bioihbjkbjnl/mcl2 huggingface dataset:
Smoking Cessation in Hispanic Construction Workers
Condition: Smoking Cessation
Intervention: Nicorette Gum; Nicoderm CQ; Smoking Quitline Referral; Behavioral Smoking Cessation Counseling
Intervention description: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy); GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy); Fax referral to the State smoking Quitline; One time face-to-face smoking cessation counseling and follow-up phone call
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study arms will be conducted simultaneously.
Masking: None (Open Label)
Enrollment: 134.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hispanics; Construction workers; Tobacco Quitline; Nicotine replacement therapy

Summary:

      Construction workers have the highest rate of smoking among all occupations, and are
      frequently exposed to a wide range of workplace hazards (e.g. toxins), which interact with
      smoking to increase their health risks. Minority construction workers, in particular, have
      higher smoking and lower cessation rates compared to other groups, and they generally show
      lower access and participation in cessation and health promotion services. The number of
      Hispanic workers employed in the construction industry in the US has tripled in the past
      decade to 2.6 million (23% of all construction workers). This study will develop, administer,
      and evaluate a novel smoking cessation program in a hard-to-reach and underserved population
      of Hispanic male construction workers using using pilot cluster randomized clinical trial
      (RCT) to test the developed intervention for feasibility and potential efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hispanic

          -  Construction worker

          -  Have smoked ≥ 5 cigarettes/day in the past year.

          -  Have access to telephone

          -  Have no plans to move in the next six months

          -  Are interested in making a serious quit attempt in the next 30 days

          -  Have no contraindication to NRT (e.g., history of hypersensitivity to nicotine, recent
             (past month) myocardial infarction, any history of serious arrhythmias or unstable
             angina pectoris, chronic dermatological disorder (e.g., psoriasis)).

        Exclusion Criteria:

          -  Inability to understand consent procedures

          -  Not Hispanic

          -  Not a construction worker

          -  Haven't smoked ≥ 5 cigarettes/day in the past year.

          -  No access to telephone

          -  Has plans to move in the next six months

          -  Not interested in making a serious quit attempt in the next 30 days

          -  Has a contraindication to NRT

          -  Has a generalized chronic dermatological disorder (e.g., psoriasis)
Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial
Condition: Apnea
Intervention: NuMask Intraoral Airway Device; Bag Valve Mask
Intervention description: NuMask Intraoral Airway Device; Conventional bag valve mask
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study comprised a randomized cross-over trial of ventilation using the NuMask Intraoral
      Mask versus conventional Bag Valve Mask in a cadaver model among United States Army combat
      medics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  United States Army Combat Medics

        Exclusion Criteria:

          -  Injuries precluding performance of bag valve mask ventilation
100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
Condition: Sustained Virologic Response; IL28B Polymorphism
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: peginterferon alfa 2a (pegasys); peginterferon alfa-2a (pegasys)
Intervention description: dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable; These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: reducing dose of peginterferon; chronic hepatitis c; Koreans; IL28B polymorphism

Summary:

      1. Randomized controlled multicenter study

        2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis
           C genotype 1

        3. IL28B polymorphism in Koreans with CHC
    

Eligibility criteria:

        Inclusion Criteria:

          -  chronic hepatitis C (anti HCV+, HCV RNA +)

          -  Genotype 1

          -  over 18 year-old

          -  Pregnancy test negative if women of childbearing age

        Exclusion Criteria:

          -  pregnant women or breast feeding women

          -  systemic chemotherapy or steroid therapy before 6 months of trial

          -  Coinfection with HAV, HBV, and HIV

          -  Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver
             disease, alcoholic liver disease, toxic hepatitis

          -  Hepatocellular carcinoma

          -  Evidence of decompensation such as variceal bleeding,ascites, encephalopathy

          -  ANC less than 1500, platelet less than 90k

          -  Cr more than 1.5 of UNL

          -  Severe psychiatric problem

          -  Poorly controlled thyroid disease

          -  Severe retinopathy
Azithromycin for Children Hospitalized With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Azithromycin; Placebo
Intervention description: Azithromycin suspension (200mg/5mL)
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 4 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; Acute asthma exacerbation; Pediatric; Azithromycin; Macrolide; Length of Stay; Hospital Medicine

Summary:

      Asthma is a chronic lung condition in children, and often requires hospitalization for acute
      exacerbations. Azithromycin has been used successfully in other chronic lung diseases,
      including cystic fibrosis. Despite limited clinical evidence, some pediatricians use
      azithromycin in children hospitalized with asthma, citing either treatment of atypical
      pathogens or its proposed anti-inflammatory properties. This study proposes a clinical trial
      to determine if azithromycin will shorten length of stay in children hospitalized with acute
      asthma exacerbations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  4-12 years of age

          -  Admission diagnosis of asthma at the Children's Hospital at Montefiore

          -  History of persistent asthma (as defined by National Heart, Lung, and Blood Institute)

        Exclusion Criteria:

          -  Concurrent bacterial infection requiring antibiotics

          -  Antibiotics received within previous 2 weeks

          -  Contraindication to azithromycin (including allergy to macrolides)

          -  Chronic lung disease other than asthma (including bronchopulmonary dysplasia, cystic
             fibrosis, bronchiectasis) or home oxygen requirement

          -  Immunodeficiency (primary or acquired)

          -  Chronic systemic steroid use

          -  Invasive or non-invasive mechanical ventilation required acutely as result of current
             asthma admission

          -  Significant cardiac co-morbidity (including hemodynamically significant cardiac
             disease or arrhythmia)

          -  Liver disease (hepatitis)

          -  Pregnancy

          -  Seizure disorder, currently on anti-epileptic medication)

          -  Receiving albuterol every 4 hours (q4h) at the time of enrollment

          -  Previous enrollment in study
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
Condition: Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors; Gastrointestinal Neoplasms; Digestive System Neoplasms
Intervention: Sunitinib Malate (SU011248)
Intervention description: Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
Intervention MeSH terms: Sunitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sunitinib; Phase IV; gastrointestinal stomal tumor; imatinib resistant or intolerant; Chinese

Summary:

      To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With
      Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-proven diagnosis of malignant GIST (Gastrointestinal Stromal Tumors).

          -  Evidence of unidimensionally measurable disease

          -  Failure of prior treatment with imatinib or intolerant to imatinib

          -  Male or female, 18 years of age or older.

          -  ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

          -  Resolution of all acute toxic effects

          -  Adequate organ function.

        Exclusion Criteria:

          -  Anticancer treatment after last dose of imatinib

          -  Major surgery within 4 weeks or radiation therapy within 2 weeks.

          -  Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.

          -  Diagnosis of second malignancy within the last 5 years.

          -  History of brain disease.

          -  Cardiac disease within 12 months.

          -  Thyroid function abnormality.

          -  Ongoing cardiac dysrhythmias.

          -  Uncontrolled hypertension.

          -  Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.

          -  HIV or AIDS related illness.

          -  Pregnancy or breastfeeding.
Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Punctal Plug
Intervention description: Punctal plugs inserted into the study eye on Day 1.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will access changes in tear protein levels and symptoms of dry eye following
      insertion of a punctal plug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with moderate to severe dry eye

        Exclusion Criteria:

          -  Previous punctal plug insertion in the last 3 months or presence of plugs at the time
             of study

          -  Contact lens wear in the 7 days prior to study start or during the study

          -  LASIK procedure in the last year

          -  Cataract or other eye surgery in the last 3 months

          -  Corneal grafts
TiLE (Time Lapse Eeva) Clinical Trial
Condition: Fertility
Intervention: Eeva
Intervention description: Embryos of subjects randomized in this group were assessed using Eeva System and morphological grading to identify optimal embryos for transfer.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 976.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: TiLE; Embryo Assessment; Pregnancy; Implantation

Summary:

      The purpose of the study was to explore the added value of adjunctive use of Early Embryo
      Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for
      transfer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All infertile subjects treated with In vitro fertilization (IVF)/intracytoplasmic
             sperm injection (ICSI)

          -  Subject age less than or equal to (<=) 40 years

          -  Less than or equal to (<=) 3 failed IVF/ICSI cycles

          -  At least 4 normally fertilized eggs (2 pronuclei [2PN]) in current cycle

          -  Normal uterine cavity

          -  Fertilization using only ejaculated sperm (fresh or frozen)

          -  Subject must have read and signed the Informed Consent Form

        Exclusion Criteria:

          -  Have clinically significant systemic disease

          -  Have abnormal, undiagnosed gynecological bleeding

          -  Have any contraindication to Controlled Ovarian Stimulation (COS) for assisted
             reproductive technologies (ART) and to gonadotropins to be used in ART

          -  Egg donor cycle

          -  Planned "freeze all" cycle (oocytes or embryos)

          -  Concurrent participation in another clinical trial
Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee; Pain, Postoperative
Intervention: Ropivacaine; Ketorolac; Clonidine; Epinephrine; 0.9% sodium chloride
Intervention description: Ropivacaine (5mg/ml)-50ml; ketorolac (30mg/ml)- 1 ml; clonidine (0.1mg/ml)- 0.8ml; epinephrine (1mg/ml)-1ml; Sodium chloride 0.9%- 47.7 ml
Intervention MeSH terms: Ketorolac; Clonidine; Epinephrine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the use of a local injection around the knee (periarticular) during
      total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The
      injection is a combination of various medications which are thought to reduce pain levels.

      Approximately 128 patients will participate in this study, half of the patients will receive
      this injection during surgery and the other half will receive a saline (salt water)
      injection. Pain scores after the surgery will be compared between the two groups.

      All patients will also receive a long-acting (24 hours) morphine injection during surgery.

      The hypothesis is that those participants receiving intrathecal Duramorph and local
      periarticular injections will have improved pain scores and reduced narcotic use when
      compared with intrathecal Duramorph alone at 48 hours postoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Written informed consent

        Exclusion Criteria:

          -  Pregnant women

          -  Creatinine clearance less than 60 ml/min

          -  BMI greater than 40

          -  Currently use greater than 80mg morphine-equivalents daily (pre-operatively)

          -  Receive a unicondylar knee replacement
Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
Condition: HIV, Pediatric
Intervention: Atazanavir; Ritonavir
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to collect safety clinical data in HIV-infected pediatric
      patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are
      receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse
      transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed HIV-1 infection diagnosed by protocol criteria

          -  Male or female children, ≥ 6 years to <17 years 6 months of age at the time of first
             treatment

          -  Antiretroviral-naïve or treatment-experienced participants with a detectable viral
             load

          -  Antiretroviral-naïve participants must have genotypic sensitivity at screening to
             atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which
             have been approved for pediatric use and dosed per local country label

          -  Antiretroviral-experienced participants must have documented genotypic and phenotypic
             sensitivity at screening to atazanavir (fold change in susceptibility <2.2) and at
             least 2 NRTIs, which have been approved for pediatric use and dosed per local country
             label.

        Exclusion Criteria:

          -  Experienced participants who received atazanavir with or without ritonavir at any time
             prior to study enrollment

          -  Antiretroviral-naive or -experienced HIV-1 infected patients with contraindication to
             study medications

          -  Documented cardiac conduction abnormality, significant cardiac dysfunction, or a
             history syncope

          -  Family history of QTc interval syndrome, Brugada syndrome, right ventricular
             dysplasia, or a corrected QTc interval of >440 ms at screening

          -  One of the following cardiac rhythm abnormalities documented on the screening
             electrocardiogram:

               1. First degree atrioventricular (AV) block, as defined by protocol

               2. Type I second degree AV block while awake, type II second degree AV block at any
                  time, complete AV block at any time, or age-adjusted heart rate <2nd percentile

          -  Coinfection with either hepatitis B or C virus
Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)
Condition: Alcoholism; Alcohol Dependence; Post-Traumatic Stress Disorder
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Cognitive-Behavioral Therapy; Naltrexone; Placebo
Intervention description: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week; Daily dosing 100 mg for 24 weeks; Pill Placebo daily dosing 24 weeks
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcoholism; Alcohol Dependence; Post-Traumatic Stress Disorder; Naltrexone; Cognitive Behavior Therapy

Summary:

      This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol
      dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a
      6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial
      therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced
      medication management intervention will accompany all treatment conditions. Follow-up
      assessments will be completed at 9 and 12 months after treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets criteria for alcohol dependence and post-traumatic stress disorder.

          -  Heavy drinking in the past 30 days (an average of more than 12 alcohol drinks per week
             with at least 1 day of 4 or more drinks).

          -  Successfully complete medical detoxification.

          -  Exhibit clinically significant trauma-related symptoms.

          -  Live in a commutable distance to the University of Pennsylvania and agree to follow-up
             visits.

          -  Aged between 18 and 65 years old.

          -  Able to provide an informed consent.

          -  Speak and read English.

        Exclusion Criteria:

          -  Current diagnosis of any substance dependence other than alcohol, nicotine, or
             cannabis.

          -  Evidence of opiate use in the past 30 days.

          -  Significant risk of violence or history of serious violent behavior during the past
             year.

          -  Continued contact with an intimate partner if assault by the partner is the index
             trauma.

          -  Changes in dosage or medication for any SSRI treatment in the three months prior to
             entering the study.

          -  Unstable or serious medical illness.

          -  Current severe psychiatric symptom.

          -  Mental retardation or another pervasive developmental disorder.

          -  Use of an investigational medication in the past 30 days.

          -  Pregnant, nursing or not using reliable contraception.