bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: placebo; AGN 203818; AGN 203818; AGN 203818
Intervention description: Part A: Placebo every 12 hours for 4 weeks; Part A: AGN 203818 3 mg every 12 hours for 4 weeks; Part A: AGN 203818 20 mg every 12 hours for 4 weeks; Part A: AGN 203818 60 mg every 12 hours for 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 211.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will explore the safety and effectiveness of different doses of AGN 203818 in
      treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2
      parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over
      4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg
      BID AGN 203818 or placebo over 12 week treatment duration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of fibromyalgia syndrome

          -  Moderate or severe pain associated with fibromyalgia

        Exclusion Criteria:

          -  Any other uncontrolled disease

          -  Pregnant or nursing females
A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Axumin PET/CT
Intervention description: Synthetic amino acid uptake agent injection followed by imaging
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Cohort
Masking: None (Open Label)
Masking description: No masking
Enrollment: 20.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men
      undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal
      therapy cohort.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male, 45 years of age or older.

          2. Diagnosis of prostate adenocarcinoma.

          3. Clinical stage T1a, T1b, T1c, T2a, T2b orT2c.

          4. Gleason score of 7 (3+4 or 4+3).

          5. PSA density less than 0.375.

          6. One, two, or three tumor suspicious regions identified on multiparametric MRI.

          7. Negative radiographic indication of extra-capsular extent.

          8. Karnofsky performance status of at least 70.

          9. Estimated survival of 5 years or greater, as determined by treating physician.

         10. Tolerance for anesthesia/sedation.

         11. Ability to give informed consent.

        Exclusion Criteria:

          1. Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.

          2. Severe lower urinary tract symptoms as measured by an International Prostate Symptom
             Score (IPSS) of 20 or greater. ( (http://www.urospec.com/uro/Forms/ipss.pdf)

          3. History of other Primary non-skin malignancy within previous three years.

          4. Diabetes.

          5. Smoker.
Effects of Treatment of Sleep Apnea on Metabolic Syndrome
Condition: Impaired Glucose Tolerance; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Glucose Intolerance
Intervention: Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP); Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)
Intervention description: Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.; Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The investigators performed a randomized, cross-over controlled clinical trial comparing 8
      weeks of Continuous Positive Airway Pressure (CPAP) to 8 weeks of sham-CPAP in patients with
      moderate to severe Sleep Disordered Breathing (SDB) and impaired glucose tolerance. A
      rigorous assessment of metabolic responses to SDB treatment in this group is of great
      clinical significance because this sample is at high risk for developing diabetes. The
      paradigm shift of CPAP as a mode of prevention can affect clinical practice in the fields of
      both primary care and sleep medicine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  moderate to severe Sleep Disordered Breathing (SDB) defined by an Apnea Hypopnea Index
             (AHI) > 15

          -  had evidence of Impaired Glucose Tolerance (IGT) defined by the mean 2-hour Oral
             Glucose Tolerance Test (OGTT) glucose of > 140 mg/dl calculated from the two 2-hour
             OGTTs performed within 3 days of each other
Improving Learning-based Treatment of Cocaine Dependence With Medication
Condition: COCAINE-RELATED DISORDERS
MeSH terms: Cocaine-Related Disorders
Intervention: d-cycloserine; sugar pill
Intervention description: 50 mg d-cycloserine; placebo
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will test the efficacy of d-cycloserine in enhancing response to learning-based
      treatment for cocaine dependence, specifically contingency management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-60 years of age (> 60 due to age-related effects on cognitive functioning)

          -  Satisfy DSM-IV criteria for cocaine dependence (primarily crack)

          -  Able to complete all study measures

          -  Currently seeking treatment for cocaine dependence

        Exclusion Criteria:

          -  Meets DSM-IV criteria for dependence on a drug other than cocaine or nicotine (may
             meet abuse criteria for other drugs)

          -  Pregnant, breast feeding, or planning to become pregnant within 3 months

          -  If female, do not agree to use an effective means of birth control during the course
             of treatment (via phone screen)

          -  History of seizure disorder, severe hepatic impairment, porphyria, serious head
             trauma, dementia, or significant cognitive impairment

          -  Diagnosis of current major psychiatric disorder besides substance dependence or abuse

          -  Reported use of DCS in the past year

          -  Illiteracy, as will be determined during in-person screening

          -  Concurrently prescribed or using ethionamide or isoniazid (both used to treat
             tuberculosis)

          -  Positive urine result for opioids at screening interview
Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; ILV-094; ILV-094; Placebo; ILV-094
Intervention description: Part 1: Placebo SC administration every 2 weeks X 10 weeks.; Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks.; Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks.; Part 2: Placebo SC administration every 2 weeks X 10 weeks; Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks
Intervention MeSH terms: Fezakinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; ACR; Methotrexate; Interleukin-22

Summary:

      The primary objective of this study is to assess the safety and efficacy of different dose
      regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with
      active rheumatoid arthritis who are taking methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets the American College of Rheumatology (ACR) 1987 revised criteria for
             classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening

          -  Active RA at the time of screening and baseline consisting of >= 5 swollen and >= 5
             tender joints (28-joint count) and at least 1 of the following at screening:
             C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h

          -  Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up
             to 25 mg weekly) for at least 8 weeks prior to the baseline visit.

        Exclusion Criteria:

          -  Subjects with other rheumatic diseases

          -  Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous
             cell carcinoma or in situ cervical cancer)

          -  Any prior use of B cell-depleting therapy
An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert
Condition: Primary Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost
Intervention description: Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
Intervention MeSH terms: Bimatoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in
      participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the
      participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12
      weeks), then had that Insert removed and a new Insert placed for another 26 weeks
      (approximately 6 months).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed FSV5-004 study.

          2. Written informed consent prior to any study procedure.

          3. Willingness to comply with the visit schedule.

        Key Exclusion Criteria:

          1. Participation in an investigational drug or device study other than FSV5-004 within
             the past 6 months or anticipated participation during the study period.

          2. Subjects who will require contact lens use during the study period.

          3. Any condition or situation (such as uncontrolled systemic disease) that, in the
             Investigator's opinion, might confound the results of the study, may put the subject
             at significant risk or might interfere with the subject's ability to participate in
             the study.
A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
Condition: Hepatitis D, Chronic
MeSH terms: Hepatitis A; Hepatitis D; Hepatitis D, Chronic; Hepatitis
Intervention: Peginterferon alfa-2a; Ribavirin
Intervention description: Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.; Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy
      and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination
      with ribavirin in participants with CHD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive hepatitis B surface antigen (HBsAg) for the prior 6 months

          -  Positive anti-delta for the prior 3 months

          -  Positive HDV RNA at Screening

          -  Elevated ALT (1 to 10 times upper limit of normal) prior to first dose

          -  Chronic, necroinflammatory hepatitis documented within the prior 18 months
             (non-cirrhotic) or 30 months (cirrhotic)

          -  Negative pregnancy and adequate contraceptive use

        Exclusion Criteria:

          -  Antiviral therapy for CHD within previous 3 months

          -  Positive for hepatitis A or C, or human immunodeficiency virus (HIV)

          -  Increased risk of metabolic liver disease

          -  Decompensated liver disease

          -  Elevated bilirubin

          -  Poor hematologic or renal function

          -  Drug/alcohol abuse within 1 year prior to study

          -  History of significant psychiatric, autoimmune, pulmonary, cardiac, oncologic, or
             thyroid disease

          -  Organ transplantation with existing functional graft

          -  Retinopathy or other ophthalmologic complication of diabetes or hypertension

          -  Inclusion in another investigational trial within previous 12 weeks
Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Korlym (mifepristone); Sugar Pill
Intervention description: 600 mg/day, oral pill, 7 days; 600 mg/day, oral pill, 7 days
Intervention MeSH terms: Mifepristone
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcohol; Relapse

Summary:

      The primary hypotheses under test are that alcohol dependent subjects treated with
      mifepristone will report decreased craving for alcohol following alcohol exposure in the
      laboratory and report significantly less drinking under naturalistic conditions, than those
      treated with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers, 18-65 years of age

          -  Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Addition (DSM-IV)
             criteria for current alcohol dependence

          -  Subjects will not be seeking treatment because the medication studies are not
             treatment trials

          -  Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the
             human lab session

          -  Negative Breath Alcohol Concentration (BAC) and a Clinical Institute Withdrawal
             Assessment-Alcohol (CIWA-A) score of < 8 at screening and time of lab session to
             eliminate acute alcohol or withdrawal effects on dependent measures

          -  Subjects must be able to complete and understand questionnaires and study procedures
             in English and sign an informed consent

        Exclusion Criteria:

          -  Significant medical disorders that will increase potential risk or interfere with
             study participation as determined by the Study Physician

          -  Female subjects with childbearing potential who are pregnant, nursing, or refuse to
             use double barrier (non-hormonal) methods of birth control for the duration of the
             study and one month thereafter

          -  Meets DSM-IV criteria for a major Axis I disorder including mood or anxiety disorders
             or substance dependence disorders other than alcohol or nicotine dependence

          -  History of allergy or hypersensitivity to the study drugs or the ingredients

          -  Treatment within the month prior to screening with 1.) an investigational drug or
             vaccine; 2.) drugs that may influence study outcomes, e.g., disulfiram (Antabuse),
             naltrexone (ReVia), acamprosate (Campral), anticonvulsants, antidepressants.

          -  In need of or currently taking any psychoactive medications.
Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
Condition: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Ombitasvir/ABT-450/Ritonavir; Dasabuvir; Ribavirin (RBV)
Intervention description: Ombitasvir/ABT-450/ritonavir combination tablets; Dasabuvir tablets; Ribavirin tablets
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Treatment naive; HCV; Interferon free; Hepatitis C Genotype 1a; Chronic Hepatitis C; Hepatitis C

Summary:

      To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV)
      ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and
      dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in
      treatment-naive HCV genotype (GT) 1a-infected adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Screening laboratory result indicating HCV genotype 1 (GT1) a infection.

          2. Chronic HCV infection.

          3. Subjects must be non-cirrhotic.

          4. Subjects must be able to understand and adhere to the study visit schedule and all
             protocol requirements as well as voluntarily sign and date an institutional review
             board (IRB) approved informed consent.

        Exclusion Criteria:

          1. Women who are pregnant or breastfeeding.

          2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human
             immunodeficiency virus antibody (HIV Ab) positive immunoassay.

          3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that
             make the subject unsuitable for this study or treatment.

          4. Current enrollment in another interventional clinical study. Previous use of any HCV
             treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting
             antiviral agent, either investigational or approved, for HCV including protease
             inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or nonstructural viral
             protein 5A (NS5A) inhibitors.

          5. History or solid organ transplant.

          6. Screening laboratory analysis that shows abnormal results.
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: 60 mg/kg azithromycin ER; 30 mg/kg azithromycin IR
Intervention description: subjects taken 60 mg/kg azithromycin ER; subjects taken 30 mg/kg azithromycin IR (Immediate Release)
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 6 Months
Maximum age: 11 Years
Healthy volunteers: No
Keywords: azithromycin, pharmacokinetics, pediatrics

Summary:

      The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical
      response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER
      (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects age 6 months to < 12 years.

          -  Have clinical signs/symptoms of acute otitis media in at least one ear.

          -  Parent(s)/legal guardian(s) provide written informed consent.

        Exclusion Criteria:

          -  Clinical significant other disease.

          -  Recent use of investigational drugs, prescription or nonprescription drugs.