bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F
      Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft
      failure after coronary artery bypass surgery.
    

Detailed description: 
      Coronary vascular disease manifested by narrowing of the coronary arteries is one of the more
      common manifestations of atherosclerotic vascular disease. The clinical manifestations of
      coronary artery disease include death, angina pectoris, myocardial infarction, congestive
      heart failure and arrhythmia. Restoration of circulation to the heart may be undertaken using
      a variety of techniques including angioplasty, stenting, and bypass grafting.

      Approximately 359,000 patients underwent coronary bypass procedures in the U.S. in 1999. Long
      term studies have observed an incidence of vein graft occlusion at 19% at 1 year, 25% at 5
      years and 50% by 15 years after operation for an overall rate of 2.5% per year after the
      first year of observation. The consequences of graft failure are as significant as those of
      primary atherosclerotic disease and include ischemia, myocardial infarction and death.

      CGT003 is a novel therapeutic that is under investigation as a treatment to prevent vein
      graft failure. It acts by inhibiting the transcription factor, E2F, which is activated in
      response to injury such as that which occurs when thin-walled vein grafts are exposed to the
      pressures of the arterial circulation. Blockade of E2F inhibits smooth muscle cell
      proliferation and redirects the vein graft remodeling that occurs within the first several
      days after implantation towards medial hypertrophy and strengthening of the medial layer and
      blunts formation of neointima. Inhibition of neotinimal formation coupled with expansion of
      the media should result in a decreased risk of the accelerated atherosclerosis and consequent
      vein graft failure over several years.
    

Intervention name(s): CGT003 (E2F Duplex Decoy)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: CABG; coronary artery bypass surgery; coronary artery disease; coronary arteriosclerosis; coronary stenosis; coronary occlusion
Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause
Condition: Menopause; Insomnia; Hot Flashes
MeSH terms: Sleep Initiation and Maintenance Disorders; Hot Flashes
Study type: Interventional

Summary: 
      The primary aim of the current study is to evaluate the effectiveness of a Cognitive
      Behavioral Therapy intervention in the treatment of menopause-associated insomnia and
      nocturnal hot flashes.
    

Detailed description: 
      This study aims to develop and evaluate a primary care-based intervention for insomnia and
      nocturnal hot flashes (nHF) in peri- and postmenopausal women. Menopause-associated insomnia
      is associated with adverse consequences including reduced quality of life, increased health
      care utilization, and risk for psychiatric disorders and medical conditions. The poor
      benefit/risk ratio of estrogen and progesterone replacement therapy and concerns about
      long-term effects of sedative hypnotics has left women desperate for new approaches to
      resolve menopause-related health problems, including poor sleep. The proposed intervention
      aims to develop and evaluate a much-needed safe treatment of menopause-associated insomnia
      that combines and enhances cognitive behavioral therapies for insomnia and hot flashes. To
      maximize the public health impact, improve access, and reduce treatment barriers (stigma and
      transportation issues), we propose to evaluate the efficacy and effectiveness of the
      intervention delivered by nurses in gynecology clinics, where women receive routine care.
      Primary outcomes, for which the study is optimally designed and sufficiently powered, are
      subjectively- and objectively-measured sleep and nHF.

      The Aims of this research are to:

        1. To explore feasibility, acceptability (willingness to be randomized and dropout rates)
           of CBTMI, and indications of efficacy/effectiveness of CBTMI in a randomized,
           placebo-controlled, pilot study.

        2. To explore the effects of CBTMI on the number and duration of arousals/awakenings that
           follow nHFs. If effective, the intervention has the potential to improve the quality of
           life in peri- and postmenopausal women and reduce the significant costs to society.
    

Intervention name(s): CBT for Menopausal Insomnia (CBTMI)
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI) includes education about sleep, sleep restriction, stimulus control, cognitive restructuring of sleep interfering thoughts, and relapse prevention; while also addressing women's beliefs about and reactions to hot flashes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menopause; Insomnia; Hot Flashes
A 2-Month Safety Follow-Up Trial
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The main purpose of the trial is to evaluate pulmonary function in subjects who had completed
      any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an
      additional 2-month safety follow-up.
    

Detailed description: 
      This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009,
      MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this
      trial. The adverse event data included are for the combined Safety population irrespective of
      previous treatments in the parent trials.
    

Intervention name(s): Technosphere Insulin Inhalation Powder; Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Subjects previously treated with Technosphere Insulin Inhalation Powder; Subjects previously treated with other anti-diabetic medications
Intervention MeSH terms: Insulin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of eligible type 1 and type 2 diabetic subjects who have
        completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030).
Genetics of Recurrent Early-Onset Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      This nationwide study will create a DNA collection to permit qualified scientists to search
      for depression-related genes.

      More than 750 families with at least two siblings who have experienced major depression are
      needed for the study. Participants will be interviewed about psychiatric and family history,
      and will be asked to provide a small blood specimen. The identification of predisposing genes
      can lead to greater understanding of the brain mechanisms involved in severe depression which
      can in turn lead to the discovery of new treatments.

      A Certificate of Confidentiality from the federal government ensures that all information
      will be strictly confidential. Blood specimens are identified only by code number (not by
      name).

      Reimbursement is provided.
    

Detailed description: 
      Studies of patterns of major depression in families suggest that 50 to 70% of the
      predisposition to major depression is caused by genes. People with recurrent depression and
      earlier ages of onset have more relatives with depression. There are probably at least
      several interacting genes, rather than a single gene as in some disorders. The identification
      of predisposing genes is likely to lead to greater understanding of the brain mechanisms
      involved in severe depression. This could lead to the discovery of new treatments.

      This study will create a DNA collection to permit qualified scientists to search for
      depression-related genes. More than 750 families with at least two siblings who have
      experienced major depression are needed for the study.

      Participants in this study will be interviewed about psychiatric and family history, and will
      be asked for a small blood specimen. Interviews can be conducted in person or by telephone.
      For telephone interviews, blood sample collection will be arranged at a location and time
      convenient for the participant. Participants will also be asked for help in inviting other
      family members to participate. No family member will be contacted without the permission and
      assistance of another participating family member.

      For information on a related study, please follow this link:

      http://clinicaltrials.gov/show/NCT00260182
    

Observational model: Family-Based
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Probands will have major depressive disorder meeting the eligibility criteria described
        below.
      
Biospecimen description: 
      Blood specimens were submitted to the NIMH repository at the Rutgers University Cell and DNA
      Repository.
    
Keywords: Depression; Depressive Disorder; Family; Genes; Genetic Techniques; Genetics; Linkage (Genetics); Nuclear Family; Recurrence; Severity of Illness Index
A Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants
Condition: Body Weight
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effects of Activamp, a product containing
      gynostemma pentaphyllum extract, on body weight, fat loss and metabolic markers in healthy
      overweight adults.
    


Intervention name(s): Activamp; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Activamp; Gynostemma pentaphyllum; Body weight; Fat Loss; Metabolic markers; Overweight participants; DXA; AMPK
Targeting Beta Cell Dysfunction With Verapamil in Longstanding T1D
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether verapamil can transiently improve beta cell
      function in those who do or do not secrete proinsulin and little/no C-peptide.
    


Intervention name(s): Verapamil
Intervention type(s): Drug
Intervention description(s): Subjects will receive oral verapamil for 12 weeks
Intervention MeSH terms: Verapamil
Intervention model: Single Group Assignment
Intervention model description: open label proof of concept study
Masking: None (Open Label)
Primary purpose: Basic Science
Iron Supplementation Among Adolescent Girls in India
Condition: Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      This study will implement and evaluate a community-based intervention to distribute and
      promote consumption of weekly iron-folic acid supplements and to provide nutrition education
      to reduce the prevalence of iron deficiency anemia among adolescent girls in West Bengal,
      India.
    


Intervention name(s): Iron-folic acid supplement
Intervention type(s): Drug
Intervention MeSH terms: Folic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Iron deficiency anemia; Adolescent girls; India
Anthocyanin Dose-escalation Study in Healthy Young Adults
Condition: Healthy
Study type: Interventional

Summary: 
      Anthocyanins are naturally existing, polyphenolic compounds found in the vacuolar sap of the
      epidermal tissues of flowers and fruits, with a pink, red, blue, or purple color. Recently,
      study of anthocyanin pigments has drawn more and more interest since several epidemiological
      studies have demonstrated their health-promoting properties, such as reducing lipid
      accumulation and decreasing oxidative stress and inflammation. Nevertheless, there is a clear
      need for advancing understanding with regard to effective amounts of intake for these
      phytochemicals. The aim of this study was to investigate the efficacy and pharmacokinetics of
      anthocyanin in healthy volunteers.
    


Intervention name(s): Anthocyanin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules with different anthocyanin content; Placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Randomized Controlled Trial; Anthocyanin; Antioxidants
Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study is designed to evaluate the safety and efficacy of the Fisher Wallace Stimulator
      FW-200 to deliver Cranial Electrotherapy Stimulation (CES) for the treatment of moderate to
      severe Major Depressive Disorder (MDD) in adults.
    

Detailed description: 
      This prospective, fully remote, randomized, controlled, triple-blind (subject, Principal
      Investigator, Sponsor) pivotal study is designed to evaluate the safety and efficacy of the
      Fisher Wallace Stimulator FW-200 to deliver Cranial Electrotherapy Stimulation (CES) for the
      treatment of moderate to severe Major Depressive Disorder (MDD) in adults.
    

Intervention name(s): Fisher Wallace Cranial Electrotherapy Stimulator (Active Device); Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
Intervention type(s): Device; Device
Intervention description(s): The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks.; The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit.
Other intervention name(s): Fisher Wallace Stimulator FW-200; FW-200
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pivotal Study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MDD; Depression; Depressive Disorder; Major Depressive Disorder; Cranial Electrotherapy Stimulation; FW-200
Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
Condition: Whole Cell Pertussis; Tetanus; Hepatitis B; Diphtheria; Haemophilus Influenzae Type b; Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP)
      booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or
      Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so
      that the subjects' parents will not know which vaccine was administered to their child. In
      the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open
      manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No
      blood samples will be taken in this safety study.
    

Detailed description: 
      Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive
      Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively,
      without or with Mencevax ACWY vaccine at 24 to 30 months of age. Subjects previously primed
      with Tritanrix-HepB/Hiberix will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix
      vaccine (at 15-18/24 m) with Mencevax ACWY vaccine at 24 to 30 months of age.
    

Intervention name(s): Tritanrix-HepB/Hib-MenAC; Tritanrix-HepB/Hiberix; Mencevax-ACWY
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine; Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine; Meningococcal Serogroups A, C, W-135 and Y Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Hib & Neisseria meningitidis serogroups A & C diseases
Study of Quadrivalent Influenza Vaccine Among Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the
      licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1),
      and the investigational TIV containing the alternate B (B2) strain in children.

      Primary Objective:

      To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011
      TIV (containing the primary B strain) and investigational TIV (containing the alternate B
      strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains
      separately among children aged 6 months to less than 9 years of age

      Secondary Objective:

      To demonstrate superiority of antibody responses to each B strain in QIV compared with
      antibody titers following vaccination with the TIV that does not contain the corresponding B
      strain, as assessed by GMT ratios and seroconversion rates.

      Observational Objective:

      To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as
      assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days
      post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and
      adverse events of special interest and serious adverse events (SAEs) collected from Visit 1
      to Visit 2.
    

Detailed description: 
      Participants will receive a single dose of their assigned vaccine during Visit 1. For those
      requiring two doses of influenza vaccine, as per Advisory Committee on Immunization Practices
      (ACIP) guidance, a second dose of the assigned vaccine will be administered at Visit 2. All
      participants will be followed up for safety (up to 6 months post final vaccination) and for
      immunogenicity up to Day 28 post-vaccination (Visit 2 or Visit 3, as appropriate).
    

Intervention name(s): Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative; Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative; Quadrivalent Influenza Vaccine, No Preservative
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.25 mL (6 to 35 months) or 0.5 mL (3 to <9 years), Intramuscular; 0.25 mL (6 to 35 months) or 0.5 mL (3 to <9 years), Intramuscular; 0.25 mL (6 to 35 months), or 0.5 mL(3 to <9 years), Intramuscular
Other intervention name(s): Fluzone®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Quadrivalent Influenza Vaccine; Trivalent Influenza Vaccine; Influenza viruses; Fluzone®
Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers
Condition: Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effectiveness of the telephone intervention
      program for caregivers of colorectal cancer.
    

Detailed description: 
      telephone Intervention refer to provide counseling and education to caregivers of colorectal
      cancer by mode of telephone
    

Intervention name(s): Telephone intervention
Intervention type(s): Behavioral
Intervention description(s): counseling and education support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: quality of life; anxiety; stress; carers; colorectal or colon cancer