bioihbjkbjnl/mcl2 huggingface dataset:
Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Intervention: o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1; Olanzapine10 mg orally daily on Days -1,0,+1 and +2; Aprepitant plus Olanzapine
Intervention description: Add aprepitant to anti-emetic regimen; add olanzapine to anti-emetic regimen; add aprepitant and olanzapine to anti-emetic regimen
Intervention MeSH terms: Olanzapine; Aprepitant; Fosaprepitant
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: autologous; myeloma; transplant

Summary:

      The purpose of this study is to help answer the following research question:

        -  Whether administration of an aprepitant containing regimen, an olanzapine containing
           regimen or regimen containing both will prevent nausea and vomiting better for patients
           undergoing an autologous stem cell transplant with melphalan chemotherapy. Both of these
           medications are approved by the United States Food and Drug Administration (FDA) for
           nausea and vomiting.

        -  Participants will be randomly assigned to one of the 3 treatment groups:

             -  Arm A: aprepitant containing anti-emetic therapy

             -  Arm B: olanzapine containing anti-emetic therapy

             -  Arm C: Aprepitant plus olanzapine containing anti-emetic therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Autologous transplant containing high dose melphalan as part of the conditioning
             regimen (single or 2 day melphalan; BEAM [carmustine, etoposide, cytarabine,
             melphalan])

          -  able to tolerate oral medications

        Exclusion Criteria:

          -  Nausea/vomiting within 12 hours before planned high dose conditioning chemotherapy

          -  Any anti-emetic treatment within 24 hours before planned high dose conditioning
             chemotherapy

          -  Pregnancy

          -  Baseline corrected QT interval (QTc) > 500 ms

          -  History of seizures

          -  History of central nervous system (CNS) disease

          -  Human immunodeficiency virus (HIV)
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: LAM group; ADV group
Intervention description: Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.; Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
Intervention MeSH terms: Lamivudine; Adefovir; Adefovir dipivoxil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 16 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: treatment naive; CHB; adefovir; monotherapy

Summary:

      This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with
      lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week
      periods.
    

Eligibility criteria:

        Inclusion criteria:

          -  Have compensated chronic hepatitis B.

          -  Have not been treated with anti HBV agents with antiproliferative activity against.
             However, previous Interferon (IFN) therapy is permitted.

          -  Ability to read, understand, and sign the informed consent.

          -  Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L

        Exclusion criteria:

          -  Having or suspected of having liver cancer.

          -  Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).

          -  Autoimmune hepatitis.

          -  Received any previous transplantation or having a plan for any transplantation.

          -  Existence of any serious complication, except hepatitis B.
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Intervention: Rifaximin
Intervention description: Oral
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 322.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will look at the safety of a drug used in participants who have had hepatic
      encephalopathy (HE) in the past.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must sign an Informed Consent Form

          -  In remission from past HE

          -  Appropriate birth control measures

          -  More than or equal to 18 years of age

          -  Must be potential for benefit from treatment

          -  Recent HE episodes

          -  Capable and willing to comply with all study procedures

          -  Participant has support network

        Exclusion Criteria:

          -  Significant medical conditions or Investigator decision not to include the participant

          -  Allergies to the study drug or similar drugs

          -  Laboratory abnormalities

          -  Recent participation in another clinical trial

          -  Problems experienced in a previous HE trial

          -  Pregnant or at risk of pregnancy

          -  Recent alcohol consumption

          -  Active or latent bacterial or viral Infections

          -  Bowel issues

          -  Recent Active Cancer

          -  On a prohibited medication
30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d.; Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d.; Metformin
Intervention description: Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets.; Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. The placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. will be administered as oral tablets.; Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator.
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 317.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting
      plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in
      patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must complete the double-blind base study (MK-0431-064-00)(NCT00397631) and
             have at least 75% compliance with study medication during the base study treatment
             period.

          -  Women of childbearing potential must continue to comply with the protocol-specified
             contraceptive methods
A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
Condition: Erythropoietic Protoporphyria
MeSH terms: Protoporphyria, Erythropoietic
Intervention: Afamelanotide
Intervention MeSH terms: Afamelanotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main objectives of the study were to evaluate the safety and tolerability of
      afamelanotide by measuring treatment emergent adverse events (AEs) and to determine whether
      afamelanotide can improve the quality of life of EPP patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female subjects with a positive diagnosis of EPP who successfully completed
             the CUV017 or CUV029 studies;

          -  aged 18-75 years (inclusive);

          -  provide written informed patient consent prior to the performance of any
             study-specific procedure.

        Exclusion Criteria:

          -  any serious adverse event considered to be related to afamelanotide or the polymer
             contained in the implant;

          -  any allergy to lignocaine or other local anaesthetic to be used during the
             administration of the study medication;

          -  EPP patients with significant hepatic involvement;

          -  personal history of melanoma or dysplastic nevus syndrome;

          -  current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other
             malignant or premalignant skin lesions;

          -  any evidence of clinically significant organ dysfunction or any clinically significant
             deviation from normal in the clinical or laboratory determinations;

          -  acute history of drug or alcohol abuse (in the last 12 months);

          -  female who is pregnant (confirmed by positive serum β-Human Chorionic Gonadotropin
             (HCG) pregnancy test prior to baseline) or lactating;

          -  females of child-bearing potential (pre-menopausal, not surgically sterile) not using
             adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide,
             intrauterine device);

          -  sexually active men with partners of child-bearing potential not using barrier
             contraception during the trial and for a period of three months thereafter;

          -  participation in a clinical trial for an investigational agent within 30 days prior to
             the screening visit;

          -  prior and concomitant therapy with medications which may interfere with the objectives
             of the study.
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
Condition: Infantile Spasms
MeSH terms: Spasm; Spasms, Infantile
Intervention: GWP42003-P
Intervention description: Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open-label
Enrollment: 9.0
Sex: All
Minimum age: 1 Month
Maximum age: 24 Months
Healthy volunteers: No
Keywords: GWP42003-P; Cannabidiol

Summary:

      This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,
      and an open-label extension phase. The open-label extension phase only will be described in
      this record. All participants will receive GWP42003-P.
    

Eligibility criteria:

        Only participants who completed the pilot or pivotal phases of the trial may proceed to
        take part in this open-label extension phase of the trial.

        Key eligibility criteria for the blinded phase were as follows:

        Key Inclusion Criteria:

          -  Participant is diagnosed with IS and has failed to respond adequately following
             treatment with 1 or more approved IS therapies.

        Key Exclusion Criteria:

          -  Participant is currently taking or has taken clobazam or any mammalian target of
             rapamycin (mTOR) inhibitor within the 2 weeks prior to the screening visit.

          -  Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB),
             of 460 msec or greater on ECG.

          -  Participant's caregiver is currently giving or has given recreational or medicinal
             cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the
             screening visit.

          -  Participant's caregiver is unwilling to abstain from giving the participant (including
             the participant's mother abstaining themselves, if breastfeeding)recreational or
             medicinal cannabis, or synthetic cannabinoid-based medications (other than the study
             drug) during the trial.

          -  Participant has any known or suspected hypersensitivity to cannabinoids or any of the
             excipients of the study drug, such as sesame oil.

          -  Participant has significantly impaired hepatic function at the screening visit.

          -  Participant has received an investigational medicinal product as part of a clinical
             trial within a minimum of 5 half-lives prior to the screening visit.
Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome
Condition: Diabetes Mellitus, Type 2; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Diabetes Mellitus; Diabetes Mellitus, Type 2; Syndrome
Intervention: Alogliptin; Placebo
Intervention description: Alogliptin tablets; Alogliptin placebo matching tablets
Intervention MeSH terms: Alogliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5380.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus - Type 2; Diabetes Mellitus; cardiovascular outcomes; heart attack; stroke; dipeptidyl-peptidase IV inhibitors; metabolic disorders; metabolic diseases; glucose metabolism disorders

Summary:

      The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once
      daily (QD), compared with placebo, in addition to standard of care, in patients with type 2
      diabetes mellitus and acute coronary syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes mellitus

          -  Is receiving monotherapy or combination antidiabetic therapy with a glycosylated
             hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and
             11.0%, inclusive, if the participant's antidiabetic regimen includes insulin)

          -  Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization.

        Exclusion Criteria:

          -  Signs of type 1 diabetes mellitus

          -  Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2
             diabetes mellitus at Screening

          -  Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or
             within the 3 months prior to Screening.
Comparing Safety and Efficacy of Dexmedetomidine and Propofol
Condition: Safety and Efficacy of Sedation Medications
Intervention: Dexmedetomidine; Propofol
Intervention description: An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete.; An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete.
Intervention MeSH terms: Dexmedetomidine; Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 3 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: dexmedetomidine; propofol; sedation; MRI; scanning; pediatric; children; Magnetic Resonance Imaging

Summary:

      This is a prospective, open label randomized study. The purpose of this study is to compare
      propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically
      identifying important patient demographics and looking at important outcomes including
      adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is 3 - 11 years

          -  Patient is scheduled for MRI at Children's Hospital Boston.

          -  Patient meets criteria to receive either dexmedetomidine or propofol sedation

          -  Patient's guardian provides written consent

        Exclusion Criteria:

          -  Patient does not meet established sedation criteria

          -  Patient has history of allergy, intolerance, or reaction to dexmedetomidine or
             propofol or hypersensitivity

          -  Patient has current, repaired, or risk for Moya-Moya disease

          -  Patient has had a stroke within the past six months

          -  Patient has uncontrolled hypertension

          -  Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker

          -  Known soy, Lecithin, or egg allergy
Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)
Condition: Cervical Cancer; Genital Warts
MeSH terms: Condylomata Acuminata
Intervention: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine; Matching Placebo
Intervention description: A 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.; A placebo 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12167.0
Sex: Female
Minimum age: 16 Years
Maximum age: 23 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent
      cervical cancer.
    

Eligibility criteria:

        Inclusion Criteria for the Base Study:

          -  Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

             --For Extension Phase:

          -  Participant received placebo or an incomplete vaccination series in the original study

             --For LTFU:

          -  Participant was randomized into the Base Study from Denmark, Iceland, Norway, or
             Sweden.

          -  Agreed to allow passive follow-up (retrospective review of registry data), analysis of
             biopsy specimens, future contact from National Registry Study Center and serum
             collection

        Exclusion Criteria for the Base Study:

          -  Prior Human Papilloma Virus (HPV) vaccination

          -  Prior abnormal Paps

          -  Prior history of genital warts

             --For Extension Phase:

          -  Prior complete HPV vaccination series

          -  Subject lives in a country in which Gardasil is approved and is within the age range
             of the local labeling for Gardasil

             --For LTFU Study:

          -  There were no exclusion criteria that did not overlap the inclusion criteria for this
             study.
A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Condition: Leiomyoma; Uterine Hemorrhage
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Hemorrhage
Intervention: Ulipristal acetate (UPA); Placebo
Intervention description: UPA tablet; Matching placebo tablet.
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 157.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the superiority of ulipristal acetate versus placebo for the
      treatment of abnormal uterine bleeding associated with uterine fibroids
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal women, 18-50 years, inclusive.

          -  Cyclic abnormal uterine bleeding (heavy or prolonged).

          -  Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in
             the first 8 days of menses.

          -  Minimum of one discrete leiomyoma observable by transvaginal ultrasound.

          -  Endometrial biopsy without evidence of malignancy or atypical or non-atypical
             hyperplasia

        Exclusion Criteria:

          -  History of uterine surgery that would interfere with the study endpoints.

          -  Known coagulation disorder including bleeding disorder or clotting disorder.

          -  History of, or current uterine, cervix, ovarian, or breast cancer.

          -  Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP),
             or total bilirubin two times or greater than the upper limit of normal rang