bioihbjkbjnl/mcl2 huggingface dataset:
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.
Evaluation of the Efficacy and Safety of VX-814 in Subjects With the PiZZ Genotype
Condition: Alpha 1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Intervention: VX-814; Placebo
Intervention description: Tablet for oral administration.; Placebo matched to VX-814 for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-814 in PiZZ
      subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects must have a PiZZ genotype confirmed at screening

          -  Plasma AAT levels indicating severe deficiency at screening

        Key Exclusion Criteria:

          -  History of a medical condition that could negatively impact the ability to complete
             the study

          -  Solid organ, or hematological transplantation or is currently on a transplant list

          -  History of use of gene therapy or RNAi therapy at any time previously

        Other protocol defined Inclusion/Exclusion criteria may apply
Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: AKST4290; Placebo
Intervention description: Oral AKST4290; Oral Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinson's Disease; Dementia; Movement Disorder; Shaking Palsy

Summary:

      This study will evaluate the efficacy and safety of AKST4290 in subjects with Parkinson's
      Disease who are currently on stable dopaminergic treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of clinically established or clinically probable PD according to MDS-PD
             criteria with at least 1 year of PD symptoms.

          -  Modified Hoehn and Yahr ≤2.5.

          -  Have notable motor worsening during off-medication state.

          -  Clear-cut improvement of motor response to levodopa medications, as assessed by the
             investigator.

          -  Must be on stable dopaminergic therapy (e.g., levodopa, dopamine agonists, monoamine
             oxidase inhibitors, catechol-O-methyl transferase inhibitors, amantadine), for at
             least 8 weeks prior to enrollment and remain on stable dose during the 12-week
             treatment period.

          -  Female subjects must not be pregnant or breastfeeding. Women of childbearing potential
             (WOCBP) must have a negative pregnancy test at Screening. WOCBP must agree to use
             highly effective contraception prior to study entry. Male subjects must be willing to
             use a barrier method of contraception.

        Key Exclusion Criteria:

          -  Secondary or atypical parkinsonian syndromes, for example, patients with parkinsonism
             from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced
             parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive
             supranuclear palsy, Lewy body dementia.

          -  History of any brain surgery for PD (e.g., pallidotomy, deep brain stimulation, or
             fetal tissue transplant).

          -  Conditions affecting the peripheral or central nervous system, unless related to PD,
             that would affect the ability to adequately perform the MDS-UPDRS and motor
             assessments: i.e., severe sensory neuropathy affecting arm or leg function, or stroke
             affecting motor or gait function.

          -  Significant alcohol or drug abuse within past 2 years.

          -  Based on ECG reading, subjects with a risk of QT prolongation.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Infliximab; Methotrexate; Methylprednisolone; Ocrelizumab; Placebo
Intervention description: Intravenous repeating dose; Oral or parenteral repeating dose; Intravenous repeating dose; Intravenous repeating dose; Intravenous repeating dose
Intervention MeSH terms: Methylprednisolone; Infliximab; Methotrexate; Ocrelizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RA; Arthritis

Summary:

      This is a Phase II, randomized, active-controlled, double-blind, double-dummy,
      parallel-group, multicenter study in the United States enrolling patients with active RA. The
      study will enroll approximately 290 patients at approximately 130 sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18 years

          -  Current treatment for RA on an outpatient basis

          -  Active disease

          -  Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg
             adalimumab SC every other week.

          -  Considered by Investigator to be a primary non-responder to their first anti-TNFÎ±
             treatment for efficacy reasons

        Exclusion Criteria:

          -  Rheumatic autoimmune disease other than RA, or significant systemic involvement
             secondary to RA

          -  History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive
             arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or
             other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory
             bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or
             other overlap syndrome)

          -  Previous treatment with a any biologic therapy for RA (including investigational
             products with the exception of etanercept or adalimumab

          -  Treatment with more than one prior anti-TNFÎ± therapy
A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Brexpiprazole; Sertraline; Brexpiprazole Matching Placebo; Sertraline Matching Placebo
Intervention description: Brexpiprazole oral tablets.; Sertraline oral capsules.; Brexpiprazole matching placebo oral tablets.; Sertraline matching placebo oral capsules.
Intervention MeSH terms: Sertraline; Brexpiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as
      monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants between the years of 18-65 with a diagnosis of PTSD
             (diagnosis can be made at screening)

        Exclusion Criteria:

          -  Index trauma event >15 years before screening

          -  Index trauma event at age <16

          -  Any traumatic event within 3 months of screening
Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE)
Condition: Proliferative Diabetic Retinopathy (PDR)
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: Ranibizumab 0.5 mg; Panretinal laser photocoagulation
Intervention description: Pre-filled syringe for intravitreal injection; PRP treatment following DRS guidelines
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: An open-label design was chosen in which the evaluation of the primary objective was performed by a reading center. The reading center that evaluated the primary and several secondary objectives was blinded to randomization and therefore assessed these objectives uninfluenced by treatment information. However, laser burns were visible on the images, and no full blinding regarding panretinal laser photocoagulation (PRP) was possible for the reading center.
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Panretinal photocoagulation; Ranibizumab

Summary:

      The purpose of this study was to assess the efficacy and safety of the anti-Vascular
      Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser
      photocoagulation (PRP) compared to PRP alone in patients with Proliferative Diabetic
      Retinopathy (PDR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Proliferative Diabetic Retinopathy

          -  Best Corrected Visual Acuity (BCVA) in study eye of at least 20 Early Treatment
             Diabetic Retinopathy Study (ETDRS) letters (20/400)

          -  Type 1 or type 2 diabetes under medical surveillance / with stabilized treatment

        Exclusion Criteria:

          -  Proliferative vitreoretinopathy in study eye

          -  Clinically significant macular edema (CSME) in the study eye

          -  Clinically non significant macular edema (CNSME) that is likely to develop to CSME in
             the study eye

          -  Uncontrolled glaucoma in either eye

          -  Other protocol-specified conditions
Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
Condition: Current or Recent History of Atrial Fibrillation
MeSH terms: Heart Failure; Atrial Fibrillation; Atrial Flutter
Intervention: bucindolol hydrochloride; metoprolol succinate; Placebo oral capsule
Intervention MeSH terms: Metoprolol; Bucindolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 267.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: atrial fibrillation; atrial flutter; heart failure; reduced left ventricle ejection fraction; electrical cardioversion; GENETIC-AF; Medtronic; bucindolol; pharmacogenetic; ARCA; Toprol; Toprol-XL; Metoprolol; Metoprolol succinate

Summary:

      This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to
      metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial
      flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic
      receptor.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must weigh at least 40 kg

          -  Possess the β1389 Arg/Arg genotype

          -  Left Ventricular Ejection Fraction (LVEF) < 0.50 assessed within 12 months prior to
             Screening

          -  At least one episode of symptomatic paroxysmal or persistent AF within 180 days of
             Screening

          -  Clinically appropriate for electrical cardioversion (ECV) if AF/AFL is present after
             study drug initiation

          -  Receiving appropriate anticoagulation therapy prior to Randomization

        Key Exclusion Criteria:

          -  NYHA Class IV symptoms at the time of Randomization

          -  Significant fluid overload at Randomization

          -  Permanent AF at Screening

          -  More than two previous ECV within 6 months of Randomization or if the most recent ECV
             failed to produce SR

          -  Presence of an LVAD, or likely to requirement LVAD placement within 6 months of
             Randomization

          -  History of a successful atrioventricular (AV) node ablation

          -  History of an AF/AFL ablation within 30 days of Randomization

          -  Evidence of an appropriate firing of an implanted cardioverter-defibrillator (ICD)
             device for ventricular tachycardia (VT) or ventricular fibrillation (VF) within 90
             days of Randomization
A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: risankizumab
Intervention description: Risankizumab administered by subcutaneous injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: risankizumab; ABBV-066; BI655066

Summary:

      This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability
      of risankizumab in participants with psoriatic arthritis (PsA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have completed all doses of study drug and Week 24 visit of the
             lead-in study.

          -  Women of childbearing potential who are sexually active, must agree to use at least
             one accepted method of contraception throughout the study, including 20 weeks after
             last dose of study drug is given.

          -  Women of childbearing potential must have a negative urine pregnancy test at Baseline
             (Week 0/V1).

          -  Participants must voluntarily sign and date an informed consent, approved by an
             Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the
             initiation of any study specific procedures.

          -  Participant is judged to be in good health as determined by the Investigator.

        Exclusion Criteria:

          -  Female participant who is pregnant, breastfeeding or is considering becoming pregnant
             during study participation, including 20 weeks after the last dose of study drug is
             given.

          -  Premature discontinuation of the study drug in the lead-in study for any reason.

          -  Use of a biologic treatment other than risankizumab since first dose of study drug in
             the lead-in study.

          -  Time elapsed is > 8 weeks since the Week 24 visit in the lead-in study.

          -  Active systemic infections during the last 2 weeks (exception: common cold) prior to
             the first dose, as assessed by the investigator.
Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: UB-311; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine
      (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and
      immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the
      secondary endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of mild Alzheimer's Disease

          -  Mini-Mental State Examination (MMSE) scores between 20 and 26 (inclusive)

          -  Clinical dementia rating (CDR) scores of 0.5 or 1

          -  Other inclusion criteria apply

        Exclusion Criteria:

          -  Clinically significant neurological disease other than Alzheimer's disease

          -  Major psychiatric disorder

          -  Severe systemic disease

          -  Serious adverse reactions to any vaccine

          -  Other exclusion criteria apply
A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
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: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mantle cell lymphoma; non-Hodgkin lymphoma; Bruton's tyrosine kinase (BTK); phosphatidylinositol 3-kinase (PI3K)

Summary:

      This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of
      2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell
      lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK)
      inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, aged 18 years or older.

          -  Documented failure to achieve at least partial response (PR) with, or documented
             disease progression after, the most recent treatment regimen.

          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

        Exclusion Criteria:

          -  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.

          -  Allogeneic stem cell transplant within the last 6 months, or autologous stem cell
             transplant within the last 3 months before the date of first dose of study treatment.

          -  Active graft-versus-host disease.

          -  Liver 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).
Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm
Condition: Hookworm Infections
MeSH terms: Infections; Hookworm Infections; Ancylostomiasis
Intervention: Mebendazole
Intervention description: Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 397.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mebendazole; Chewable tablet; Hookworm; Soil-transmitted helminths; Efficacy; Safety; Acceptability

Summary:

      The rational of this study is to provide evidence on the safety and efficacy of a new
      chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged
      children infected with hookworm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female children aged between 3 and 12 years;

          -  Written informed consent signed by caregiver;

          -  Was examined by a study physician before treatment;

          -  Provided two stool samples at baseline;

          -  Hookworm EPG > 100 and at least two Kato-Katz thick smears slides with more than one
             hookworm egg;

        Exclusion Criteria:

          -  Pregnant;

          -  Presence or history of major systemic or chronic illnesses, as assessed by a medical
             doctor, such as can upon initial clinical assessment;

          -  Suffers from severe anemia (Hb < 80 g/l);

          -  Received anthelminthic treatment or metronidazole within past four weeks.

          -  Attending other clinical trials during the study.