bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Scientific background:

      Obesity is a known risk factor for cardiovascular disease, metabolic syndrome, and diabetes.
      In Israel, the prevalence of obesity and diabetes among Arab females is 2 and 2.8 times
      higher than Jewish females, respectively. The economic impact of obesity and overweight in
      terms of illness, disease and lost productivity is estimated to amount to 2-9% of the
      national health budget in countries with high GDP. Diabetics have medical expenditure that is
      2.4 times higher than non diabetics per capita.

      Lifestyle modification is an effective tool in reducing morbidity and health care expenditure
      but despite that most family practitioners usually treat the complications of obesity rather
      than preventing it.

      PACE is a comprehensive health promotion guide in counseling patients to an active healthy
      lifestyle. PACE is designed to assist the primary health care providers to promote physical
      activity and dietary changes during routine office visits.

      Objectives:

      To asses the impact of PACE program on increasing the amount of physical activity, improving
      clinical and metabolic indices, increasing the documentation of lifestyle indices in the
      medical records and reducing health care expenditure and utilization.

      Working hypothesis:

      Implementing a modified PACE protocol can achieve this objectives in Arab women.

      Methodology:

      The investigators will conduct a structured, multidisciplinary and continuous primary care
      based intervention, assisted by trained health promoters and applying a locally adjusted PACE
      protocol.
    


Intervention name(s): Lifestyle counseling by applying a modified PACE protocol
Intervention type(s): Behavioral
Intervention description(s): Lifestyle counseling by applying a modified PACE protocol to obese Arab women
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical activity (PA); obesity; life style modification; physical activity; diet; BMI reduction; clinical and metabolic measure; health expenditure; improvement of patient readiness for lifestyle change
Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The planned study is to determine the pharmacokinetic properties of Esketamine and safety
      assessment with inhaled Esketamine after different number of inhalations and different dosing
      sequences within three parts of the study.
    

Detailed description: 
      This is to be one-centre, single ascending dose and double-blind placebo controlled multiple
      dose three part study of Esketamine DPI (dry powder inhaler) in healthy volunteers.

      PART A is a single dose, open-label part with Esketamine DPI inhalations administered with
      dose escalation between cohorts.

      PART B is a single dose, open-label part with Esketamine DPI inhalations administered in
      different dosing sequences with dose escalation between cohorts.

      PART C is a multiple dose, double-blind, placebo-controlled part with Esketamine DPI
      inhalations administered in different cycles of treatment (with four dosing sequences within
      two weeks) with dose escalation between cohorts. Participants in this part will be randomized
      to receive Esketamine DPI or placebo in 3:1 ratio.

      Pharmacokinetic properties and safety of Esketamine DPI will be determined following
      different number of inhalations in PART A, different dosing sequences in PART B and different
      cycles of treatment in PART C.
    

Intervention name(s): Esketamine DPI; Esketamine DPI; Esketamine DPI; Placebo DPI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive different number of consecutive Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts.; Participants will receive different dosing sequences of Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A of the study.
Dose: very low, low, medium, high.; Participants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. There will be dose escalation between cohorts. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A and PART B of the study.
Dose: very low, low, medium, high.; Participants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio.
In each cohort, number of placebo inhalations within a dosing sequence will correspond to number of Esketamine DPI inhalations.
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a
      booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix
      at 12-18 months of age, in children primed with the same vaccines in primary study
      NCT00680914.
    


Intervention name(s): GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A); Wyeth-Lederle's Prevenar™; GSK Biologicals' Hiberix™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection, administered as a single dose; Intramuscular injection, administered as a single dose; Intramuscular injection, administered as a single dose
Other intervention name(s): Pneumococcal vaccine GSK1024850A; Hib
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Safety; Pneumococcal vaccine; Immunogenicity; Pneumococcal disease; Booster vaccination
Therapeutic Antibodies Against Prion Diseases From PRNP Mutation Carriers
Condition: Prion Diseases
MeSH terms: Prion Diseases
Study type: Observational [Patient Registry]

Summary: 
      The human Prion diseases can be classified into sporadic, acquired and inherited forms.
      Inherited forms usually manifest in higher age so there have to be factors preventing Prion
      propagation in young mutation carriers. Antibodies against the flexible tail of Prions have
      been shown to be protective in mice. The investigators intend to screen mutation carriers and
      controls for the presence of Prion autoantibodies.
    


Intervention name(s): blood draw
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male or female carriers of a mutation in the Prion protein gene of any age and their wild
        type siblings.
Efficacy of Probiotic Milk Formula on Blood Lipid and Intestinal Function
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Probiotic contained milk formula (PMF) intervention for 10 weeks considerably improves
      gastrointestinal function by modulating fecal movement, intestinal microflora as well as
      decrease cholesterol and thus help in the management of hypercholesterolemia.
    

Detailed description: 
      Current randomized placebo-controlled, double-blind was designed to assess the effect of
      probiotic contained milk formula (PMF) on lipid profile and intestinal function in healthy
      mild hypercholesterolemic subjects. Totally forty healthy mild hypercholesterolemic subjects
      (180-220 mg/dL) were randomly chosen and divided into two groups as placebo or experimental
      group. All the subjects were requested to drink either PMF (experimental) or skimmed milk
      drink formula-Placebo (30 gm mixed with 200 mL of water) for 10 weeks and continued by 2
      weeks of the follow-up period. Supplementation of PMF for 10 weeks significantly improved (p<
      0.05) the fecal weight, fecal movement (decreased fecal GI passing time) by improving
      intestinal microflora (increasing beneficial bacterial species like Lactobacillus,
      Bifidobacterium spp) and Lag time of LDL oxidation. In addition, intake of PMF substantially
      reduced (p< 0.05) the levels of total cholesterol (TC) and low-density lipoprotein
      cholesterol (LDL-c) and thus showcasing its cardioprotective efficacy. Therefore PMF is
      recommended for the management of hypercholesterolemia.
    

Intervention name(s): Probiotic Milk Formula
Intervention type(s): Combination Product
Intervention description(s): Drink 200 mL of PMF for 10 weeks and followed by 2 weeks of follow up period for monitor any adverse effect
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled, randomized parallel clinical trial
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Probiotics; cholesterol; LDL-c; Hypercholesterolemic; Fecal movement
Effect Of Virtual Reality Glasses Used During Splint Application On Children's Pain And Anxiety Levels.
Condition: Pain, Acute; Anxiety Acute; Fractures, Bone
MeSH terms: Acute Pain; Fractures, Bone; Anxiety Disorders
Study type: Interventional

Summary: 
      The study in order to evaluate the effect of virtual reality glasses during splint in
      children on pain and anxiety due to the procedure.
    

Detailed description: 
      The study was carried out as a randomized controlled experimental study in order to evaluate
      the effect of virtual reality glasses during splint in children aged 6-12 years on pain and
      anxiety due to the procedure.

      The sample of the research consisted of 80 childrens who came to Karabuk University Training
      and Research Hospital orthopedic policlinic and emergency between 1 May and 31 October 2021
      for the splint application. In the study, two groups consisted of experimental group (n=40)
      and control group (n=40) were determined.

      The "Participant Information Form", the "Wong Baker Pain Scale", the "State Anxiety Inventory
      for Children", virtual reality glasses and pulse oximeter were used to collect data. The
      pain, anxiety and vital signs of the children in the experimental and control groups were
      recorded before, during and after the splint.

      The video chosen by the children in the experimental group was shown with virtual reality
      glasses during the splint application. In the control group a video wasn't shown during the
      splint application. Chi square, Mann Whitney U, Bonferroni and Friedman tests were used in
      the analysis of data.
    

Intervention name(s): The group using virtual reality glasses
Intervention type(s): Other
Intervention description(s): The video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was carried out as a randomized controlled. In the study, two groups consisted of experimental group (n=40) and control group (n=40) were determined.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; child; fracture; nurse; pain; splint; virtual reality glasses
Effects of AkPharma's Calcium Glycerophosphate Nasal Spray Wash
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Over 20 million Americans have allergic nasal symptoms including stuffiness, sneezing and a
      "runny" nose. AkPharma's Calcium Glycerophosphate used as a nasal spray wash is believed to
      improve these symptoms without side effects common to over the counter and prescription
      medication. It is hypothesized that Calcium Glycerophosphate will have a perceived
      improvement in breathing comfort.
    

Detailed description: 
      Subjects will be screened for inclusion and exclusion criteria and consented if they fit the
      same criteria. They will be instructed on keeping a nasal diary of symptoms "runny, itchy,
      congestion, sneezing, voice changes and throat clearing". They will have blood drawn for
      allergy testing. After a 1 week run-in, subjects will return their diary. If they still
      qualify based on the diary they will have baseline labs drawn and baseline breathing test
      (Spirometry) performed. They will also have a nasal wash and specimen collection performed.
      They will be instructed on use of the nasal wash. There will be three more weekly visits
      before study conclusion which will include diary submission, Spirometry and nasal wash and
      specimen collection. On the final visit blood will again be collected as well.
    

Intervention name(s): Calcium Glycerophosphate Nasal Spray Wash
Intervention type(s): Other
Intervention description(s): Nasal wash two to six times per day
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rhinitis; stuffy nose; congestion; Sneezing
Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will measure and compare changes in insulin production and sensitivity using the
      hyperglycemic clamp technique in obese patients with impaired glucose tolerance and
      hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide
      (HCTZ).
    


Intervention name(s): Hydrochlorothiazide (HCTZ); Comparator: Placebo to HCTZ; Isosorbide mononitrate (ISMN); Comparator: Placebo to ISMN
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.; Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period; ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period; Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period
Other intervention name(s): HCTZ
Intervention MeSH terms: Hydrochlorothiazide; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs)
      antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the
      study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up
      study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      The primary study was to evaluate the immunogenicity and protective efficacy of hepatitis B
      vaccine administered according to a 0, 1, 2, 12 month schedule in newborns of anti-hepatitis
      B envelope antigen positive (HBeAg+) and anti-hepatitis B surface antigen positive (HBsAg+)
      mothers. Results from the primary study have shown that the vaccine was immunogenic and
      protected neonates of HBeAg positive mothers against hepatitis B chronic carriage. The
      present study is carried out to evaluate the anti-HBs persistence and the prevalence and
      incidence of other hepatitis B markers (HBsAg, anti-hepatitis B core antigen {anti-HBc},
      HBeAg, Alanine aminotransferase/Aspartate aminotransferase {ALT/AST}), and the clinical
      significance of the HBsAg and anti-HBc positive cases observed during the long-term from year
      16-20. No vaccine will be administered during the long term follow up period.
    

Intervention name(s): Blood sampling
Intervention type(s): Procedure
Intervention description(s): A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B™ vaccine.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B
Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single-masked, 2×3 crossover, randomized, dispensing clinical trial to evaluate the
      visual performance and subjective responses of the JJVC Investigational Contact Lens.
    


Intervention name(s): JJVC Investigational Multifocal Contact Lens; Dailies Total 1® Multifocal Contact Lens
Intervention type(s): Device; Device
Intervention description(s): senofilcon A C3; delefilcon A
Other intervention name(s): Test; Control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The aim of this study is to look at the effectiveness of repetitive transcranial magnetic
      stimulation (rTMS) as a therapeutic intervention for patients with schizophrenia. The primary
      outcome is improvement in negative symptoms related to schizophrenia. The investigators are
      focusing on negative symptoms given their greater resistance to pharmacological and other
      established therapies. If the investigators trial were to show beneficial effects, its
      clinical significance would be great.
    

Detailed description: 
      This study builds on the results of a previous phase 1, single-site study in which we
      demonstrated the safety of image-guided theta burst stimulation (TBS) form of rTMS over the
      cerebellar vermis (Demirtas-Tatlidede et al., 2010) in eigh patients with schizophrenia.

      The primary goal of the present study is to assess efficacy of iTBS to the cerebellar vermis
      on positive and negative symptoms of schizophrenia. A second, added goal is to investigate
      the mechanisms of the expected clinical improvement.

      Schizophrenia is a leading cause of mental disability and current treatments still remain
      only partially successful for many patients. Our underlying hypothesis is that modulation of
      the cerebellar vermis may enhance activity of the neural systems that sub-serve cognition and
      emotion, reestablish the disturbed cerebellar regulation in schizophrenic patients, and
      produce clinical improvement.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
Other intervention name(s): Transcranial Magnetic Stimulation; Noninvasive Brain Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; repetitive Transcranial Magnetic Stimulation
Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies
Condition: Infant, Premature, Diseases
MeSH terms: Infant, Premature, Diseases
Study type: Observational

Summary: 
      Alterations to microvascular blood flow in premature infants, are known to contribute to
      several major disease entities.

      The optically-measured tissue blood flow, to determine tissue perfusion that can be use to
      detect blood loss.
    

Detailed description: 
      The researchers want to use optical technologies to non-invasively detect blood flow that can
      tell the onset of blood loss. The research can measure blood flow in stable premature infants
      in the Neonatal Intensive Care Unit over the duration of several weeks.

      The technologies are Laser Speckle Imaging and Diffuse Optical Spectroscopy.

      Laser Speckle Imaging non-contact imaging technology, is sensitive to blood flow in
      superficial tissues. Diffuse Optical Spectroscopy, a probe-based contact technology like
      pulse oximetry, measures hemoglobin concentrations and states deeper below the skin surface.
    

Intervention name(s): Laser Speckle Imaging and Diffuse Optical Spectroscopy
Intervention type(s): Device
Intervention description(s): Laser Speckle Imaging and Diffuse Optical Spectroscopy
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Study population will be selected from University of California Irvine Medical Center at
        Neonate Intensive Care Unit