bioihbjkbjnl/mcl2 huggingface dataset:
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Entecavir; Entecavir + Tenofovir
Intervention description: Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks; Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks
Intervention MeSH terms: Tenofovir; Entecavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 669.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effectiveness of entecavir plus tenofovir
      combination therapy with that of entecavir monotherapy. Safety will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis B virus (HBV) infection (hepatitis B e antigen [HbeAg]-positive or
             negative) disease

          -  Nucleoside- and nucleotide-naive

          -  Males or females ≥16 years of age (or minimum age of consent in a given country)

          -  Compensated liver function

          -  HBV DNA >1.72*10*5*IU/mL (approximately 10*6*copies/mL) for HbeAg-positive
             participants

          -  HBV DNA >1.72*10*4*IU/mL (approximately 10*5*copies/mL) for Hbe-Ag-negative
             participants

          -  Alanine aminotransferase level ≥*upper limit of normal (ULN) and ≤10*ULN

        Exclusion Criteria:

          -  Evidence of decompensated cirrhosis

          -  Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus

          -  Laboratory values out of protocol-specified range
A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: SYM-1219; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical trial is to test the safety and efficacy of the oral
      investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are premenopausal adult females or post menarchal adolescent girls ≥12 years of age in
             good general health

          -  Have a clinical diagnosis of bacterial vaginosis, defined as having all of the
             following criteria:

          -  Off-white (milky or gray), thin, homogeneous vaginal discharge

          -  Vaginal pH ≥ 4.7

          -  Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic
             examination of the vaginal saline wet mount

          -  A positive 10% KOH Whiff test

          -  Have a Gram stain slide Nugent Score ≥ 4 at the Baseline Visit (Day 1)

        Exclusion Criteria:

          -  Are pregnant, lactating, or planning to become pregnant during the study

          -  Are menstruating or have vaginal bleeding at the Baseline Visit (Day 1)

          -  Are suspected clinically (or confirmed diagnostically) of having alternative causes of
             vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis,
             Neisseria gonorrhoeae or Herpes simplex

          -  Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14
             days prior to the Baseline Visit (Day 1)
Pilot Trial of Deferasirox in the Treatment of Porphyria Cutanea Tarda
Condition: Porphyria Cutanea Tarda
MeSH terms: Porphyria Cutanea Tarda; Porphyrias, Hepatic; Porphyria, Erythropoietic; Porphyrias
Intervention: Deferasirox
Intervention description: 250 mg of deferasirox once daily for 6 months
Intervention MeSH terms: Deferasirox
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Exjade PCT Study; PCT Study; Porphyria Cutanea Tarda

Summary:

      To determine the efficacy and tolerability of deferasirox in the treatment of Porphyria
      Cutanea Tarda.

      Primary objective - the elimination of all blistering within 6 months of treatment.

      Secondary objective - decrease in total body iron levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of Porphyria Cutanea Tarda based on clinical exam and 24-hour urine
             porphyrin levels

          -  have Porphyria Cutanea Tarda for at least 3 months prior to enrollment with active
             blistering (3 blisters or erosions per month)

          -  women of childbearing potential must use an effective method of contraception during
             the study, however this cannot include hormonal contraception (oral contraceptives,
             hormone patches, Depo-Provera injections, NUVA Ring, etc.)

          -  treatment naive patients or patients unresponsive or intolerant of phlebotomy

          -  Ferritin level is greater than or equal to 25ng/mL

        Exclusion Criteria:

          -  patients with serum creatinine above the upper limit of normal

          -  patients receiving phlebotomy who are controlled on this therapy

          -  pregnant or breast feeding females

          -  patients with liver transaminases more than 5 times the upper limit of normal

          -  patients with a history of hypersensitivity to deferasirox

          -  patients with a history of pre-existing renal condition, or receiving medication that
             depresses renal function

          -  patients on other chelators

          -  history of non-compliance to medical regimens.
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
Condition: Anemia
MeSH terms: Anemia
Intervention: Epoetin alfa or beta; RO0503821 (1x/2 Weeks); RO0503821 (1x/4 Weeks)
Intervention description: intravenously 3 times weekly for 52 weeks, as prescribed; 60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.; 120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 673.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of intravenous Mircera, given as maintenance
      treatment for renal anemia in chronic kidney disease patients on dialysis who were previously
      receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target
      sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  chronic renal anemia;

          -  on dialysis therapy for at least 12 weeks before screening;

          -  receiving IV epoetin for at least 8 weeks before screening.

        Exclusion Criteria:

          -  women who are pregnant, breastfeeding or using unreliable birth control methods;

          -  administration of another investigational drug within 4 weeks before screening, or
             during the study period.
Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Imatinib; Sildenafil; Bosentan
Intervention description: Film coated tablets, oral administration; Oral Administration; Oral Administration
Intervention MeSH terms: Imatinib Mesylate; Bosentan; Sildenafil Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; Pulmonary Vascular Resistance; Imatinib; Bosentan; Sildenafil

Summary:

      The purpose of this study was to investigate the effects of QTI571 (imatinib) on
      pharmacokinetics of bosentan and sildenafil at steady state when co-administered to
      participants with pulmonary arterial hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with Pulmonary arterial hypertension (PAH) in World Health Organization
             (WHO) Diagnostic Group 1, with pulmonary vascular resistance > 800 dyne*sec*cm^-5,

          -  On stable doses of bosentan and sildenafil

        Exclusion Criteria:

          -  Other diagnosis of PAH in World Health Organization (WHO) Diagnostic Group 1 such as
             congenital large or small unrepaired systemic to pulmonary shunts, portal
             hypertension, Human Immunodeficiency Virus (HIV) infection, glycogen storage disease,
             Gaucher's disease, hereditary hemorrhagic teleangiectasia, hemoglobinopathies,
             myeloproliferative disorders, veno-occlusive pulmonary disease

          -  Significant lung diseases not related to PAH

          -  Significant cardiovascular system disorders, hematological system disorders, liver
             insufficiency

          -  Significant diseases in other organ system.

        Other protocol-defined inclusion/exclusion criteria may apply
Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1
Condition: Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Glecaprevir/Pibrentasvir
Intervention description: Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic hepatitis C virus (HCV); Hepatitis; HCV genotype; aspartate aminotransferase; platelet; Aspartate aminotransferase to Platelet Ratio Index (APRI); glecaprevir; pibrentasvir; Sustained Virologic Response 12 weeks post dosing (SVR12)

Summary:

      A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in
      treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and
      with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and
             indeterminate GT may be acceptable.

          -  Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or
             equal to 1, at time of screening.

          -  Does not have current active hepatitis B virus infection defined as:

               -  positive hepatitis B surface antigen (HBsAg), OR

               -  hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of
                  quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core
                  (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])

          -  Platelets ≥ 150,000 cells/mm³

          -  Albumin ≥ lower limit of normal (LLN)

          -  Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥
             1,000 IU/mL at Screening and for at least 6 months before Screening.

          -  No past history/evidence of cirrhosis.

          -  No history of hepatocellular carcinoma.

          -  Hepatitis C virus treatment-naïve (had not received a single dose of any approved or
             investigational anti-HCV medication).

          -  If female, the subject must not be pregnant, breastfeeding, or considering becoming
             pregnant during the study and for 30 days after the last dose of study drug.
A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.
Condition: Pain
Intervention: OROS hydromorphone HCl; Oxycodone
Intervention description: 8 to 32 mg once daily for 52 weeks (flexible dosing); 10, 20, or 40 mg twice a day for 52 weeks (flexible dosing)
Intervention MeSH terms: Oxycodone; Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 504.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic noncancer pain; pain; analgesia; analgesic opioid; oxycodone; hydromorphone

Summary:

      The purpose of this study is to compare the effectiveness and safety of sustained- release
      hydromorphone, formulated to release slowly over time, taken once daily, and controlled-
      release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will
      also determine the dose of sustained-release hydromorphone that provides a level of pain
      control that is equal to the pain control provided by control-released oxycodone
      (equi-analgesic dosage).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with chronic noncancer pain severe enough to require continuous opioid
             therapy (a score of at least 5 in "pain right now" on a 11 point numeric rating scale)
             who have never received an opioid or are currently treated with a weak opioid, and who
             experience insufficient pain control.

        Exclusion Criteria:

          -  Patients who have been treated with strong opioids (including hydromorphone and
             oxycodone) within the last 4 weeks prior to study inclusion or who will probably
             undergo any treatment (e.g. neurological techniques, surgery) within the next 6
             months, which may abruptly alter degree or nature of pain experienced

          -  patients with a history of disease(s), current illness, or therapy which would
             preclude them from participation in the study

          -  and patients who are pregnant or nursing.
Safety and Efficacy of CDB-2914 for Emergency Contraception
Condition: Emergency Contraception
MeSH terms: Emergencies
Intervention: CDB-2914
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1623.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing
      pregnancy when taken 3 to 5 days after unprotected sexual intercourse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or more

          -  Menstruating women with regular menstrual cycle between 24 and 35 days and
             intra-individual variations less than or equal to 5 days

          -  Request emergency contraception between 48 hours and 120 hours after unprotected
             intercourse as defined by lack of contraceptive use, or condom breakage (including
             condoms lubricated with spermicide) or other barrier contraceptive method failure

          -  No current use of hormonal contraception and having had at least one complete
             menstrual cycle (2 menses) since having stopped hormonal contraception

          -  For women with a recent history of Depo Provera use, the most recent injection must
             have been at least 9 months before study entry and followed by at least one complete
             menstrual cycle (2 menses)

          -  Willing to not use hormonal methods of contraception until study completion

          -  At least one complete menstrual cycle (2 menses) post delivery, miscarriage or
             abortion

          -  Able to provide informed consent in English

          -  Give voluntary, written informed consent, and agree to observe all study requirements
             (the subject needs to be available for follow-up over the next 6 weeks)

          -  Willing to abstain from further acts of unprotected intercourse during participation
             in the study and until pregnancy status has been ascertained

        Exclusion Criteria:

          -  One or more acts of one unprotected intercourse more than 120 hours before requesting
             emergency contraception in the current cycle

          -  All acts of unprotected intercourse (in the current cycle) within 48 hours of
             presentation

          -  Currently pregnant as confirmed by positive HSUP test performed at screening

          -  Currently breast-feeding

          -  Current use of hormonal contraception

          -  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

          -  Currently enrolled in any other trial of an investigational medicine
Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Otelixizumab; Placebo
Intervention description: infusion; Infusion
Intervention MeSH terms: Muromonab-CD3
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 179.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: new onset type 1 diabetes; juvenile diabetes; T1DM; Type 1 diabetes

Summary:

      DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective
      is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in
      insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed
      meal-stimulated C-peptide.

      Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3
      otelixizumab, 1/3 placebo). These study agents will be administered as an addition to
      insulin, diet, and other standard of care treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 12-17

          -  Diagnosis of diabetes mellitus, consistent with ADA criteria

          -  No more than 90 days between diagnosis and administration of study compounds

          -  Requires insulin for type 1 diabetes mellitus, or has required insulin at some time
             between diagnosis and administration of study compounds. In Canada, has to be using
             insulin at the time of dosing.

          -  Stimulated C-peptide level greater than 0.20 nmol/L and less than or equal to 3.50
             nmol/L

          -  Positive for one or more of the autoantibodies typically associated with T1DM:
             antibody to glutamic acid decarboxylase (anti-GAD); antibody to protein tyrosine
             phosphatase-like protein (anti-IA-2); zinc transporter autoantibodies (ZNT8); insulin
             autoantibodies (IAA). A subject who is positive for insulin autoantibodies (IAA) and
             negative for the other autoantibodies will only be eligible if the subject has used
             insulin for less than 7 days total.

        Exclusion Criteria:

        •Other, significant medical conditions based on the study doctor's evaluation
A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced Cancer
Condition: Neoplasms
Intervention: Herceptin
Intervention description: Herceptin will be administered as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
Intervention MeSH terms: Trastuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to provide continued access to intravenous (IV) Herceptin and to
      evaluate long-term outcomes and overall safety in participants with stable disease and human
      epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who
      have completed a prior study with IV Herceptin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ongoing participants from any completed global Roche-sponsored Herceptin trial

          -  Participants enrolled in any Roche-sponsored Herceptin trial who have at least stable
             disease (or whose disease has not recurred) during Herceptin therapy at the end of the
             lead-in trial

          -  Available study termination data (including tumor assessment and laboratory data) on
             the Case Report Form for the lead-in trial

          -  Judged eligible by the investigator following a thorough risk/benefit assessment, if
             signs of chronic heart failure developed during the lead-in trial

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  Women of childbearing potential unless using effective contraception as determined by
             the investigator

          -  Severe dyspnea at rest requiring supplementary oxygen therapy

          -  Severe uncontrolled systemic disease