroids (any dose) may
continue therapy up until the new regimen has started at investigator discretion.
After the start of protocol therapy, corticosteroids can be used at investigator's
discretion and tapered to lowest possible dose
- Active graft versus (vs.) host disease (after allogeneic stem cell transplantation) at
- Major surgery (including bowel resection) =< 3 weeks prior to registration
- Must not be currently eligible or have declined high-dose therapy with autologous stem
cell transplantation rescue or chimeric antigen receptor (CAR)-T cell therapy
- Primary mediastinal (thymic) large B-cell lymphoma (PMBL)
- Known active central nervous system (CNS) lymphoma. Patients with previous CNS
involvement can enroll if the CNS component is inactive
- Patients who are on active anticoagulant therapy with direct oral anticoagulants
(DOACs), aspirin or warfarin are not eligible due to potential bleeding. EXCEPTIONS:
Patients who are on aspirin (81 mg) for primary prevention of cardiovascular disease
can enroll, but the ASA needs to be held while on this protocol therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 8/3/22. Questions regarding updates should be directed to the study team contact
CureGN: Cure Glomerulonephropathy Network
A Registry and Biospecimen Collection to Advance the Diagnosis and Care of Patients with Glomerular Diseases
- Diagnosis of MCD, FSGS, MN, or IgAN on first diagnostic kidney biopsy, per specified pathology definitions.
- First diagnostic kidney biopsy within 5 years of study enrollment.
- Access to first kidney biopsy report and/or slides.
- All ages.
- Willing to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site.
- Informed consent and, where age appropriate, informed assent.
- ESKD, defined as chronic dialysis or kidney transplant.
- Solid organ or bone marrow transplant recipient at time of first kidney biopsy.
- Diagnosis of any of the following at the time of first diagnostic kidney biopsy:
- Diabetes mellitus;
- Histopathologic findings of diabetic glomerulosclerosis;
- Systemic lupus erythematosus;
- HIV infection;
- Active malignancy, except for non-melanoma skin cancer;
- Active Hepatitis B or C infection, defined as positive viral load.
A Phase IIB Randomized Trial of Oral Tamoxifen vs. Topical 4-hydroxytamoxifen Gel vs. Control in Women with Atypical Hyperplasia or Lobular Carcinoma In Situ
A Study to Evaluate Oral Tamoxifen vs. TamGel vs. Control in Women with Atypical Hyperplasia or Lobular Carcinoma In Situ
- Willing to return to enrolling institution for follow-up
- Willing to complete required testing
- Ability to complete questionnaire by themselves or with assistance
- Female (sex that was assigned at birth)
- Ipsilateral intact breast with histology confirmation of atypical ductal or lobular
hyperplasia, or LCIS, within the last 12 months, whether surgically excised or not.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Willingness to agree to use ONE effective form of birth control (abstinence is not an
allowed method) prior to study entry and for the duration of study participation, and
for 2 months following the last dose of study medications. Effective birth control
methods are: copper IUD [intrauterine device], diaphragm/cervical cap/shield,
spermicide, contraceptive sponge, condoms. Women of childbearing potential must have a
negative pregnancy test within five days before starting study medications. Should a
participant become pregnant or suspect she is pregnant while participating in this
study; the participant should inform the study physician immediately.
- Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e.
tanning beds) for the duration of the study.
- Participants must have acceptable organ and marrow function as defined below within 30
days of randomization: judged by treating physician's evaluation of baseline
- Negative urine pregnancy test, if of childbearing potential. and / or FSH to verify
- Clinically suspicious mass/lesions Breast cancer in the past 5 years.
- Prior thromboembolism within last 5 years (history of varicose veins and superficial
phlebitis is allowed) Current pregnancy or lactation History of other prior breast
cancer-specific therapy within the previous 2 years (chemotherapy, anti-HER2 agents,
endocrine agents, everolimus, CDK4-6 inhibitors).
- Cytotoxic chemotherapy for any indication in last 2 years.
- Prior use of SERMS or AIs including tamoxifen, raloxifene, anastrozole, letrozole, or
exemestane for prevention or therapy within 5 years.
- Exogenous sex steroid, including oral contraceptive pill use within 1 month prior to
research core needle biopsy (CNB).
- Use of vaginally administered estrogens and hormone coated IUD such as Mirena is
permitted History of any prior ipsilateral breast radiotherapy. Previous unilateral
radiation of the contralateral side is allowed.
- Skin lesions on the breast that disrupt the stratum corneum (eg eczema, ulceration).
- History of endometrial neoplasia
- Current smoker. Cessation for at least 6 weeks
- Current users of potent inhibitors of tamoxifen metabolism. The potent inhibitors of
tamoxifen metabolism are: bupropion, cinacalcet, fluoxetine, paroxetine, quinidine.
- Participants may not be receiving any other investigational agents within 90 days of
enrollment or during this study.
- History of allergic reactions to tamoxifen.
- Uncontrolled intercurrent illness that in the judgement of the treating physician
would make them unsuitable for study participation
- Anticoagulation meds and clinical concern for discontinuing meds for study research
- Identification of a clinically suspicious mass on examination.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 10/12/22. Questions regarding updates should be directed to the study team contact.
Therapeutic and Side Effects of Invasive and Noninvasive Brain Stimulation
A Study to Evaluate Therapeutic and Side Effects of Brain Stimulation
Key Inclusion Criteria:
Patients that receive brain stimulation for evaluation or treatment of neurological diseases including intractable epilepsy, chronic pain syndromes and brain tumors.
Key Exclusion Criteria:
Patients that do not receive brain stimulation for evaluation or treatment of neurological diseases including intractable epilepsy, chronic pain syndromes, and brain tumors.
Insomnia in patients with metastatic non small cell lung cancer.
Metastatic Non-Small Cell Lung Cancer Insomnia
- Have a diagnosis of metastatic non small cell lung cancer.
- Undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy.
- Subjects will be limited to older than 18 years old at the time of diagnosis.
- Have advanced terminal cancer, severe depression, or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing).
- Regular use of psychotropic medication other than hypnotics (e.g., antidepressants) per chart review.
Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.
Noninvasive Evaluation of Renal Allograft Fibrosis by MRI
Noninvasive Evaluation of Renal Allograft Fibrosis by MRI
- Age 18-80 years.
- Recipient of kidney transplantation 4 or more years.
- Competent and able to provide written informed consent.
- Ability to comply with protocol.
- Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, or stroke, that would, in the opinion of the investigators, compromise the safety of the patient.
- Severe chronic liver, heart, or lung disease.
- Undergoing acute rejection.
- Contra-indication to biopsy; bleeding disorders.
- Chronic infection.
- Any active malignancy and undergoing therapy.
- Kidney or ureteric stone.
- Unable to give valid informed consent.
- Known pregnancy or intent to conceive during the study period.
- Pacemaker, implantable defibrillator, magnetically active metal fragments, claustrophobia, or other contraindication to MRI.
- Federal medical center inmates.
Eligibility last updated 9/13/22. Questions regarding updates should be directed to the study team contact.