bioihbjkbjnl/mcl2 huggingface dataset:
Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section
Condition: Pruritus; Cesarean Section
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      Background: Common adverse side effects related to the use of neuraxial opioids in the
      obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor
      antagonists, in particular ondansetron, have been identified as possible antipruritic agents.
      It was reported that dexamethasone plus ondansetron is more effective than ondansetron for
      prevention of postoperative nausea and vomiting but no additional effect on treating
      pruritus.

      Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron
      versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative
      nausea and vomiting (PONV).

      Methods: A prospective randomized double blind study that will be conducted between June 2016
      and June 2017. Patients will be randomly allocated into two groups. The first group will
      receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV
      ondansetron plus 8 mg dexamethasone.
    

Detailed description: 
      A prospective randomized double blind study will be conducted between June 2016 and June
      2017. The sealed envelope technique will be used to randomly allocate females scheduled for
      elective cesarean section into two groups. After obtaining informed consent, all eligible
      patients will receive spinal anesthesia. The first group will receive 4 mg intravenous (IV)
      ondansetron with 2 ml saline while the other group will receive 4 mg IV ondansetron plus 8 mg
      (2 ml) dexamethasone.
    

Intervention name(s): Ondansetron (Zofran); Dexamethasone (Decadron); Spinal anesthesia
Intervention type(s): Drug; Drug; Other
Intervention description(s): Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia; Intravenous administration of 8 mg dexamethasone 15 minutes before spinal anesthesia; Intrathecal anesthesia by 10 mg hyperbaric marcain, 5 mcg sufentanyl and 150 mcg morphine using 27 G spinal needle (27 G Quincke needle)
Intervention MeSH terms: Dexamethasone; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
An Assessment of Prasugrel on Healthy Adults and Sickle Cell Adults
Condition: Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the exposure to prasugrel's active metabolite and the
      pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).
    


Intervention name(s): Prasugrel
Intervention type(s): Drug
Intervention description(s): Oral, daily for 12 days
Other intervention name(s): LY650315; CS747; Effient; Efient
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether teplizumab slows the loss of β cells and
      preserves β cell function in children and adolescent 8-17 years old who have been diagnosed
      with T1D in the previous 6 weeks..

      Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
    

Detailed description: 
      This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center
      study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal
      antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1
      diabetes (within 6 weeks of diagnosis). Approximately 300 participants will be randomized at
      a ratio of 2:1 to either the teplizumab group or the placebo group.

      Teplizumab or matching placebo will be administered in two courses 6 months apart. Each
      course of treatment will include daily infusions for 12 days. The total study duration for
      each participant will be up to 86 weeks.

      The primary objective is to determine whether two courses of teplizumab administered 6 months
      apart slows the loss of β cells and preserves β cell function over 18 months (78 weeks) in
      children and adolescents 8-17 years old who have been diagnosed with T1D in the previous 6
      weeks.

      The secondary objectives are to evaluate improvements in key clinical parameters of diabetes
      management, to determine the safety and tolerability of teplizumab, and to evaluate the
      pharmacokinetics (PK) and immunogenicity of teplizumab
    

Intervention name(s): teplizumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Treatment; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 3, randomized, double-blind, placebo-controlled, multinational, multicenter study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: T1D, type 1 diabetes, recent-onset T1D
Scotoma Reduction in AMD Patients Treated With Ranibizumab
Condition: Macular Degeneration
MeSH terms: Scotoma; Macular Degeneration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a trial aimed at patients with advanced wet macular degeneration and macular scarring
      treated wiht intravitreal injections of Lucentis.
    

Detailed description: 
      Patients with severe wet macular degeneration and scarring in the center of the retina may
      benefit from treatment if the size of the blind spot is reduced wiht injections of Lucentis.
    

Intervention name(s): intravitreal injection Lucentis (ranibizumab)
Intervention type(s): Drug
Intervention description(s): intravitreal injection Lucentis (ranibizumab)
Intervention MeSH terms: Ranibizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amd; disciform; fibrosis; Lucentis; scotoma
Mindfulness-based Therapy in Chronic Tinnitus
Condition: Chronic Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      In the present randomized waiting-list-controlled study the investigators examined a specific
      manualized mindfulness-based therapeutic approach in the treatment of chronic tinnitus.
    

Detailed description: 
      In the current randomized waiting-list-controlled pilot study, we investigate a new
      manualized therapeutic approach, which is based on mindfulness- and body-psychotherapy and
      which has been specifically developed for the treatment of tinnitus patients (Tinnitus
      Atemtherapie; http://www.maria-holl.de/). Essential components of the treatment program
      include mindfulness, meditation, selfmassage, and breathing exercises. These components are
      intended to help patients use their inner resources to accept responsibility for themselves,
      become more self-sufficient and develop symptom acceptance.
    

Intervention name(s): Mindfulness-based therapy; Treatment after waiting time
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treatment was performed as group therapy at two training weekends which were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22).; Treatment was performed after completion of the active arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness-based therapy; chronic tinnitus;
Phase I Pharmacokinetic Study (SALBLOCK)
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess the extent to which the charcoal prevents the
      absorption of salmeterol and fluticasone via the GI tract. The assessment will be based on
      comparing the pharmacokinetic parameter area under the concentration-time curve (AUCt).
    


Intervention name(s): salmeterol / fluticasone propionate
Intervention type(s): Drug
Intervention description(s): 100/1000 μg oral capsule
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Booster Injection in Subjects Who Previously Completed a 3-dose Schedule
Condition: Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study was to assess and describe the booster effect of a tetravalent CYD
      dengue vaccine dose administered about 5 years or more after the completion of a 3-dose
      vaccination schedule in Singapore.

      Primary Objective:

        -  To demonstrate the non-inferiority in terms of geometric mean of titer ratios (GMTRs) of
           a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in
           participants from CYD28 trial (participants from Group 1 only).

      Secondary Objectives:

        -  If the primary objective of non-inferiority achieved: To demonstrate the superiority, in
           terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine
           injection in participants from CYD28 trial (participants from Group 1 only).

        -  To describe the immune responses elicited by the CYD dengue vaccine booster or placebo
           injection in participants who received three doses of the CYD dengue vaccine in the
           CYD28 trial in all participants.

        -  To describe the neutralizing antibody levels of each dengue serotype Post Dose 3 (CYD28
           participants) and immediately prior to booster or placebo injection in all participants.

        -  To describe the neutralizing antibody persistence 6 months, 1 year and 2 years post
           booster or placebo injection in all study participants.

        -  To evaluate the safety of booster vaccination with CYD dengue vaccine in all
           participants.
    

Detailed description: 
      Healthy adolescents and adults received 3 doses of the tetravalent dengue vaccine 5-6 years
      earlier in a previous CYD dengue vaccine trial (CYD28 - NCT00880893) received either a
      booster injection of CYD dengue vaccine or a placebo on Day 0. They were evaluated for safety
      and antibody persistence of the booster injection up to 2 years post-vaccination.
    

Intervention name(s): CYD Dengue Vaccine (5 dose formulation); Placebo, NaCl 0.9%
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Dengue Hemorrhagic Fever; Dengue Virus; CYD Dengue Vaccine
A Study to Assess the Relative Bioavailability of Process Variants of Selumetinib in Healthy Male Volunteers
Condition: Healthy Volunteers Bioequivalence or Bioavailability Study
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to assess, against a reference selumetinib capsule, if the drug levels of a variant
      of selumetinib capsule are comparable, and to assess how drug levels differed in another
      variant of Selumetinib in Healthy Male Volunteers.
    


Intervention name(s): selumetinib 75mg single dose; selumetinib 75mg single dose; selumetinib 75mg single dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 blue capsules of 25 mg given as a single dose; 3 capsules of 25 mg given as a single dose; 3 capsules of 25 mg given as a single dose
Other intervention name(s): Selumetinib; Selumetinib; Selumetinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioequivalence; bioavailability; pharmacokinetics; Phase I; AZD6244; cancer
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination
      therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be
      randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180
      micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36
      or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from
      week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The
      anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for
      group 3, and the target sample size is 100-500 individuals.
    


Intervention name(s): Entecavir; Entecavir; peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.5mg po daily for 24 weeks; 0.5mg po daily from week 13 to week 36; 180 micrograms sc/week for 48 weeks; 180 micrograms sc/week from week 21 to week 68
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Safety and Tolerability in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and
      tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated
      therapeutic exposure under clinical investigation. In the event of poor tolerability in Part
      A of this study Part B may be conducted to explore higher doses using titration. Participants
      in both Parts A and B will participate in a 9 day wash-out period of current medication
      (Study Days 1-9); participants coming into the study on aripiprazole will remain on their
      current therapy throughout.
    

Detailed description: 
      The primary objective of this study was to evaluate the safety and tolerability of escalating
      doses of LY2140023 in subjects with schizophrenia.

      The secondary objectives of this study were:

        -  to characterize the pharmacokinetic (PK) parameters of LY2140023 and its active moiety -
           LY404039 in subjects with schizophrenia

        -  to explore higher doses of LY2140023 in subjects with schizophrenia for use in further
           regulatory studies

        -  to compare safety of LY2140023 to aripiprazole (ARP)

        -  to access changes in pharmacodynamic (PD) measures (Clinical Global Impression-Severity
           Scale [CGI-S], Extrapyramidal Symptoms [EPS], and Brief Psychiatric Rating Scale [BPRS])

      This was an inpatient, open-label, multiple-dose, multi-center study to evaluate the safety
      and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated
      maximum therapeutic exposure under investigation.
    

Intervention name(s): LY2140023; Aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): pomaglumetad methionil; Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
Condition: Opioid-related Disorders; Buprenorphine; HIV; Cognition; HIV Infections
MeSH terms: Opioid-Related Disorders
Study type: Observational

Summary: 
      The purpose of this study is to examine how Buprenorphine, a form of opioid addiction
      treatment, changes the ability to think and reason among people addicted to opiates, who are
      either HIV negative or HIV positive. In addition, blood samples will be stored for HIV+ and
      HIV- individuals who take buprenorphine to study its effect. This study hypothesizes that the
      HIV positive participants will demonstrate significant improvement in thinking and reasoning
      ability at 3 and 6 months compared to baseline, but that their thinking and reasoning ability
      will still be lower than HIV negative participants. This study also hypothesizes the
      biomarkers in participants' blood samples will be associated with measures of change in
      thinking and reasoning ability.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects for this study will be drug users with a diagnosis of opioid dependence who are
        initiating buprenorphine therapy at a DoSA clinic or at the CHCC. The study population is
        expected to reflect the ethnic composition of the opioid-dependent population in the Bronx.
        This population is composed of 40% women, and is 24% African-American, 58% Hispanic and 17%
        Caucasian. Both males and females with opioid dependence who are initiating buprenorphine
        will be recruited for the proposed study, and, based on our previous studies, we expect to
        recruit high proportions of women and minorities.
      
Biospecimen description: 
      Whole blood, Urine
Internet-based Treatment of Early Childhood Fecal Incontinence
Condition: Encopresis
MeSH terms: Encopresis
Study type: Interventional

Summary: 
      Encopresis, also known as fecal incontinence, is the voluntary or involuntary passage of
      stools causing soiling of clothes by a child over 4 years of age. The purpose of this study
      is to evaluate an Internet intervention for the treatment of encopresis.
    

Detailed description: 
      An estimated 2.3% of children suffer from encopresis. Enhanced Toilet Training (ETT) is one
      of the most effective ways of treating this disorder. When delivered by skilled and
      knowledgeable clinicians, ETT is twice as effective as intensive medical management alone.
      Although ETT is effective in treating encopretic children, there are six major barriers to
      its implementation: 1) availability of a knowledgeable and skilled clinician; 2) parental
      acceptance of referral to a mental health professional; 3) expense of service; 4) burden of
      time and distance to access such specialty services; 5) child resistance to disclosure of
      embarrassing material; and 6) willingness of the child and parent to follow treatment
      recommendations. This project will circumvent these barriers by developing an interactive
      Internet-based ETT program. The study will then assess the feasibility of the program by
      determining the acceptance, function, and effectiveness of the intervention.

      This project will have four phases. Phase 1 will identify optimal Internet and treatment
      elements as well as issues in need of experimental investigation. Phase 2 will investigate
      how to enhance Internet interventions. Phase 3 will evaluate the relative benefit of adding
      the Internet treatment to clinical services provided by clinicians in the fields of medicine
      and mental health. Phase 4 will investigate the relative long-term benefits of adding such an
      Internet-based intervention to professional care to determine its impact on symptom
      improvement, relapse prevention, quality of life, and its cost-effectiveness. Phase 4 will
      also assess to what extent the program is disseminated worldwide when made available on the
      Internet.
    

Intervention name(s): Internet-based intervention UCanPoopToo; treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Internet-based intervention to administer Enhanced Toilet Training (ETT).; Routine clinical care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Encopresis; Internet; Web; Treatment; Intervention
First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845
Condition: Pelvic Inflammatory Disease
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first in human study that will investigate the safety, tolerability and
      pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845
      using a placebo controlled, randomized, single center design.
    


Intervention name(s): BAY1834845; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group; Single dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Study Evaluating IMA-026 in Healthy Japanese Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending,
      single subcutaneous or intravenous doses of IMA-026 in healthy Japanese male subjects
    


Intervention name(s): IMA-026
Intervention type(s): Drug
Intervention description(s): SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of AZD5658 following
      ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated
      dose.
    

Detailed description: 
      This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to
      assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting
      after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.
    

Intervention name(s): AZD5658; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension, escalating single doses; oral suspension,single doses
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: First in man study evaluating AZD5658 in Type 2 Diabetics.; Effect of fasting; Safety; Tolerability