bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV Vaccine
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine safety and immunogenicity (ability to induce an
      immune response) of a novel HIV vaccine based on adeno-associated virus (AAV)
    

Detailed description: 
      The need for a vaccine to prevent AIDS and interrupt transmission of HIV is indisputable. To
      be effective, an HIV vaccine will have to induce cellular and humoral immune responses that
      are durable and potent. Intra-muscular delivery of HIV genes enclosed within recombinant
      adeno-associated virus (rAAV) protein capsid has been shown to be a potent inducer of both
      antibodies and T-cell responses in animal studies. tgAAC09, consisting of single-stranded DNA
      from Clade C HIV-1 genes for the gag, protease and part of the reverse transcriptase proteins
      enclosed within a rAAV serotype 2 protein capsid, was developed as one component of a
      multi-component HIV vaccine. The purpose of this study is to evaluate the safety and
      immunogenicity of tgAAC09 in healthy, HIV-seronegative volunteers.
    

Intervention name(s): tgAAC09
Intervention type(s): Biological
Intervention description(s): one or 2 doses of AAV-2 HIV vaccine (tgAAC09) at 3 dosage levels, dose escalation and dose optimization
Other intervention name(s): AAV-2 HIV Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV vaccine; Adeno-associated virus vactored vaccine; HIV-1 subtype C; Safety; Immunogenicity; Biodistribution; HIV prevention
Study of OFATUMUMAB as Part of the Scheme of Reduced Intensity Conditioning in High Risk Non-Hodgkin Lymphoma B Patients
Condition: B-Cell Lymphomas
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is rate of acute graft-versus-host disease II-IV measured at day
      +365according to conventional criteria (Przepiorka et al. 1995) in patients with high risk
      non-Hodgkin lymphoma B subjects with Allogeneic Stem Cell Transplant
    

Detailed description: 
      In addition to above:

        -  Rate of progression-free survival (PFS) at 12, 24, 36 and 60 months post-transplant
           defined as the time between the infusion of progenitors and the disease progression or
           death. Patients alive or in complete remission will be censored at the time of last
           follow up

        -  Transplant-related mortality (TRM) at 12, 24, 36 and 60 months after transplantation,
           defined as any death not caused directly by lymphoma (any death caused by complications
           related to transplantation).

        -  Overall survival (OS) defined as the time between infusion of progenitors and the
           patient's death from any cause. Alive Patients will be censored at the time of last
           follow-up

        -  Incidence of chronic graft versus host disease (GVHD) wide at 1 and 5 years according to
           conventional criteria (Atkinson et al. 1989) and Filipovich et al. (BBMT, 2005).

        -  Rate of event-free survival (DFS) defined as time interval between diagnosis of lymphoma
           and lymphoma progression or relapse or death if the above does not occur.

        -  Successful graft implantation: is defined as:

             1. º: three consecutive days with absolute neutrophil count greater than 0.5 * 109 / L

             2. ° thrombocythemia exceeds 20 * 109 / L.

        -  Reconstitution of the immune system: lymphocyte count populations CD20, CD3, CD4 and CD8
           and immunoglobulinemia serum (days +100, 180, 360, 18 months and 24 months).

        -  intercurrent infections. All sorts of infections (viral, fungal and bacterial)will be
           recorded

        -  Safety assessment by the standards of Common Terminology Criteria for adverse events v.
           4.0
    

Intervention name(s): Ofatumumab
Intervention type(s): Drug
Intervention description(s): Ofatumumab as part of the reduced intensity conditioning regimen (RIC)
Other intervention name(s): ARZERRA
Intervention MeSH terms: Ofatumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hodgkin; disease; ofatumumab
Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler (MICRODOPPLER PLACENTA)
Condition: Preeclampsia and Intrauterine Growth Restriction
MeSH terms: Pre-Eclampsia; Fetal Growth Retardation; Placental Insufficiency
Study type: Observational

Summary: 
      To identify fetuses small for their gestational-age who have reached their appropriate growth
      potential from growth-restricted fetuses due to placental insufficiency is uneasy. Intra
      Uterine Growth Restriction (IUGR) increases the risk for indicated preterm delivery, neonatal
      mortality and morbidity. Therefore, improving the knowledge of the placental perfusion is
      essential to better identify and manage fetal chronic oxygen deprivation associated with
      placental insufficiency. Thus, the investigators propose to study placental microcirculation
      with a more efficient Doppler than conventional Doppler use in clinical practice. The
      Ultrafast Doppler is being able to map placental blood flow and could have potential impact
      in placental insufficiency diagnosis and prevention. Moreover, this Doppler could
      discriminate maternal and fetal vascularization.

      The hypothesis is that Ultrafast Doppler could help clinician to diagnose and manage
      preeclampsia and IUGR during pregnancy.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women
      
Keywords: microDoppler; placenta; preeclampsia; intrauterine growth restriction
A Database for Emotion Analysis Using Physiological and Psychological Assessment by 40FY
Condition: Psychological Stress; Heart Rate Variability; Mental Health Services
MeSH terms: Stress, Psychological
Study type: Observational

Summary: 
      A comprehensive study examining the physiological, emotional and psychological aspects of
      stress among Korean adults
    

Detailed description: 
      A dataset for the analysis of affective states of Korean adults. Participants' facial and
      finger videos were recorded using a cell phone camera, while watching six emotion-eliciting
      video stimuli, each three minutes in length (two of each: neutral, positive, and negative).
      Participants were asked to rate their emotion and arousal in terms of arousal and valence
      levels. The ECG data were collected using a 1-lead ECG while watching the six
      emotion-eliciting video stimuli. Psychological assessments were conducted using
      self-administered scales measuring psychological status and personality.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We recruited Adults between the ages of 19 and 45 who can read fluently in Korean. All
        study participants understood the study procedures and provided written informed consent
        according to the Declaration of Helsinki.
      
Keywords: Contactless measurement of Heart Rate Variability; Mobile digital mental health monitoring; Psychological assessment
A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of LBVE013
      (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) or LBVE014
      (Pneumococcal 14-valent conjugate vaccine [diphtheria CRM197 protein]) in healthy adults.
    


Intervention name(s): Pneumococcal conjugate vaccine
Intervention type(s): Biological
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs
Condition: Visual Acuity
Study type: Interventional

Summary: 
      The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL
      for far, near and intermediate vision.
    


Intervention name(s): Trifocal Intraocular Lens; Bifocal Intraocular Lens; Low Addition Bifocal Intraocular Lens
Intervention type(s): Device; Device; Device
Intervention description(s): bifocal intraocular lens (IOL); trifocal intraocular lens (IOL); low near addition intraocular lens (IOL)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      The purpose of this observational study is to determine whether the vaccine (UB 311),
      targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term
      immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's
      disease (AD) who previously received UB 311-treatment. Amyloid beta was selected as the
      target antigen based on supporting evidence of the hypothesis that places the accumulation of
      amyloid beta at the initiating step of AD.
    


Intervention name(s): Observational
Intervention type(s): Biological
Intervention description(s): Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Enrolled subjects who received UB 311-treatment in the initial UBI Protocol V118 (Protocol
        V118-AD) Phase I trial are eligible for continued follow-up to week 48
      
Biospecimen description: 
      Periodic blood samples collected for serum and measurement of anti-Amyloid-beta antibody
      levels.
    
Keywords: Alzheimer's disease; amyloid beta; vaccine
Pharmacotoxicology of Trichloroethylene Metabolites
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a research study to look at how Dichloroacetate (DCA), and investigational drug and
      chloral hydrate are broken down in the body. The purpose of the study is to better understand
      how humans metabolize these two common chemicals that are widely present in the environment.
      The study focuses on how the drug chloral hydrate is broken down and how it effects DCA
    

Detailed description: 
      The subject's general health is assessed by a history and physical exam and routine blood
      work. I normal the individual undergoes five nights of receiving 1.5ug/kg of chloral hydrate.
      On day 6 the individual receives 2.5 micrograms/kg of Dichloroacetate (DCA) and kinetics are
      drawn. After 30 days the subject comes back and receives 1.5ug/kg of chloral hydrate for five
      nights and has kinetics drawn on night one and five. On days 6-9 the subject returns for a
      blood draw. After 30 days the same process as above is done except the subject receives 1gram
      of chloral hydrate for five nights and 25mg/kg of Dichloroacetate one day then 30 days later
      the subject receives 1gram of chloral hydrate for five nights and has kinetics done on night
      one and five and blood samples drawn on days 6-9
    

Intervention name(s): Dichloroacetate environmental dose; Chloral Hydrate environmental dose; Dichloroacetate therapeutic dose; Chloral Hydrate therapeutic dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): On day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics.; Study subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5.; Subjects receive 25 mg/kg DCA on Day 6. Pharmacokinetics are done on nights 1 and nights 5.; Subject is given 25 mg/kg of Chloral Hydrate for five nights.
Other intervention name(s): DCA; DCA
Intervention MeSH terms: Chloral Hydrate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dichloroacetate; Chloral Hydrate; Metabolism
Tobacco and Socioeconomic Disadvantage
Condition: Tobacco Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized clinical trial comparing 3 brief interventions designed to increase motivation to
      quit smoking in socioeconomically disadvantaged smokers.
    

Detailed description: 
      The investigators propose a randomized clinical trial comparing 3 brief interventions
      designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.
      Participants will be randomly assigned to receive a) A brief motivational interviewing
      intervention, b) A nicotine replacement therapy sampling intervention, or c) A referral-only
      intervention.
    

Intervention name(s): Motivational Interviewing; Nicotine Replacement Therapy Sampling; Referral Only
Intervention type(s): Behavioral; Drug; Behavioral
Intervention description(s): Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.; Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.; Participants are provided with a written referral for tobacco dependence treatment.
Other intervention name(s): Nicotine Replacement Therapy; Referral
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial in which participants are randomized to one of three groups.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: tobacco; smoking; cigarette
The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients
Condition: Burn
MeSH terms: Burns
Study type: Interventional

Summary: 
      Adequate sleep is an important aspect of any healing process, and because it is known that
      children recovering from burns suffer long term sleep disruptions, the investigators believe
      that Healing Touch may improve the quality and quantity of sleep in the pediatric burn
      population.
    

Detailed description: 
      This study examines the impact of Healing Touch on the quality and quantity of sleep in
      pediatric burn survivors. Polysomnography recordings are obtained in order to assess
      nocturnal sleep in conjunction with Healing Touch; which is done on 1 of 2 nights during
      Polysomnography. Soft background music is played on both nights.

      Healing Touch is performed by one of 2 Healing Touch Certified Practitioners.
    

Intervention name(s): Healing Touch
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: polysomnography; sleep; healing touch; pediatric burn
A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the effects of BMS-986278 on Drospirenone (DRSP) and
      Ethinyl Estradiol (EE) when administered as a combined oral contraceptive in healthy female
      participants.
    


Intervention name(s): BMS-986278; Drospirenone/Ethinyl Estradiol
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; BMS-986278; Hormonal contraceptives; Ethinyl estradiol; Drospirenone; Pulmonary fibrosis
A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of
      CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched
      healthy control subjects with normal hepatic function.

      Degrees of hepatic impairment will be determined during screening by the subject's score
      according to Child-Pugh Classification Criteria.
    

Detailed description: 
      Subjects will be enrolled in Groups 1 through 5 as follows:

        -  Group 1: Approximately 6 to 8 male or female subjects with mild hepatic impairment (with
           a Child-Pugh score of ≥ 5 to ≤ 6) will be enrolled in Group 1.

        -  Group 2: Approximately 6 to 8 male or female subjects with moderate hepatic impairment
           (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group 2.

        -  Group 3: Approximately 6 to 8 healthy male or female subjects with normal hepatic
           function will be enrolled in Group 3. Subjects in Group 3 will be matched to subjects in
           Group 2 with respect to sex, age (± 10 years), and weight (± 10% body mass index [BMI]).
           Group 3 will also serve as the control group for Group 1.

        -  Group 4: Approximately 6 to 8 male or female subjects with severe hepatic impairment
           (with a Child-Pugh score of ≥ 10 to ≤ 13) will be enrolled in Group 4.

        -  Group 5: Approximately 6 to 8 healthy male or female subjects with normal hepatic
           function will be enrolled in Group 5. Subjects in Group 5 will be matched to subjects in
           Group 4 with respect to sex, age (± 10 years), and weight (± 10% BMI).

      This study employs a staged design as follows:

        -  Subjects with mild or moderate hepatic impairment and matching healthy subjects with
           normal hepatic function (Groups 1 through 3) will be enrolled concomitantly.

        -  At least 4 subjects with mild or moderate hepatic impairment must demonstrate
           satisfactory safety and tolerability for up to 4 days after dosing before subjects with
           severe hepatic impairment may be dosed.

        -  Two subjects with severe hepatic impairment must demonstrate satisfactory safety and
           tolerability for up to 4 days after dosing before the remaining subjects with severe
           hepatic impairment may be dosed.
    

Intervention name(s): CC-90001
Intervention type(s): Drug
Intervention description(s): CC-90001
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CC-90001; Pharmacokinetics; Hepatic Impairment; Healthy subjects
A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination
      with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus
      (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in
      Japan.
    

Detailed description: 
      This is a single-arm study to evaluate the efficacy and safety of TMC435 in combination with
      the standard of care (SoC), PegIFNα-2a (P) and ribavirin (R), in adult, genotype 1
      HCV-infected participants who relapsed after previous IFN-based therapy in Japan. The study
      objective is to evaluate the efficacy of TMC435 by the percentage of participants with
      undetectable HCV ribonucleic acid (RNA). Participants will receive 12 weeks of treatment with
      TMC435 (100 mg) once daily plus PR followed by 12 or 36 weeks of treatment with PR. TMC435 is
      a 100-mg capsule and will be taken orally (via the mouth). Treatment with PR will last 24 or
      48 weeks. Pegylated interferon is supplied as a vial containing 1.0 mL solution with 180 µg
      PegIFNα-2a and will be injected by a syringe under the skin once weekly. Ribavirin is given
      as 200-mg tablets (daily dose: 600-1000 mg), taken orally two times a day after meals. The
      participants will receive oral capsules of TMC435 (100 mg) once daily up to Week 12.
    

Intervention name(s): TMC435; Pegylated interferon (pegIFN alpha-2a); Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100-mg capsule once daily for 12 weeks; 180 mcg injected subcutaneously (by a syringe under the skin) once weekly for 12 to 36 weeks (or until Week 48).; 200-mg tablets (daily dose: 600-1000 mg) taken orally (by mouth) two times a day for 12 to 36 weeks (or until Week 48).
Other intervention name(s): PEGASYS; COPEGUS
Intervention MeSH terms: Interferons; Ribavirin; Peginterferon alfa-2a; Simeprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; Hepatitis C virus; Interferon Alfa-2a; Ribavirin; Viral RNA
Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study (0954A-314)
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      An efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to
      amlodipine at week 12 in Korean patients with essential hypertension
    


Intervention name(s): MK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks
Intervention type(s): Drug
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the safety and tolerability of
      BI 409306 in healthy young and elderly male and female volunteers following oral
      administration of repeated rising doses, given once daily over 14 days to young healthy
      genotyped and elderly healthy male/female volunteers.
    


Intervention name(s): BI 409306 BS; BI 409306 BS; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Medium dose film-coated tablet; High dose film-coated tablet; Film-coated tablet
Intervention MeSH terms: BI 409306
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment