bioihbjkbjnl/mcl2 huggingface dataset:
The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga-PSMA-11 PET Scan
Intervention description: Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.
Masking: None (Open Label)
Masking description: Two separate radiologists (one from Nuclear Medicine and one from MRI) will read images in a blinded fashion and provide their findings for the surgeons to use in treatment planning.
Enrollment: 51.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Obtain PSMA-PET imaging preoperatively and calculate performance for predicting
      extra-prostatic extension based on whole-mount pathology (gold standard).

      Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on
      appropriate preservation of surrounding structures important for genito-urinary function
      including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).

      Directly compare PSMA-PET performance for predicting extra-prostatic extension to
      standard-of-care assessments.

      Assess quality of life changes from preoperative baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Men diagnosed with clinically significant prostate cancer who are scheduled or
             scheduling for prostatectomy 2. Prostate pathology results consistent with:

               1. > 3 cores of Gleason 3+4 or

               2. NCCN unfavorable intermediate risk or

               3. NCCN high-risk or

               4. NCCN very-high risk 3. Scheduled for standard of care MRI or has recently
                  completed standard of care MRI (within 6 months).

        Willing and able to lie still for approximately 50 minutes in an enclosed space for the
        PET/CT and MRI

        Exclusion Criteria:

          -  1. Participation in another investigational trial involving research exposure to
             ionizing radiation concurrently or within 30 days.

             2. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect
             prostate imaging).

             3. Significant acute or chronic medical, neurologic, or illness in the subject that,
             in the judgment of the Principal Investigator, could compromise subject safety, limit
             the ability to complete the study, and/or compromise the objectives of the study.
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: NBI-98854
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, rollover study to collect long-term safety, tolerability, and
      investigator- and participant-reported pharmacodynamic (PD) data after chronic administration
      of NBI-98854 in pediatric participants with Tourette Syndrome (TS), as well as to provide
      open-label access to NBI-98854 for the treatment of TS for pediatric participants who have
      taken part in a Phase 2 NBI-98854 study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of Tourette Syndrome (TS)

          2. Have participated in the NBI-98854-TS2004 or NBI 98854-TS2005 Phase 2 studies

          3. If using maintenance medication(s) for TS and/or TS spectrum diagnoses (e.g.
             obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]),
             be on stable doses

          4. Be in good general health

          5. Subjects of childbearing potential who do not practice total abstinence must agree to
             use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently during the screening, treatment and follow-up periods of the study

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month
             before screening

          2. Have a known history of long QT syndrome or cardiac arrhythmia

          3. Have a known history of neuroleptic malignant syndrome

          4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)

          5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors

          6. Have a blood loss ≥250 mL or donated blood within 56 days, or donated plasma within 7
             days, before the start of the study

          7. Have a known history of substance dependence, substance (drug) or alcohol abuse within
             3 months before the start of the study

          8. Have a significant risk of suicidal or violent behavior

          9. Have received an investigational drug within 30 days before the start of the study or
             plan to use an investigational drug (other than NBI-98854) during the study

         10. Are currently participating in another NBI-98854 clinical study

         11. Are pregnant (for females)
Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Tisagenlecleucel
Intervention description: Tisagenlecleucel Cell Dispersion for Infusion given once during the study.
The approved dose range for tisagenlecleucel is: 0.2 to 5.0×106 CAR positive viable T cells / kg for patients' ≤ 50 kg body weight or 0.1 to 2.5×108 CAR-positive viable T cells for patients > 50 kg body weight.
Intervention MeSH terms: Tisagenlecleucel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 2 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: CTL019; Kymriah; Tisagenlecleucel; B-Cell Acute Lymphoblastic Leukemia; Leukemia; ALL; Pediatric; Young Adult; Reinfusion

Summary:

      This was a multi-center Phase II study investigating the efficacy and safety of reinfusion of
      tisagenlecleucel in pediatric and young adult patients with acute lymphoblastic leukemia
      (ALL) who were treated with tisagenlecleucel and experience B cell recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent must be obtained prior to participation in the study

          -  Must have an additional dose of unexpired, commercial tisagenlecleucel available and
             prescribed by a physician in the course of medical practice

          -  Age up to and including 25 years

          -  Patients must have CD-19+ Leukemia

          -  Patients who were previously treated with tisagenlecleucel and present with evidence
             of B-cell recovery as defined by: Peripheral blood (PB) absolute B lymphocyte count ≥
             50/µL, OR PB B lymphocyte ≥ 10% of the total lymphocytes

        Exclusion Criteria:

          -  Prior gene therapy other than tisagenlecleucel

          -  Prior adoptive T cell therapy other than tisagenlecleucel

          -  Active CNS involvement by malignancy

          -  Active or latent hepatitis B or active hepatitis C, or any uncontrolled infection at
             screening

          -  HIV positive test within 8 weeks of screening
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Gemcitabine; pazopanib
Intervention description: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.; Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent; persistent

Summary:

      Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common
      cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian
      cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients
      with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib
      is a novel agent has recently been approved for the treatment of subjects with advanced renal
      cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers
      such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and
      safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for
      recurrent or persistent ovarian cancer. This is an open label study in which subjects will be
      randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib.
      Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle.
      Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All
      subjects will be monitored for toxicity and other indicators of safety (labs, physical exams,
      vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5
      years following the conclusion of treatment to evaluate efficacy. The primary endpoints of
      the study are progression free survival and overall survival, which will be assessed at three
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years old

          -  Must have measurable or detectable ovarian, fallopian or primary peritoneal cancer

          -  Must have been treated previously with carboplatin, cisplatin or another
             organoplatinum compound

        Exclusion Criteria:

          -  Women who are pregnant or nursing

          -  History of congenital long QT syndrome

          -  Active bleeding or at risk of a bleeding disorder

          -  Other significant medical condition or history of medical condition which may put the
             patient at risk
FET-PET for Evaluation of Response of Recurrent GBM to Avastin
Condition: Glioblastoma Multiforme; GBM
MeSH terms: Glioblastoma
Intervention: 18F-FET
Intervention description: Radiotracer, surrogate marker for protein synthesis
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: FET; Fluoroethyl tyrosine; GBM; Response to treatment; Avastin; Brain Tumor

Summary:

      Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET
      will predict durable benefit in patients receiving anti-angiogenic benefit for presumed
      recurrent GBM (i.e. progression-free survival and overall survival). We have defined one
      primary specific aim, for which we expect to obtain definitive results, and two secondary
      aims, under which we plan to generate preliminary data to support a future, larger project.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. GBM patients with changes on MRI suggestive of recurrence who have not yet
             initiated antiangiogenic therapy. 2. Age ≥ 18 3. Anticipated survival >3 months 4.
             Able to give informed consent 5. Capable of undergoing scan without the need for
             sedation or general anesthesia.

        Exclusion Criteria:

          1. Active intracranial infection or nonglial brain mass.

          2. Recent large intracranial hemorrhage (<1 month; size to be determined by principal
             investigator)

          3. Pregnant or nursing. Quantitative serum hCG testing will be performed prior to the
             initial and each -subsequent FET- PET scan on all females of childbearing potential.
             Our BWH Radiation Safety Committee and Partners IRB requires stat serum ß-hcG
             pregnancy tests.

          4. Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled
             imaging visits.

             -
Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Pazopanib
Intervention description: Pazopanib, 800 mg by mouth daily each 21 day cycle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pazopanib; Non Squamous Non Small Cell Lung Cancer; After Progress on first line therapy; Using Bevacizumab

Summary:

      This is an open label Phase II Trial that using the investigational anti-cancer agent,
      Pazopanib to see whether non-squamous non-small cell lung cancer will respond to its use by
      decreasing the size of the tumor or stopping its growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Stage IIIB (with malignant pleural or pericardial effusion or supraclavicular lymph
             node involvement) or stage IV NSCLC

          -  Evidence of progression while on bevacizumab

          -  Patients treated for CNS metastases who are asymptomatic with no requirement for
             steroids for 2 weeks prior to first dose of study drug

        Exclusion Criteria:

          -  Prior malignancy

          -  Clinically significant gastrointestinal abnormalities

          -  Presence of uncontrolled infection or nonhealing wound, fracture, or ulcer

          -  History of cardiovascular conditions within the past 6 months
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Condition: Preterm Delivery; Inadequate Milk Production
MeSH terms: Premature Birth
Intervention: Merotocin; Placebo
Intervention description: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).; Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: No
Keywords: Inadequate Milk Production

Summary:

      Induction and support of lactation in women with preterm delivery and inadequate milk
      production.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Delivered at the hospital system associated with the trial center

          -  Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days

          -  Willing to express milk at least 5 times every 24 hours during the observation period
             and 6 to 8 times every 24 hours during the treatment and post-treatment follow up

          -  Produced < 200 mL milk in 24 hours prior to randomization

          -  Delivered 96 to 192 (+4) hours prior to randomization

        Exclusion Criteria:

          -  Pre-pregnancy body mass index (BMI) > 50 kg/m^2

          -  Mastitis

          -  History of breast trauma, breast surgery, nipple piercing

          -  Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary
             surgery/radiation therapy

          -  Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note:
             gestational diabetes is allowed (also when requiring the use of insulin for treatment)

          -  Unstable thyroid disease

          -  Moderate or severe renal or hepatic impairment

          -  Mental illness

          -  Significant nasal congestion or mucous production

          -  Use of anti-psychotic drugs within past 12 months
Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CD2475/101 40 mg; Doxycycline 100 mg; Placebo
Intervention description: Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.; Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks; Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 662.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: acne vulgaris; inflammatory lesions

Summary:

      The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for
      16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry
      Forward, Intent To Treat) in inflammatory lesion counts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects 12 years of age or older

          -  acne vulgaris with facial involvement

          -  A score of 3 (Moderate) or 4 (Severe) on the Investigator's Global Assessment Scale
             (inflammatory)

          -  25 to 75 inflammatory lesions (papules and pustules) on the face (including the nose)

        Exclusion Criteria:

          -  More than two acne nodules/cysts on the face

          -  Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne, etc.),
             or severe acne requiring systemic retinoid treatment

          -  Underlying diseases or other dermatologic conditions that require the use of
             interfering topical or systemic therapy such as, but not limited to, atopic
             dermatitis, perioral dermatitis or rosacea

          -  Beard or facial hair which might interfere with study assessments

          -  planning excessive exposure to sun or ultraviolet light during the study (i.e. natural
             or artificial sunlight, including tanning booths and sun lamp)

          -  Use of oral contraceptives solely for control of acne

          -  Liver function test alanine transaminase (ALT) and/or aspartate transaminase (AST) 2.5
             times above upper limit of normal

          -  Renal function test serum creatinine at 150 umol/L (17 mg/L) or higher

          -  Presence of oral or genital candidiasis or history of multiple episodes of oral or
             genital candidiasis

          -  Females who intend to conceive a child within 5 months following Baseline visit

          -  Males who intend to conceive a child with partner during the study period

          -  Requiring concomitant use of methoxyflurane
A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
Condition: Drooling
MeSH terms: Sialorrhea; Parkinson Disease
Intervention: Botulinum Toxin Type B (Myobloc); Matched placebo to Myobloc
Intervention MeSH terms: rimabotulinumtoxinB; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Sialorrhea

Summary:

      To determine safety, tolerability and preliminary efficacy of intraglandular injections of
      MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parkinsons' Disease patients with Sialorrhea for at least 3 months

        Exclusion Criteria:

          -  Patients with non-idiopathic PD parkinsonism

          -  Patients previously exposed to botulinum toxins

          -  Patients with a history of aspiration pneumonia, moderate/severe choking and/or
             moderate/severe dysphagia

          -  Patients with prior salivary gland surgery
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; semaglutide; oral placebo
Intervention description: Once-daily oral administration as tablets.; Once-weekly,injected s.c./subcutaneously (under the skin) using a pen; Once-daily oral administration as tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 632.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to examine the dose range,
      escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI above or equal to 25 and below or equal to 40 kg/m^2

          -  Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or
             who have been on a stable dose of metformin for at least 30 days prior to screening

          -  HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)

        Exclusion Criteria:

          -  Subjects on selected oral medication with a narrow therapeutic window, such as
             warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and
             anticonvulsants

          -  History of chronic pancreatitis or idiopathic acute pancreatitis

          -  Chronic malabsorption, regardless of aetiology

          -  History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease

          -  Treatment with glucose lowering agent(s) other than metformin as stated in the
             inclusion criteria in a period of 90 days before the screening visit