bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
Condition: Chronic Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: LDV/SOF; RBV
Intervention description: LDV/SOF 90/400 mg FDC tablet administered orally once daily; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 870.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 1 (GT-1); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; GS-7977; GS-5885; Ribavirin; Open Label; Sofosbuvir; Additional relevant MeSH terms:; Hepatitis; Hepatitis, Chronic; Hepatitis C; Hepatitis C, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Antimetabolites; Molecular Mechanisms of Pharmacological Action

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of
      ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without
      ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic
      genotype 1 HCV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18, with chronic genotype 1 HCV infection

          -  HCV treatment-naive

          -  HCV RNA > 10,000 IU/mL at screening

          -  Cirrhosis determination; a liver biopsy may be required

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Co-infection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
             skin cancers)

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol
Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Fluoride; Fluoride and triclosan
Intervention description: Brush half mouth once with assigned study treatment; Brush half mouth once with assigned study treatment
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective is to develop a method to determine active ingredient uptake in oral care
      products.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteer 18 - 65 years of age (inclusive).

          -  Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding
             third molars)

          -  Able and willing to sign the informed consent form.

          -  Plaque score of at least 1.5 on the modified Quigley-Hein plaque index.

          -  No known history of allergy to personal care/consumer products or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study

        Exclusion Criteria:

          -  Medical condition which requires pre-medication prior to dental procedures/visits

          -  Medical condition which precludes not eating/drinking for 2 hours

          -  Advanced periodontal disease (gum disease)

          -  5 or more decayed, untreated dental sites (cavities)

          -  Diseases of the soft or hard oral tissues

          -  Orthodontic appliances

          -  Abnormal salivary function

          -  Use of drugs that can affect salivary flow

          -  Use of antibiotics one (1) month prior to or during this study

          -  Use of any over the counter medications other than analgesics (i.e. aspirin,
             ibuprofen, acetaminophen, naproxyn, etc)

          -  Pregnant or breastfeeding.

          -  Participation in another clinical study in the month preceding this study

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection
Condition: Chronic HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF; RBV
Intervention description: LDV/SOF 90/400 mg FDC tablet administered orally once daily; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 341.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV)
      fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or
      treatment-experienced Japanese participants with chronic genotype 1 HCV infection.
      Participants receive 12 weeks of treatment and continue assessments during a 24-week
      posttreatment follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight ≥ 40 kg

          -  HCV RNA ≥ 10^5 IU/mL at screening

        Exclusion Criteria:

          -  Current or prior history of any clinically-significant illness (other than HCV)

          -  Pregnant or nursing female or male with pregnant female partner

          -  Chronic liver disease of a non-HCV etiology

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: TC-5214; Placebo
Intervention description: Tablet, oral, twice daily for 8 weeks; Tablet, oral, twice daily for 8 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 319.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression; Safety; add-on therapy

Summary:

      The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like
      medicine tablet or capsule, but contains no active medicine) is safe and effective when taken
      together with another antidepressant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated informed consent before initiation of any study-related
             procedures.

          -  The patient must have a clinical diagnosis of major depressive disorder (MDD) with
             inadequate response to no more than one antidepressant.

          -  Out-patient status at enrollment and randomization.

        Exclusion Criteria:

          -  Patients with a lifetime history of bipolar disorder, psychotic disorder or
             post-traumatic stress disorder.

          -  Patients with a history of suicide attempts in the past year and/or seen by the
             investigator as having a significant history of risk of suicide or homicide.

          -  History of renal insufficiency or impairment or conditions that could affect
             absorption or metabolism of the investigational product in this patient population
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
Condition: Anogenital Human Papilloma Virus Infection; Condyloma Acuminata
MeSH terms: Papillomavirus Infections; Papilloma
Intervention: V501; Placebo
Intervention description: Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant; Formulated with AAHS adjuvant
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1124.0
Sex: Male
Minimum age: 16 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus
      [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to
      26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence
      of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501
      reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection,
      condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal,
      or perineal cancer compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese

          -  No clinical evidence of gross genital lesion suggesting sexually-transmitted disease
             and no clinically present external genital warts

          -  Other inclusion criteria will be discussed with the investigator during screening

        Exclusion Criteria:

          -  History of known prior vaccination with an HPV vaccine or plans to receive one outside
             the study

          -  History of external genital warts

          -  History of severe allergic reaction that required medical intervention

          -  Received immune globulin or blood-derived products in the past 6 months or plan to
             receive any before Month 7 of the study

          -  History of splenectomy, is currently immunocompromised, or has been diagnosed with
             immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic
             lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory
             bowel disease, or other autoimmune condition

          -  Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or
             topical corticosteroids and certain regimens of systemic corticosteroids

          -  Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular
             injections

          -  Ongoing alcohol or drug abuse within the past 12 months
A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: rituximab [Mabthera/Rituxan]
Intervention description: Intravenous repeating dose
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 60 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of brief induction therapy with a
      chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with
      MabThera or no further therapy. 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 60-75 years of age;

          -  B-cell follicular NHL;

          -  no previous treatment;

          -  active disease, with rapid progression.

        Exclusion Criteria:

          -  other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or
             squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of
             the breast treated with lumpectomy;

          -  long-term use (>1 month) of systemic corticosteroids;

          -  central nervous system involvement;

          -  history of significant cardiovascular disease;

          -  positive test result for HIV, or hepatitis B or C.
A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection
Condition: Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Glecaprevir/Pibrentasvir
Intervention description: Film-coated tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C Virus (HCV); Genotype 1 - 6; Metavir System Fibrosis Score; Glecaprevir; Pibrentasvir; Treatment naïve; Cirrhosis; Compensated cirrhosis

Summary:

      This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of
      glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in
      Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without
      cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had positive plasma hepatitis C virus (HCV) antibody and HCV ribonucleic
             acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening Visit.

          -  Participant must have been documented as without cirrhosis with METAVIR equivalent
             fibrosis stage of F2 to F3 or with compensated cirrhosis (F4) based on results of a
             liver biopsy, or FibroScan, or FibroTest score.

          -  Participants who were known to be HCV/Human Immunodeficiency Virus (HIV) co-infected
             may have been enrolled if they had a positive test result for anti-HIV antibody at
             Screening and were: naïve to treatment with any antiretroviral therapy (ART), or on a
             stable, qualifying HIV ART regimen for at least 8 weeks prior to Baseline.

          -  Participants with compensated cirrhosis only: Absence of hepatocellular carcinoma
             (HCC) within 3 months prior to Screening or a negative ultrasound at Screening.

        Exclusion Criteria:

          -  Current hepatitis B virus (HBV) infection on screening tests.

          -  Any current or past clinical evidence of Child-Pugh B or C classification (score of >
             6) or clinical history of liver decompensation including ascites on physical exam,
             including hepatic encephalopathy or variceal bleeding.

          -  Receipt of any investigational or commercially available anti-HCV agents.
A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects
Condition: Asthma
MeSH terms: Asthma; Respiratory Aspiration
Intervention: levalbuterol tartrate HFA inhalation aerosol; placebo
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Maximum age: 48 Months
Healthy volunteers: No
Keywords: Acute Asthma exacerbation

Summary:

      This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects
      birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's
      office with an acute bronchospasm. Subjects presenting to the ED or physician's office with
      an acute bronchospasm must have a history of reactive airways disease, based on subjects'
      parent/guardian report.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female from birth to 48 months of age, inclusive, whose parent(s) or legal
             guardian(s) provide written informed consent prior to study participation and are
             willing to comply with study procedures.

          2. Subject experiencing acute bronchospasm requiring a bronchodilator and who have a
             history of wheezing.

        Exclusion Criteria:

          1. Subject with a severe illness that, in the opinion of the Investigator, could
             jeopardize subject safety.

          2. Subject received ≥ 8 puffs (MDI) of a beta-2 agonist or 2.5 mg of nebulized
             levalbuterol, or albuterol 5.0 mg within 4 hours prior to ED or physician's office
             admittance.

          3. Subject received ipratropium within 4 hours prior to ED or physician's office
             admittance.

          4. Subject who participated in an investigational drug study within 30 days prior to
             enrollment, or who previously participated in the current study.

          5. Subject with a known sensitivity to levalbuterol or racemic albuterol or any of the
             excipients contained in any of these formulations.

          6. Subject using any prescription drug (including beta-blockers) with which levalbuterol
             or racemic albuterol sulfate administration is contraindicated.

          7. Subject with a history of clinically significant abnormalities that could interfere
             with the metabolism or excretion of the study medication (eg, renal, hepatic,
             metabolic, or endocrine abnormalities).

          8. Subject with a history of cancer.
Topical DHEA Against Vaginal Atrophy
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Intervention: Placebo; DHEA (0.25%); DHEA (0.5%); DHEA (1.0%)
Intervention description: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.; Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.; Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.; Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Intervention MeSH terms: Dehydroepiandrosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: Female
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Vulvar/vaginal atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa

Summary:

      The purpose of this study is to determine the dose-response of vaginal mucosa parameters to
      the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from
      vaginal atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women (non hysterectomized or hysterectomized)

          -  Women between 40 and 75 years of age

          -  Willing to participate in the study and sign an informed consent

          -  Women having a low maturation index (no greater part of guidance than 5% of
             superficial cells on vaginal smear)

          -  Women having a vaginal pH above 5

          -  Women who have self-identified at least one moderate to severe symptoms of
             vulvovaginal atrophy

        Exclusion Criteria:

          -  Undiagnosed abnormal genital bleeding

          -  Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy

          -  The administration of any investigational drug within 30 days of screening visit

          -  Endometrial hyperplasia at biopsy performed at screening or endometrial cancer

          -  Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the
             4 weeks to 6 months (depending on the product used) prior study entry
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Condition: Fever
MeSH terms: Fever
Intervention: ibuprofen; acetaminophen
Intervention description: Ibuprofen, 10 mg/kg; Acetaminophen, 10mg/kg
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Pediatric; Fever

Summary:

      The primary objective of the study is to determine the superiority of a single dose of
      intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first
      two hours of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have written informed consent provided by legal parent, guardian, or authorized agent
             prior to participation in the study or study-only related procedures.

          2. Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.

          3. Have new (less than 7 days) onset of fever, documented by temperature greater than or
             equal to 101.0 ºF (38.3 ºC).

        Exclusion Criteria:

          1. Have inadequate intravenous access.

          2. Have received antipyretic drug therapy within 2 hours before dosing.

          3. Have any history of allergy or hypersensitivity to NSAIDs or aspirin.

          4. Have received another investigational drug within the past 30 days.

          5. Be otherwise unsuitable for the study, in the opinion of the Investigator.

          6. Have a fever due to hyperthermia.

          7. Pregnant or nursing.