bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasonographic Evaluation of Drug Spread in Epidural Space During Caudal Block in Children
Condition: Children Who Need Urological Surgery
Study type: Observational

Summary: 
      Caudal block is the world-widely used technique for an effective postoperative analgesia in
      children undergoing OPD-based infra-umbilical surgery. Because the caudal block is usually
      performed with a single-shot, proper dosage is required to achieve sufficient analgesic
      levels. Several clinical researches have been performed to assess the drug spread levels
      using mathematical equation, X-ray evaluation, and ultrasonography during caudal block in
      children. In our previous study using fluoroscopy, we obtained the results that the
      established weight-based doses provided adequate block levels for each type of surgery.

      Ultrasonography is precise tool to evaluate the spinal structures and can provide estimated
      information in real time during caudal or epidural block in children.

      The aim of this study is to evaluate the drug spread level with a weight-based doses using
      ultrasonography during caudal block in children and assess the reliability of the real time
      ultrasonography to determine the drug spread levels. After general anesthesia, the patient
      will be placed in lateral decubitus position for caudal block. Total 1.5 ml/kg of 0.15%
      ropivacaine will be injected into the caudal space. The spread level will be step-wise
      evaluated using ultrasonography at the injected drug dose of 0.5 ml/kg, 1.0 ml/kg, 1.25
      ml/kg, and 1.5 ml/kg.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        3 months old ~ 5 years old children undergoing minor infra-umbilical urological surgery
      
Keywords: caudal block, children, ultrasound, urological surgery
Omega-3 Fatty Acids in Tourette's Disorder
Condition: Tourette's Disorder
MeSH terms: Tourette Syndrome
Study type: Interventional

Summary: 
      This study examines the safety and efficacy of omega-3 fatty acids (fish oil) for the
      treatment of Tourette's Disorder.
    

Detailed description: 
      This is a 20-week, double-blind, placebo (olive oil) controlled study examining supplemental
      fish oil in the treatment of tic and OCD symptoms.
    

Intervention name(s): Omega-3 Fatty Acids; Olive oil
Intervention type(s): Drug; Drug
Intervention description(s): Omega-3 fatty acids (derived from fish oil); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourette's Disorder, Obsessive-Compulsive Disorder, tics
Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to determine whether a short-term administration of an
      investigational study drug may provide evidence of improvement in cognitive functioning in a
      group of stable male subjects with schizophrenia.
    

Detailed description: 
      The goal of this study is to determine whether the short-term (4 week), double-blind
      administration of Merck L-830982 provides evidence of improvement in cognitive functioning in
      stable male subjects with schizophrenia. This initial, small sample size study (n=9 on
      L-830982 and n=6 on placebo) is restricted to males in order to reduce the variance that
      might be attributable to the well-documented sex differences in the clinical features of
      schizophrenia.
    

Intervention name(s): Merck L-830982; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.; Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
Other intervention name(s): MK-0777
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia
A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of the investigational
      medicinal product CVI-HBV-002.
    

Detailed description: 
      A randomized, double-blinded, placebo-controlled, parallel, multicenter, phase 2b study to
      evaluate the efficacy and safety of CVI-HBV-002 in patients with chronic hepatitis B taking
      Tenofovir disoproxil fumarate/Tenofovir disoproxil
    

Intervention name(s): CVI-HBV-002; Normal Saline(placebo)
Intervention type(s): Biological; Biological
Intervention description(s): Investigational Product; Investigational Product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety of NGOIS Compared to BSS Plus in Pediatric Patients
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus
      for use during cataract surgery in Pediatric patients.
    


Intervention name(s): Next Generation Ophthalmic Irrigating Solution (NGOIS); BSS Plus
Intervention type(s): Drug; Drug
Intervention description(s): Volume sufficient to irrigate adequately during cataract surgery; Volume sufficient to irrigate adequately during cataract surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Periodontitis and Upper gi Post-operative Complications
Condition: Periodontitis; Surgery--Complications
MeSH terms: Periodontitis; Postoperative Complications
Study type: Interventional

Summary: 
      Periodontitis is a infection of mouth gingival mucosa and connecting tissue. It has been
      shown in previous studies to have a effect on the risk of heart diseases getting worse and
      elevate risk in heart surgery. The investigators are studying periodontitis and how it
      affects upper gastrointestinal tract patients complication rates and the quality of
      complications.
    

Detailed description: 
      Before patricipating patients go to preop, the investigators have them take a mouth rinsing
      quick-test, periosafe(c), that tells specifically about periodontitis. Participants go to
      surgery (upper gi) and have a normal operation following our clinics standards and normal
      follow up. After the investigators analyze the patient data concerning possible complications
      and do they have relations between the positive periodontitis results. Participants are also
      given advice about seeing a dentist if positive results are seen, but the operating surgeons
      do not get to know the mouth rinsing test results.
    

Intervention name(s): periosafe
Intervention type(s): Diagnostic Test
Intervention description(s): mouth rinsing quick-test
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All the patients that have upper-gi surgery in our time frame are asked to join in the study
Masking: Single (Care Provider)
Primary purpose: Prevention
Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Gastroesophageal reflux disease (GERD) is a common problem in cystic fibrosis (CF). It may
      lead to worsening lung function and more respiratory infections for a person with CF. This
      study will look at treating GERD with a medication, esomeprazole. The medication stops
      stomach acid from being made. The study will see if there are fewer respiratory infections
      and improved lung function in patients with CF when taking esomeprazole.
    

Detailed description: 
      This is a randomized, placebo controlled intervention study in patients with CF who have a
      history of frequent exacerbations. Treatment duration is 6 months.
    

Intervention name(s): Esomeprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sugar pill
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: CF
The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion
Condition: To Assess the Impact of Bile Acids on Human Glukagon-like-peptide-1 Secretion
Study type: Interventional

Summary: 
      The last couple of years it has been shown that bile acids not only acts as simple
      emulsifiers of fat, but constitutes a complex metabolic integrator which not only have an
      influence on fat digestion and lipid metabolism, but also modulates the energy expenditure in
      (brown) adipose tissue and muscle tissue. This action is due to stimulation of the receptor
      TGR5 by bile acids. Recently scientists have discovered that this receptor in rodents is also
      expressed on the surface of intestinal L-cells (which normally secrets Glucagon-Like
      Peptide-1 (GLP-1) in response to nutrient stimulation). The stimulation of this receptor has
      shown a GLP-1 secretion from the intestinal cells which is interesting since GLP-1 has a
      central role in maintaining normal glucose tolerance and thus blood sugar. Given the above,
      bile acids has an important impact on intestinal GLP-1 secretion. Whether these scientific
      findings can be proven in human beings is uncertain.

      The primary hypothesis is that stimulating gall bladder emptying via Cholecystokinin (CCK) in
      healthy subjects will result in a significant GLP-1 response. We also hypothesize that adding
      orally Metformin or a sequestrant ("a bile acid binder") will further enhance this GLP-1
      response.
    


Intervention name(s): Acetaminophen; Metformin; Colesevelam; Cholecystokinin-8; Saline
Intervention type(s): Drug; Drug; Drug; Other; Other
Intervention description(s): Acetaminophen dissolved in 50 ml of water; Metformin + acetaminophen dissolved in 50 ml of water; Colesevelam + acetaminophen dissolved in 50 ml of water; iv. infusion of CCK-8, 24 pmol/kg/hour for the first 60 minutes; iv. saline infusion 40 ml/hour for the first 60 minutes
Other intervention name(s): Paracetamol; CCK-8
Intervention MeSH terms: Acetaminophen; Metformin; Cholecystokinin; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Bile acids; Gall bladder emptying; Human; Glucagon like peptide 1; GLP-1
Immunogenicity and Safety Study of NBP606 in Healthy Infants
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the immunogenicity and safety of primary vaccination with NBP606
      compared to the existing commercial vaccine, when given concomitantly with routine pediatric
      vaccinations.
    


Intervention name(s): NBP606; Prevnar13
Intervention type(s): Biological; Biological
Intervention description(s): A single intramuscular injection into the thigh; A single intramuscular injection into the thigh
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Evaluation of the Effectiveness of the Anti-aging Effect of a Supplement in Improving Skin Conditions
Condition: Aging Well
Study type: Interventional

Summary: 
      A unicentric, blind, non-comparative clinical study to evaluate facial and body anti-aging
      efficacy of a supplement in female participants through clinical, subjective and instrumental
      evaluations.
    

Detailed description: 
      A unicentric, blind, non-comparative clinical study to evaluate facial and body anti-aging
      efficacy of a supplemente in female participants through clinical, subjective and
      instrumental evaluations.

      It will be necessary 33 female participants aged between 35 and 60 years old with signs of
      aging on the face and neck, complaining of body flaccidity and gynoid lipodystrophy.

      The participant will remain in the study for 90 days using the product. Visits will be
      scheduled in D0, D45 and D90.

      Instrumental evaluations: Evaluated on each visit:

        -  Skin elasticity and firmness using Cutometer - D0, D45 and D90;

        -  Skin hydration using Corneometer- D0,D45 and D90;

        -  Detection and accuracy of fine lines and wrinkles using Visia -D0,D45 and D90

        -  Dermal thickness and density in the thigh region using Ultrasound Voluson E8 before
           using the product (D0) and after 90 (D90) days of continuous use;

        -  Participants will respond to a subjective assessment using a questionnaire to capture
           possible feelings of discomfort during the study and subjective efficacy.

        -  A dermatologist will be available to monitor the participants throughout the study and
           respond an assessment of clinical efficiency
    

Intervention name(s): A power supplement
Intervention type(s): Dietary Supplement
Intervention description(s): A dietary supplement containing vitamins and collagen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dermal aging, elastic fiber, collagen
Cytosponge and Dietary Therapy in EoE
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional

Summary: 
      This study is being done to see if the investigators can use only the cytosponge ( A 10
      minute, in office procedure that does not require sedation) to replace the 6-10 endoscopies
      routinely perform during dietary restriction and food reintroduction in EoE?
    

Detailed description: 
      Dietary Therapy has been shown to be successful in the treatment of adult and pediatric
      patients with eosinophilic esophagitis Dietary studies were initially reported in children,
      but the results appear to be similar in adult patients. Elemental diets are successful in
      70-95% of patients but are poorly tolerated. A six food elimination diet has been effective
      in about 70% of adult patients with EoE . In these adult studies skin prick testing was not
      helpful in predicting which foods would lead to a flare of disease when reintroduced into the
      diet. Therefore, the current standard of care requires multiple EGDs with esophageal biopsy
      during the dietary restriction and reintroduction phases of this study. Since the
      investigators are making lifelong dietary decisions during this process of food
      reintroduction, it is imperative the investigators be accurate. Unfortunately, these multiple
      EGDs have significant cost and are invasive procedures with some risk. Moreover, there is
      significant indirect costs with travel and time off work for the patients and drivers.
      Previous studies have found the esophageal sponge to be an accurate technique of accessing
      esophageal eosinophilia in EoE . The sponge is swallowed as a 12 mm capsule on a string. The
      capsule rapidly dissolves upon entering the stomach and the sponge then expands and can be
      pulled out the mouth five minutes after ingestion. In previous studies, the procedure was
      very well tolerated and all patients preferred the sponge to endoscopy.

      Therefore the sponge is a well tolerated, inexpensive, very low risk procedure that would be
      an ideal option to replace EGD esophageal sampling in the evaluation of dietary treatment of
      EoE.
    

Intervention name(s): Cytosponge
Intervention type(s): Device
Intervention description(s): A capsule with a string attached with a sponge inside is swallowed. The string is held without any tension to allow the capsule to move into the stomach. The string will be held for five minutes to allow the capsule to dissolve in the stomach; a round mesh sponge about the size of a quarter is released.
Other intervention name(s): sponge
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: EOE
Biomarkers in Repetitive Transcranial Magnetic Stimulation (rTMS) for Adolescent Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The Researchers are going to gather information regarding the use of rTMS as a treatment for
      depression in adolescents with Major Depressive Disorder. The researchers also hope to learn
      if measures of brain activity (cortical excitability and inhibition) collected with
      transcranial magnetic stimulation (TMS) can be used to identify which patients will benefit
      from certain types of rTMS treatment.
    

Detailed description: 
      Phase I is a double-blind, randomized, biomarker-stratified trial of 1 Hz vs. 10 Hz rTMS.
      Phase II is for participants who do not respond to Phase I treatment and is a biomarker
      guided, double-blind trial of continuous vs intermittent theta burst stimulation (TBS).
      Please note that transcranial magnetic stimulation (TMS) biomarkers will be collected in this
      protocol during the course of the proposed interventions. Participants in Phase I will be
      offered enrollment in a separate protocol with baseline and posttreatment 7 Tesla Magnetic
      Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) scans
    

Intervention name(s): NeuroStar TMS Therapy® System; NeuroStar XPLOR®
Intervention type(s): Device; Device
Intervention description(s): The NeuroStar TMS Therapy® System is a computerized electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the cerebral cortex. It is a non-invasive tool used for the treatment of Participants with Major Depressive Disorder (MDD) who have not achieved sufficient clinical benefit from antidepressant pharmacotherapy.; NeuroStar XPLOR® is a clinical research option for the NeuroStar TMS Therapy System that provides features necessary to conduct randomized controlled trials and other TMS research.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: adolescent; biomarkers
Free-Living Physical Activity and Energy Expenditure
Condition: Obesity
Study type: Observational

Summary: 
      We have recently validated a new device for measurement of physical activity and found it to
      detect type, duration and intensity of many types of physical activity at better than 98%
      accuracy. After further validating this device to determine if it can also accurately assess
      energy expenditure, we will use it to collect cross-sectional data on free-living physical
      activity and energy expenditure in adolescent girls.
    


Time perspective: Prospective
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall hypothesis is that plastic bags used in combination with WHO thermoregulation
      care will reduce the incidence of hypothermia in preterm/low birth weight and full term
      infants when compared to routine WHO thermoregulation care alone. Part V is comparing use of
      a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following
      removal from their incubator to assist with temperature regulation.
    

Detailed description: 
      Due to limited resources and numbers of incubators, hospitals in developing countries remove
      infants from incubators at lower weights than in developed countries, putting infants at
      increased risk for hypothermia. This study will compare the incidence of hypothermia during
      the 72 hours after incubator removal of infants randomized to receive standard incubator
      removal (control group) or standard incubator removal with a plastic bag covering their
      torsos and lower extremities (intervention group). The axillary temperature of each infant
      will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72
      hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain,
      hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia,
      sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis,
      intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of
      time in an incubator will be recorded throughout their hospitalization for all infants. With
      an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66%
      relative risk reduction), a sample size of 118 will be used to have a power of 80% and a
      confidence interval of 95%.
    

Intervention name(s): Hypothermia prevention with plastic bag; Hypothermia prevention without plastic bag
Intervention type(s): Procedure; Procedure
Intervention description(s): Upon removal from the incubator, infant will be placed into a plastic bag to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. The infant will be wrapped in a blanket and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.; Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypothermia; Newborn; Incubator; Plastic bag; Normothermia
Do Hip Injections Improve Short-Term Biomechanical Outcomes In Patients With Hip Pain
Condition: Hip Pain
Study type: Observational

Summary: 
      The purpose of this project is to determine the effect of hip injections on hip biomechanics
      in patients with hip pain.
    


Intervention name(s): Assessment following hip injection
Intervention type(s): Other
Intervention description(s): Assessment to evaluate the effect of the hip injection on biomechanics.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Potential subjects will be all patients receiving a hip injection for hip pain.
      
Keywords: hip pain