bioihbjkbjnl/mcl2 huggingface dataset:
Hyperpolarized 13C Pyruvate MRI for Treatment Response Assessment in Pancreatic Ductal Adenocarcinoma
Condition: Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Hyperpolarized Carbon C 13 Pyruvate; Magnetic Resonance Imaging (MRI)
Intervention description: Given IV prior to imaging; Undergo MRI
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperpolarized 13C Pyruvate; Pancreatic Cancer

Summary:

      This phase II trial investigates whether magnetic resonance imaging (MRI) using
      hyperpolarized carbon-13 (13C) pyruvate can be useful for evaluating early treatment response
      in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally
      advanced) or spread to other places in the body (metastatic). Hyperpolarized 13C pyruvate is
      different from standard clinical MRI contrast (e.g. gadolinium) in that it provides
      information on how a tumor processes nutrients. MRI is used to see tumor uptake and breakdown
      of hyperpolarized carbon-13 pyruvate molecules, which can tell how the tumor processes
      nutrients. Hyperpolarized 13C pyruvate MRI may help in understanding how the tumor responds
      to the treatments patients may be receiving.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic pancreatic ductal adenocarcinoma, with at least one
             target lesion in the abdomen measuring >= 1 cm

          -  The subject is able and willing to comply with study procedures and provide signed and
             dated informed consent

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Patients who because of age, general medical or psychiatric condition, or physiologic
             status cannot give valid informed consent

          -  Patients unwilling or unable to undergo magnetic resonance (MR) imaging, including
             patients with contraindications to MRI, such as cardiac pacemakers or non-compatible
             intracranial vascular clips

          -  Poorly controlled hypertension, defined as either systolic > 170 or diastolic > 110.
             The addition of anti-hypertensives to control blood pressure is allowed for
             eligibility determination

          -  Congestive heart failure >= class III

          -  Myocardial infarction within the past year

          -  History of QT prolongation on electrocardiogram (EKG), defined as pretreatment QTs >
             440 msec in males or > 460 msec in females

          -  Pregnant and lactating females
A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Parsaclisib
Intervention description: Parsaclisib tablets administered orally with water and without regard to food
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Follicular lymphoma; non-Hodgkin lymphoma (NHL); phosphatidylinositol 3-kinase (PI3K) δ inhibitor

Summary:

      The purpose of this study is to assess the objective response rate of parsaclisib treatment
      in participants with relapsed or refractory follicular lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or older.

          -  Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin
             lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.

          -  Ineligible for hematopoietic stem cell transplant.

          -  Must have been treated with at least 2 prior systemic therapies.

          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
             as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥
             1.0 cm in the longest perpendicular dimension as assessed by computed tomography or
             magnetic resonance imaging.

          -  Must be willing to undergo an incisional, excisional, or core needle lymph node or
             tissue biopsy or provide a lymph node or tissue biopsy from the most recent available
             archival tissue.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

        Exclusion Criteria:

          -  Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.

          -  History of central nervous system lymphoma (either primary or metastatic).

          -  Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta
             (PI3Kδ) inhibitors, or a pan-PI3K inhibitor.

          -  Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).

          -  Allogeneic stem cell transplant within the last 6 months, or autologous stem cell
             transplant within the last 3 months before the date of study treatment administration.

          -  Active graft-versus-host disease.

          -  Participants positive for hepatitis B surface antigen or hepatitis B core antibody
             will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid
             (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be
             eligible if they are negative for HCV-ribonucleic acid (RNA).
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
Condition: Gastroparesis
MeSH terms: Gastroparesis; Nausea; Vomiting
Intervention: Aprepitant; Placebo
Intervention description: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks; Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Intervention MeSH terms: Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gastroparesis; nausea; vomiting

Summary:

      The principal objective of this multicenter, randomized, placebo-controlled trial is to
      evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with
      placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older at registration

          -  Gastric emptying scintigraphy within 2 years of registration

          -  Normal upper endoscopy or upper GI series within 2 years of registration

          -  Symptoms of chronic nausea or vomiting compatible with gastroparesis or other
             functional gastric disorder for at least 6 months (does not have to be contiguous)
             prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of
             greater than or equal to 21

          -  Significant nausea defined with a visual analog scale (VAS) score of greater than or
             equal to 25 mm on a 0 to 100 mm scale

        Exclusion Criteria:

          -  Another active disorder which could explain symptoms in the opinion of the
             investigator

          -  Use of narcotics more than 3 days per week

          -  Significant hepatic injury as defined by significant alanine aminotransferase (ALT)
             and aspartate aminotransferase (AST) elevations of greater than 2x the upper limit of
             normal (ULN) or a Child-Pugh score of 10 or greater

          -  Contraindications to aprepitant such as hypersensitivity or allergy

          -  Concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride

          -  Pregnancy or nursing

          -  Any other condition, which in the opinion of the investigator would impede compliance
             or hinder the completion of the study

          -  Failure to give informed consent
18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
Condition: Cardiac Sarcoidosis; Myocardial Inflammation
MeSH terms: Myocarditis; Sarcoidosis; Inflammation
Intervention: 18F-FSPG
Intervention description: Patients receive 8mCi of 18F-FSPG and undergo PET/MRI imaging (or PET/CT for patients with metal implants) to determine the ability of 18F-FSPG to localize to cardiac sarcoidosis or myocardial inflammation.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PET/MR

Summary:

      The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using
      18F-FSPG PET/MRI (or PET/CT for participants with metal implants).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is ≥ 18 years old at the time of the scan

          -  Patient with known or suspected cardiac sarcoidosis.

          -  Patient is capable of complying with study procedures

          -  Patient can remain still for duration of imaging procedure

        Exclusion Criteria:

          -  Patient is pregnant or nursing

          -  Metallic implants (contraindicated for MRI)

          -  History of renal insufficiency (only for MRI contrast administration)
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: PF-06651600; PF-06700841; Placebo
Intervention description: 200 mg QD during induction and 50 mg QD during Maintenance; 60 mg QD during induction and 30 mg QD during maintenance; Placebo
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model description: The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Phase 2; randomized; double-blind; placebo; alopecia areata; safety; efficacy; JAK; janus kinase; moderate; severe

Summary:

      This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an
      extension period. The study will have a maximum duration of approximately 113 weeks. This
      includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday
      (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind)
      Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension
      Period and a 4 week Follow up Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18 75 years of age, inclusive, at time of informed
             consent.

          -  Must have moderate to severe alopecia areata:

        Exclusion Criteria:

          -  History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

          -  Infected with hepatitis B or hepatitis C viruses.

          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis (TB)

          -  Have received any of the following treatment regiments specified in the timeframes
             outlined below:

        Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of
        first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks
        of first dose of study drug: Participation in other studies involving investigational
        drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or
        attenuated live vaccine.

        Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy
        (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning
        booth/parlor.

        Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal
        medications with unknown properties or known beneficial effects for AA.
HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Intervention: Hydrocortisone
Intervention description: Hydrocortisone 50 mg IV Q6h
Intervention MeSH terms: Hydrocortisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will be conducted as a single-center, prospective, open-label, randomized trial
      that will evaluate adult patients admitted with septic shock to the medical critical care
      unit (MCC). The objective of the study is to determine if the use of hydrocortisone plus
      fludrocortisone is associated with a faster resolution of shock (defined as 24 hours
      vasopressor free) when compared to the use of hydrocortisone alone in medical, critically ill
      septic shock patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Critically ill medical patients requiring addition of stress dose steroid therapy
             (hydrocortisone) in addition to pressors for septic shock management during ICU stay

          -  Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in
             combination therapy group

        Exclusion Criteria:

          -  Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock
             management during ICU stay

          -  Fludrocortisone/hydrocortisone initiated by any service other than critical care
             medicine

          -  Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside
             facility)

          -  Patients not appropriate for study inclusion as determined by provider discretion

          -  Patients receiving steroid therapy not in accordance with assigned group per location
             (MCC1 or MCC2)

          -  Patients re-admitted to the MCC during the same admission and restarted on vasopressor
             therapy will be noted during data collection and only the initial admission will be
             included for analysis

          -  Any patient receiving greater than one dose of hydrocortisone 100 mg

          -  Physical or medical contraindication to receiving PO or PER FT (per feeding tube)
             fludrocortisone
Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS
Intervention description: Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is < 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII.
Intervention MeSH terms: Factor VIII
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 12 Years
Maximum age: 24 Years
Healthy volunteers: No
Keywords: Hemophilia; Prophylaxis; Youth; Young Adults; Feasibility

Summary:

      The primary objective of this study is to test the feasibility of a large-scale clinical
      trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy
      outcomes so that we can better plan a large-scale study; we will estimate the effect size and
      variability of effect and resource utilization of once-daily prophylaxis to allow us to set a
      sample size for a definitive trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A (<1% factor VIII)

          -  Age 12 to 24 years inclusive

          -  Male

          -  No current factor VIII inhibitor (an inhibitor will be defined as ≥ 0.6 Bethesda
             Units) within the past year

          -  Able to participate in a home infusion program with adequate peripheral venous access
             as assessed ny the treating investigator

        Exclusion Criteria:

          -  Important co-morbidities (Acquired Immunodeficiency Syndrome or symptomatic HIV
             infection, symptomatic hepatitis B or C infection)

          -  Other concomitant acquired or congenital bleeding disorder (e.g. von Willebrand's
             Disease)

          -  Receiving factor VIII replacement through central venous catheter
Mesenchymal Stemcells for Radiation Induced Xerostomia
Condition: Xerostomia
MeSH terms: Xerostomia
Intervention: Mesenchymal stem cell; Isotonic NaCl
Intervention description: Stemcells injected into submandibularis
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The current study aims to assess the safety and feasibility of the injection of autologous
      adipost tissue derived MSCs on radiation-induced salivary gland hypofunction and xerostomia
      in head and neck cancer participants. The project can potentially help to develop a
      clinically relevant treatment option for the growing number of patients suffering from
      xerostomia after radiotherapy. The development of new therapies is especially important,
      since only sub-optimal symptomatic treatments are currently available and the symptom of
      xerostomia greatly reduces the quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

        Previous radiotherapy for HPV-positive oropharyngeal head and neck cancer with bilateral
        irradiation of the neck.

          -  2 years follow-up without recurrence

          -  Clinically reduced salivation and hyposalivation, evaluated by a screening

          -  Unstimulated salivary flow rate between less than 0.2ml/min and above 0.05ml/min

          -  Only participants with previous T1-T2 and N0, N1 or N2a.

          -  Informed consent

          -  Grade 1-3 xerostomia as evaluated by the UKU side effect rating scale

        Exclusion Criteria:

          -  Any cancer in the previous 2 years

          -  Xerogenic medications

          -  Any other diseases of the salivary glands, e.g. Sjögrens syndrome, sialolithiasis,
             etc.

          -  Pregnancy or planned pregnancy within the next 2 years

          -  Breastfeeding

          -  Any other disease/condition judged by the investigator to be grounds for exclusion

          -  Treatment with anticoagulant that cannot be stopped during the intervention period.
Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is to examine a moderate hypofractionation regimen of proton beam therapy for high
      risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are
      treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the
      regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180
      centigray/fraction) simultaneously. The overall treatment time is 5 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male; Age ≥ 18 years.

          -  Histological confirmation of adenocarcinoma of the prostate within 6 months of study
             enrollment.

          -  Clinical stage T1-2 N0 M0, Gleason Score 7, Prostate Specific Antigen (PSA) 20-100
             ng/mL, or Clinical stage Any T N0 M0, Gleason Score 8-10, PSA ≤ 100 ng/mL, or Clinical
             stage T3-4 N0 M0, any Gleason Score, PSA ≤ 100 ng/mL, or Clinical stage T1-2 N0 M0,
             Gleason Score 4+3, PSA 10-20 ng/mL

          -  Zubrod performance score (PS) ≤ 1

          -  Total bilirubin, aspartate aminotransferase, alkaline phosphatase, and serum
             creatinine: < 2 x upper normal limit

          -  Signed informed consent.

        Exclusion Criteria:

          -  Any known nodal (N1) or distant metastasis (M1)

          -  Previous androgen deprivation therapy lasting more than 6 months

          -  History of inflammatory bowel disease

          -  Presence of a hip prosthesis

          -  Prior pelvic radiotherapy or prostatectomy

          -  Prior or concurrent antineoplastic agents (chemotherapy)

          -  Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years
             of diagnosis of prostate cancer.

          -  Inability to start the protocol treatment within 1 month after study enrollment.

          -  Medical or psychiatric conditions that preclude informed decision-making or compliance
             with the protocol treatment or follow-up