bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1
Condition: Primary Hyperoxaluria Type 1 (PH1)
MeSH terms: Hyperoxaluria, Primary
Intervention: Placebo; Lumasiran
Intervention description: Placebo by SC injection; Lumasiran by SC injection
Intervention MeSH terms: Lumasiran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: PH1; Primary hyperoxaluria; RNAi therapeutic; siRNA; AGT; Oxalate

Summary:

      The purpose of this study is to evaluate the efficacy and safety of lumasiran in children and
      adults with primary hyperoxaluria type 1 (PH1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to provide written informed consent or assent and to comply with study
             requirements

          -  Confirmation of PH1 disease

          -  Meet the 24 hour urine oxalate excretion requirements

          -  If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90
             days

        Exclusion Criteria:

          -  Clinically significant health concerns (with the exception of PH1) or clinical
             evidence of extrarenal systemic oxalosis

          -  Clinically significant abnormal laboratory results

          -  Known active or evidence of HIV or hepatitis B or C infection

          -  An estimated GFR of < 30 mL/min/1.73m^2 at screening

          -  Received an investigational agent within 30 days or 5 half-lives before the first dose
             of study drug or are in follow-up of another clinical study

          -  History of kidney or liver transplant

          -  Known history of multiple drug allergies or allergic reaction to an oligonucleotide or
             GalNAc

          -  History of intolerance to subcutaneous injection

          -  Women who are pregnant, planning a pregnancy, or breast-feeding or those of child
             bearing potential and not willing to use contraception

          -  History of alcohol abuse within the last 12 months, or unable or unwilling to limit
             alcohol consumption throughout the study
Maintaining Nonsmoking
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; Initial Individual counseling; Check-ins with medical staff; Extended Individual Counseling - Health Model; Extended Individual Counseling - Relapse Prevention Model
Intervention description: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.; Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.; Monthly brief (10-15 minutes) meetings with medical staff.; Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.; Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration.
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking; Tobacco; Nicotine; Smoking cessation

Summary:

      The research is based on a chronic disorder model of cigarette smoking which suggests that
      long-term treatment targeted to prevent relapse may be useful. Based on this model, the
      investigators have developed a relapse prevention treatment to intervene on five areas
      important in relapse prevention, including fluctuating motivation, depression, withdrawal,
      weight gain, and social support. This treatment protocol has produced high long-term
      abstinence rates when implemented in a clinical research setting. The current study will
      evaluate the treatment model when implemented in a medical outpatient setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Must be smoking 5 or more cigarettes per day

        Exclusion Criteria:

          -  Previous history of bipolar/manic-depressive disorder

          -  Current diagnosis of schizophrenia

          -  Acute life threatening diseases

          -  Evidence of alcohol or other drug abuse so severe that the patient is judged to be
             potentially unable to comply with the protocol

          -  Pregnancy or lactation

          -  Individuals with out of normal range blood pressure, active angina, valve disease,
             valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery
             bypass grafting (CABG) within one year, and Congestive heart failure (CHF)
EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
Condition: Generalized Anxiety Disorder (GAD)
MeSH terms: Anxiety Disorders
Intervention: Extended-release lorazepam; Placebo
Intervention description: Extended-release lorazepam capsules; Placebo capsules
Intervention MeSH terms: Lorazepam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 495.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients
      with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5)
      and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will
      be measured by a statistically significant greater mean reduction from baseline compared to
      endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton
      Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women between the ages of 18-65 years and

          -  Diagnosed with GAD and

          -  No other psychiatric conditions, and are otherwise medically healthy.

        Exclusion Criteria:

          -  Women who are pregnant or lactating.
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
Condition: Melanoma; Skin Cancer
MeSH terms: Melanoma
Intervention: BMS-986205; Nivolumab; Placebo
Intervention description: specified dose on specified day; Specified dose on specified day; Specified dose on specified day
Intervention MeSH terms: Nivolumab; Linrodostat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to
      nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to
      be removed by surgery, and has not previously been treated
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  12 years and older unless not permitted by local regulations; in that case 18 years
             old and older

          -  Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to
             1

          -  Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the
             American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)

          -  Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or
             metastatic melanoma)

          -  Measurable disease per RECIST v1.1

        Exclusion Criteria:

          -  Active brain metastases or leptomeningeal metastases

          -  Uveal or ocular melanoma

          -  Participants with active, known, or suspected autoimmune disease

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured

        Other protocol defined inclusion/exclusion criteria could apply
Docetaxel in Node Positive Adjuvant Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Docetaxel; 5-fluorouracil; Doxorubicin; Cyclophosphamide
Intervention description: intravenous; intravenous; intravenous; intravenous
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Fluorouracil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1491.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: adjuvant treatment

Summary:

      The purpose of this study was to compare disease-free survival after treatment with docetaxel
      in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with
      doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary
      lymph nodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven breast cancer (invasive adenocarcinoma with at least one
             axillary lymph node showing evidence of tumor among a minimum of six resected lymph
             nodes).

          -  Definitive surgical treatment must be either mastectomy, or breast conserving surgery
             with axillary lymph node dissection for operable breast cancer. Margins of resected
             specimen from definitive surgery must be histologically free of invasive
             adenocarcinoma and ductal carcinoma.

        Exclusion criteria:

          -  Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy,
             chemotherapy).

          -  Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.
C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: C1 Esterase Inhibitor
Intervention description: Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: C1 Inhibitor; Hereditary angioedema; Acute HAE attack

Summary:

      Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional
      C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be
      life-threatening and may even result in fatalities, especially in case of involvement of the
      larynx.The planned extension study is designed to enrol subjects that participated in the
      pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24
      months or until the licensing procedure for C1-INH is finalized, whatever comes first.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented congenital C1-INH deficiency

          -  Acute HAE attack

          -  Participation in base study CE1145_3001 (NCT00168103)

        Key Exclusion Criteria:

          -  Acquired angioedema

          -  Treatment with any other investigational drug besides CE1145 in the last 30 days
             before study entry
A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: TEZ/IVA; IVA; Placebo; Placebo
Intervention description: Participants weighing <40 kg received TEZ 50 mg/IVA 75 mg FDC tablet and those weighing ≥40 kg received TEZ 100 mg/IVA 150 mg FDC tablet.; Participants weighing <40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet.; Placebo matched to TEZ/IVA FDC; Placebo matched to IVA
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA)
      in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the
      F508del mutation (F/F) or heterozygous for F508del with an eligible residual function
      mutation (F/RF).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous for F508del or heterozygous for F508del and an RF mutation (as defined in
             the protocol).

          -  Participants with ppFEV1 of ≥70 percentage points adjusted for age, sex, height.

          -  Participants with a screening LCI2.5 result ≥7.5.

          -  Participants who are able to swallow tablets.

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension.

          -  Colonization with organisms associated with a more rapid decline in pulmonary status.

          -  Solid organ or hematological transplantation.

        Other protocol defined Inclusion/Exclusion criteria may apply.
Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: GP2015
Intervention description: Enbrel comparator
Intervention MeSH terms: GP2015
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Biosimilars; Rheumatoid Arthritis; Etanercept

Summary:

      Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate
      to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic
      drugs (DMARD) including methotrexate (MTX).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR
             20110 criteria >/= 6 months at the time of baseline visit

          -  Patient must have active disease defined as DAS28-CRP>/=3.2

          -  Patients must have CRP level above ULN >5mg/l) or erythrocyte sedimentation rate (ESR)
             >/=28mm/h

          -  Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after
             proper dose escalation according to local standards

        Exclusion Criteria:

          -  Previous exposure to etanercept in the past

          -  Patients with functional status class IV according to the ACR 1991 revised criteria

          -  History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by
             imaging and/or by the QuantiFERON-TB Gold test at screening
Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin
Condition: Urogential Chlamydia Trachomatis Infection
MeSH terms: Infections; Communicable Diseases; Chlamydia Infections
Intervention: Doxycyline Hyclate tablet; Vibramycin (doxycyline hyclate) capsule
Intervention description: 200 mg tablet, once daily for 7 days; 100 mg capsule, twice daily for 7 days, over-encapsulated
Intervention MeSH terms: Doxycycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 495.0
Sex: All
Minimum age: 19 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Chlamydia

Summary:

      Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day
      for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7
      days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary
      efficacy endpoint is microbiological cure at Day 28. Safety assessments are adverse events,
      changes in vital signs and laboratory test results.
    

Eligibility criteria:

        Inclusion Criteria:

          -  19-45 years of age, male or female

          -  presumed diagnosis of urogenital C. trachomatis infection

          -  use condoms during sexual activity during study (enrollment thru day 28)

        Exclusion Criteria:

          -  Clinical diagnosis pelvic inflammatory disease or epididymitis at baseline

          -  Diagnosis of N. gonorrhoea

          -  HIV infection

          -  Active Hepatitis B or C infection

          -  Prior hysterectomy (partial or total)

          -  Treatment with antimicrobial therapy with known activity against urogenital C.
             trachomatis within 28 days of enrollment
A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Intervention: Duloxetine Hydrochloride
Intervention description: Administered orally
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 9 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine
      hydrochloride in Japanese children and adolescents with depressive disorder.
    

Eligibility criteria:

        -  a) Participants extended from B058(1701A3631) study.

          -  b) New participants.

        Inclusion Criteria

          -  a) Participants who have completed 7 weeks of dosing in the B058(1701A3631) study and
             give signed informed consent to continue duloxetine administration in this study.

          -  b) Participants diagnosed with Major Depressive Disorder or persistent depressive
             disorder and completely meet the criteria of major depressive episode as defined by
             the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with
             the Mini International Neuropsychiatric Interview for Children and Adolescents
             (MINI-KID) ver.7.0.2.

          -  b) Participants whose incipient age of depression was ≥7 years old.

        Exclusion Criteria:

          -  a, b) Have a current or previous diagnosis (DSM-5) of the following as judged by the
             investigator:

               -  Neurodevelopmental disorders

               -  Schizophrenia spectrum and other psychotic disorders

               -  Bipolar and related disorders

               -  Trauma and stressor-related disorders

               -  Disruptive · Impulse Control · and Conduct disorders

          -  a, b) Have a current diagnosis (DSM-5) of the following as judged by the investigator:

               -  Obsessive-compulsive and related disorders

               -  Anorexia nervosa, Bulimia nervosa, Binge-eating disorder

               -  Sleep-wake disorders

               -  Neurocognitive disorders

               -  Disruptive mood dysregulation disorder

          -  a, b) Have personality disorders, in the judgment of the investigator.
Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202
Condition: Central Abdominal Bulging
Intervention: LIPO-202; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of
      clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18
      (NCT02397499) or LIPO-202-CL-19 (NCT02398188). No risks related to treatment are anticipated
      as subjects will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in
      this follow-on study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or non-pregnant female subjects who completed Study LIPO-202-CL-18 or
             LIPO-202-CL-19

          -  Capable of providing written consent

          -  Willing to comply with the study procedures and schedule

        Exclusion Criteria:

          -  Female subjects who are pregnant or are not using adequate birth control methods

          -  Plan on starting a weight loss or exercise program during the study

          -  Plan to enroll in another investigational drug or device study

          -  Unlikely or unable to adhere to the study visit schedule