bioihbjkbjnl/mcl2 huggingface dataset:
Study of A Cell-Phone System to Improve Health of Youth With Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      FL3X is an integrated diabetes self-management system that incorporates modern cell phone
      technology with behavioral modification approaches to improve diabetes self-management in
      high-risk youth. Utilizing such approaches will increase adherence to diabetes management
      behaviors and improve glucose control by providing increased autonomy over diabetes care.
    

Detailed description: 
      FL3X utilizes diabetes care providers (diabetes educators) as health coaches to employ
      behavioral modification techniques including motivational interviewing and problem solving
      skills training. Coaches help adolescents and their families learn these techniques to
      improve diabetes self management behaviors and diabetes care.
    

Intervention name(s): health coaching with technology support
Intervention type(s): Behavioral
Intervention description(s): Intensive behavior change support. Engaging participants to take an active role in their diabetes care using motivational interviewing, technology, family communication, problem solving skills.
Other intervention name(s): FL3X
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motivational interviewing; problem solving skills; family communication; technology support; cell phone system
Comparison of Self and Clinician Administered Rating Scales in Patients With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The primary objective is to establish the concurrent validity of the clinician administered
      Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS) and the patient administered
      Attention Deficit Hyperactivity Disorder Self Report Scale (ASRS) v1.1 Symptom Checklist.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who are enrolled
        in the study Protocol 2003-P-001313: "Prevention of Cigarette Smoking in ADHD Youth with
        CONCERTA."
      
Keywords: Attention Deficit Hyperactivity Disorder (ADHD); Adolescent
Human Repeat Insult Patch Test to Evaluate Personal Lubricants
Condition: Erythema; Edema
MeSH terms: Erythema
Study type: Interventional

Summary: 
      The purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as
      a result of repeated occlusive patch. The intervention will be applied for a total of 9
      induction applications, followed by an approximately 2 week rest period, then followed by a
      24-72 hour Challenge applications.
    


Intervention name(s): "Chameleon" Personal Lubricant
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Primary Prophylaxis of Gastric Varix Bleed
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection
      will be better than both beta-blocker therapy and no treatment in prevention of gastric
      variceal bleed. The investigators conducted a randomized controlled trial in patients with
      gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with
      cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed
      from gastric varices.
    

Detailed description: 
      Patients are followed up every 3 months or at the time of end point or complications.
    

Intervention name(s): Endoscopic cyanoacrylate injection; Beta-blocker (propranolol)
Intervention type(s): Procedure; Drug
Intervention description(s): Endoscopic cyanoacrylate injection in gastric varix
Other intervention name(s): Glue injection in gastric varix
Intervention MeSH terms: Propranolol; Adrenergic beta-Antagonists
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Oral Micronized Progesterone Effects on Perimenopausal Menstrual Flow
Condition: Perimenopause; Menstrual Cramps
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the within-woman effect of oral micronized progesterone
      (Progesterone 300 mg at bedtime) on semi-quantitative menstrual flow measured by the DivaCup®
      (menstrual cup with volume indicators at 7.5, 15 and 30 ml) or by counting the number of
      soaked normal-sized sanitary products such as normal-sized tampons or pads as well as length
      of flow and frequency and severity of menstrual cramps (on a 0-4 scale) in women with hot
      flushes and night sweats who are qualified to enroll in the primary perimenopausal hot flush
      trial stratified by whether they are in Early or Late Perimenopause.
    

Detailed description: 
      The study will be a double-masked, placebo-controlled 28-day (4 week) baseline, 84-day (12
      week) experimental trial, with a maximum number of 125 potential enrollees, with stratified
      random therapy assignment by Early or Late Perimenopause. Participants who meet the inclusion
      criteria for the original Progesterone for Perimenopausal Vasomotor Symptoms Study will be
      invited to join this additional sub-study. As part of the primary trial they will be randomly
      assigned into either the Progesterone or placebo group on a 1:1 basis. Primary and secondary
      data will be collected continuously throughout the study by completion of the Daily
      Perimenopause Diary-flow starting at baseline and continuously throughout the study.
    

Intervention name(s): Oral Micronized Progesterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dose of 300 mg of Progesterone is a physiological one that maintains the serum progesterone at or above the luteal (normal post-ovulatory) threshold for 24 hours. This duration of action is important because Progesterone is not safely taken during waking hours because of its soporific effects.; pill with no effect
Other intervention name(s): progesterone
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Progesterone; Menstrual Flow
A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism (MEM)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will attempt to study the effect of memantine, on memory, and motor
      praxis/expressive language skills in children with autism.

      The investigators will recruit children ages 6-12 years who are verbal and meet criteria for
      Autism Spectrum Disorder. The children will be assessed for memory function, expressive
      language output and motor skills/praxis. They will then be randomized to memantine or placebo
      for 6 months. The effects of this medication and its safety in this population will be
      studied over the 6 month period.
    

Detailed description: 
      Abnormalities in the modulation of the glutamate system have been reported by multiple
      investigators studying animal models, post-mortem brains, and single gene disorders that have
      overlapping phenotypes with autism. Abnormalities in glutamatergic function have been
      reported in disorders affecting a variety of behavioral and neurological domains, from mood
      stability, to cognitive flexibility, memory, and motor function. Numerous studies have
      reported a variety of memory and motor deficits in children with autism. Whereas the
      neurobiology of such deficits is an area of active research, there is a paucity of
      intervention research for such deficits in autism. This study will attempt to study the
      effect of an N-methyl-D-aspartate receptor (NMDA) inhibitor, memantine, on memory, and motor
      praxis/expressive language skills in children with autism.

      Methods: Children ages 6-12 years who are verbal and meet criteria for Autism Spectrum
      Disorder will be recruited across 2 sites. After consent, the children will be assessed for
      memory function, expressive language output and motor skills/praxis. They will then be
      randomized 1:1 to memantine versus placebo for 6 months. The effects of this medication on
      the above mentioned symptoms domains as well as its safety in this population will be studied
      over the 6 month period.
    

Intervention name(s): Memantine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Memantine will be initiated at 3 mg. The dose will be increased every week by 3 mg for a maximum of 12mg for subjects weighing ≥ 60kg, 9mg for subjects weighing ≥ 40 kg but <60 kg, and 6 mg for subjects weighing ≥ 20 kg but < 40kg.
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Autism; Psychopharmacology; Clinical Trial; Children
Effect of Addition of Mannitol to Bupivacaine on IANB Success and Post-endodontic Pain
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol
      in patients with irreversible pulpitis in mandibular molars.
    

Detailed description: 
      Patients with irreversible pulpitis in mandibular molars will be selected according to the
      eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone
      or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.
    

Intervention name(s): bupivacaine plus mannitol; bupivacaine alone
Intervention type(s): Drug; Drug
Intervention description(s): local anesthesia; local anesthesia
Other intervention name(s): vivacaine plus mannitol; vivacaine
Intervention MeSH terms: Mannitol; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: inferior alveolar nerve block; long-acting local anesthesia; bupivacaine; mannitol; symptomatic irreversible pulpitits
The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.
Condition: Heart Failure; Type 2 Diabetes
MeSH terms: Heart Failure; Hyperglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Diabetes and Heart Failure are diseases with high morbidity and increased risk of death.
      Former investigations has shown that diabetes worsens the prognosis of heart failure. However
      it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac
      function.

      Our hypothesis is that short term dysregulation affects left ventricular function and
      exercise capacity in insulin treated type 2 diabetics with and without heart failure.

      To elucidate this hypothesis diabetic patients with and without heart failure will be
      investigated after overnight state of either high or normal blood glucose levels on two
      separate occasions. Metabolic and hormonal parameters will be measured. Systolic and
      diastolic cardiac function will be assessed, exercise capacity and post exercise regional
      myocardial tissue velocity as well as 6 minutes walk test will be investigated on both
      occasions. The study will be a randomized cross-over design.
    


Intervention name(s): insulin
Intervention type(s): Drug
Intervention description(s): There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interleukin-1 Receptor Antagonist Gene Polymorphism and Adverse Pregnancy Outcome in Turkish Women
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Observational

Summary: 
      The investigators hypothesized that the IL-1A (+4895), IL-1B (+3954), and IL-1RN gene
      polymorphisms may be associated with PLBW. Smoking has been well documented by numerous
      studies as a major environmental risk factor for periodontitis and adverse pregnancy
      outcomes. Therefore, the investigators only selected non-smoking individuals in this study as
      the smoking-related risk could obscure the polymorphism-related increase in risk for
      periodontitis and adverse pregnancy outcomes. This study aimed to determine the association
      between IL-1A (+4895), IL-1B (+3954), and IL-1RN polymorphisms with adverse pregnancy
      outcomes and periodontitis in a non-smoking Turkish population.
    

Detailed description: 
      Pregnant women between 18-35 years of age with single gestation and with ≥20 on-crowded teeth
      excluding third molars were included in this study. Subjects were divided into normal birth
      (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant
      with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB
      group. Women who delivered infants whose birth weight was below 2500 g or before 37 weeks of
      gestation were placed in the PLBW group. Current/past tobacco user, alcohol abuse, history of
      high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta
      previa were the exclusion criteria for this study. Maternal, obstetric, and demographic
      factors such as maternal age, maternal education, regular prenatal care, genitourinary tract
      infections during pregnancy, total number of births, previous PLBW, and antibiotic use during
      the pregnancy period were also recorded.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women between 18-35 years of age with single gestation and with ≥20 on-crowded
        teeth excluding third molars were included in this study. Subjects were divided into normal
        birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an
        infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in
        the NB group. Women who delivered infants whose birth weight was below 2500 g or before 37
        weeks of gestation were placed in the PLBW group.
      
Biospecimen description: 
      Whole blood
    
Keywords: Periodontitis; adverse pregnancy outcomes; IL-1 polymorphism
Phase II Study to Assess Safety & Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by TIV
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001
      in thirty six (36) volunteers 50-65 years of age.

      All subjects will receive an intramuscular (IM) injection, in each one of three visits, with
      a 21±2 days interval between treatments.
    

Detailed description: 
      Subjects will undergo screening procedures within 30 days prior to first vaccination which
      will include medical history, vital signs, ECG, physical examination and safety blood and
      urine lab tests.

      On the first treatment visit, eligible subjects will undergo pre-dose physical examination
      and vital signs, and a blood sample will be drawn for baseline cellular immunogenicity and
      circulating Interferon gamma (IFN-g). They will then receive an IM injection of either
      vaccine or placebo, according to the above treatment assignment, into the deltoid muscle
      preferably of the same arm. The subjects will remain under medical supervision for 2 hrs (±
      15 min) at which time they will be released from the Clinical research center.

      The second treatment will take place 21 (±2) days after the first vaccination. Procedures
      will be the same as that of Visit 2 Additional two follow-up visits will take place at
      approximately 24 hrs and 48h The third treatment will take place 21 (±2) days after the
      second vaccination. Procedures will be the same as that of Visit 2 21 days later, each
      subject will be immunized with the seasonal influenza vaccine approved for 2014/15 year.

      A Study Termination visit will take place at 21 (±2) days after last vaccination. Adverse
      events (AEs) and changes in concomitant medications will be recorded, vital signs will be
      measured and the subjects will undergo physical examination and ECG. Blood and urine samples
      will be collected for safety.
    

Intervention name(s): M-001; TIV; Saline
Intervention type(s): Biological; Drug; Other
Intervention description(s): A recombinant epitope based universal vaccine against seasonal and pandemic influenza; HA based seasonal influenza vaccine, for 2014/15 seson; Placebo
Other intervention name(s): Multimeric-001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza Prime universal vaccine M-001 Multimeric
Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over
      2,000 individuals and is on path for licensure. This study will be a Phase II to evaluate
      three different immunization schedules and two different modes of delivery. The study will
      look at condensed schedules. Study will randomize subjects to one of four arms.
    

Detailed description: 
      This is a Phase II, randomized, open-label immunogenicity and safety study of different
      immunization schedules and delivery systems (syringe and needle vs. the Stratis™) in healthy,
      vaccinia-naïve adults 18 years to 40 years of age, inclusive. Approximately 352 subjects will
      be enrolled and randomized to one of four study arms. Study Arm A (N=88) will receive a two
      dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) via the SC route using a syringe
      and needle on Day 1 and 29. Study Arm B (N=88) will receive a two dose regimen of IMVAMUNE®
      (1x10^8 TCID50/0.5 mL per dose) via the SC route using a syringe and needle on Day 1 and 15.
      Study Arm C (N=88) will receive a two dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL) via
      the SC route using a syringe and needle on Day 1 and 22. Study Arm D (N=88) will receive a
      two dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL) via the SC route using the Stratis™ on
      Day 1 and 29. Immunogenicity assessments will be performed using ELISA and PRNT. Safety
      assessments will be done via solicited injection site and systemic reactions. Unsolicited AEs
      will be collected until 28 days post last injection and SAEs for the duration of the
      subjects' study participation. Safety laboratory assessments will be performed at baseline
      and 14 days after each vaccination. Primary outcome measures: For each subject, the peak PRNT
      will be defined as the highest titer among all available measurements post second
      vaccination; Occurrence of solicited local injection site reactions in subjects receiving
      vaccine via the Stratis™ compared to syringe and needle administration as collected on the
      memory aid and by in clinic assessment. Parent protocol to sub-study 13-0027.
    

Intervention name(s): MVA Smallpox Vaccine
Intervention type(s): Biological
Intervention description(s): Subjects receive two dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) via the SC route using either a syringe and needle or the Stratis™ system. Arm A receives doses via syringe and needle on days 1 and 29; Arm B receives doses via syringe and needle on days 1 and 15, Arm C receives doses via syringe and needle on days 1 and 22, Arm D receives doses via Stratis on days 1 and 29.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Smallpox, vaccine, IMVAMUNE, Stratis, parent protocol
Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment
Condition: Depression; Anxiety Disorder
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to determine the influence of supplementation of probiotic
      Lactobacillus Plantarum 299V vs. placebo of probiotic during antidepressant monotherapy with
      SSRI (Selective Serotonin Reuptake Inhibitor) in patients with major depression.
    

Detailed description: 
      For period of 8 weeks patient will receive probiotic Lactobacillus Plantarum 299V or its
      placebo as a supplementation of regular depression treatment with SSRI (Escitalopram or
      Sertraline). Psychometric and biochemical parameters will be monitored and evaluated. At day
      one, after 3 weeks (day 21) and after 8 weeks (day 56) of the study psychometric parameters
      will be measured such as Hamilton Depression Rating Scale, PSS-10 Scale, SCL-90 scale. At day
      one and after 8 weeks (day 56) of the study cognitive functions will be measured using: CVLT-
      California Verbal Learning Test, RFFT Ruff Figural Fluency Test, Stroop Test, Connecting
      Points Test (A and B), Attention and Perceptivity Test. At day one and after 8 weeks (day 56)
      of the study biochemical parameters will be measured such as: morning cortisol, pro and
      anti-inflammatory cytokines, tryptophan and its kynurenic pathway metabolites concentrations.
    

Intervention name(s): Lactobacillus Plantarum 299v; Crystalline cellulose powder; Escitalopram; Sertraline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and probiotic - 2x1 caps. per day of Lactobacillus Plantarum 299V (10mld colony forming units in 1 caps.) for 8 weeks.; Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and placebo of probiotic - 2x1 placebo caps. filled with micro-crystalline cellulose powder for 8 weeks.; 5-20mg daily; 50-100mg daily
Intervention MeSH terms: Sertraline; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; microbiota-gut-brain axis; Lactobacillus Plantarum 299v; probiotic