bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Tenofovir disoproxil fumarate (TDF) tablets; Adefovir dipivoxil (ADV) tablets
Intervention description: white, almond-shaped, film-coated tablets containing 300mg of TDF; white to off-white, round, biconvex tablets containing 10mg of ADV
Intervention MeSH terms: Tenofovir; Adefovir; Adefovir dipivoxil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 512.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: tenofovir disoproxil fumarate; chronic hepatitis B; adefovir dipivoxil

Summary:

      This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate
      the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This
      study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating
      Chinese subjects with CHB (hepatitis B e antigen [HBeAg] positive subjects and HBeAg negative
      subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF
      300 mg administered once daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HBeAg positive/negative CHB with blood HBVDNA≥10^5 copies/mL and elevated ALT

          -  Nucleoside and nucleotide naïve CHB subjects. Previous lamivudine treatment is allowed
             in less than 10% of the total study population

        Exclusion Criteria:

          -  subjects with hepatocellular carcinoma (HCC) potential or decompensated liver disease

          -  subjects with acute liver disease due to other causes

          -  subjects with medication history of immunosuppressive therapy, immunomodulatory
             therapy, systemic cytotoxic agents, chronic antiviral agents including Chinese herbal
             medicines known to have activity against HBV (e.g., lamivudine, hepatitis B
             immunoglobulin (HBIg)) within the previous 6 months prior to randomisation into this
             study
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness; Paresis
Intervention: ARGX-113; Placebo
Intervention description: Intravenous administration of ARGX-113; Intravenous administration of placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the
      efficacy, safety, tolerability, quality of life and impact on normal daily activities of
      ARGX-113 in patients with gMG.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with the ability to understand the requirements of the trial, provide written
             informed consent, and comply with the trial protocol procedures.

          2. Male or female patients aged ≥ 18 years.

          3. Diagnosis of MG with generalized muscle weakness meeting the clinical criteria for
             diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) class
             II, III, IVa and IVb.

        Other, more specific inclusion criteria are defined in the protocol

        Exclusion Criteria:

          1. Pregnant and lactating women, and those intending to become pregnant during the trial
             or within 90 days after the last dosing.

          2. Male patients who are sexually active and do not intend to use effective methods of
             contraception during the trial or within 90 days after the last dosing or male
             patients who plan to donate sperm during the trial or within 90 days after the last
             dosing.

          3. MGFA Class I and V patients.

          4. Patients with worsening muscle weakness secondary to concurrent infections or
             medications.

          5. Patients with known seropositivity or who test positive for an active viral infection
             at Screening with:

               -  Hepatitis B Virus (HBV) (except patients who are seropositive because of HBV
                  vaccination)

               -  Hepatitis C Virus (HCV)

               -  Human Immunodeficiency Virus (HIV)

        Other, more specific exclusion criteria are further defined in the protocol.
A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 122-0551 Foam; Vehicle Foam
Intervention description: Topical Foam; Topical Foam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and
      safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with
      plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2%
             and no more than 12% affected body surface area.

          -  Subject has an Investigator's Global Assessment (IGA) score of at least three
             (moderate) at study start.

          -  If subject is a woman of childbearing potential, she must have a negative urine
             pregnancy test and agree to use an effective form of birth control for the duration of
             the study.

        Exclusion Criteria:

          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

          -  Subject has a physical condition which, in the investigator's opinion, might impair
             evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk
             by study participation.

          -  Subject has used any phototherapy (including laser), photo-chemotherapy or other forms
             of photo based therapy for the treatment of their psoriasis within 30 days prior to
             study start.

          -  Subject has used any systemic methotrexate, retinoids, systemic corticosteroids
             [including intralesional, intra-articular, and intramuscular corticosteroids],
             cyclosporine or analogous products within 90 days prior to study start.

          -  Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental
             therapy) within five half-lives of the biologic prior to study start.

          -  Subject had prolonged exposure to natural or artificial sources of ultraviolet
             radiation within 30 days prior to study start or is intending to have such exposure
             during the study.
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mirikizumab SC; Mirikizumab IV; Placebo SC
Intervention description: Administered SC; Administered IV; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1177.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Interleukin-23 (IL-23); IL-23p19; Inflammatory Bowel Disease

Summary:

      The purpose of this study is to evaluate the efficacy and safety of mirikizumab as
      maintenance therapy in participants who completed as clinical responders in the prior 12-week
      induction study LUCENT-1 (NCT03518086).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and
             without early termination of study drug.

          -  Are willing and able to complete the scheduled study assessments, including endoscopy
             and daily diary entry.

          -  If female, must meet the contraception requirements.

        Exclusion Criteria:

          -  Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified
             (indeterminate colitis) during the induction study AMAN (NCT03518086).

          -  Participants with a bowel resection or other surgery for the treatment of UC during
             the previous induction study AMAN (NCT03518086), or are likely to require surgery for
             the treatment of UC during study AMBG.

          -  Participants with evidence of colonic dysplasia or have been diagnosed with cancer of
             the gastrointestinal tract during study AMAN (NCT03518086).

          -  Participants diagnosed with clinically important infection including, but not limited
             to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the
             induction study AMAN (NCT03518086).

          -  Participants who initiate a new prohibited medication during the induction study AMAN
             (NCT03518086).

          -  Participants with certain laboratory abnormalities prior to start of AMBG that would
             require permanent discontinuation from study drug.
Open Label Study of Long Term Safety Evaluation of Alirocumab
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Lipid-Modifying Therapy (LMT)
Intervention description: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.; Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Intervention MeSH terms: Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 986.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering
      therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had
      completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and
      LTS11717 (NCT01507831).

      Secondary Objectives:

        -  To evaluate the long-term efficacy of alirocumab on lipid parameters.

        -  To evaluate the long-term immunogenicity of alirocumab.
    

Eligibility criteria:

        Inclusion criteria:

        Participants with heFH who had completed one of the four parent studies (EFC12492,
        R727-CL-1112, EFC12732 and LTS11717).

        Exclusion criteria:

        Significant protocol deviation in the parent study; Any permanent treatment discontinuation
        from the parent study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Olaparib; Paclitaxel; Placebo
Intervention description: Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily.; IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.; Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.
Intervention MeSH terms: Paclitaxel; Olaparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 525.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This study is a phase III, multi-centre study of olaparib in combination with paclitaxel,
      compared with placebo in combination with paclitaxel in patients with advanced gastric cancer
      who have progressed following first-line therapy. Patients will be from China, Japan , Korea
      and Taiwan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced gastric cancer (including GEJ) that has progressed following first-line
             therapy.

          -  Patients must be ≥18 years of age. Age ≥20 if Japanese

          -  Provision of tumour sample (from either a resection or biopsy).

          -  At least one lesion (measurable and/or non-measurable) that can be accurately assessed
             by imaging (CT/MRI) at baseline and following up visits.

        Exclusion Criteria:

          -  More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy
             with more than 6 month wash out period) for the treatment of gastric cancer in the
             advanced setting.

          -  Any previous treatment with a Polyadenosine 5'-diphosphoribose [poly-(ADP-ribose)]
             polymerisation (PARP) inhibitor, including olaparib.

          -  Patients with second primary cancer, except: adequately treated non-melanoma skin
             cancer, curatively treated in-situ cancer of the cervix, or other solid tumours
             curatively treated with no evidence of disease for ≥5 years.

          -  Human Epidermalgrowth Factor Receptor-2 (HER2) positive patients.
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Sotagliflozin; Sotagliflozin; Placebo
Intervention description: High dose Sotagliflozin, once daily, before the first meal of the day; Low dose Sotagliflozin,once daily, before the first meal of the day; Placebo, once daily, before the first meal of the day
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 782.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: High level of sugar (glucose) in the blood

Summary:

      This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose
      or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when
      used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have
      inadequate glycemic control with insulin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant who gave written informed consent to participate in the study in
             accordance with local regulations.

          -  Adult participants 18 years and older with a diagnosis of T1D made at least 1 year
             prior to informed consent.

          -  Participants treated with insulin or insulin analog delivered via continuous
             subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).

          -  Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed
             the study diary as required per protocol.

          -  At the Screening Visit, A1C was between 7.0% to 11.0%.

          -  Females of childbearing potential must use an adequate method of contraception and
             have a negative pregnancy test.

        Exclusion Criteria:

          -  Use of antidiabetic agent other than insulin or insulin analog at the time of
             screening.

          -  Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to
             screening.

          -  Chronic systemic corticosteroid use.

          -  Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the
             Investigator.
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Risankizumab; Autoinjector
Intervention description: Risankizumab to be injected subcutaneously (SC); Single dose pre-filled autoinjector containing risankizumab for SC injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Risankizumab; Plaque Psoriasis

Summary:

      The objectives of this study were to evaluate the usability of the combination product of
      risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and
      tolerability of risankizumab administered by AI for the treatment of adult participants with
      moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the
             baseline visit

          -  Participant meets following disease activity criteria:

               -  Stable moderate to severe chronic plaque psoriasis, defined as ≥ 10% body surface
                  area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score
                  ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 12 at Screening and baseline
                  visit

               -  Candidate for systemic therapy as assessed by the investigator

        Exclusion Criteria:

          -  Participant has history of active skin disease other than psoriasis that could
             interfere with the assessment of psoriasis

          -  Participant has history of erythrodermic psoriasis, generalized or localized pustular
             psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset
             guttate psoriasis

          -  Participant has previous exposure to risankizumab
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole Lauroxil; Paliperidone Palmitate
Intervention description: Intramuscular injection; study drug provided using a pre-filled syringe; Intramuscular injection
Intervention MeSH terms: Aripiprazole; Paliperidone Palmitate; Aripiprazole lauroxil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alkermes; schizophrenia; aripiprazole lauroxil; ARISTADA; ARISTADA INITIO

Summary:

      This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA
      INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a diagnosis of schizophrenia

          -  Requires acute treatment for symptoms of schizophrenia

          -  Willing and able to be confined to an inpatient study unit for up to 3-4 weeks

          -  Has experienced at least one previous hospitalization for schizophrenia

          -  Has been able to achieve outpatient status for more than 3 months in the past year

          -  Has a body mass index (BMI) between 18.0 and 40.0 kg/m^2

          -  Resides in a stable living situation when not hospitalized

          -  Has an identified reliable caregiver (for example, family member)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Poses a current suicide risk

          -  Pregnant, planning to become pregnant, or breastfeeding

          -  Initiated first antipsychotic treatment within the past 12 months

          -  Has received a long-acting injectable antipsychotic in the past 3 months

          -  Has participated in a clinical study involving any investigational product within the
             past 3 months, or is currently participating in a clinical study involving an
             investigational product.

          -  A positive urine drug test for drugs of abuse

          -  Additional criteria may apply
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2539.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metabolism and Nutrition Disorder; Prediabetes

Summary:

      This is a study of tirzepatide in participants with overweight and obesity. The main purpose
      is to learn more about how tirzepatide affects body weight. The study has two phases: A main
      phase and an extension phase. The main phase of the study will last 72 weeks. Participants
      with prediabetes will continue in the extension for another 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and
             previous diagnosis with at least one of the following comorbidities: hypertension,
             dyslipidemia, obstructive sleep apnea, cardiovascular disease

          -  History of at least one unsuccessful dietary effort to lose body weight

        Exclusion Criteria:

          -  Diabetes mellitus

          -  Change in body weight greater than 5 kg within 3 months prior to starting study

          -  Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of
             obesity

          -  History of pancreatitis

          -  Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia syndrome type 2 (MEN-2)

          -  History of significant active or unstable major depressive disorder (MDD) or other
             severe psychiatric disorder within the last 2 years

          -  Any lifetime history of a suicide attempt