bioihbjkbjnl/mcl2 huggingface dataset:
Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
Condition: Methamphetamine Use Disorder
Intervention: Naltrexone: Vivitrol®; Placebo (PLB) Injectable; Bupropion: Wellbutrin XL®; Placebo (PLB) Oral
Intervention description: Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks; Placebo: 4 intramuscular injections administered every 3 weeks; Bupropion: 450 mg oral dose daily; Placebo: once-daily oral placebo tablets
Intervention MeSH terms: Naltrexone; Bupropion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: During the study, participants may or may not be switched to another group due to the adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Methamphetamine; Methamphetamine Use Disorder; Naltrexone; Bupropion; Vivitrol®

Summary:

      This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy
      of extended-release naltrexone plus bupropion as a combination pharmacotherapy for
      methamphetamine use disorder. Participants will be randomly assigned to the active medication
      combination (AMC) group or matching placebo group and will receive medications over the
      course of 12 weeks. Follow-ups will occur in weeks 13 and 16.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 65 years old;

          -  Interested in reducing/stopping methamphetamine use;

          -  Speak English;

          -  Agree to use acceptable birth control (if applicable);

          -  Be opioid-free at randomization;

          -  Willing to comply with all study procedures and medication instructions;

          -  Agree to use a cell phone (or similar study device) to take videos of medication
             dosing.

        Exclusion Criteria:

          -  Medical or psychiatric condition which would make participation unsafe;

          -  Recently participated in a study of pharmacological or behavioral treatment for
             methamphetamine use disorder;

          -  Recently taken an investigational drug;

          -  Prescribed and taken naltrexone or bupropion ≤ 30 days from consent;

          -  Current or planned extended absence during study period (e.g., jail, surgery, pending
             legal action);

          -  Currently pregnant or breastfeeding.
Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: adalimumab (D2E7); placebo
Intervention description: Adalimumab 40 mg every other week, subcutaneous; Placebo every other week, subcutaneous
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given
      every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an
      inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal
      anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1
      disease-modifying antirheumatic drug (DMARD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be >= 18 years of age

          -  meet Modified NY Criteria definition of ankylosing spondylitis (AS)

          -  have diagnosis of active AS based on protocol specified criteria

          -  inadequate response or intolerance to >= 1 nonsteroidal antiinflammatory drug (NSAID)

          -  be able and willing to learn to self-administer subcutaneous (SC) injections

        Exclusion Criteria:

          -  Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C

          -  History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative
             disease

          -  Previous anti-tumor necrosis factor therapy

          -  Treatment with disease-modifying antirheumatic drugs (DMARDs - other than
             methotrexate, hydroxychloroquine, and sulfasalazine)

          -  Treatment with intra-articular corticosteroid joint injections within 4 weeks of study
             dosing

          -  Biologic or investigational therapy within 6 weeks of study dosing

          -  Treatment with intravenous (IV) antibiotics within 30 days of study dosing

          -  Treatment with oral antibiotics within 14 days of study dosing
Escitalopram (Lexapro) for Depression MS or ALS
Condition: Major Depression; Multiple Sclerosis; Amyotrophic Lateral Sclerosis
MeSH terms: Multiple Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: escitalopram
Intervention description: After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.
Intervention MeSH terms: Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Amyotrophic Lateral Sclerosis; ALS; Multiple Sclerosis; MS; Major Depression; Depression; Major Depressive Disorder; antidepressants; Escitalopram; Lexapro

Summary:

      The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major
      depressive disorder in patients who have ALS or MS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 18 and 70 years of age with documented ALS or MS,

          -  DSM-IV episode of non-psychotic Major Depression,

          -  ≥14 score on the 17-item HAM-D,

          -  Ability to give informed consent.

        Exclusion Criteria:

          -  History of psychotic disorders,

          -  Psychotic depression,

          -  Bipolar depression,

          -  Suicide risk,

          -  History of substance abuse in the previous 6 months,

          -  History of unstable medical disorders,

          -  Pregnancy or planning for pregnancy,

          -  Severity of ALS or MS that limits participating in the study protocol.
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Evolocumab; Ezetimibe; Placebo to Evolocumab; Placebo to Ezetimibe
Intervention description: Administered by subcutaneous injection; Administered orally once a day; Administered by subcutaneous injection; Administered orally once daily
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 615.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia

Summary:

      The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC)
      monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on
      percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a
      10-year Framingham risk score of 10% or less.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 to ≤ 80 years of age

          -  National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III)
             Framingham risk score of 10% or less

          -  Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL

          -  Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

          -  History of coronary heart disease

          -  New York Heart Association (NYHA) III or IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension

          -  Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)

          -  Uncontrolled hypothyroidism or hyperthyroidism
A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study
Condition: Keratosis, Actinic
MeSH terms: Keratosis, Actinic; Keratosis; Recurrence
Intervention: MAL Cream; Vehicle cream
Intervention description: No intervention will be administered as a part of this study. Participants who received MAL cream in RD.06.SPR.112199 study will be rolled over in the study.; No intervention will be administered as a part of this study. Participants who received vehicle cream in RD.06.SPR.112199 study and achieved complete response, will be rolled over in the study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose for this study is to assess recurrence of Actinic Keratosis in
      participants achieving complete response treated in earlier study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have completed earlier study RD.06.SPR.112199 (NCT04085367) and
             achieved complete response at last visit

          -  Participants fully understand and sign an informed consent form (ICF) before any study
             procedure begins

          -  Participants willing and able to perform all study protocol requirements

        Exclusion Criteria:

          -  Participants developing or experiencing any condition that may not be safe for them or
             not compliant will be excluded

          -  Pertinent not compliant with study conditions or PI instructions during the earlier
             study - Lumexia Ph 3
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Condition: Submental Fat; Healthy
Intervention: ATX-101; Placebo
Intervention description: Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events; Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction
      of submental fat.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Any participant who completed follow-up visits at 12 and 24 weeks after the last dose
             in one of the two predecessor studies

          2. Willingness to comply with the schedule and procedures of this study.

          3. Signed informed consent form (ICF).

        Exclusion Criteria:

        1. Participants who have had any treatment or condition (e.g., pregnancy or metabolic
        disease, which may lead to unstable weight) that may affect assessment of safety or
        efficacy since enrollment in the predecessor study.
Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)
Condition: Chronic Hepatitis C; Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Intervention: peginterferon alfa-2b (SCH 54031)
Intervention description: 0.5 µg/kg subcutaneously once weekly for 60 months
Intervention MeSH terms: Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 631.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hepatitis C; Cirrhosis

Summary:

      The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no
      treatment for the prevention of disease progression in adult subjects with compensated
      cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a
      interferon plus ribavirin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at entry 18-65 years;

          -  Non-responders to previous treatment (minimum of 3 months) with an alpha interferon
             plus ribavirin;

          -  Liver biopsy demonstrating cirrhosis

        Exclusion Criteria:

          -  Any other cause for liver disease other than chronic hepatitis C;

          -  History or presence of complications of cirrhosis;

          -  Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;

          -  Diseases or conditions that could interfere with participation in the study
Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS topical; Vehicle topical
Intervention description: topical treatment; topical treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 371.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III
      Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with
      Mild to Severe Scalp Psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating females 18 years of age and older.

        Exclusion Criteria:

          -  Females who are pregnant, lactating or likely to become pregnant during the study.
Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients
Condition: Osteoporosis; Chronic Kidney Disease
MeSH terms: Osteoporosis; Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Denosumab (Prolia)
Intervention description: 60 mg s.c. injection at baseline and after 6 months
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoporosis; Osteopenia; Denosumab; Transplantation; Kidney

Summary:

      The primary objective of the study is to examine the effect of denosumab on lumbar spine bone
      mineral density (BMD) after one year of treatment in newly transplanted renal allograft
      recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck,
      changes in body height, changes in bone mineral metabolism parameters, incidence of
      fractures, and allograft function at one year. Safety measurements include the occurrence of
      rejection episodes, infectious complications, graft loss and mortality.

        -  Trial with medicinal product
    

Eligibility criteria:

        The key inclusion criteria are:

          1. Male or female adult de novo kidney, kidney-pancreas or kidney-islet, or kidney-liver
             transplant recipients

          2. Functioning graft within 28 days after transplantation (creatinine having decreased to
             <200 micromol/l without the need for dialysis)

          3. Being on standard triple immunosuppression including a calcineurin antagonist
             (cyclosporine or tacrolimus), mycophenolate (MMF or MPA) and steroids, with or without
             induction treatment with basiliximab or anti-thymocyte globulin

        Key exclusion criteria are:

          1. Age <18 years

          2. Rising creatinine after initial drop <200 micromol/l or creatinine >200 micromol/l at
             baseline

          3. Evidence of early acute rejection, either suspected clinically and/or proven by biopsy

          4. Presence of severe osteoporosis as evidenced by a T score <-4 at the hip, femoral neck
             or any of the 4 vertebrae L1 to L4

          5. Evidence of severe hyper- or hypoparathyroidism (iPTH >800 ng/l or <10 ng/l)

          6. Hypocalcemia (total calcium <1.8 mmol/l) or hypercalcemia (total calcium >2.7 mmol/l)

          7. Steroid-free de novo immunosuppression scheme
Confirmatory Study of OPC-12759 Ophthalmic Suspension
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: OPC-12759 Ophthalmic suspension; Hyalein Mini Ophthalmic solution
Intervention description: OPC-12759 Ophthalmic suspension 2%; Hyalein Mini Ophthalmic solution 0.1%
Intervention MeSH terms: Rebamipide; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 188.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective
      compared with active control in dry eye patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Out patient

          2. Subjective complaint of dry eye that has been present for minimum 20 months

          3. Ocular discomfort severity is moderate to severe

          4. Corneal - conjunctival damage is moderate to severe

          5. Unanesthetized Schirmer's test score of 5mm/5minutes or less

          6. Best corrected visual acuity of 0.2 or better in both eyes

        Exclusion Criteria:

          1. Presence of anterior segment disease or disorder other than that associated with
             keratoconjunctivitis sicca

          2. Ocular hypertension patient or glaucoma patient with ophthalmic solution

          3. Anticipated use of any topically-instilled ocular medications or patients who cannot
             discontinue the use during the study

          4. Anticipated use of contact lens during the study

          5. Patient with punctal plug

          6. Any history of ocular surgery within 12 months

          7. Female patients who are pregnant,possibly pregnant or breast feeding

          8. Known hypersensitivity to any component of the study drug or procedural medications

          9. Receipt of any investigational product within 4 months.
Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure
Condition: Pneumothorax
MeSH terms: Pneumothorax
Intervention: Bio-Seal Plug
Intervention description: Deployment of the Bio-Seal plug in needle track
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 339.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lung biopsy

Summary:

      BS-1053 A Prospective Randomized Multi-Centered Safety and Efficacy Evaluation of the
      Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient must meet all medical conditions for lung biopsy;

          -  The patient must be at least 18 years of age;

          -  The patient, or legal representative, must understand and provide written consent for
             the procedure;

          -  The patient has a non-calcified, radiologically suspicious opacity or lung nodule,
             including a metastatic lung module, or mass of at least 1.0 cm in size; as determined
             by CT scan equipped with measurement software. Suspicious nodules observed by CT scan
             are defined as non-calcified masses with convex borders, not known to be stable.
             Suspicious nodules can also be defined as masses demonstrating opacity on chest x-ray
             that are suspicious by radiographic or clinical means and require biopsy.

        Exclusion Criteria:

          -  Patients with radiological findings of bullous emphysema located in the area of the
             anticipated biopsy and biopsy needle track;

          -  Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory
             status;

          -  Female patients who are pregnant. Note: patients of childbearing potential must have a
             serum or urine pregnancy test no more than one week prior to the biopsy procedure, and
             be instructed not to have unprotected sexual intercourse after the test until the
             biopsy procedure is completed.

          -  Patients who are uncooperative or cannot follow instructions.

          -  Patients who are currently enrolled in another IDE or IND clinical investigation that
             has not completed the required follow-up period.