bioihbjkbjnl/mcl2 huggingface dataset:
A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Sarilumab; Sulfasalazine; Leflunomide; Bucillamine; Tacrolimus; Mizoribine
Intervention description: Pharmaceutical form:solution; Pharmaceutical form: Tablet Route of administration: Oral; Pharmaceutical form: Tablet Route of administration: Oral; Pharmaceutical form: Tablet Route of administration: Oral; Pharmaceutical form: Capsule Route of administration: Oral; Pharmaceutical form: Tablet Route of administration: Oral
Intervention MeSH terms: Sulfasalazine; Mizoribine; Bucillamine; Tacrolimus; Leflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To document the long-term safety of sarilumab added to non-methotrexate (non-MTX)
      disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.

      Secondary Objective:

      To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.
    

Eligibility criteria:

        Inclusion criteria:

        Diagnosis of rheumatoid arthritis (RA), according to the American College of
        Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis
        Classification Criteria with >=3 months disease duration.

        Moderately to severely active RA defined as:

          -  At least 4 of 68 tender joints and 4 of 66 swollen joints at screening visit.

          -  High sensitivity C-Reactive Protein (hs-CRP) >=4 mg/L or Erythrocyte Sedimentation
             Rate (ESR) >=28 mm/hr at screening visit.

        For the combination stratum:

        Participants who had continuous treatment with non-biologic DMARDs other than MTX for at
        least 12 weeks prior to the randomization and on a stable dose for a minimum of 6 weeks
        prior to screening.

        For the monotherapy stratum:

        Participants who per investigator judgment were any of inappropriate, intolerant or
        inadequate to MTX treatment.

        Exclusion criteria:

        Participants <20 years of age. Prior treatment with tumor necrosis factor (TNF) antagonists
        or any other RA-directed biologic agents without the appropriate off-drug period prior to
        screening.

        Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R)
        antagonist therapies, including but not limited to tocilizumab or sarilumab.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: Clobex® Shampoo; Clobex® Vehicle Shampoo; Clobex® Shampoo
Intervention description: Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks.; Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months.; Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months.
Intervention MeSH terms: Clobetasol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: maintenance; scalp psoriasis; Galderma

Summary:

      The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex®
      Shampoo 0.05% when used twice weekly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 18 years or older.

          -  Subjects with moderate to severe scalp psoriasis

        Exclusion Criteria:

          -  Subjects who needed systemic treatment for their body psoriasis

          -  Subjects with a washout period for topical treatment(s) on the scalp less than:

               -  Corticosteroids 2 weeks

               -  All other anti-psoriasis medications 2 weeks

          -  Subjects with a washout period for systemic treatment(s) less than:

               -  PUVA therapy 4 weeks

               -  Biological therapies 12 weeks

               -  Treatments other than biologicals with a possible efficacy on psoriasis 4 weeks

               -  Treatment known to worsen psoriasis 2 weeks
A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: DCV; SOF; RBV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with
      Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients
      with liver cirrhosis.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation,
        please visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Genotype 3 HCV

          -  HCV RNA ≥10000 IU (International Unit)/mL

          -  Compensated Liver Cirrhosis

          -  BMI 18-40 kg/m2

          -  Previously treated for HCV or never treated for HCV

        Exclusion Criteria:

          -  Infection with HCV other than Genotype 3. Mixed infection of any genotype

          -  Evidence of decompensated liver disease

          -  Previous exposure to NS5A inhibitors

        Other protocol defined inclusion/exclusion criteria could apply
A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Disease Progression
Intervention: Laquinimod
Intervention description: One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1047.0
Sex: All
Healthy volunteers: No
Keywords: Relapsing Multiple Sclerosis

Summary:

      To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled
      MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability
      and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing
      multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all
             Termination visit activities) according to the MS-LAQ-302 protocol.

          2. Women of child-bearing potential must practice an acceptable method of birth control
             [acceptable methods of birth control in this open label extension phase include:
             surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch
             (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's
             vasectomy or double-barrier method (condom or diaphragm with spermicide)] during the
             study and up to 30 days after the last dose of the study drug..

          3. Subjects must be willing and able to comply with the protocol requirements for the
             duration of the study.

          4. Subjects must be able to comprehend, sign and date a written informed consent prior to
             entering the MS-LAQ-302E study.

        Exclusion Criteria:

          1. Premature discontinuation from the MS-LAQ-302 study, for any reason.

          2. Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E)
             visit] or breastfeeding.

          3. Subjects with clinically significant or unstable medical or surgical condition
             detected or worsened during the MS-LAQ-302 study, which preclude safe participation
             and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude
             participation in the MS-LAQ-302E study.

          4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
AZD0585 Phase III Long-term Study in Japan
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: AZD0585; AZD0585 placebo
Intervention description: 1g soft capsule; 1g soft capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 383.0
Sex: All
Minimum age: 20 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      This study is a randomised, double-blind phase III long-term study to evaluate efficacy and
      safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients
      with hyperlipidemia accompanied by hypertriglyceridemia .
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Japanese men or women, ≥20 years of age.

          -  Subjects must meet all of the following criteria;

               1. Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range
                  150 - 499 mg/dL

               2. %TG change between Visit 2 and Visit 3 must be within 30%

               3. %LDL-C change between Visit 2 and Visit 3 must be within 25%

        Key Exclusion Criteria:

          -  Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters.

          -  Known lipoprotein lipase impairment or deficiency, or Apolipoprotein C-II deficiency
             or familial dysbetalipoproteinemia.

          -  Current or history of pancreatitis.

          -  Type I diabetes mellitus, use of insulin, or haemoglobin A1c >10% at Visit 1.
Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Blood Sampling
Intervention description: At 2, 3, 4, 5, 6 years after booster vaccination.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Immunogenicity; Children; Neisseria meningitidis; Long-term antibody persistence; Safety; Serogroups A, C, W-135, and Y

Summary:

      The purpose of this study is to evaluate the long-term antibody persistence as well as safety
      of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster
      vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039
      Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039
      (NCT00474266) at 12 through 23 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL the following criteria at study entry:

          -  Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
             of the investigator, can and will comply with the requirements of the protocol.

          -  A male or female who has received primary and booster vaccination with the MenACWY-TT
             or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039
             Y2, 3, 4, 5 (112036), respectively.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If ANY exclusion
        criterion applies, the subject must not be included in the study:

          -  Child in care.

          -  History of meningococcal disease.

          -  Administration of a meningococcal polysaccharide or a meningococcal polysaccharide
             conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT:
             039 Y2, 3, 4, 5 (112036).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma
Condition: Nasal Polyps
MeSH terms: Nasal Polyps; Polyps
Intervention: Fevipiprant 150 mg; Fevipiprant 450 mg; Placebo
Intervention description: Fevipiprant (QAW039) 150 mg once daily administered orally as tablet; Fevipiprant (QAW039) 450 mg once daily administered orally as tablet; Placebo once daily administered orally as tablet
Intervention MeSH terms: Indoleacetic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double blind, double dummy study design.
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nasal Polyposis; Asthma; Nasal polyp score (NPS); Nasal congestion score (NCS); Bronchial Diseases; Lung Diseases; Nose Diseases; Respiratory Hypersensitivity; Fevipiprant; QAW039

Summary:

      A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg,
      compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing
      endoscopic nasal polyp score in adult (≥ 18 years) patients with nasal polyposis and
      concomitant asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score
             >= 4 with minimum score of 2 in each nostril.

          -  Concomitant diagnosis of asthma for a period of at least 6 months prior to screening.

          -  Patients on stable asthma treatment of at least inhaled corticosteroids (any dose)
             alone for at least 6 months prior to screening or ICS for 6 months prior to screening
             with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to
             screening.

        Exclusion Criteria:

          -  Asthma exacerbation, within 6 weeks prior to screening, that required systemic
             corticosteroids, hospitalization or emergency room visit.

          -  Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of
             OCS for a period of 1 month or more, within 1 year of screening

          -  Use of biologics for asthma or any other indications, that has the potential to
             interfere/affect either asthma or nasal polyposis disease progression, within 6 months
             of screening.

          -  Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30
             days of screening or during the run-in period.

          -  Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of
             screening.

          -  History of nasal surgery modifying the structure of the nose such that assessment of
             the nasal polyp score is not possible.

          -  Patients with baseline ACQ-5≥1.5
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer
Condition: Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Mirvetuximab soravtansine; Paclitaxel; Pegylated liposomal doxorubicin; Topotecan
Intervention description: Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.; Paclitaxel will be administered per dose and schedule specified in the arm.; Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.; Topotecan will be administered per dose and schedule specified in the arm.
Intervention MeSH terms: Paclitaxel; Maytansine; Doxorubicin; Liposomal doxorubicin; Topotecan; Mirvetuximab soravtansine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 366.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epithelial ovarian cancer; Fallopian tube cancer; Primary peritoneal cancer; IMGN853; ADC; Antibody drug conjugate; ImmunoGen; Antibody; Folate receptor alpha; mirvetuximab soravtansine; Phase 3; platinum-resistant; MIRV

Summary:

      This is a Phase 3, open label, randomized study designed to compare the safety and efficacy
      of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's
      choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal
      cancer and/or fallopian tube cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be diagnosed with advanced epithelial ovarian cancer, primary
             peritoneal cancer or fallopian tube cancer

          -  Participants must have folate receptor alpha positive tumor expression as defined in
             the protocol

          -  Participants must have platinum-resistant ovarian cancer, defined as progression
             within 6 months from completion of a minimum of four cycles of platinum-containing
             therapy.

          -  Participants must have received at least one but no more than three prior systemic
             treatment regimens and for whom single-agent chemotherapy is appropriate as the next
             line of treatment

          -  Participants must have at least one lesion that meets the definition of measurable
             disease by RECIST 1.1

        Exclusion Criteria:

          -  Diagnosis of clear cell, low grade ovarian cancer or mixed tumors

          -  Participants with primary platinum-refractory disease

          -  Serious concurrent illness or clinically relevant active infection as defined in the
             protocol

          -  Prior treatment with mirvetuximab soravtansine

          -  Women who are pregnant or breast feeding
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
Condition: Contraception
Intervention: CDB-2914; Levonorgestrel
Intervention description: Single dose; Single dose
Intervention MeSH terms: Levonorgestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2221.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to
      levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern
             Ireland (UK) and 18 years or more in Ireland and US

          -  present within 120 hours of unprotected intercourse

          -  regular menstrual cycles

          -  No current use of hormonal contraception

          -  Willing to not use hormonal methods of contraception until study completion

          -  At least one complete menstrual cycle (2 menses) post miscarriage, delivery or
             abortion

          -  For women who present more than 72 hours after intercourse, decline the insertion of
             an Intra Uterine Device for emergency contraception

          -  Able to provide informed consent

          -  Willing to abstain from further acts of unprotected intercourse until study completion

        Exclusion Criteria:

          -  One or more acts of unprotected intercourse more than 120 hours

          -  current or recent use of hormonal methods of contraception

          -  currently pregnant or breastfeeding

          -  tubal ligation or current use of IUD

          -  Use of hormonal emergency contraception since last menstrual period

          -  Current use of IUD

          -  Tubal ligation

          -  Partner with a vasectomy

          -  Unsure about the date of the last menstrual period

          -  Severe asthma insufficiently controlled by oral glucocorticoid

          -  Hypersensitivity to the active substance levonorgestrel or any of the excipients of
             the drug products used in the study
A 6-Month Extension Study of OTO-104 in Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Intervention: OTO-104
Intervention description: Single intratympanic injection of 12 mg OTO-104
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label extension study of a single intratympanic injection of OTO-104 given
      every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study
      104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of
      OTO-104) in order to be eligible for this open-label extension study.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3
             (104-201508) clinical study.

          -  Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS
             criteria

        Exclusion Criteria includes, but is not limited to:

          -  Subject is pregnant or lactating.

          -  Subject has a history of immunodeficiency disease.

          -  Subject has experienced an adverse reaction to intratympanic injection of steroids.