bioihbjkbjnl/mcl2 huggingface dataset:
The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity
Condition: Feeding and Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity
      during the following year?
    

Detailed description: 
      The investigators examined the influence of teaching mothers to feed infants with their head
      in an upright position and evaluated the infant ear and respiratory morbidity during a
      one-year follow-up. Mothers of 88 infants born during 2011 were instructed by trained nurses
      at Maternal-Child-Health clinics to feed their infants with their head in upright position
      (intervention group). The control group consisted of 75 mothers of infants of similar
      socioeconomic background who fed their infant regularly without any instructions and were
      followed at another Maternal-Child-Health clinic. Feeding position was evaluated at the
      beginning and the end of the study, and morbidity data of both groups were evaluated at every
      3-month follow-up meeting. The study was part of the PhD thesis of Efrat Danino, Head Nurse
      of Pediatric Department at Hadassah Medical Organization.
    

Intervention name(s): upright head position
Intervention type(s): Behavioral
Intervention description(s): Bottle feeding of infants with their head in upward and not supine head position
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 month old infants were recruited from 2 Mother-Child-Health clinics and followed for 12 months. Mothers from intervention group were instructed to feed their babies (88 infants) with their head in upright position. Mothers from control group (75 infants) fed their infant regularly without any instructions . Respiratory and ear morbidity were evaluated during the following 12 month period.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: infant; feeding position; respiratory; ear
Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention
Condition: Prolapse
MeSH terms: Prolapse
Study type: Interventional

Summary: 
      Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as
      endurance, strength, stretching and information. Evidence concludes that it is not harmful to
      return to activity after lumbar disc surgery, and restrictions to activities after these
      operations are today more or less nonexistent. Some studies have shown that high intensity
      programs might be more effective, but they are probably more expensive. In recent years
      cognitive interventions have received more attention in rehabilitation programs after lumbar
      disc surgery. The cognitive approach is focused on providing patient knowledge to reduce
      uncertainty so that he or she can understand what is important after lumbar disc surgery so
      that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient to
      resume normal activities. Reviews ask for how much treatment are needed in a rehabilitation
      program after lumbar disc surgery.

      The study will be a randomized clinical trial. The study will compare two different
      post-operative rehabilitation programs (general information or general information + exercise
      therapy). Both groups will begin treatment 1 day after surgery. Subjects in exercise therapy
      group are supposed to continue with exercises 3 months.

      In this study the following hypothesis will be studied:

        1. Brief intervention, an educational model, alone after lumbar disc surgery do have the
           same effect on pain in legs and low back as brief intervention, an educational model,
           combined with exercise therapy.

        2. Exercises which are instructed after lumbar disc surgery in a rehabilitation program,
           are being done by the patients.
    


Intervention name(s): Brief intervention, an educational model; Exercise therapy
Intervention type(s): Other; Other
Intervention description(s): The goal of the the brief intervention is to provide the patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases.; Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation,surgery,brief intervention, exercises
A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis
Condition: Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the overall response to desmopressin treatment among previously untreated
      enuretic children aged 5-15 years after 3 and 6 months of treatment.

      To investigate the influence of possible predictive factors on response after 3 and 6 months
      of treatment.

      To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety
      profile of oral desmopressin in children with primary nocturnal enuresis.
    

Detailed description: 
      To evaluate the overall response to desmopressin treatment among previously untreated
      enuretic children aged 5-15 years after 3 and 6 months of treatment.

      To investigate the influence of possible predictive factors on response after 3 and 6 months
      of treatment.

      To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety
      profile of oral desmopressin in children with primary nocturnal enuresis.
    

Intervention name(s): Primary nocturnal enuresis
Intervention type(s): Drug
Intervention description(s): Desmopressin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary nocturnal enuresis
Study To Assess Safety, Tolerability and Efficacy of Intravenous Cabaletta in Patients With Machado-Joseph Disease
Condition: Machado-Joseph Disease / Spinocerebellar Ataxia 3
MeSH terms: Spinocerebellar Ataxias; Spinocerebellar Degenerations; Machado-Joseph Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      -  This is an exploratory, randomized, parallel-group, dose escalation and dose-controlled
           study without a placebo arm.

        -  Eligible patients will be randomized in a 1:1 ratio (double-blind) to receive Cabaletta
           in 2 doses, once weekly for 22 weeks (total of 24 weeks of treatment).
    


Intervention name(s): Cabaletta for IV infusion once weekly during 24 weeks; Cabaletta for IV infusion once weekly during 24 weeks
Intervention type(s): Drug; Drug
Intervention description(s): Cabaletta for IV infusion once weekly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bioblast, Randomized, parallel-group, and dose-controlled
Outcome of Two Protocols in Poor Responders in Assisted Reproductive Technology (ART) Cycle
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to
      the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments
      have been suggested for increasing pregnancy rate. In this study, the investigators will
      compare the outcome of Microflare protocol and Flare up regimen in poor responders.
    

Detailed description: 
      In this randomized clinical trial study, a total of 200 infertile women with poor ovarian
      response who undergo IVF / ICSI treatment cycle at Royan Institute will enroll in this study
      and will randomly be divided into two groups of 100 patients. This study has been approved by
      Royan ethics committee and written consent will be obtained from each patient.

      The patients will be randomized to one of two groups of Flare Up or Microdose GnRh agonist
      flare up.

      Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), Estradiol, will be evaluated on
      day 2 or 3 and when follicle size become >14.

      2 weeks after embryo transfer, the patients will be tested for serum β-hCG for assessing the
      pregnancy. The clinical pregnancy will be clarified by the number of women with gestational
      sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of
      implantation, the number of gestational sacs will be considered.
    

Intervention name(s): Microdose GnRh; Flare up
Intervention type(s): Drug; Drug
Intervention description(s): Microflare protocol in poor responders for IVF/ICSI; Flare up protocol in poor responders for IVF/ICSI
Other intervention name(s): Case; Standard treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Poor responder; Flare up; Micro dose GnRH agonist flare up; IVF/ICSI
Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth
Condition: Neonatal Complications
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      Extensive animal studies have indicated that antenatal betamethasone exposure results in
      altered developmental trajectories of several fetal systems. Follow up of a randomized
      controlled trial has shown that antenatal betamethasone exposure might result in insulin
      resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have
      clearly demonstrated that betamethasone-induced growth alterations were dose-related.

      In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung
      function, similar to those obtained after a full dose.

      Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the
      potential long term effects of this drug, is not inferior to a full dose to promote fetal
      lung maturation in Humans.
    

Detailed description: 
      The BETADOSE project consist in a randomized, multicenter, double blind placebo-controlled
      non inferiority trial comparing a standard dose regimen (24 mg) to a reduced dose regimen (12
      mg) of betamethasone given to prevent the neonatal complications associated with very preterm
      birth.A betamethasone course consists in 2 injections of 12 mg betamethasone 24 hours apart
      for a total dose of 24 mg.

      The first injection will be unmasked in both group. In both group, women will receive a first
      12 mg injection of betamethasone according to local protocols.

      Randomization will be performed after the first injection. Women will then receive either a
      placebo injection (reduced dose regimen, 12 mg only from the first injection) or a second 12
      mg betamethasone injection (standard dose regimen, 12 mg from the first injection and 12 mg
      from the second injection=24 mg). This protocol allows women sent from level 1 and 2 to level
      3 perinatal centers after having already received their first injection to participate.

      In case of multiple antenatal betamethasone courses, women will receive their second course
      according to the same design as in their first course.
    

Intervention name(s): betamethasone 24 mg; 12mg betamethasone +placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Site Selection for Intracutaneous Saline Delivery
Condition: Intracutaneous Drug Delivery
Study type: Interventional

Summary: 
      The goal of this exploratory study is to select the optimal body site for intracutaneous
      delivery of 0.5 milliliters of saline from the FLUGEN 101.2 microneedle-based device.
    

Detailed description: 
      Test ability to inject saline into various sites on body.
    

Intervention name(s): Injection to deltoid; Injection to forearm; Injection to thigh
Intervention type(s): Device; Device; Device
Intervention description(s): Deliver 0.5 milliliters of saline intradermally; Deliver 0.5 milliliters of saline intradermally; Deliver 0.5 milliliters of saline intradermally
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: microneedle-based array; hollow microneedle; intracutaneous; drug delivery; vaccine delivery
Study to Assess the Tolerability and Efficacy of Anacetrapib in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease (MK-0859-019)
Condition: Coronary Heart Disease (CHD); CHD Risk-Equivalent Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of anacetrapib (100 mg) for 24 weeks relative to
      placebo, on plasma concentrations of Low Density Lipoprotein Cholesterol and assess the
      safety and tolerability of anacetrapib (100 mg) in participants with CHD/CHD risk-equivalent
      disease on stable dose regimen of statin with or without other lipid-modifying therapy. The
      two year extension to this study will further evaluate the long-term safety profile and
      efficacy of anacetrapib in CHD/CHD-risk equivalent patients who are on ongoing therapy with a
      statin with or without other lipid-modifying therapy.
    

Detailed description: 
      The 76 week treatment period is followed by a 12 week reversibility phase which can be
      extended by up to another 12 weeks in order to allow participants who have completed their
      week 88 visit to continue in the study until the Extension study is ready to be implemented.

      In the optional extension, participants will be assigned to the same treatment arm to which
      they were assigned in the base study. The total duration of the extension study will be up to
      116 weeks; which will include a 2 year treatment period, followed by a 12 week reversal
      phase. A post-extension study follow-up phone call will be completed 12 weeks after
      discontinuation or completion of study treatment. Participants previously treated with
      anacetrapib or placebo will be invited in a 4:1 ratio in an optional extended reversal phase.
      The total duration of the extended reversal phase will be 1 year.

      Participants previously treated with anacetrapib in the DEFINE study will be followed
      periodically for up to 4 years to determine plasma levels of anacetrapib. Participants will
      also be invited to participate in a sub-study consisting of one clinic visit to measure
      anacetrapib levels in the plasma and the subcutaneous adipose tissue.

      ACRONYM: DEFINE= Determining the EFficacy and Tolerability of Cholesteryl ester transfer
      protein (CETP) INhibition with AnacEtrapib
    

Intervention name(s): anacetrapib; Comparator: placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive one tablet of anacetrapib 100 mg once daily for 76 weeks.; Participants will receive one placebo tablet once daily for 76 weeks.
Other intervention name(s): MK0859
Intervention MeSH terms: Anacetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CHD/CHD risk-equivalent disease; Coronary Heart Disease (CHD)
Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5-7
      days in children with community-acquired pneumonia (CAP).

      Secondary objectives are to assess Pharmacokinetics, Efficacy and Acceptability of
      telithromycin 20 mg/kg qd for 5-7 days in children with CAP.
    


Intervention name(s): Telithromycin (HMR3647)
Intervention type(s): Drug
Intervention MeSH terms: Telithromycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Community-Acquired pneumonia; CAP; children; Child
Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5
      mg treprostinil diethanolamine tablet strengths in healthy volunteers.
    

Detailed description: 
      This study was designed to assess the pharmacokinetic linearity and comparative
      bioavailability of UT-15C SR (treprostinil diethanolamine) following the administration of a
      single tablet containing 0.5 mg, 1 mg and 2.5 mg UT-15C in healthy volunteers.
    

Intervention name(s): Treprostinil diethanolamine
Intervention type(s): Drug
Intervention description(s): Treprostinil diethanolamine sustained release oral tablets.
Other intervention name(s): UT-15C
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary arterial hypertension; Treprostinil; Pharmacokinetics
Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth
Condition: Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis
MeSH terms: Hepatitis A; Hepatitis B; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will only include infants born to mothers who are tested as seronegative for human
      immunodeficiency virus (HIV) & hepatitis B surface antigen (HBsAg). The purpose of this study
      is to demonstrate in infants who received a birth dose of hepatitis B vaccine that
      Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with
      respect to immunogenicity of the hepatitis B antigen.
    

Detailed description: 
      Randomized study with two groups to receive one of the following vaccination regimens:

        -  GSK Biologicals' Tritanrix™-HepB/Hib-MenAC

        -  GSK Biologicals' Tritanrix™-HepB/Hiberix™
    

Intervention name(s): DTPw-HBV/Hib-MenAC conjugate vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Is the Expression of the GLUT5 Specific Fructose Transport Protein Abnormal in Patients With Fructose Intolerance?
Condition: Irritable Bowel Syndrome; Fructose Intolerance
MeSH terms: Irritable Bowel Syndrome; Fructose Intolerance
Study type: Observational

Summary: 
      In this study we will investigate the expression of the fructose transport protein GLUT5 in
      the small intestine in patients with functional GI disoders and fructose intolerance compared
      to matched healthy controls.
    

Detailed description: 
      Intolerances to food are a major complaint of patients with functional gastrointestinal
      disorders (FGID) and even commoner in patients with inflammatory bowel disorders (IBD)
      (Barrett JS et al. Aliment Pharmacol Therap 2009;30:165-174). The most common forms of food
      intolerance are FODMAP (fermentable oligo-, di- and monosaccharide and polyol) -related, of
      which fructose and lactose are the best known. The prevalence of lactose and fructose
      intolerance in IBS patients is between 50 and 70% (Wilder-Smith CH et al. Gastroenterology
      2009;136 (Suppl. 1): A324). Recent high quality studies have shown that the reduction of
      ingested FODMAP can lead to significant and long-term symptom improvement in patients shown
      to be intolerant by breath-testing. While the pathophysiology behind lactose intolerance is
      the reduction in small intestinal lactase availability, the mechanism in fructose intolerance
      and its relationship to malabsorption are unknown. One possible and so far uninvestigated
      mechanism is a reduction in the expression or activity of the specific fructose transporter,
      GLUT5, which is mainly responsible for luminal absorption of fructose. GLUT5 is mainly found
      in the small intestine, as well as various extra-intestinal organs. The clinical relevance of
      GLUT5 expression for food intolerances in humans has not been reported, but in a mouse model
      deletion of GLUT5 led to decreased absorption of dietary fructose and typical signs of
      malabsorption (Barone S et al. J Biol Chem 2009;284:5056-5066). The control of GLUT5 is
      dynamic and considerable upregulation together with increased absorption of fructose is
      evident in diabetes mellitus, while expression is decreased by inflammation and
      lipopolysaccharide endotoxin, an integral component of the outer membrane of all
      gram-negative bacteria, through the action of pro-inflammatory cytokines, such as TFN-a.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients referred to our practice for evaluation of symptoms consistent with FGID
        undergoing upper GI endoscopy with biopsy and fructose breath testing as part of their
        usual clinical evaluation.
      
Keywords: IBS; fructose intolerance; GLUT 5; GLUT 2
A Study for Treatment of Partial Seizures in Children
Condition: Partial Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety profile of the investigational medication,
      Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.
    


Intervention name(s): Divalproex Sodium (Depakote Sprinkle Capsules)
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Partial Seizures