bioihbjkbjnl/mcl2 huggingface dataset:
Dietary Intervention and Assessment of Obesity-related Gene Methylation Levels in Overweight Women
Condition: Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The clinical study aimed to study the effect of an intervention with foods containing folate
      and hazelnut oil to assess whether this diet could modulate the methylation levels of two
      obesity-related genes, LEP and POMC, in addition to impacting body weight and values of lipid
      profile of overweight women. The hypothesis of the clinical study is that the intervention
      diet could reduce the methylation levels of the genes mentioned and this would impact on the
      reduction of body weight and improvement of the lipid profile of the women studied.
    

Detailed description: 
      The intervention study was carried out with a sample selected by randomization, and n = 40
      adult women classified as overweight were considered for the study. After assessing the
      eligibility criteria, women were instructed to have stable weight, eating habits and levels
      of physical activity constant to those found during the baseline, as well as receiving an
      individual diet plan one week before starting the dietary intervention. Before the start of
      the intervention, the 40 women were allocated to four groups of 10 each, and three groups
      started the individual diet plan for weight maintenance with a focus on vegetables and
      legumes with antioxidant and folate-rich action, and were also invited to consume foods
      fortified with folic acid and foods naturally rich in folate to achieve a usual folate intake
      close to the RAS (≥400 µg), this amount was for intervention group 1 and 2, group 3 received
      a lower amount (approximately half of the consumption of groups 1 and 2) and group 4 was the
      control group.

      Still referring to the intervention, the participants of the three groups received advice
      from a nutritionist, responsible for this research and all the printed material free of
      charge, including pre-packaged foods, and also delivered hazelnut oil capsules, used as a
      source of monounsaturated fat. Counseling sessions with the nutritionist were offered daily
      at the homes during the entire period of the intervention, except for group 4, where the
      monitoring was weekly, to maintain eating habits.

      After the end of the 8 weeks of the intervention, the third stage of the study began, which
      consisted of anthropometric assessment, analysis of the dietary intake of the 24-hour food
      record and blood collection for biochemical tests and DNA methylation.
    

Intervention name(s): Dietary folate and hazelnut oil
Intervention type(s): Other
Intervention description(s): Intervention with folate-rich diet and hazelnut oil supplement in capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Epigenetic; Obesity; Diet; Folate; Monounsaturated fat
Kinetics of B Cell Response in Infants Menjugate Vaccination
Condition: Prevention of Meningococcal Infection
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Kinetics of B cell response in infants Menjugate vaccination
    


Intervention name(s): Meningococcal C conjugate vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Meningococcal Meningitis; vaccines, conjugate; immunology; infant; antibody persistence
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in
      participants with type 1 diabetes mellitus.

      There are 2 parts to this study. Part A is investigating how the body processes LY900014 and
      the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study
      treatment is given by subcutaneous injection. Part B of the study is investigating how the
      body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin
      lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion
      (CSII) pump.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the study will last about 40 days in each part.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Administered via SC injection; Administered via SC injection
Other intervention name(s): Ultra-Rapid Lispro; Humalog; LY275585
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to
      evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and
      hepatitis B therapeutic vaccine versus interferon alfa-2b alone in chronic hepatitis B
      patients with entecavir achieving HBeAg seroclearance. Patients were randomized to one of 3
      groups to receive different antiviral treatment.
    

Detailed description: 
      Patients who have been pretreated with entecavir for at least one year, with HBV (Hepatitis B
      Virus) DNA less than 1000 copies/ml and HBeAg seroclearance were randomized to one of 3
      groups, to receive Entecavir 0.5 mg po daily for 72 weeks, or Interferon alfa-2b 600wIU qod
      iH for 48 weeks plus Entecavir 0.5mg qd po for 8 weeks, or Interferon alfa-2b 600wIU qod iH
      for 48 weeks plus Entecavir 0.5mg qd po for 8 weeks plus interleukin 2 25 wIU qod iH for 12
      weeks plus Hepatitis B Vaccine 60ug qm im for 48 weeks.
    

Intervention name(s): Entecavir; Interferon alfa-2b; Interleukin 2; Hepatitis B Vaccine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In arm 1, Entecavir is used for 48 weeks and the follow up 24 weeks as conventional control, In arm 2 and 3, Entecavir is used for 8 weeks.; In arm 2 and 3, interferon alfa-2b is used for 48 weeks; In arm 3, Interleukin 2 is used for 12 weeks; In arm 3, Hepatitis B Vaccine is used for 48 weeks
Other intervention name(s): ETV; IFN a-2b; IL-2
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Entecavir; Interleukin-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First Time in Human Study of Protexia
Condition: Intervention for Nerve Agent Exposure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      immunogenicity of Protexia, an experimental drug being developed to protect soldiers against
      the effects of nerve agents.

      Volunteers will be entered into one of five groups. Four of the groups will receive a single
      intramuscular dose of Protexia or saline placebo on Study Day 1 and will participate in the
      study for approximately 71 days. One of the groups will receive two intramuscular doses of
      Protexia or saline placebo - one dose on Study Day 1 and the second dose on Study Day 72.
      This group will participate in the study for approximately 142 days.

      All volunteers will remain at the study site as an inpatient for three days after they are
      dosed and will be monitored closely by the study doctors and staff. After that, volunteers
      will return to the study site as outpatients at predetermined intervals. Groups 1, 2, 4, 5
      will have a total of 6 follow-up visits and Group 3 will have a total of 12 follow-up visits.

      It is expected that this study will provide important information on the safety and
      tolerabiity of Protexia at one and two doses.
    

Detailed description: 
      Protexia is a pegylated form of recombinant human butyrylcholinesterase (PEG-rBChE).
      Butyrylcholinesterase (BChE) is a naturally-occurring enzyme found in minute quantities in
      the blood. PharmAthene produces PEG-rBChE from the milk of transgenic goats. The enzyme is
      purified from the goat milk, formulated and pegylated to create Protexia.

      This is a dose escalation study of five dose levels of Protexia. Safety data through 14 days
      post-dosing will be evaluated by an independent Safety Monitoring Committee (SMC) prior to
      escalating to a higher dose. The safety and tolerability of Protexia will be assessed using
      the DMID Adult Toxicity Table, May 2001 (Appendix D).

      If a dose limiting toxicity (DLT) is identified in any dosing group, dosing will be suspended
      until the AE(s) is/are assessed. The SMC will determine if the study can continue or if the
      previous dose will be declared the maximum tolerated dose (MTD). It is possible that an
      additional dosing group at a dose midway between the previous dosing group and the dose level
      that exceeded the MTD may be enrolled after consultation and agreement of the SMC.
    

Intervention name(s): Protexia; Protexia; Protexia; Protexia; Protexia
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Single 50 mg IM dose; Single 100 mg dose; Two 250 mg doses, IM, one at Day 1 and one at Day 72; Single 500 mg dose, IM; Single 750 mg dose, IM
Other intervention name(s): PEG-rBChE; PEG-rBChE; PEG-rBChE; PEG-rBChE; PEG-rBChE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder
Condition: Attention Deficit/Hyperactivity Disorder; Bipolar Disorder
MeSH terms: Bipolar Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      ADHD in the adult population is associated with several measures of harmful dysfunction. For
      example, adult ADHD is associated with high rates of separation/divorce and never-married
      status, lower educational attainment and occupational achievement, absenteeism, presenteeism,
      and job termination, as well as decreased social function. Individuals with adult ADHD are
      more likely than controls to have a comorbid diagnosis of bipolar disorder, alcohol and
      substance abuse, as well as antisocial personality disorder.

      Psychostimulants are the most frequently employed medications in the treatment of adult ADHD.
      Several psychostimulants are Health Canada and US FDA-approved for the treatment of ADHD
      symptoms in adulthood.

      Hitherto, no trial has evaluated the safety and efficacy of a psychostimulant in the
      treatment of ADHD symptomatology in adult individuals with bipolar disorder.

      Vyvanse is the first prodrug stimulant indicated for the treatment of adult (and pediatric)
      ADHD. Vyvanse is a therapeutically inactive molecule (i.e. prodrug). After oral ingestion,
      lisdexamfetamine is converted to l-lysine, a naturally occurring essential amino acid, and
      active d-amphetamine, which is responsible for the drug's activity. Vyvanse provides a longer
      duration of effect consistent throughout the day with reduced potential for risk of abuse.
      Vyvanse is generally well tolerated with an adverse event profile similar to other
      psychostimulant medications. Available evidence indicates that in most treated subjects,
      Vyvanse is weight-neutral and/or is associated with weight loss. Moreover, in some
      individuals, it is associated with improvement in both glucose and lipid homeostasis.

      The evaluation of safety/tolerability profiles as well as the effectiveness of
      lisdexamfetamine in a "real-world" population has significant translational value.
    


Intervention name(s): lisdexamfetamine dimesylate
Intervention type(s): Drug
Intervention description(s): Dosage form: Capsules; Dosage strength: 30-70mg/day, flexible dosing; Duration: 4 weeks
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals who have a diagnosis of Bipolar Disorder and ADHD.
Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with
      inoperable hepatocellular carcinoma.
    


Intervention name(s): Irinotecan plus capecitabine
Intervention type(s): Drug
Intervention description(s): Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for
Intervention MeSH terms: Capecitabine; Irinotecan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the taste and smell acceptability of cefdinir (Omnicef) antibiotic suspension and
      azithromycin (Zithromax) antibiotic suspension following a single dose of each medication.
    

Detailed description: 
      The Primary Purpose for the study is "Other". Per ClinicalTrias.gov, more information
      regarding the primary purpose is described here; this study is a pediatric taste test.
    

Intervention name(s): cefdinir (Omnicef); azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml; 2.5 ml of cherry flavored oral suspension 100 mg/5 ml
Other intervention name(s): ABT-198; Omnicef; cefdinir; Zithromax
Intervention MeSH terms: Azithromycin; Cefdinir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: pediatric taste test; antibiotic taste test; cefdinir; azithromycin
Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study
Condition: Atherosclerosis; Stroke
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      1) Research questions:

      1a. Can non-sonographer health care professionals in a community medical office practice
      setting be trained to detect and evaluate subclinical atherosclerosis?

      1b. Can carotid ultrasound performed in community office practices improve physician use of
      evidence-based, risk-reducing interventions and patient motivation to adhere to therapeutic
      recommendations?
    

Detailed description: 
      Health care providers from five medical practices will complete a 2-day training program that
      teaches instrumentation, scanning, measurement, quality assurance, and interpretation. They
      also will learn about CV risk assessment, intervention, and how to use an ultrasound-based CV
      risk stratification and treatment algorithm. After certification, each site will recruit 70
      patients from their practice (total N=350). Subjects will complete their routine office visit
      and a pre-test survey designed to assess motivation and intention to change. The physician's
      initial plan of action based on usual care will be recorded. Next, the subject will have a
      standardized CV risk carotid ultrasound. The physician will revise his/her treatment plan
      based on the scan results and an ultrasound-based risk assessment algorithm that includes CV
      risk factors and ultrasound data. Evidence-based treatment recommendations for lifestyle
      changes and risk factor targets will be provided. The physician's scan-based plan of action
      will be recorded. The subject will be informed of the results and repeat the survey. All
      images, interpretations, and recommendations will be reviewed by the UW AIRP.
    

Intervention name(s): Carotid Ultrasound
Intervention type(s): Other
Intervention description(s): All subjects that meet the inclusion criteria at each certified site will be invited to participate and go through the same intervention (questionaire-scan-post scan questionaire and 1 month follow up questionaire)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Atherosclerosis; Cardiovascular Risk Prevention; Carotid Ultrasound; Handheld ultrasound; Office Practice; Carotid Intima Media Thickness; Carotid Plaque
The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effects of two doses of synthetic peptide construction 3 ( SPC3 ) on HIV-1
      plasma levels (as measured by RNA PCR Amplicor) and on lymphocyte subsets in patients with
      initial viral load above 10,000 copies/ml. To study the safety of SPC3 and the kinetics of
      HIV-1 plasma level changes.
    

Detailed description: 
      The first five patients receive SPC3 daily for 3 weeks. If that dose is tolerated, the dose
      is increased and given to the next 5 patients for 3 weeks. The remaining ten patients receive
      a dose of SPC3 based on response to the previous two dose levels. Patients are followed
      through day 28.
    

Intervention name(s): Peptide Construction 3, Synthetic
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Antiviral Agents
Validation of Schema Scale of Mental Health Service
Condition: Mental Health Services; Personality
Study type: Observational

Summary: 
      Digital Mental Health Service, MINDLiNG, has developed Schema Scale that identifies
      individual's personality based on schema theory. The goal of this study is to determine the
      reliability and validity of the Schema Scale.
    

Detailed description: 
      Most of the mental health service programs are limited to targeting specific psychiatric
      symptoms, which does not necessarily consider the personality and characteristics of
      individuals. To provide more personalized mental health care service, it is essential to
      identify the personality of individuals through valid psychological test.

      Thus, MINDLiNG has developed the Schema Scale based on schema theory and psychodynamic theory
      in order to provide personalized and evidence-based treatment at the level of psychotherapy.

      This study was conducted to evaluate the validity and reliability of the Schema Scale. The
      scale was administered online on non-clinical population (n = 234). The internal consistency
      of Schema Scale was evaluated. In addition, its factor structured was studied by exploratory
      and confirmatory factor analyses. Concurrent validity was examined by comparing the extracted
      Schema Scale factors with other psychological tests using Pearson's correlation tests.
    

Intervention name(s): Digital Psychological Test: Schema Scale
Intervention type(s): Diagnostic Test
Intervention description(s): Thirty-five questionnaire, 5-point likert scale
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All adults who are willing to complete the online questionnaires.
      
Keywords: maladaptive schema; mental health problem; personality test; digital mental health service
Online Trial of Meditation and Behavior
Condition: Meditation
Study type: Interventional

Summary: 
      This study investigates how different types of meditation may affect behaviors and emotions.
      The study is conducted entirely online and involves listening to 4-weeks of a guided
      meditation training. The meditation involves either Loving-Kindness or Relaxation techniques.
      The purpose of the study is to assess changes in behaviors and emotions using standard
      questionnaires, reports of real-world behavior, and online behavioral tasks. The overarching
      goal is to help clarify how mind-body practices may improve some aspects of well-being.
    


Intervention name(s): Loving-Kindness Meditation; Relaxation Meditation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Approximately 15-minute sessions are administered 6 days per week; Approximately 15-minute sessions are administered 6 days per week
Other intervention name(s): Metta Meditation; Progressive Muscle Relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Alveolar Recruitment Maneuver During Pneumoperitoneum
Condition: Oxygen Deficiency
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Alveolar recruitment maneuver had been reported of improving arterial oxygenation and
      pulmonary mechanics and reduce the pulmonary complications. Investigator designed this study
      for comparision of incidence of pulmonary complications after applying alveolar recruitment
      maneuver during peumoperitoenum for laparoscopic surgery.
    

Detailed description: 
      Peumopritoneum might increase the pulmonary dead space and deteriorate the pulmonary
      mechanics. Especially in the eldery, decreased pulmonary function might aggravate negative
      response to pneumoperitoneum. Alveolar recruitment maneuver had been reported of improving
      arterial oxygenation and pulmonary mechanics. Investigator designed this study for
      comparision of the incidences of pulmonary complications after applying alveolar recruitment
      maneuver or not during peumoperitoenum for laparoscopic surgery in the elderly patients.
    

Intervention name(s): alveolar recruitment maneuver; conventional ventilation
Intervention type(s): Procedure; Procedure
Intervention description(s): applying alveolar recruitment maneuver using the anesthesia machine; conventional ventilation using the anesthesia machine
Other intervention name(s): ARM; conventional
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: ARM group-applying alveolar recruitment maneuver Conventional goup-not applying alveolar recruitment maneuver
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention