bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain
Condition: Thyroid Carcinoma; Thyroidectomy
MeSH terms: Thyroid Neoplasms
Intervention: Usage of Fibrin sealant; Thyroidectomy
Intervention description: Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection; surgical removal of bilateral thyroid glands
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Neck dissection

Summary:

      Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well.
      However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel
      is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus
      reducing op time and postoperative drain, which is important to minimize hospital stay. The
      investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted
      procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior
      compartment neck dissection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  proven thyroid carcinoma

          -  Thyroidectomy with anterior compartment neck dissection

        Exclusion Criteria:

          -  No use of harmonic scalpel during surgery

          -  coagulation abnormality

          -  refuse to participate
Expanded Access Program for Maraviroc At Multiple Centers
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: maraviroc
Intervention description: The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.
Intervention MeSH terms: Maraviroc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Enrollment: 1047.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: HIV Infections

Summary:

      To provide access to maraviroc to patients who have limited or no therapeutic treatment
      options and to collect more safety data in a broader patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be failing to achieve adequate virologic suppression on their current
             regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening

          -  Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay

          -  Minimum age must be 16 years or minimum adult age as determined by local regulatory
             authorities or directed by local law.

        Exclusion Criteria:

          -  Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having
             previously prematurely discontinued Maraviroc in trials
Optimizing Tobacco Dependence Treatment in the Emergency Department
Condition: Tobacco Use Disorder
MeSH terms: Emergencies; Tobacco Use Disorder
Intervention: Brief Negotiated Interview (BNI); Nicotine replacement therapy (NRT); CT Smokers Quitline (QL); SmokefreeText (Text)
Intervention description: Brief motivational interview on smoking behavior; 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.; Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.; Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Enrollment: 1056.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators propose an innovative full-factorial design in a cohort of 1056 adult
      smokers in an urban emergency department (ED), to test the efficacy of four key intervention
      components: motivational interviewing, medication, quitline referral, and texting. At the
      trial's completion, a mixed-methods approach will be used to identify the components that
      were efficacious within the proposed cost constraint, along with feasibility and
      acceptability to providers and subjects. The investigators will then assemble an intervention
      that maximizes efficacy, given a cost-effectiveness constraint and findings from a
      qualitative analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  have smoked >= 100 cigarettes lifetime

          -  describe themselves as every or some day smokers

          -  smoke at least 5 cigarettes/day

          -  own a cellphone with texting capability

          -  are able to give written informed consent

        Exclusion Criteria:

          -  Inability to read or understand English

          -  currently receiving formal tobacco dependence treatment

          -  life-threatening or unstable medical, surgical, or psychobehavioral condition

          -  unable to provide at least one collateral contact

          -  live out-of-state

          -  leaving the ED against medical advice

          -  pregnant (self-report or urine testing), nursing, or trying to conceive.
Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
Condition: Myasthenia Gravis, Generalized
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: zilucoplan (RA101495); Placebo
Intervention description: Daily subcutaneous (SC) injection; Daily subcutaneous (SC) injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to
      confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized
      Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of
      0.3 mg/kg zilucoplan or placebo for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IV] at
             Screening

          -  Positive serology for acetylcholine receptor (AChR) autoantibodies

          -  MG-ADL Score of ≥ 6 at Screening and Baseline

          -  QMG score ≥ 12 at Screening and Baseline

          -  No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated
             to occur during the 12-week Treatment Period

          -  No change in immunosuppressive therapy, including dose, for at least 30 days prior to
             Baseline or anticipated to occur during the 12-week Treatment Period

        Exclusion Criteria:

          -  Thymectomy within 12 months prior to Baseline or scheduled to occur during the 12 week
             Treatment Period

          -  History of meningococcal disease

          -  Current or recent systemic infection within 2 weeks prior to Baseline or injection
             requiring intravenous (IV) antibiotics within 4 weeks prior to Baseline
An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Lasmiditan
Intervention description: oral tablet
Intervention MeSH terms: Lasmiditan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, randomized, open-label study in subjects with migraine who have
      completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK
      (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is
      designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan
      100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute
      treatment of migraine. Long term efficacy will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able and willing to give written informed consent and authorize Health Insurance
             Portability and Accountability Act (HIPAA).

          -  Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed
             COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as
             enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE:
             Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 >12 weeks
             prior or if they have not participated in either prior study, but meet eligibility
             criteria outlined for COL MIG-302.)

          -  Females of child-bearing potential must be using or willing to use a highly effective
             form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD),
             abstinence or vasectomized partner).

          -  Able and willing to complete an electronic diary to record details of all migraine
             attacks treated with study drug.

        Exclusion Criteria:

          -  Any medical condition or clinical laboratory test which in the judgment of the
             Investigator makes the subject unsuitable for the study.

          -  Pregnant or breast-feeding women.

          -  Women of child-bearing potential not using or not willing to use highly effective
             contraception.

          -  Participant is at imminent risk of suicide (positive response to question 4 or 5 on
             the Columbia Suicide Severity Rating Scale (C-SSRS).

          -  Initiation of or a change in concomitant medication to reduce the frequency of
             migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK
             (NCT02605174).

          -  Participation in any clinical trial of an experimental drug or device since completing
             EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection
Condition: Hepatitis C Virus (HCV)
MeSH terms: Infections; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ombitasvir/paritaprevir/ritonavir and dasabuvir; ribavirin
Intervention description: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet; Tablet
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C Infection

Summary:

      This study seeks to assess the safety and efficacy of treatment with
      ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic,
      genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or
      treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without
      Ribavirin (RBV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C virus (HCV) infection

          -  Non-cirrhotic subjects

          -  Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection

          -  HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated
             interferon (pegINF) with or without ribavirin (RBV)

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus
             antibody (HIV Ab)

          -  HCV genotype of any subtype other than GT1a or unable to subtype

          -  Prior or current use of any investigational or commercially available anti-HCV agents
             other than IFN, pegIFN or RBV. Subjects with previous participation in trials of
             investigational direct-acting antiviral agents (DAAs) may be enrolled if they can
             produce documentation that they received only placebo.

          -  Current enrollment in another interventional clinical study or receipt of any
             investigational product within 6 weeks prior to study drug administration.
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Condition: Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Intervention: flibanserin; placebo
Intervention description: patients will be randomized to flibanserin or placebo in a double-blind manner; patients will be randomized to flibanserin or placebo in a double-blind manner
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 949.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to assess the safety and efficacy of 24-week course of
      flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally
      postmenopausal women.
    

Eligibility criteria:

        Inclusion criteria:

          -  Naturally postmenopausal women of any age with at least one ovary

          -  Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least
             six months duration

          -  Stable, monogamous heterosexual relationship for at least one year

          -  Willing to discuss sexual issues

          -  Willing to engage in sexual activity at least once a month

          -  Normal Pap smear

          -  Normal mammogram

          -  Normal uterine lining

          -  Able to comply with daily use of handheld data entry device

        Exclusion criteria:

          -  Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder,
             Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity
             Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition

          -  Partner with inadequately treated organic or psychosexual dysfunction

          -  Sexual function impaired by psychiatric disorder

          -  Sexual function impaired by gynecological disorder

          -  Major Depression

          -  Suicidal behavior or ideation

          -  Major life stress that could impair sexual function

          -  Substance abuse
A Follow-up Extension Study to Evaluate the Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects Who Received Three Doses of the Vaccine in the HPV-058 Study
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Dysplasia
Intervention: Blood sampling for antibody determination
Intervention description: In order to assess the persistence of immune responses seven to eight years after the last vaccine dose against HPV-16/18, a blood sample (~5 mL) will be taken from all the subjects, at Day 1.
Intervention MeSH terms: Antibodies
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: Female
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immune response; Cervarix; Persistence; Chinese; Human papillomavirus

Summary:

      The purpose of this study is to evaluate the persistence of immune response in subjects who
      received the HPV-16/18 vaccine, seven to eight years after the last dose of primary
      vaccination in the HPV-058 study. No new subjects will be enrolled in this extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects/subject's parents/legally acceptable representative(s) [LAR(s)] who, in the
             opinion of the investigator, can and will comply with the requirements of the
             protocol.

          -  Written informed consent obtained from the subject or subject's parents/LAR(s) prior
             to performing any study specific procedure.

          -  Written informed assent obtained from the subjects below the legal age of consent.

          -  Subjects who received all three doses of the HPV-16/18 vaccine in the HPV-058 study.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine which may have
             an impact on the study objectives) during the period starting 30 days (Day 29 to Day
             1) before the study visit.

          -  Concurrently participating in another clinical study, in which the subject has been or
             will be exposed to an investigational or a non-investigational vaccine/product
             (pharmaceutical product or device).

          -  Previous vaccination against HPV outside the HPV-058 study.

          -  Subjects with contraindications related to blood draw such as blood disorders and
             anticoagulants use.
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
Condition: Asthma
MeSH terms: Asthma
Intervention: Symbicort Turbuhaler; Terbutaline Turbuhaler
Intervention description: 160/4.5μg for 3 days; 0.4 mg for 3 days
Intervention MeSH terms: Terbutaline; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Asthma; Symbicort Turbuhaler

Summary:

      The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler®
      160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on
      top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006
             definition

          -  FEV1> 70% of predicted normal value pre-bronchodilator

        Exclusion Criteria:

          -  Having a known or suspected allergy to study therapy (active drugs or additive)

          -  Having a known clinical history of hypertension, relevant arrhythmias or other heart
             disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart
             failure

          -  Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or
             with depot parenteral glucocorticoids within 3 months

          -  Respiratory infection significantly affecting the asthma, as judged by the
             investigator within 4 weeks
Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)
Condition: Cataract
MeSH terms: Cataract
Intervention: Centrum; Placebo
Intervention description: Multivitamin/mineral supplement containing US RDA levels of nutrients. 1 tablet a day for the expected duration of follow-up (on average 10 yrs).; placebo tablets manufactured to mimic Centrum tablets.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1020.0
Sex: All
Minimum age: 55 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cataract; Nutritional supplements

Summary:

      The Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related
      Cataract (CTNS) is a 13-year study designed primarily to evaluate the safety and efficacy of
      a vitamin-mineral supplement (Centrum) containing recommended daily-allowance dosage (RDA) in
      preventing age-related cataract or delaying its progression in participants with early or no
      cataract at baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical and photographic diagnosis of early or no age-related cataract

          -  Participants with early cataract must have at least one eligible eye with VA score
             20/32 or better

          -  Participants with no cataract must have VA score 20/32 or better in both eyes.

        Exclusion Criteria:

          -  Advanced cataract

          -  Bilateral aphakia or pseudophakia

          -  Any ocular disease or condition that might complicate the future evaluation of
             cataract

          -  Regular use of nutritional supplements

          -  Failure to take at least 75% of run-in medication

          -  Cancer with evidence of recurrence in the past 5 years

          -  Major cerebral or cardiovascular events in past 12 months

          -  Current participation to other clinical trials

          -  Any condition likely to prevent adherence to CTNS follow-up schedule