bioihbjkbjnl/mcl2 huggingface dataset:
SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
Condition: Parkinson's Disease Dementia (PDD)
MeSH terms: Parkinson Disease; Dementia
Intervention: SYN120; Placebo
Intervention description: SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).; Placebo QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: PDD; Parkinson's Disease Dementia; patients taking a cholinesterase inhibitor.

Summary:

      The purpose of this study placebo-controlled, randomized, double-blind study is to assess the
      safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already
      treated with a stable dose of a cholinesterase inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parkinson's Disease Dementia

          -  Patient has a routine caregiver

          -  Taking a stable cholinesterase inhibitor.

          -  Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive

        Exclusion Criteria:

          -  History of any significant neurologic or psychiatric disease other than PD

          -  Any other condition or clinically significant abnormal findings that would make the
             patient unsuitable for the study

          -  Unpredictable motor fluctuations that would interfere with administering assessments
Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
Condition: Disinhibition Syndrome
Intervention: AVP-786; Placebo
Intervention description: d6-DM/Q; matching placebo
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Disinhibition

Summary:

      Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of a Neurodegenerative Disorder including frontotemporal
             dementia, Alzheimer's disease (AD), progressive supranuclear palsy (PSP), corticobasal
             degeneration (CBD), dementia with Lewy bodies (DBL), vascular cognitive disorders, or
             Huntington's disease, at least 3 months prior to Baseline

          -  The participant has behavior from 2 of the 3 categories of disinhibited behavior from
             the definition of the behavioral variant of frontotemporal dementia

          -  The behavioral changes are not due to a pre-existing major psychiatric disorder (e.g.,
             schizophrenia, bipolar disease, etc.) and are not due to the direct effect of systemic
             illness, drug action, or substance use

          -  Disinhibition scale score of ≥4 on the 3 core disinhibition items of the Frontal
             Behavioral Inventory (FBI) at Screening and Baseline

        Exclusion Criteria:

          -  Participants with symptoms of disinhibition that is not secondary to Neurodegenerative
             Disorders

          -  Participants with myasthenia gravis

          -  Participants with co-existent clinically significant or unstable systemic diseases
             that could confound the interpretation of the safety results of the study (e.g.,
             malignancy [except skin basal-cell carcinoma or untreated prostate cancer], poorly
             controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or
             hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or
             unstable valvular heart disease)
A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma
Condition: Allergic Asthma
MeSH terms: Asthma; Airway Obstruction
Intervention: omalizumab; omalizumab; placebo
Intervention description: Aged Liquid; subcutaneous repeating dose; Lyophilized; subcutaneous repeating dose; Subcutaneous repeating dose
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: AQUA; anti-CD11; CD11a; Asthma; Allergy

Summary:

      This was a multicenter, randomized, double-blind, parallel-group, three-arm,
      placebo-controlled study designed to demonstrate the efficacy of two different formulations
      of omalizumab compared with placebo in reducing the airway reaction to an inhaled
      aeroallergen solution in adult subjects with mild allergic asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent Form

          -  Meet criteria for the diagnosis of allergic asthma

          -  Be between the ages of 18 to 65 years

          -  Have a normal chest X-ray within 2 years of screening

        Exclusion Criteria:

          -  Need daily controller medication for asthma

          -  History of hypersensitivity to the study drug or to drugs with similar chemical
             structures or to any ingredients, including excipients of the study medication or
             drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)

          -  Have a documented medical history of anaphylaxis

          -  Have lung disease other than mild allergic asthma

          -  Have taken other investigational drugs within 30 days or 5 half-lives prior to the
             screening visit, whichever is longer

          -  Are unable or unwilling to comply with study procedures and visits

          -  Are pregnant or lactating

          -  Have significant medical illness other than asthma, including malignancies, parasitic
             infections, immune system disorders, and thrombocytopenia

          -  Have been treated with omalizumab within 12 months prior to screening

          -  Currently smoke or have a history of smoking more than 10 pack-years

          -  Have a history of drug or alcohol abuse, which, in the judgment of the investigator,
             may put the subject at risk for being unable to participate fully in the study for the
             duration of the study
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Condition: Anemia; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: AKB-6548
Intervention description: Different dose levels
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; erythropoietin; safety; efficacy; tolerability; pharmacokinetics

Summary:

      The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of
      repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 to 79 years of age, inclusive

          -  Chronic Kidney Disease Stage 3 or Stage 4

          -  Hemoglobin (Hgb) < 10.5 g/dl

          -  TSAT > 20% and CBC indicating normocytic red blood cell morphology

        Key Exclusion Criteria:

          -  BMI > 40

          -  Red blood cell transfusion within 12 weeks.

          -  Androgen therapy within the previous 21 days prior to study dosing

          -  Therapy with any approved or experimental erythropoiesis stimulating agent (ESA)
             within the 10 weeks prior to the Screening visit

          -  Participants meeting the criteria of ESA resistance within the previous 4 months

          -  Individual doses of intravenous iron of 250 mg or larger within the past 21 days

          -  AST or ALT >1.8x ULN.

          -  Alkaline phosphatase >2x ULN.

          -  Total bilirubin >1.5x ULN.

          -  Uncontrolled hypertension

          -  New York Heart Association Class III or IV congestive heart failure

          -  Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to
             dosing
Assessing the Safety of Buprenorphine in People With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: buprenorphine
Intervention description: Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
Intervention MeSH terms: Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the safety of changing pain medications (opioids) adult sickle cell
      patients take to another type of medication therapy (buprenorphine). Patients will be asked
      questions about their quality of life. Other tools for assessment will also be administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sickle Cell Disease, any genotype

          -  On disease modifying therapy (either chronic transfusions or hydroxyurea)

          -  On chronic daily full agonist opioid therapy with doses ranging from 90 to 400
             morphine equivalents

          -  Have greater than 5 acute care visits in the last 6 months or have daily pain of 7 or
             higher on the Visual Analog Scale despite chronic opioid therapy.

          -  Able to provide consent

          -  Has medical insurance

        Exclusion Criteria:

          -  Acute vaso-occlusive crisis on day of or day prior to buprenorphine initiation

          -  Use of methadone as long acting opioid (due to prolonged half-life and limited data in
             other populations)

          -  Use of illicit drugs as documented by urine toxicology screen (except for THC)

          -  Pregnancy

          -  Acute or severe bronchial asthma

          -  Hypersensitivity to buprenorphine or any component of the product

          -  Medical disorder, condition, or history that in the investigator's judgement would
             impair the patient's ability to participate or complete this study or render the
             patient to be inappropriate for enrollment.
Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer
Condition: Thyroid Gland Carcinoma
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Gallium Ga 68-labeled PSMA-11; Magnetic Resonance Imaging; Positron Emission Tomography (PET)
Intervention description: Given IV; Undergo MRI in combination with PET; Undergo PET in combination with MRI
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot clinical trial studies how well Gallium-68 prostate specific membrane antigen
      positron emission tomography (PET) work in diagnosing patients with thyroid cancer.
      Diagnostic procedures, such as 68Ga-PSMA PET, may more accurately diagnose thyroid cancer and
      find out how far the disease has spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of thyroid cancer

          -  Whole body 18F-FDG PET/computed tomography (CT) or I-131 scintigraphy within the past
             90 days of the scheduled 68Ga-PSMA PET demonstrating uptake

          -  Creatinine =< 3.0 mg/dL

          -  Ability to understand a written informed consent document, and the willingness to sign
             it

        Exclusion Criteria:

          -  Patients who have had active infection within 15 days of study enrollment that may be
             considered to interfere with 68Ga-PSMA PET imaging by the study investigators

          -  Patients who are unable to have placement of intravenous line access

          -  Pregnant or breastfeeding women

          -  Patients not capable of undergoing a PET/MRI study due to weight, claustrophobia, or
             inability to lie still for the duration of the exam
CT-011 MAb in DLBCL Patients Following ASCT
Condition: Lymphoma, Large Cell, Diffuse; Lymphoma, Mixed Cell, Diffuse; Primary Mediastinal Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin
Intervention: CT-011
Intervention description: IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
Intervention MeSH terms: Pidilizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma, Large B-Cell, Diffuse; Transformed Follicular Lymphoma; Stem cell transplantation; Relapsed; Refractory

Summary:

      Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is
      the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL)
      following relapse of the disease. Although many people are cured of their lymphoma with this
      therapy, the disease comes back in a certain proportion of patients. The purpose of this
      study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients
      with DLBCL who have received autologous peripheral blood stem cell transplantation. All final
      eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post
      autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with
      treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be
      conducted throughout the study till 18 months post autologous PBSCT. Approximately 70
      patients will participate in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient's age is 18 years or older, both genders.

          2. Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse
             mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.

          3. The lymphoma is chemosensitive.

          4. The lymphoma did not progress since pre-transplant chemotherapy.

          5. ECOG performance status 0-1.

        Exclusion Criteria:

          1. Serious other illness.

          2. Active autoimmune disease.

          3. Type 1 diabetes.

          4. Known immune deficiency.

          5. Clinical evidence of primary or secondary brain or spinal cord involvement by
             lymphoma.

          6. Active bacterial, fungal, or viral infection.

          7. Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus
             viremia.

          8. Pregnant or nursing (positive pregnancy test).

          9. Other concurrent clinical study or investigational therapy.
Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized Approach
Condition: Parkinson; Tremor
MeSH terms: Parkinson Disease; Tremor
Intervention: incobotulinumtoxinA; Saline
Intervention description: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm.; same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance.
Intervention MeSH terms: incobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tremor; Parkinson; botulinum; Xeomin

Summary:

      The scientific aim of this study is to investigate the efficacy and safety of
      incobotulinumtoxinA (Xeomin-Merz Pharmaceuticals) in the tremor of Parkinson"s disease. Our
      hypothesis is that injection of Xeomin into the muscles of arm, forearm and hand decreases
      the tremor amplitude and frequency leading to improvement of the patient"s function.
    

Eligibility criteria:

        Inclusion Criteria.

          1. Age more than 18 years

          2. Both sexes

          3. all races/ethnic groups.

          4. Meeting the clinical diagnosis of Parkinson's disease with presence of moderate to
             severe Parkinson tremor that is refractory to standard medical treatments and which
             limits the patient"s functionality and/or poses significant discomfort.

          5. Subjects who are able to read, speak, and understand English.

        Exclusion Criteria.

          1. Existing significant acute medical condition (i.e. cardiovascular, endocrine,
             hematologic, neoplastic, infectious, or autoimmune disorders) or significant
             swallowing or breathing difficulties.

          2. Pregnancy or planned pregnancy (determined by urine pregnancy test).

          3. Active breast feeding.

          4. Enrollment in any clinical trial (currently or within the past 3 months) in which
             treatments are imposed by a protocol.

          5. Any subject for whom botulinum toxin treatment would be contraindicated; known allergy
             or sensitivity to medication.

          6. Subjects who are younger than 18 years of age. Neuromuscular-junction disorders.

          7. Evidence of acute pathology in neuro-imaging.

          8. Axis I diagnosis determined by a neurologist or psychiatrist.

          9. Use of Anesthetic medications within two weeks and corticosteroid injections within 4
             weeks of enrollment.

         10. Those who received botulinum toxin injections in the past 4 months.
A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer
Condition: Hepatocellular Carinoma
MeSH terms: Vaccinia
Intervention: JX-594 recombinant vaccina GM-CSF
Intervention description: Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver Cancer; HCC; first line HCC; Pexa-Vec; JX-594

Summary:

      This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients
      with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with
      sorafenib, and the safe administration of JX-594 in five weekly IV infusions.
    

Eligibility criteria:

        KEY Inclusion Criteria:

          -  Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma
             (HCC)

          -  Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the
             arterial phase on CT scanning)

          -  ECOG performance status 0, 1 or 2

          -  Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites

          -  Platelet count ≥50,000 plts/mm3

          -  WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3

          -  Hemoglobin ≥10 g/dL

          -  Adequate liver function

        KEY Exclusion Criteria:

          -  Received sorafenib as previous treatment for HCC for more than 14 days

          -  History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis
             requiring systemic therapy for > 4 weeks)

          -  Prior treatment with JX-594

          -  Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or
             medication

          -  Severe or unstable cardiac disease

          -  Viable CNS malignancy associated with clinical symptoms

          -  Pregnant or nursing an infant

          -  Significant bleeding event within the last 12 months.