bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
Condition: Non-infectious Uveitis
MeSH terms: Uveitis
Intervention: AIN457; Placebo
Intervention description: AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake; Matching placebo to AIN457
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Quiescent uveitis; intermediate uveitis; panuveitis; posterior uveitis; uveitis; NVS Definition: Words or phrases that best describe the protocol. Keywords help users find studies in the database.; Avoid acronyms, abbreviations and trade names.; Examples: Heart failure, aliskiren, heart attack, cardiovascular diseases; Psoriasis, inflammatory skin disease, scaly patches

Summary:

      This extension study will assess the safety and efficacy of AIN457 versus placebo for
      maintaining uveitis suppression when reducing systemic immunosuppression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed the entire treatment period of the 24 week core study

        Exclusion Criteria:

          -  Inability or unwillingness to undergo repeated subcutaneous injections; inability to
             comply with study or follow-up procedures; any medical or psychiatric condition which,
             in the investigator's opinion wouldpreclude the participant from adhering to the
             protocol or completing the study per protocol.

        Other protocol-defined inclusion/exclusion criteria may apply.
Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
Condition: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Intervention: Placebo tamsulosin hydrochloride OCAS 0.4 mg; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg; tamsulosin hydrochloride OCAS 0.4 mg; tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg); tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
Intervention description: tablet; tablet; tablet; tablet; tablet; tablet
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1334.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No
Keywords: EC905; Solifenacin succinate; Tamsulosin hydrochloride OCAS; Treatment; Benign Prostatic Hyperplasia; Vesomni; Lower Urinary Tract Symptoms

Summary:

      Clinical study to examine the efficacy, safety and tolerability of combination therapy of
      tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin
      hydrochloride in the treatment of males with LUTS associated with BPH with a substantial
      storage component.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months

          -  A total International Prostate Symptom Score (IPSS) of ≥13

          -  A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL
             during free flow

          -  A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient
             Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3
             day micturition diary (at randomization)

        Exclusion Criteria:

          -  Any significant Post Void Residual volume (>150 mL)

          -  A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal
             ultrasound

          -  Evidence of a symptomatic urinary tract infection
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
Condition: Cholestasis
MeSH terms: Cholestasis
Intervention: multicomponent lipid emulsion; pure soybean oil lipid emulsion
Intervention description: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.; Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 24 Weeks
Maximum age: 30 Weeks
Healthy volunteers: No
Keywords: preterm; parenteral nutrition; cholestasis; fish oil

Summary:

      The purpose of this study is to compare the effects of a multicomponent lipid emulsion
      containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil
      with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis,
      infant growth, infant morbidity and the biochemical assessment of liver enzymes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inborn infants with a gestational age of less than 30 weeks

          -  Who required parenteral nutrition for at least 7 days

        Exclusion Criteria:

          -  Evidence of congenital infection

          -  Perinatal asphyxia

          -  Congenital anomalies

          -  Severe IVH

          -  Thrombocytopenia

          -  Shock or circulation failure

          -  Renal or hepatic disorders.
Aspirin in Patients With Myocardial Infarction and Thrombocytopenia
Condition: Thrombocytopenia; Myocardial Infarction
MeSH terms: Myocardial Infarction; Thrombocytopenia; Infarction
Intervention: Aspirin
Intervention description: 325 mg by mouth on Day 1 only, followed by 160 mg by mouth daily
Intervention MeSH terms: Aspirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Healthy volunteers: No
Keywords: Thrombocytopenia; Platelet Function; Acute Coronary Syndrome; Myocardial Infarction; Heart Attack; Aspirin

Summary:

      Primary Objective:

      To determine the risk of bleeding from ASA therapy in thrombocytopenic patients who develop
      Acute Coronary Syndrome (ACS), and assess its effect on the overall morbidity and mortality
      in these patients as well as platelet functions.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Presenting for Cardiology consult at M.D. Anderson Cancer Center.

          2. Platelet count between 100,000 and 20,000.

          3. Acute Coronary Syndrome diagnosed with their first 12 lead EKG.

          4. Patients that continue to show evidence of MI by cardiac enzymes with CPK levels > 2
             normal limits, CK-MB levels 10% above normal limits, and Troponin I levels > 1.4ug/L
             will be considered positive for MI.

          5. Ability to give consent.

        Exclusion Criteria:

          1. Contraindications to aspirin including severe intolerance or true allergy, active
             bleeding, hemophilia, active retinal bleeding, severe untreated hypertension, active
             peptic ulcer, or other significant source of gastrointestinal or genitourinary
             bleeding, brain metastasis, and altered mental status.

          2. Unwillingness or inability to give consent.

          3. Progressive heart failure, unstable angina not responding to medical therapy for 24
             hours, or ventricular tachycardia, necessitating thrombolysis, and angioplasty.

          4. Patients that rule out for MI by cardiac enzymes panel after the first 24 hours.

          5. Patients that rule in for MI and have Platelet count > 100,000.

          6. Patients with platelet count < 20,000.
Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment (MCI)
MeSH terms: Cognitive Dysfunction
Intervention: Behavioral Activation (BA); Supportive Therapy (ST)
Intervention description: BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.; ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Mild Cognitive Impairment; Memory

Summary:

      The goal of this study is to determine whether increasing participation in cognitive,
      physical, and/or social activities prevents cognitive decline in older African Americans
      (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for
      Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent
      cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this
      hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and
      older) will be randomized to Behavior Activation (BA) (a behavioral intervention that
      increases participation in daily activities) or Supportive Therapy (ST) (a person-centered
      psychotherapy that involves active listening and offering support focusing on participants'
      problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in
      cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and
      better quality of life than ST-treated subjects at 24 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 65 years and older

          -  Having a friend/relative willing to serve as a Knowledgeable Informant (KI)

          -  Diagnosis of aMCI-MD

          -  Self-identified as African American

        Exclusion Criteria:

          -  Psychiatric diagnosis, including dementia and major depression

          -  Sensory deficits that preclude neuropsychological testing

          -  Institutional residence

          -  Reduced life expectancy due to known terminal illness
Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS
Condition: Pneumococcal Vaccines
Intervention: 13 valent Pneumococcal Conjugate Vaccine; 13 valent Pneumococcal Conjugate Vaccine; 13 valent Pneumococcal Conjugate Vaccine; 23-valent Pneumococcal Polysaccharide Vaccine; 23-valent Pneumococcal Polysaccharide Vaccine
Intervention description: 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1; 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1; 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 720.0
Sex: All
Minimum age: 60 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccines, Pneumococcal Conjugate Vaccine

Summary:

      The objective of this study is to compare the safety, tolerability and immunologic response
      to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that
      have never received a previous dose of 23vPS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female, aged 60 to 64 years.

          -  Healthy.

        Exclusion Criteria:

          -  Previous vaccination with any licensed or experimental pneumococcal vaccine.

          -  History of severe adverse reaction associated with a vaccine.

          -  Immunodeficiency.
A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: adalimumab 40 mg; sirukumab 100 mg; sirukumab 50 mg; Placebo
Intervention description: SC injections; SC injections; SC injections; SC injections
Intervention MeSH terms: Adalimumab; 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: 559.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis; CNTO 136; Sirukumab; Adalimumab; HUMIRA®

Summary:

      The primary objective is to investigate the efficacy of sirukumab monotherapy compared with
      adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are
      intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate
      or who are inadequate responders to methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening

          -  Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66
             swollen joints, at screening and at baseline

          -  Have previous or current treatment with methotrexate (MTX) and are considered
             intolerant to MTX, and/or are considered inappropriate for treatment with MTX,
             (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or
             an inadequate responder to methotrexate

          -  Must not have received MTX or any other non-biologic DMARD including but not limited
             to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2
             weeks prior to the first administration of the study agent

          -  C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at
             screening

        Exclusion Criteria:

          -  Has Functional Class IV as defined by the ACR Classification of Functional Status in
             Rheumatoid Arthritis

          -  Has ever received biologic therapy for RA, including but not limited to the following:
             TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept

          -  Has ever used tofacitinib therapy or any other JAK inhibitor

          -  Has received intra-articular, intramuscular, or IV corticosteroids for RA, including
             adrenocorticotrophic hormone during the 4 weeks prior to first study agent
             administration

          -  Has received leflunomide within 24 months before the first study agent administration
             and has not undergone a drug elimination procedure, unless the M1 metabolite is
             measured and is undetectable
A Study to Evaluate Chronic Hepatitis C Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267, ABT-333; Ribavirin; Placebo for ABT-450/r/ABT-267; Placebo for ABT-333; Placebo for ribavirin
Intervention description: ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Capsule (double-blind treatment period), tablet (open-label treatment period); Tablet; Tablet; Capsule
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 636.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus; Hepatitis C Genotype 1; Hepatitis C; Treatment-Naïve; Interferon-Free; Chronic Hepatitis C; Viekira Pak; ombitasvir; paritaprevir; dasabuvir

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and
      ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as
      dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected
      treatment-naïve adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be post-menopausal for at least 2 years or surgically sterile or
             practicing specific forms of birth control

          -  Chronic hepatitis C, genotype 1-infection and HCV RNA level greater than 10,000 IU/mL
             at screening

          -  Subject has never received antiviral treatment for hepatitis C infection

          -  No evidence of liver cirrhosis

        Exclusion Criteria:

          -  Positive screen for drugs or alcohol

          -  Significant sensitivity to any drug

          -  Use of contraindicated medications within 2 weeks of dosing

          -  Certain predefined abnormal laboratory tests

          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Adjuvanted QIV (aQIV); Non-adjuvanted QIV
Intervention description: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV); Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1601.0
Sex: All
Minimum age: 12 Months
Maximum age: 7 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza Vaccine; MF59 adjuvant

Summary:

      Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared
      to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial
      V118_05. Subjects will receive either the Same or Alternate Type of Vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

        In order to participate in this study, all subjects must meet ALL of the inclusion criteria
        described.

          -  Subject's parent/legal guardian has voluntarily given written informed consent after
             the nature of the study has been explained according to local regulatory requirements,
             prior to study entry.

          -  Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve
             subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118_05.

          -  For naïve subjects in parent trial V118_05 to have received two doses of the same
             study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).

        Exclusion Criteria:

          -  Previous immunization with any influenza vaccine (licensed or investigational) within
             6 months prior to enrollment.

          -  Subjects with a clinical condition representing a contraindication to intramuscular
             vaccination or blood draws.

          -  Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to
             participate in another clinical trial while enrolled in V118-05E3.

        Additional eligibility criteria may be discussed by contacting the site.
Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy
Condition: Allergy
Intervention: Short Ragweed Pollen Allergenic Extract; Placebo
Intervention description: Daily sublingual administration of Short Ragweed Pollen Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.; Placebo: Glycero-COCAs sublingual
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 429.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to demonstrate that SLIT administered pre-and
      co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short
      ragweed pollen season.
    

Eligibility criteria:

        Inclusion Criteria:

          -  allergic to ragweed

        Exclusion Criteria:

          -  not allergic to ragweed

          -  history of anaphylaxis

          -  subject with chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled
             hypertension, or other chronic or immunological disease

          -  Asthmatic subjects with FEV1 or PEF less than or equal to 80% predicted

          -  Subjects who have received experimental drug within 30 days prior to study admission

          -  Subjects who have received anit-IgE medications in the last 12 months

          -  Subjects who have received ragweed immunotherapy in the last 3 years

          -  Subjects who are currently users of inhaled, intramuscular, or intravenous
             corticosteroids, tricyclic anti-depressants, beta blockers, and MAO inhibitors

          -  Subjects refusing to sign epi-pen training form

          -  Females who are pregnant or breast feeding