bioihbjkbjnl/mcl2 huggingface dataset:
Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
      erlotinib together with radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation
      therapy works in treating older patients with stage I, stage II, stage III, or stage IV
      esophageal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess the overall survival of older patients with stage I-IV squamous cell carcinoma or
           adenocarcinoma of the esophagus or gastroesophageal junction treated with erlotinib
           hydrochloride in combination with radiotherapy.

      Secondary

        -  Assess the proportion of patients achieving mucosal complete response after treatment
           with this regimen.

        -  Determine the progression-free survival of patients treated with this regimen.

        -  Assess the effect of this regimen on dysphagia control, performance status, and overall
           quality of life of these patients.

        -  Investigate the correlation between smoking status and overall survival of these
           patients.

        -  To correlate the Epidermal growth factor receptor (EGFR) and phosphor Epidermal growth
           factor receptor (pEGFR) expression by IHC and EGFR mutation status with clinical
           outcomes.

      OUTLINE: This is a multicenter study.

      Patients receive oral erlotinib hydrochloride once daily for 1 year in the absence of disease
      progression or unacceptable toxicity. Patients undergo external beam radiotherapy 5 days a
      week in weeks 1-4 or 5 days a week for the first 5.5 weeks.

      Tumor tissue samples are analyzed by IHC for the expression of E-cadherin, P-cadherin,
      vimentin, cytokeratin, phospho-S6, and Ki67.

      After completion of study treatment, patients are followed at 30 days and annually
      thereafter.
    

Intervention name(s): erlotinib hydrochloride; immunohistochemistry staining method; radiation therapy
Intervention type(s): Drug; Other; Radiation
Intervention description(s): Oral; Correlative Study; Radiation Treatment
Intervention MeSH terms: Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; stage I esophageal cancer; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer
Sports to Prevent Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to learn whether overweight children who participate in an after
      school team sports program improve their health as much as overweight children in a more
      traditional health education program.
    

Detailed description: 
      There is an urgent need for feasible, effective, and cost-efficient programs to help
      overweight children control their weight. To start to address this unmet need, we are
      evaluating after school team sports as an intervention for reducing weight gain among
      low-income and at-risk of being overweight, and overweight children. After school sports
      programs may be generalizable, motivating, and cost-efficient interventions for long-term
      weight control among at-risk and overweight children. The infrastructure needed to provide
      such programs already exists in most communities. In contrast, more traditional, medically-
      and behaviorally-oriented treatment programs are expensive, generally not very effective,
      often inconvenient, and not available in most communities. While children involved in team
      sports tend to be more physically fit than their uninvolved peers, team sports has not yet
      been tested as a method to increase involvement of at-risk and overweight children in regular
      physical activity. As an added bonus, these sports programs can displace typical after school
      television viewing and snacking. Team sports is a potentially innovative and high impact
      approach for intervening with at-risk and overweight children, as it may provide an
      opportunity to reduce weight gain while increasing social interaction and self-esteem. If our
      proposed research finds that team sports are an efficacious intervention for reducing weight
      gain among low-income, at-risk and overweight children, it is an intervention approach that
      could be rapidly diffused and tested for effectiveness. The policy implications of these
      findings would be great, encouraging expanded access to team sports programs to a population
      that has not been previously targeted or included.

      We propose a 1 year randomized controlled trial comparing weight changes among low-income,
      overweight children randomized to participate in an after school team sports program versus a
      traditional weight control/health education program.
    

Intervention name(s): After school team sports program; After school health education program
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Physical activity
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
Condition: Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Streptococcal Infections; Gram-Positive Bacterial Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The study compared the magnitude of the antibody response and safety of a GBS Trivalent
      Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the
      study investigated the maternal to fetal transfer of antibodies induced by the
      investigational vaccine.
    


Intervention name(s): Group B streptococcus vaccine
Intervention type(s): Biological
Intervention description(s): Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Group B streptococcus; GBS; Vaccine; Prevention of group B streptococcus infection
Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents
Condition: Depressive Symptoms; Depression; Adolescent Behavior
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a mobile application (app) called "Goal2QuitVaping"
      to help adolescents quit vaping nicotine. Goal2QuitVaping was developed by our research team
      to assist with quitting vaping. Participants will be randomly assigned to either download the
      mobile app, "Goal2QuitVaping", or not. If provided with Goal2QuitVaping, participants will be
      asked to use the app regularly, at least once per day, throughout the study duration.
      Participants will be asked to complete electronic questionnaire measures throughout the study
      period. Participation in this study will take about 4 weeks.
    


Intervention name(s): Behavioral Activation Therapy app; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Goal2QuitVaping focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.; Participants will be provided educational material about quitting vaping nicotine with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Resistant Maltodextrin Supplementation: Gastrointestinal Health
Condition: Healthy
Study type: Interventional

Summary: 
      Resistant maltodextrin (RMD) is an indigestible water soluble fiber that increases fecal bulk
      by enhancing growth of specific microbial populations; however the effect of RMD on
      bifidobacteria and total fecal weight is not clear. The purpose of this research study is to
      determine whether incorporating about ¼ cup of a fiber supplement into the diet will induce
      beneficial changes in gastrointestinal function, the fecal microbiota profile (increased
      number of healthy bacteria in stool) and immune processes resulting in improved quality of
      life.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study. After obtaining informed
      consent, participants will be randomized to either consume 0, 15 or 25 grams of resistant
      maltodextrin (RMD) during the first arm of the study. During the first intervention period,
      participants will consume the RMD everyday for 3 weeks. After a 2-week post intervention
      period, participants will be crossed to one of the other treatments for 3 weeks, followed by
      a 2-week post intervention and then receive the final intervention for 3 weeks.

      Participants will complete daily questionnaires and weekly gastrointestinal symptom
      questionnaires during the intervention and post-intervention periods. Stool samples will be
      collected at the baseline and final time points of each intervention. Dietary intake will
      also be assessed weekly during each intervention period.
    

Intervention name(s): 15 g RMD; 25 g RMD; 0 g RMD
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 15 grams of resistant maltodextrin; 25 grams of resistant maltodextrin; 0 grams of resistant maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: gut microbiota; fiber; diet quality; immunity
Goal-directed Fluid Management Versus Conventional Fluid Management in Laparoscopic Hysterectomy
Condition: Surgery
Study type: Interventional

Summary: 
      Fluid management is critical in patients undergoing surgery. Goal-directed fluid management
      (GDFM) protocols have been shown to decrease the length of hospital stay. In this study, we
      aimed to compare the effects of conventional fluid management with Pleth Variability Index
      (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the
      duration of hospital stay.
    

Detailed description: 
      Fluid management is critical in patients undergoing surgery. Goal-directed fluid management
      (GDFM) protocols have been shown to decrease the length of hospital stay in various kinds of
      surgical procedures. In this study, we aimed to compare the effects of conventional fluid
      management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine
      levels, postoperative kidney injury and the duration of hospital stay. Patients will be
      randomized to one of the study arms: group1 (conventional fluid management arm) will receive
      0.9 % NaCl at a rate of 4- 8 mL/kg/h, a 250-ml bolus crystalloid/ colloid injection will be
      administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg.; group 2
      (GDFM); group 2 (GDFM group) will receive 0.9 % NaCl at rate of 2 mL/kg/h, a 250-mL bolus
      crystalloid/colloid injection will be administered when PVI is higher than 13 % over 5 min.
      In both groups, when MAP is still < 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus
      ephedrine will be administered. The groups will be compared concerning postoperative blood
      lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital
      stay.
    

Intervention name(s): PVI
Intervention type(s): Device
Intervention description(s): A pulse oximetry probe which transfers data to the monitor with software able to calculate PVI data. The monitor automatically and continuously calculates the respiratory variations in the photoplethysmogram from data collected noninvasively via a pulse oximetry sensor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Motor Imagery Ability After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Individuals with stroke may experience sensory-motor deficit and/or neglect, with possible
      reduction in motor imagery ability (MI). To our knowledge, no study completely investigated
      MI ability in one individual whereas MI practice can be performed using visual or kinesthetic
      modalities (respectively visualizing with mind's eyes or imagining movement using sensation)
      and internal or external perspectives (performing action as spectator or as actor). This
      study aims to investigate MI ability in patients with stroke as compared to aged-matched
      healthy individuals. The investigators will assess explicit MI ability using 3 questionnaires
      (Movement Imagery Questionnaire-RS - MIQ-RS, Kinesthetic and Visual Imagery Questionnaire-20
      - KVIQ-20, Vividness of Movement Imagery Questionnaire-2 - VMIQ-2) and 2 tests (imagined Time
      Up and Go - iTUG, imagined Box and Block test - iBBT). Outcome parameters will be i) the
      composite score of vividness measured for all tests using Likert scales, ii) the temporal
      equivalence between MI and Physical practice (PP - where MI/PP ratio equal to 1 indicate good
      MI ability and respect of temporal equivalence between MI and PP) and iii) the amplitude of
      electrodermal activity. The investigators will also study implicit MI ability using a hand
      laterality judgment task. Outcomes parameters will be response time (i.e. the duration to
      identify the hand laterality) and the percentage of correct responses.
    


Intervention name(s): Assessment of motor imagery ability; Assessment of motor imagery ability of healthy subject
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will last 3 hours ± 45 minutes, the assessment will be spread over 3 sessions of 1 hour ± 15 minutes on one week. The time between two sessions will depend on patient fatigability and availability. The VMIQ-2 and the KVIQ-20 will be realized during the first session. In the second session, patients will perform the hand laterality judgment task and the MIQ-RS. During the last session the Timed up and go and the box and block test will be realized.; The intervention will last 2 hours ± 15 minutes. All the tests will be spread over 1 session. Assessment order will be VMIQ-2, KVIQ-20, the hand laterality judgment task, the after a break MIQ-RS, iTUG and iBBT.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the
      treatment of Taiwanese patients with diabetes and high cholesterol.
    


Intervention name(s): atorvastatin; atorvastatin; atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks; Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks; Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Intervention Delivered by App Instant Messaging to Increase Use of Effective Contraception Among Young Women in Bolivia
Condition: Contraception
Study type: Interventional

Summary: 
      This randomised controlled trial will establish the effect a contraceptive intervention
      delivered by mobile phone app instant messaging on use of effective contraception in Bolivia.
      Woman aged 16-24 will be randomised to have access to Centro de Investigacion, Educacion y
      Servicios's sexual and reproductive health app (control) or the app plus 0-3 instant messages
      a day for 4 months (intervention). Participants will complete a questionnaire at baseline and
      4 month follow-up.
    


Intervention name(s): Contraceptive instant messages; Mobile phone app
Intervention type(s): Behavioral; Other
Intervention description(s): Contraceptive Instant messages; Mobile phone app
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Reproductive health
Brain Mechanisms of Overeating in Children
Condition: Pediatric Obesity; Inhibition; Decision Making; fMRI
MeSH terms: Pediatric Obesity; Hyperphagia
Study type: Observational

Summary: 
      The proposed research will follow healthy weight children who vary by family risk for obesity
      to identify the neurobiological and appetitive traits that are implicated in overeating and
      weight gain during the critical pre-adolescent period. The investigator's central hypothesis
      is that increased intake from large portions of energy dense foods is due in part to reduced
      activity in brain regions implicated in inhibitory control and decision making, combined with
      increased activity in reward processing pathways. To test this hypothesis, the investigators
      will recruit 120 healthy weight children, aged 7-8 years, at two levels of obesity risk
      (i.e., 60 high-risk and 60 low-risk) based on parent weight status. This will result in 240
      participants: 120 children and their parents.
    

Detailed description: 
      In aim one, the investigators will use functional magnetic resonance imaging to characterize
      the brain regions which are activated in response to food portion size and compare these
      regions between high- and low-risk children.

      Second, the investigators will determine the relationship between brain response to visual
      portion size cues and measured food intake when portions are increased in the laboratory.

      Third, the investigators will determine the relationship between brain response to large
      portions and other validated measures of overeating, including satiety responsiveness and the
      amount of calories children consumed from high calorie snacks when they are not hungry (i.e.,
      eating in the absence of hunger).

      Fourth, the investigators will conduct follow-up visits one year after baseline to determine
      the extent to which baseline brain and behavioral responses to portion size predict gains in
      adiposity assessed by anthropometrics (body weight, height, and dual-energy x-ray
      absorptiometry).

      Secondary study endpoints include the relationship between child behavioral and brain
      response to food portion size and physical activity assessed by accelerometry and
      questionnaires, inhibitory control assessed by a stop signal test, reward-related design
      making assessed by a computer task, working memory assessed by an N-back task loss of control
      eating, child sleep, child working memory, child meal microstructure assessed by
      observational meal coding, parent rated eating behaviors, and parental feeding practices.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parents and their 7-8 year old children in Centre County, Pennsylvania and surrounding
        areas.
      
Keywords: Obesity; Portion Size Effect; fMRI; Functional Magnetic Resonance Imaging; Inhibition; Decision Making; Satiety Responsiveness; Anthropometrics; DXA; Reward Processing; Working Memory; Meal microstructure
New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to:

        1. Evaluate the efficacy and safety of the new antipsychotics, quetiapine (300-500mg/day)
           and risperidone (3-4mg/day) compared to each other and to fluphenazine (10-15mg/day), a
           high potency typical antipsychotic in patients who meet the DSM IV criteria for
           schizophrenia.

        2. To evaluate the efficacy and safety of quetiapine (1200mg/day) in patients who have not
           responded to conventional and newer antipsychotics.

        3. To evaluate the effectiveness of quetiapine (300-500mg/day), and risperidone (3-5mg/day)
           compared to each other and fluphenazine (10-15mg/day) in the treatment of hostility and
           aggression in treatment-resistant schizophrenic patients.

        4. To evaluate the effectiveness of quetiapine (300-500mg/day) and risperidone (3-5mg/day)
           compared to each other and fluphenazine (10-15mg/day) on rates of discharge, quality of
           life, and independent living skills.

        5. To assess prolactin levels and to evaluate any relationship with sexual dysfunction and
           menstrual irregularities.

        6. To evaluate the possible differential impact of treatment conditions on cognitive
           functioning including measures of attention, motor speed, problem solving, verbal and
           visual memory, and verbal processing speed.

        7. To measure changes in weight and health consequences associated with weight changes.
    

Detailed description: 
      This is a three arm multi-center randomized double-blind study. After open label treatment
      with each individual being optimized with routine antipsychotic treatment for 4-6 weeks to
      prospectively establish lack of response to conventional antipsychotic therapy, approximately
      180 patients with schizophrenia who are experiencing clinically significant psychotic
      symptoms will be recruited (minimum 150 enrolled) in the double-blind period of the study.
      All participants will sign consent forms before participating in this research study. If
      participants choose to enroll in the high dose quetiapine arm (period IIIb), they will sign
      an additional consent form before entering period IIIb.
    

Intervention name(s): Quetiapine, Risperidone, Fluphenazine
Intervention type(s): Drug
Intervention MeSH terms: Risperidone; Quetiapine Fumarate; Fluphenazine; Fluphenazine depot; Fluphenazine enanthate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment