bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
Condition: Respiratory Tract Diseases
MeSH terms: Respiratory Tract Diseases
Intervention: DR-5001; Placebo
Intervention description: All randomized subjects received a single tablet of both Type-4 and Type-7 ADV vaccines on Day 0. Both vaccine tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted.; All randomized subjects received a single tablet each of the placebos matching Type-4 and Type-7 ADV vaccines on Day 0. Both placebo tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4040.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acute respiratory disease prevention; Adenovirus

Summary:

      This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the
      safety and efficacy of oral DR-5001 in reducing the attack rate of febrile acute respiratory
      disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Military recruit in training

          -  Male or female; if female, must be of non-childbearing potential or with a documented
             negative pregnancy test </= 72 hours prior to study medication administration and
             agree not to become pregnant

        Exclusion Criteria:

          -  Female nursing an infant or planning on nursing during the study

          -  Immunosuppressed for any reason, including past (within last 6 months) or current
             treatment with immunosuppressive therapy

          -  Known allergy to any component of the vaccines and/or placebo tablets

          -  Immunocompromised sexual partner or immunocompromised individuals in home
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: lurasidone
Intervention description: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 817.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bipolar; Depression; Lurasidone; Latuda

Summary:

      This clinical study is designed to test the hypothesis that lurasidone is effective,
      tolerable, and safe for the treatment of patients with bipolar I depression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is judged by the investigator to be suitable for participation in a 24-week
             clinical trial involving open-label lurasidone treatment

          -  Subject has completed the 6-week treatment period and all required assessments on the
             final study visit (Day 42, Visit 8) of either Study D1050235, NCT#00868452 or Study
             D1050236, NCT#008668699.

        Exclusion Criteria:

          -  Imminent risk of suicide, injury to self or to others, or damage to property

          -  Subject has evidence of severe movement disorders.

          -  Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235, NCT#00868452
             or D1050236, NCT#008688699).
Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
Condition: Carcinoma, Renal Cell; Kidney Neoplasms
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: Interferon Alfa; CCI-779; Interferon Alfa and CCI-779
Intervention description: Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter.; 25 mg of CCI-779 given Intra Venously once per week; 15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week
Intervention MeSH terms: Interferons; Interferon-alpha; Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 626.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Renal Cell Carcinoma; Kidney Cancer

Summary:

      The primary objective of this study is efficacy. The primary efficacy endpoint of this study
      is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus],
      administered intravenously [IV] once weekly and the combination of CCI-779, administered IV
      once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW],
      compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in
      poor-prognosis subjects with advanced RCC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  This study will be conducted in subjects with histologically confirmed, advanced
             (stage IV or recurrent disease) RCC who have not received prior systemic therapy for
             their disease,

        Exclusion Criteria:

          -  Subjects with central nervous system (CNS) metastases

          -  Prior anticancer therapy for RCC

          -  Prior investigational therapy/agents within 4 weeks of randomization
Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: SM-13496 (lurasidone HCl); SM-13496 (lurasidone HCl); Placebo; Risperidone
Intervention description: Lurasidone HCl: 40 mg/day; Lurasidone HCl: 80 mg/day
Intervention MeSH terms: Risperidone; Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients
      with schizophrenia.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Patient meets DSM-IV criteria for schizophrenia.

          -  Patient is 18 or older but younger than 75 years of age on the day of signing informed
             consent.

          -  Patient understands the objectives, nature, and other aspects of the study and
             voluntarily agrees to participate in the study by providing written informed consent.

        Main Exclusion Criteria:

          -  Patient has a history of neuroleptic malignant syndrome, water intoxication, or
             paralytic ileus.

          -  Patient has Parkinson's disease.

          -  Patient has a history or complication of malignancy.
Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
Condition: Intrauterine Fetal Demise
MeSH terms: Fetal Death; Stillbirth
Intervention: Misoprostol; Misoprostol
Intervention description: 200 mcg buccal misoprostol administered every 6 hours for up to 48 hours until fetus is delivered.; 100 mcg buccal misoprostol administered every 6 hours for upto 48 hours
Intervention MeSH terms: Misoprostol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 153.0
Sex: Female
Healthy volunteers: No
Keywords: intrauterine fetal death; misoprostol

Summary:

      The purpose of the proposed study is to test - in a randomized, blinded trial - two different
      doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for
      fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced stage of
      pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely
      evacuation is vital in order to avoid the possibility of, among other things, potentially
      life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these
      cases include dilatation and evacuation (D&E) surgery (in less advanced pregnancies) and
      labor induction with a variety of products. Misoprostol has been demonstrated to be as
      effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this
      indication in a number of small, non-FDA-approved trials which have been published in the
      peer-reviewed literature. In the absence of more formal study of this treatment, however,
      dosages are not standardized, pathways of administration vary, and other uncertainties
      linger. The purpose of the protocol proposed herein is to formally establish, via a
      randomized, double-blinded study, the safety and effectiveness of misoprostol for this
      indication, and to compare the value of two distinct doses, so that providers may
      henceforward proceed with greater authority and confidence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women presents with spontaneous fetal death

          -  Gestational age of fetus between 14-28 weeks

        Exclusion Criteria:

          -  Transmural uterine scar;

          -  Allergies or other contraindications to use of misoprostol;

          -  Placental abruption with active hemorrhage;

          -  Complete placenta previa;

          -  Extreme uterine structural anomalies;

          -  Or other contraindications to vaginal delivery of the fetus;

          -  Presentation in active labor (moderate to severe contractions every 10 minutes); or

          -  Four or more previous deliveries
Sub-clinical Inflammation and Iron Supplementation
Condition: Anemia
MeSH terms: Inflammation
Intervention: Iron group; Vitamin A group; Iron and vitamin A group; Placebo group
Intervention description: Ferrous fumarate, 60 mg, weekly dose; Retinol, weekly dose, 15,000 IU; Ferrous fumarate, Retinol combination group, weekly dose; folic acid only as placebo group
Intervention MeSH terms: Vitamins; Folic Acid; Vitamin A; Iron; Retinol palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 402.0
Sex: Female
Minimum age: 12 Years
Maximum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: anemia; iron supplementation; sub-clinical inflammation; adolescents

Summary:

      Anemia and vitamin A deficiency (VAD) are major nutritional problems in the world and also in
      Myanmar. Both nutrient deficiencies result from interaction of several causal factors, and a
      better understanding of the etiology to interpret the prevalence and to formulate appropriate
      measures to reduce these deficiencies is necessary. There is a growing concern on the role of
      sub-clinical inflammation on the nutritional status indicators during the nutritional status
      assessment. However, there is lack of information on the role of inflammation on the iron
      supplementation. The adolescent period is a window of opportunity to improve the
      preconceptional iron status of the girls and recently gained much attention. The purpose of
      the study is to understand the role of inflammation on iron and vitamin A status during iron
      and vitamin A supplementation. The findings will show the extent to which iron
      supplementation has been hampered by inflammation and to formulate the necessary measures to
      overcome the interference.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adolescent girls (age 12-19 years)

          -  already experienced menarche

          -  anemic girls (Hb<120 g/L)

          -  no known illness (apparently healthy)

          -  free from haemoglobinopathy

          -  No regular consumption of iron and vitamin A supplement during the last 3 months

        Exclusion Criteria:

          -  subjects with chronic illness

          -  subjects with severe anaemia

          -  who do not give the consents
Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Placebo; Nicotine
Intervention description: Dosage Form: Oral NRT; Dose: 0 mg; Frequency: up to 4 times per hour; Duration: 12 weeks; Dosage Form: Oral NRT; Dose: 1 mg;Frequency: up to four times per hour; Duration:12 weeks
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 257.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking Cessation; Tobacco Use Disorder

Summary:

      This study is to see if a new nicotine replacement therapy safely helps people to quit
      smoking if it is used the way it would be if it were sold at the pharmacy and used at home.
      Approximately 1500 subjects will be enrolled into the study. The study will require
      participants to use the treatment for 12 weeks and there will be a 14-week follow-up period.
      The study will be conducted in approximately 20 pharmacies across the United States.

      At the first visit to the pharmacy, participants will be asked some questions to see if they
      are eligible to participate. Participants will be asked to sign a consent form if they agree
      to participate. Participants will answer some more questions, and blow into a machine to
      measure their carbon monoxide (CO) levels to make sure they qualify for the trial.
      Participants will be asked to go to a nearby dentist who will look at their mouths.
      Participants will go back to the pharmacy and if they qualify, they will be given a supply of
      their assigned treatment. They will have an equal chance of receiving a treatment that has a
      drug in it or one that has no drug in it. They will be given a diary to keep track of how
      much of the treatment they use.

      Subjects will go to the pharmacy four more times to hand in their diaries and blow into a
      machine that will measure their CO levels. At the last visit, subjects will have their mouths
      examined by a dentist again to have their mouth checked.

      Subjects will receive four telephone calls during the study where they will be asked some
      questions.

      After the 12 week treatment period, subjects will receive two to three more telephone calls,
      where they will be asked to answer some questions. Participants may be asked to come back to
      the pharmacy two more times to blow into the carbon monoxide machine again.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be males or females 18 years of age or older who currently smoke
             cigarettes and are willing to stop smoking

        Exclusion Criteria:

          -  Subjects must not have a recent history of unstable angina, myocardial infarction or
             stroke

          -  They must not have a suspected malignant and/or erosive oral lesion
Correction of Myopia Evaluation Trial 2
Condition: Myopia
MeSH terms: Myopia
Intervention: Progressive Addition Lenses (PALs); Single Vision Lenses (SVLs)
Intervention description: Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition; Single vision lenses
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 118.0
Sex: All
Minimum age: 8 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Myopia; Progressive Addition Lenses (PALs); Single Vision Lenses (SVLs); Accommodative lags; Near esophoria; Refractive error

Summary:

      The purpose of the study is to determine if progressive addition lenses (PALs) versus single
      vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative
      responses (i.e., large accommodative lags) and near esophoria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Refractive error determined by cycloplegic autorefraction which meets all of the
             following:

               1. Spherical equivalent: -0.50 to -3.00 D in both eyes

               2. Astigmatism <= 1.5 D in both eyes

               3. Anisometropia <= 1.00 D difference between eyes in spherical equivalent

          -  Visual acuity is at least 20/20 with best subjective refraction in both eyes

          -  Accommodative response at near (33 cm) is less than 2.0D by non-cycloplegic
             autorefraction

          -  Near esophoria (>= 2.0 PD) present by alternate prism and cover test (APCT) at near
             using best refractive correction determined from non-cycloplegic subjective refraction

        Exclusion Criteria:

          -  Strabismus present by cover-uncover test at far, near, and/or near with +2.00D over
             best subjective refraction

          -  Current or prior use of PALs, bifocals, or contact lenses in either eye (prior or
             current use of SVLs is allowed)
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 210 mg brodalumab; 140 mg brodalumab; ustekinumab; placebo
Intervention description: 210 mg brodalumab administered SC; 140 mg brodalumab administered SC; 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.; placebo administered SC
Intervention MeSH terms: Ustekinumab; Brodalumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1881.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: psoriasis, brodalumab, AMG 827

Summary:

      The purpose of this study is to assess the safety and efficacy of brodalumab at two different
      doses compared with placebo in participants with moderate to severe plaque psoriasis.

      A second purpose of this study is to assess the safety and efficacy brodalumab at two
      different doses compared with ustekinumab in participants with moderate to severe plaque
      psoriasis.

      A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens
      of brodalumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has had stable moderate to severe plaque psoriasis for at least 6 months

          -  Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at
             screening and at baseline

        Exclusion Criteria:

          -  Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
             medication-induced psoriasis, or other skin conditions at (eg, eczema) that would
             interfere with study evaluations

          -  Subject has known history of Crohn's disease

          -  Subject has any other significant concurrent medical condition or laboratory
             abnormalities, as defined in the study protocol

          -  Subject has not stopped using certain psoriasis therapies as defined in the study
             protocol

          -  Subject has previously used ustekinumab or any anti-IL-17 biologic therapy

          -  Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in
             the study

          -  Female subject is unwilling to use highly effective methods of birth control unless 2
             years post-menopausal or surgically sterile
Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: vedolizumab; Placebo
Intervention description: Vedolizumab for intravenous infusion; Placebo intravenous infusion
Intervention MeSH terms: Vedolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 416.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study in patients with moderately to severely active Crohn's disease is designed to
      establish the efficacy and safety of vedolizumab for the induction of clinical response and
      remission.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 80

          -  Diagnosis of moderately to severely active Crohn's disease

          -  Crohn's Disease involvement of the ileum and/or colon

          -  Demonstrated, over the previous 5 year period, an inadequate response to, loss of
             response to, or intolerance of at least one conventional therapy as defined by the
             protocol

          -  May be receiving a therapeutic dose of conventional therapies for inflammatory bowel
             disease (IBD) as defined by the protocol

        Exclusion Criteria

          -  Evidence of abdominal abscess at the initial screening visit

          -  Extensive colonic resection, subtotal or total colectomy

          -  History of >3 small bowel resections or diagnosis of short bowel syndrome

          -  Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

          -  Have received non permitted therapies within either 30 or 60 days, depending on the
             medication, as stated in the protocol

          -  Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection

          -  Active or latent tuberculosis