bioihbjkbjnl/mcl2 huggingface dataset:
e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls
Condition: Pregnancy; Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of an online pregnancy prevention
      intervention that was adapted from the evidence based small group intervention SiHLE.
    

Detailed description: 
      The investigators will test the hypothesis that by the end of the study, women who receive
      the e-SIHLE intervention will have a 35% increase in reliable contraception use compared to
      attention control website, DIVAS, which is a health and nutrition education program.

      Both arms of the study were designed for African-American women who are 18-19 years old.
    

Intervention name(s): BUtiful.; DIVAS.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 website sessions include themes that teach: gender empowerment, assertive communication skills, goal setting, pregnancy and STI/HIV risk, safer sex behaviors, proper condom use, positive attitudes and norms towards consistent condom use, contraception, partner involvement in safer sex, and responsibility for their own health.; Attention control arm: 8 website sessions that include topics on: healthy eating, choosing nutritional snacks, sugar and salt intake, physical activity, stress management, foods for beauty.
Other intervention name(s): BUtiful; DIVAS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy; STI; STD
Mercury Levels in Premature and LBW Infants Receiving Thimerosal-containing Vaccines
Condition: Mercury Levels
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      The goal of the study is to find out how much mercury is in the blood, urine, and stools of
      premature and low birth weight infants who have received standard childhood vaccines that are
      given to all infants in Argentina. Seventy-two newborn premature and low birth weight infants
      from Durand Acute General hospital will participate in this study. Each infant in the study
      will need to make two visits, one at the time of vaccination and another 12 hours to 30 days
      later. Urine, stool, and a small sample of blood will be taken at each visit.
    

Detailed description: 
      The primary objective is to describe the levels of mercury in the blood of premature newborns
      greater than or equal to 32 weeks and less than 37 weeks gestation and birth weight greater
      than or equal to 2000 grams but less than 3000 grams, who receive the routine birth dose of
      Hepatitis B immunization containing ethyl mercury in the form of thimerosal and the birth
      dose of BCG immunization, and to evaluate the excretion of mercury in these newborns by
      examining mercury levels in stool and urine. Secondary objectives are: 1) to determine the
      half-time of mercury in blood following vaccination of premature and low birth weight infants
      with thimerosal-containing vaccines, and 2) to screen premature and low birth weight infants
      for evidence of early effects of thimerosal on the kidney by measurement of urinary gamma
      glutamyl transpeptidase levels. All infants will have stool, urine, and blood samples
      collected prior to receipt of routine birth hepatitis B and BCG immunization. Cord blood will
      serve as the baseline blood specimen. Each infant will be seen once at a predetermined
      follow-up visit time point. There will be 6 follow-up visit time points, with sampling from
      12 infants at each time point. All infants will provide blood, urine, and stool specimens at
      the assigned follow-up visit.
    

Time perspective: Prospective
Keywords: Thimerosal, mercury levels, low birth weight, Argentina
Dysfunctional Attention Processes in Fear of Blushing: Specificity and Changeability
Condition: Phobia, Social
MeSH terms: Phobia, Social
Study type: Interventional

Summary: 
      Blushing is associated with a heightened self-focused attention. In our study we are
      interested if this self-focused attention can be shown experimentally and if it can be
      changed by therapy and training. For the experimental part of the study, we want to compare
      blushing fearful individuals to social anxious participants who are not fearful of blushing
      and to healthy controls who report to blush either seldom or quite often. In the
      therapeutical part of our study, we compare an attention training to the standard cognitive
      behavioral therapy for social anxiety disorder in an intensive group therapy approach.
    

Detailed description: 
      Fear of blushing is a specific syndrome in social anxiety disorder. Although attentional
      biases for social anxiety disorders have often been reported, specific data for fear of
      blushing are still missing. In this study, dysfunctional attention processes are examined by
      the use of various questionnaire measures and attention tests (e.g. Stroop test, task
      switching paradigm) comparing fear of blushers, other social phobia patients, healthy
      volunteers who report to blush seldomly respectively often. The second goal of the study is
      to examine if these attention processes can be changed by training and therapy. Therefore,
      individuals who fulfill DSM-IV criteria for social anxiety disorder and report fear of
      blushing as main problem, are treated with attention training and with CBT for social anxiety
      disorder. Therapy will be held in the form of intensive weekend group therapy. Differences in
      outcomes for both therapy types and in changeability of attention processes on objective test
      data are examined. Stability of results are tested up to 6-month and 12-month after
      post-assessment.
    

Intervention name(s): Task Concentration Training; Standard CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Task Concentration Training TCT following Bögels et al. (1997).; Standard CBT following the Clark-and-Wells (1995) model of social anxiety disorder, relying on the German manual for SAD (stangier et al., 2006). Includes the model, role-plays with and without safetey behavior, video-feedback.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; Social Phobia; Fear of blushing; attention; attention training; cognitive behavior therapy
A Ketogenic Diet Acts on Cortical But Not Subcortical Responsivity in Migraineurs
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      A short ketogenic diet (KD) treatment can prevent migraine attacks and correct excessive
      cortical response. Here, investigators aim to prove if the KD-related changes of cortical
      excitability are primarily due to cerebral cortex activity or are modulated by the brainstem.

      Through the stimulation of the right supraorbital division of the trigeminal nerve, there
      will be concurrently interictally recorded the nociceptive blink reflex (nBR) and the
      pain-related evoked potentials (PREP) in 18 migraineurs patients without aura before and
      after 1-month on KD, while in metabolic ketosis. nBR and PREP reflect distinct brain
      structures activation: the brainstem and the cerebral cortex respectively. It will be
      estimated nBR R2 component area-under-the-curve as well as PREP amplitude habituation as the
      slope of the linear regression between the 1st and the 2nd block of 5 averaged responses.
    


Intervention name(s): Ketogenic diet
Intervention type(s): Dietary Supplement
Intervention description(s): Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ketogenic Diet
TMS in Aphasia Recovery
Condition: Aphasia
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      Stroke often causes substantial problems in speaking or understanding speech. Treatments for
      these problems are currently very limited. Limited studies to date suggest that repetitive
      Transcranial Magnetic Stimulation (TMS) to the side of the brain opposite to the side on
      which the stroke occurred may improve language function. The investigators are testing this
      hypothesis by giving daily 20 minute sessions of repeated TMS to the right (unaffected) side
      of the brain; the investigators test language function with a variety of tests both before
      and after the treatment with TMS and subjects are required to undergo functional MRI scans
      before and after treatment. TMS is a procedure in which a coil is placed next to the head of
      the subject and an electrical current passes through the coil causing a magnetic field that,
      in turn, causes a small electric current in the portion of the brain underneath the coil.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation; Sham TMS
Intervention type(s): Device; Device
Intervention description(s): Active TMS will be at 90% motor threshold; Sham TMS will be administered
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study involves two arms. The study involves a sham treatment control for half of the patients; all patients randomized to the sham treatment will be enrolled in the treatment phase after completing the sham treatment. Patients will be randomly assigned to the treatment arm or the sham treatment arm of the study. There are 3 phases: a pre-treatment evaluation phase in which baseline language and imaging data are obtained and the optimal site for stimulation is determined; a treatment phase during which TMS is delivered on 10 occasions; and a post-treatment phase during which effects of the treatment will be assessed using behavioral measures as well as fMRI at 2 and 6-months. Participants in the sham arm will undergo the same behavioral testing, MRI, and fMRI that will be administered in the treatment protocol. After the 2-month follow up visit, patients in the sham arm will be told that they did not receive real TMS and will be offered the opportunity to enter the treatment arm.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
High-Intensity Interval Training on Pre-Hypertensive Subjects
Condition: Metabolism Disorder; Hypertension
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      Despite exercise training decrease blood pressure in 'average' terms, there is a wide
      interindividual variability after exercise training, being yet unknown what mode of exercise
      (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less
      non-responder (NR) prevalence (i.e., percentage of subjects who experienced a
      non-change/worsened response after training in some outcome).
    

Detailed description: 
      Despite exercise training decrease blood pressure in 'average' terms, there is a wide
      interindividual variability after exercise training, being yet unknown what mode of exercise
      (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less
      non-responder (NR) prevalence (i.e., percentage of subjects who experienced a
      non-change/worsened response after training in some outcome).
    

Intervention name(s): High Intensity Interval Training; Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): High Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.; Moderade Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the bioequivalence of a Merck clinical trial formulation of
      ondansetron compared to a non-U.S. marketed formulation of ondansetron.
    


Intervention name(s): ondansetron clinical trial formulation; ondansetron marketed formulation
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.; Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
Other intervention name(s): ZOFRAN™; ZOFRAN™
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
Condition: Tetanus; Poliomyelitis; Hepatitis B; Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and immunogenicity of new formulations of GSK
      Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination
      course to healthy infants at 2, 3 and 4 months of age.
    

Detailed description: 
      This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading
      to the update of the exclusion criteria.
    

Intervention name(s): Infanrix hexa™; Prevenar 13®; GSK217744
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3 doses, intramuscular into left thigh; 3 co-administered doses, intramuscular into right thigh; 3 doses, intramuscular into left thigh
Other intervention name(s): DTPa-HBV-IPV/Hib; Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: combination vaccine; Primary vaccination
Stylet Angle for McGrath Videolaryngoscopy
Condition: Intubation
Study type: Observational

Summary: 
      The McGrath videolaryngoscope (VL) provides excellent laryngoscopic views, but directing an
      endotracheal tube is not easy, so routine using of stylet is recommended. The goal of this
      study is to determine the appropriate angle of stylet by comparing time to intubation (TTI).
    


Intervention name(s): intubate with 60° angled stylet; intubate with 60° angled stylet
Intervention type(s): Device; Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients scheduled for elective surgery requiring orotracheal intubation in our hospital
Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Heart failure is a clinical syndrome that is the common end of several cardiac diseases with
      symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve
      respiratory and general functional capacity of these patients, there are strategies that can
      be used such as inspiratory muscle training and peripheral muscle training (dynamic
      resistance training).
    

Detailed description: 
      After agreement with the written informed consent, 35 subjects with severe heart failure were
      included in this study. They were randomized in three groups: controls, low-intensity and
      moderate-intensity group. All volunteers were assessed at Baseline and 8-weeks intervention.
      Cardiac events were registered following two years from baseline. The present study aimed to
      assess the effects of a combined program of inspiratory and peripheral muscle training on
      respiratory and general functional capacity and quality of life in patients with chronic
      heart failure.
    

Intervention name(s): control; moderate-intensity group; low-intensity group
Intervention type(s): Other; Other; Other
Intervention description(s): No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation; Patients will be submitted to a 8-weeks training program with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (50% 1 RM, increased every 2-weeks).; Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 kg each)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: muscle training; walking test; chronic heart failure; functional capacity
School-Based Obesity Prevention Program
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The overarching goal of this initiative is to reduce the prevalence and occurrence of obesity
      and increase the remission of obesity in children and adolescents through implementation of a
      Comprehensive School Nutrition Policy designed to promote changes in the school environment
      that will reinforce students' development of healthy eating and physical activity patterns
      inside and outside of school.
    

Detailed description: 
      The proposed research aims to evaluate the effects of a school-based nutrition policy
      initiative on prevalence, incidence and remission of overweight (BMI > 95th percentile). It
      is a partnership between the Food Trust, the School District of Philadelphia and the
      University of Pennsylvania. Participants are approximately 1500 students from ten schools in
      grades four through eight. Half of the schools were randomized to a comprehensive School
      Nutrition Policy Initiative (SNPI) based on CDC's Guidelines to Promote Lifelong Healthy
      Eating. The SNPI is a community-based intervention administered by the Comprehensive School
      Nutrition Policy Task Force that is comprised of 40 individuals representing the public and
      private sectors. The goal of the SNPI is to change the school environment to: support healthy
      eating, increase physical activity, and decrease the prevalence of childhood overweight and
      diet-related diseases. The remaining study participants are in five control schools, matched
      for ethnicity, SES, and type of food service. Most students are African American and qualify
      for free and reduced meals at school (household income < 185% of the poverty level adjusted
      for household size). Assessments of weight, height, intake, activity, inactivity and eating
      disorder symptomatology are being conducted at baseline and 1 and 2 years.
    

Intervention name(s): Nutrition Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: School-based; Obesity; Prevention
Novel Treatment For Pusher Syndrome Using Physical Therapy
Condition: Pusher Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to see if a specific physical therapy intervention speeds
      recovery from stroke-related "pusher syndrome."
    


Intervention name(s): Novel physical therapy; Standard physical therapy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; pusher syndrome; contraversive pushing; lateropulsion; rehabilitation; physical therapy
A Study Comparing Blood Levels After Single-Dose Administration Of Artesunate Sachets (Pfizer) Versus Single-Dose Administration Of Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg)
      Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is
      the World Health Organization Reference standard for artesunate The secondary objective is to
      assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).
    


Intervention name(s): artesunate sachets; Arsuamoon
Intervention type(s): Drug; Drug
Intervention description(s): single dose 50 mg (2 X 25 mg) artesunate sachets; single dose 50 mg arsuamoon tablet
Intervention MeSH terms: Artesunate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence study-artesunate sachets-arsuamoon tablet
Nicotine Patch, Blood Flow and Oxidative Stress Study
Condition: Healthy
Study type: Interventional

Summary: 
      This study will address the hypothesis that nicotine, like cigarette smoking acting as a
      pro-oxidant may have adverse effects on arterial function.
    

Detailed description: 
      Smoking causes >400,000 deaths from cardiovascular disease (CVD) per year. The molecular
      basis of smoking induced tissue injury remains unclear but considerable evidence supports a
      role for oxidant stress (OS).

      Arterial function has been shown to be impaired in smokers even before the onset of
      angiographically demonstrable atherosclerosis. Defects in endothelium dependant flow mediated
      vasodilatation (FMD) are seen in those at risk of or with overt vascular disease.

      Cigarette smoking is highly addictive. Spontaneous quit rates approximate 3%. Even those
      using nicotine replacement therapy (NRT) have high relapse rates (67-75%) on completion of
      the 8-12 week course of NRT. Thus there is interest in the use of extended NRT as a "safer"
      alternative to cigarette smoking. However such assumptions may be premature. Nicotine
      demonstrates proxidant effects in vitro and in small studies has been associated with
      endothelial dysfunction. Studies simultaneously assessing the effects of nicotine on
      oxidative stress and arterial function in humans have not been performed.

      The current proposal will address the hypothesis that nicotine, like cigarette smoking acting
      as a pro-oxidant may have adverse effects on arterial function.
    

Intervention name(s): transdermal nicotine patch (7mg)
Intervention type(s): Drug
Intervention description(s): A 7mg transdermal nicotine patch will be applied to the subject's arm for an 8 hour period.
Other intervention name(s): Nicotine patch; Habitrol; Nicoderm CQ; Nicotrol
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)