bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Insulin on BP Change During Adolescence
Condition: Cardiovascular Diseases; Hypertension; Obesity; Insulin Resistance; Diabetes Mellitus
MeSH terms: Cardiovascular Diseases; Insulin Resistance
Study type: Observational

Summary: 
      To define the relation of insulin resistance during childhood and adolescence to the
      development of the insulin resistance syndrome in young adulthood.
    

Detailed description: 
      BACKGROUND:

      The insulin resistance syndrome (IRS) is associated with a considerable increase in the risk
      of cardiovascular disease in adults. The disorder most likely is inherited to some degree
      with onset in childhood and early adolescence. The IRS is best defined by quantitative data
      from euglycemic insulin clamp studies. The investigators have developed a unique data base in
      children, and by continuing repeated studies and follow-up in early adulthood together with
      studies in parents and siblings this study should provide important insight into the
      occurrence and progression of cardiovascular disease in later life.

      DESIGN NARRATIVE:

      The study is designed to: 1) define the relation of insulin resistance during childhood and
      adolescence to the development of insulin resistance syndrome (hypertension, dyslipidemia,
      obesity, and insulin resistance) in young adulthood; and 2) define the relation of insulin
      resistance within families. The original cohort consists of 357 children who have had two
      euglycemic insulin clamp studies (at mean ages 13 and 15 years). The specific aims are: to
      (1) repeat anthropometric and blood pressure measurements at mean ages 18, 19, and 20 and
      obtain insulin clamps, lipid levels, echocardiograms, and DEXA at mean age 21 in the
      children; and (2) obtain the measurements, blood and DNA samples, echocardiogram, and insulin
      clamp in the parents and siblings of the children. Statistical genetics methods are used to
      estimate heritability and genetic correlations among the insulin resistance syndrome traits.
      These data address the hypotheses that 1) insulin resistance in childhood predicts insulin
      resistance and cardiovascular risk factors in young adulthood; 2) insulin resistance in
      parents is associated with insulin resistance and cardiovascular risk factors in their
      children; 3) in fat children, BMI and insulin resistance at mean age 13 predicts
      cardiovascular risk, but in thin children only insulin resistance is a similar predictor; 4)
      insulin resistance has significant heritability; and 5) there are significant genetic
      correlations between insulin resistance and the insulin resistance traits. At least 300 of
      the original cohort of 357 who have had two euglycemic insulin clamps continue on in the
      study. The study continues through July, 2008.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with HBP
Immune-Pineal Axis Function in Chronic Tension-Type Headache
Condition: Chronic Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether electroacupuncture is effective in the
      treatment of chronic tension-type headache, measured by Headache Impact Test, Visual Analogue
      Scale and biomarkers.
    

Detailed description: 
      Tension-type headache can be defined as a constant sensation of pressure or heaviness, and is
      a highly-prevalent condition in the health services. The objective of the present study is to
      investigate the function of the immuno-pineal axis in chronic tension headache, focussed on
      the neuro-immune regulatory dysfunction. In addition, the effect of neuro-stimulation
      (electroacupuncture) on the function of this axis will also be studied.

      This is a clinical Trial study, randomised, in parallel, cross-over with a blinded assessor,
      and with a sham placebo control.

      The study will be carried out in the Clinical Research Outpatient Clinic of the Hospital de
      Clínicas de Porto Alegre (HCPA), with women aged between 18 and 60 years old. The
      participants will respond to questionnaires at the beginning and end of each therapeutic
      intervention, with 24-hour urine, blood and saliva collection. The therapeutic intervention
      will include: 10 electroacupuncture sessions and 10 sham placebo sessions. The measurements
      taken will be: quality of life, depression, impact of headache on daily life, sleep quality,
      chronotropic types, immuno-inflammatory mediators, levels of 6-sulfatoxymelatonin, and
      salivary cortisol.

      Through these interventions it is hoped that patients will present an improvement in their
      pain presentation, quality of life and sleep, as well as central autonomic regulation.
      Evidence for these hypotheses will support a minimally-invasive treatment, with few
      side-effects and a low cost.
    

Intervention name(s): Electroacupuncture; Placebo Sham
Intervention type(s): Device; Device
Intervention description(s): Eletroacupuncture performed using acupuncture needles.; Placebo Sham is performed using electrodes, without electrical stimulation. Lights and sounds were identical to active treatment.
Other intervention name(s): Electrical acupuncture; Placebo; Sham
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Chronic Tension-Type Headache; Electroacupuncture; Headache Impact; BDNF; TNF
Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones
Condition: Term; Healthy; Motor Delay; Development, Infant
Study type: Interventional

Summary: 
      this study compares motor development of two groups of healthy term babies at the end of
      their first year of life. Parents of the intervention group have received a training program
      consisting in advices about correct positions, stimuli, how to play or how to carry their
      babies. The purpose of this study is to know if motor development can be improved by the
      environment.
    

Detailed description: 
      infants of the intervention group are enrolled by the main investigator in the hospital in
      the next two or three days after birth. Infants of the control group are enrolled by the
      pediatricians at the age of 9 months old in the Primary Care Service.

      Intervention group:

        1. Four training sessions (before the baby is 1 month old, at 3 months, at 6 and at 9
           months old) teaching the main motor milestones to get in the next 3 months and how to
           help infants with the correct stimuli, positions or plays; triptychs containing the main
           points explained at the session and links to short videos about the given advices.

        2. Two evaluations of motor milestones at the age of 9 and 12 months old.

      Control group:

      1. Two evaluations of motor milestones at the age of 9 and 12 months old.
    

Intervention name(s): Training program
Intervention type(s): Other
Intervention description(s): Training program consisting in 4 sessions with information about milestones to achieve and advices for motor development. Triptychs and short videos containing the main points containing the main points.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention and control group.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: motor milestones; term; newborn; motor development
Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass
Condition: Clinically Severe Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Observational

Summary: 
      The main aim of this study is to analyze and report the very long-term outcomes after primary
      laparoscopic proximal Roux-en-Y gastric bypass surgery for clinically severe obesity.
    

Detailed description: 
      There is lack of very-long term outcomes after bariatric surgery; A few series have been
      reported. However, most of them analyze medium-term outcomes. For RYGB, there are just two
      retrospective cohort studies reporting very long-term outcomes. Both studies have an open
      approach and a proximal Roux-en-Y configuration with different pouch orientation and size.
      MacLean´s series, with a better follow-up rate (83.4%), had a 67.6%EWL at a mean of 11.4
      years; Failure rates were 20 and 35% for the morbidly obese and super obese, respectively. We
      will analyze our own series with a laparoscopic approach, vertically, lesser-curve base <
      10-15ml pouch and proximal Roux limb. The main end-points for our study are 1) Morbidity
      including status of specific biochemical markers & Mortality, 2) Weight loss expressed as BMI
      or %EWL, 3) Trends in major comorbidities and 4) Assessment of Quality of Life.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had clinically severe obesity and underwent a primary laparoscopic Roux-en-Y
        Gastric Bypass more than years ago were identified form a prospectively maintained database
        at UCSF Fresno / ALSA med group, Inc Minimally Invasive Surgery Program.
      
Keywords: severe obesity; morbid obesity; gastric bypass; efficacy of gastric bypass
Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects
Condition: Postoperative Complications; Constipation
MeSH terms: Constipation; Postoperative Complications
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first multiple-dose experience in humans with MOA-728 in an oral formulation.
      This study will provide an assessment of the safety, tolerability, and pharmacokinetics (PK)
      of MOA-728 following administration of ascending multiple oral doses to healthy subjects.
    


Intervention name(s): MOA-728
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Keywords: Safety; Health; Pharmacokinetics; ileus
Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging
Condition: Lung Inflammation
MeSH terms: Pneumonia; Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this research study is to gain understanding of the basic responses of the
      lung to inflammation and specifically if a certain medication can reduce the inflammation
      alone or in combination with another. Inflammation is the way our bodies react to irritation
      or injury, and involves red, warm, and often painful swelling of the affected tissue. "Acute
      lung injury" involves inflammation that is not specific to one area of the lung and is caused
      by any one of several conditions: infection, trauma, breathing toxic substances, etc. When
      lung injury is severe, not enough oxygen can get into the body; this can lead to the need for
      mechanical support of breathing (mechanical ventilation), problems with brain, heart or other
      organ function, and in some cases, death.
    


Intervention name(s): Zileuton; Pioglitazone placebo; Zileuton placebo; Pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation; Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.; Placebo tablets provided by manufacturer of Zyflo CR (Cornerstone Therapeutics), 2 tablets po bid x 5 days prior to endotoxin instillation until 24 hours after endotoxin.; PPAR-gamma agonist
Other intervention name(s): Zyflo; Actos
Intervention MeSH terms: Pioglitazone; Zileuton; Hydroxyurea
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Lung inflammation; positron emission tomography; fluorodeoxyglucose; rosiglitazone; zileuton; lung anti-inflammatory therapy
A Comparison Study of Prototype Continuous Glucose Sensors in the Intradermal and Subcutaneous Spaces
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare two continuous glucose sensors, one placed
      subcutaneous (under the skin) and one placed intradermal (in the skin) over 12-14 hours.
    

Detailed description: 
      This was a single site, non-randomized study. The study consisted of a screening visit (Visit
      1), during which the subject was consented and the inclusion and exclusion criteria
      confirmed, an experimental intervention (Visit 2) and a follow-up visit (Visit 3). The
      experimental intervention was based on an initial glucose clamp involving a basal intravenous
      (IV) insulin infusion and IV insulin boluses plus IV glucose infusion / IV glucose boluses as
      required to maintain euglycemic, hypoglycemic and hyperglycemic plateaus respectively in 41
      subjects with Type 1 or Type 2 Diabetes. At the end of hour five of the study the glucose
      clamp was discontinued and subjects given a standardized meal to stimulate a hyperglycemic
      excursion

      Each subject participated in one experimental intervention. During the glucose clamp
      intervention, the subject's blood glucose was continuously monitored either by means of the
      Biostator or by frequent venous blood glucose measurements based on a standard lab method
      (YSI STAT2300 analyzer), and measured by means of the BD Technologies test devices, and the
      Medtronic Guardian CGM. Once the clamp was discontinued the Biostator was discontinued as
      well. During the unclamped period and meal the subjects BG was monitored via the YSI Glucose
      Analyzer, the BD CGM sensor and the Medtronic Guardian CGM.
    

Intervention name(s): BD Continuous glucose monitor (BD CGM); YSI Glucose Analyzer; Medtronic Guardian CGM
Intervention type(s): Device; Device; Device
Intervention description(s): Continuous glucose monitoring for 12-14 hours; Continuous glucose monitoring for 12-14 hours; Continuous glucose monitoring for 12-14 hours
Other intervention name(s): MiniMed Guardian CGM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Diabetes; Type 1 diabetes; Type 2 diabetes; Diabetes mellitus; Blood glucose; Continuous blood glucose monitoring; CGM
What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
Condition: Eustachian Tube Dysfunction; Sudden Hearing Loss; Meniere Disease
MeSH terms: Hearing Loss; Meniere Disease; Hearing Loss, Sudden
Study type: Interventional

Summary: 
      Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable
      ventilation ear tube made with gelatin.
    

Detailed description: 
      Institutional Review Board- Park Nicollet Institute approval was granted 3/2011 for 15
      patients to be enrolled in pilot study of use of a bioabsorbable ventilation ear (PE) tube.
      IRB stated compliance with FDA as defined in 21 CFR, Part 56 and with regulations of DHHS.
      Federal assurance number FWA00000914. Prior to commencing this study, IRB approval was
      obtained and each participating clinician completed the NIH training for "Protecting Human
      Research Participants".

      14 patients (15 ears) were enrolled in this study and were examined by 2 independent
      examiners at approximately 3, 6 and 12 week follow-ups. Lumen patency and time to complete
      resorption were documented by each examiner. There were no adverse reactions. This pilot
      study suggests that there is utility for a bioabsorbable ear tube made from gelatin material,
      as the device was found to break down over the expected time frame and remained functional
      long enough to have clinical utility.
    

Intervention name(s): PE tube
Intervention type(s): Device
Intervention description(s): Gelatin mixed with antibiotic and steroid ear drop to create a rigid device that maintains a lumen, acting as an intermediate-duration bioabsorbable ear tube.
Intervention model: Single Group Assignment
Intervention model description: 14 patients underwent placement of a novel absorbable ventilation tube to test utility of this prototype device and monitor resorption over a period of weeks. 14 participants were approved for this study of feasibility to allow for patients who did not follow up per the study protocol.
Masking: None (Open Label)
Primary purpose: Device Feasibility
This Study in Healthy Men Tests How the Body Takes up BI 1467335
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the absolute bioavailability of BI
      1467335 with an intravenous microdose formulation containing labelled [C-14] BI 1467335 and
      an unlabelled oral tablet formulation of BI 1467335 in healthy male subjects.

      The secondary objective is the evaluation of additional pharmacokinetic parameters following
      the two treatments.
    


Intervention name(s): BI 1467335; BI 1467335 (C-14) intravenous solution
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablet; Intravenous solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending
      intravenous doses of TAK-954.
    

Detailed description: 
      The drug being tested in this study is called TAK-954. This study will assess the safety,
      tolerability, PK and PD of single ascending TAK-954 higher intravenous doses than those
      previously studied.

      The study will enroll approximately 6 participants. Participants will be randomly assigned
      (By chance, like flipping a coin) to one of the three treatment sequences-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need).

      In each treatment sequence, each participant will receive 2 doses of active drug out of 3
      dose levels (TAK-954 0.5 mg, TAK-954 1 mg, or TAK-954 2 mg) and 1 dose of Placebo. Dose
      escalation will be based on the available safety/tolerability data from the previous period.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 73 days. Participants will make a final visit on
      Day 16 after receiving their last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-954; TAK-954 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-954 infusion administered intravenously.; TAK-954 placebo-matching infusion intravenous.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Drug Therapy
Chewing Capability Study for Infants and Toddlers
Condition: Healthy
Study type: Observational

Summary: 
      The main objective of the study is to conduct a pilot study on the characterization of the
      mastication abilities of infants and toddlers using different commercial cereal based
      products in order to gain knowledge and be able to plan future studies.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The subjects investigated will be healthy infants and toddlers ranging from 9 to 36 months
        in 5 groups:

          -  9 months (±2 weeks),

          -  12 months (±1 month),

          -  18 months (±2 months),

          -  24 months (±2 months),

          -  36 months (±3 months).
Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients presented with primary dysmenorrhea composed the study population. One gram
      paracetamol and 100 mg tramadol in 100 ml saline with a slow infusion were compared in
      ceasing dysmenorrhea in the emergency department
    

Detailed description: 
      Patients over 18 years old who presented with dysmenorrhea composed the study population.
      Patients received painkiller within the last six hours, physical findings consistent with
      peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction,
      pregnancy or woman with lactation and denied to give inform consent were the exclusion
      criteria. The pain of the study patients is measured with the visual analogue scale at
      baseline, 15th and 30th minutes and 1 hour after study drug administration. At the end of the
      60 minutes, rescue drug need is also recorded.
    

Intervention name(s): tramadol; paracetamol
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg tramadol in 100 ml saline with slow infusion; Intravenous 1 gm paracetamol in 100 ml saline with slow infusion
Other intervention name(s): perfalgan
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit
      the study site over a period of approximately 14 weeks.
    

Detailed description: 
      This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit
      the study site over a period of approximately 14 weeks. Subjects will be titrated to an
      optimum dose of study treatment and assessed for safety and efficacy. Dermal response will be
      evaluated at each visit by the investigator. Subjects with high dermal response scores or
      scores that persist at the same application site and have no improvement after up to 4
      evaluations (not to exceed a two week period) will be discontinued from the study and
      referred to a study specific dermatologist for specialized skin sensitivity skin patch
      testing.
    

Intervention name(s): Daytrana
Intervention type(s): Drug
Intervention description(s): Methylphenidate Transdermal System (MTS)
Other intervention name(s): MTS
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment