bioihbjkbjnl/mcl2 huggingface dataset:
Combined Foley Catheter Balloon and PGE2 Vaginal Ovule for Induction of Labor at Term: A Randomized Study
Condition: Unfavorable Cervix, Cervical Ripening
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the addition of transcervical Foley catheter balloon and vaginal
      prostaglandin E2 in induction of labor at term. Half of participants will be used combine
      transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will
      be used alone vaginal prostaglandin E2.
    

Detailed description: 
      An unfavorable cervix during induction decreases the success rate of labor induction and
      vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable
      cervices. Application of transcervical Foley catheter is an effective mechanical method and
      has the advantages of lower cost and lowest rate of fetal heart rate changes due to
      tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1
      and PGE2 are reported to be more effective than mechanical methods to achieve vaginal
      delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and
      transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley
      balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon
      catheter.
    

Intervention name(s): Foley catheter; PGE2
Intervention type(s): Device; Drug
Intervention description(s): An 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution.; 10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.
Other intervention name(s): propess
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by
      BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in
      Australia by Alphapharm in the fed state
    


Intervention name(s): metformin (Diabex); metformin (Glucophage™); metformin (Glucophage™); metformin (Diabex)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 500 mg, Once daily, single dose; Tablets, Oral, 500 mg, Once Daily, single dose; Tablets, Oral, 1000 mg, Once daily, single dose; Tablets, Oral, 1000 mg, Once daily, single dose
Other intervention name(s): Diabex; Glucophage™; Glucophage™; Diabex
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to determine the safety and pharmacokinetics of CDX-0159 administered
      subcutaneously in healthy subjects.
    

Detailed description: 
      CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is
      expressed on mast cells.

      The study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159
      administered subcutaneously in healthy subjects.
    

Intervention name(s): CDX-0159; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Single subcutaneous dose of one of four dosages of CDX-0159; Single subcutaneous dose of normal saline
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CDX0159-05
Breast Study Investigating a New Light Technique to Monitor Changes in Breast Tissue Density
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to test the ability of a technique called Transillumination
      Breast Spectroscopy (TIBS) to monitor an individual's breast density changes over time.
    

Detailed description: 
      Breast density is an established physical risk factor for breast cancer, applicable to the
      entire female population in a pre-breast-screening program and, unlike other risk factors,
      was shown to be affected by an intervention treatment. High breast tissue density is
      associated with increased risk of breast cancer. Transillumination Breast Spectroscopy (TIBS)
      uses a white light to provide spectral information on breast tissue density and composition
      (e.g. water, lipid, hemoglobin and other biomolecules). The overall goal of the TIBS program
      is to develop a technique that can identify individuals at high risk for breast cancer who
      would benefit most from improved screening methods and a risk reducing intervention (e.g.
      diet and lifestyle changes) and can monitor the efficacy of the risk reducing intervention
      itself in an individual. In a previous study, we demonstrated a high correlation between
      breast density assessed by TIBS and density identified by x-ray mammography. The current
      study is testing TIBS ability to monitor changes in an individual's breast density over time
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cases recruited from the Reproductive Biology Unit at Mount Sinai Hospital and the
        University Health Network community. Controls recruited from University Health Network
        community and the University of Toronto community. (Toronto, Ontario, Canada)
      
Keywords: Breast Transillumination Spectroscopy; Optical Transillumination Spectroscopy; Breast Cancer Risk
Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.
Condition: Effect of Probiotics on Infections in Infants.
MeSH terms: Infections; Communicable Diseases; Virus Diseases
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week
      probiotic supplementation on the incidence and duration of infectious episodes in infants
      aged 6 to 12 months.
    

Detailed description: 
      Probiotics are live bacteria that offer a health benefit to the host when administered via
      the diet in adequate amounts. Probiotic supplementation is safe for use in infants to the
      elderly and has demonstrated beneficial effects for a wide variety of health conditions such
      as acute diarrhea, antibiotic-associated diarrhea, allergies, and inflammatory bowel disease.
      The immune-enhancing benefits of probiotics are attractive, particularly for infants, a group
      that is particularly prone to a variety of infections, e.g. respiratory tract infection,
      strep throat, and diarrhea. Probiotic supplementation has been utilized in previous studies
      of childhood infections with promising results.

      In this study, the safety and effectiveness of 12-week probiotic supplementation on the
      incidence and duration of infectious episodes in infants aged 6 to 12 months will be
      determined. The subjects will receive follow-on formula containing 1 million CFU/g
      Lactobacillus rhamnosus HN001 (trademarked DR20), 1 million CFU/g Bifidobacterium animalis
      subsp. lactis HN019 (trademarked DR10), or placebo formula for at least three feeds per day
      for 12 weeks.
    

Intervention name(s): Lactobacillus rhamnosus; Bifidobacterium animalis subsp. lactis; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Probiotics for infants; Bacterial and viral infections in infants
Evaluation of the Efficiency of Single Aligner Appliance for Treatment of Mild Crowding Cases in Adults.
Condition: Crowding of Anterior Mandibular Teeth
Study type: Interventional

Summary: 
      36 participants who have mild crowding from the Orthodontic Department at University of
      Damascus Dental School will be randomly assigned into two groups.

        1. In the experimental group, patients will be treated using single aligner appliance in
           order to align their crowding teeth.

        2. Control group will undergo typical orthodontic treatment using an MBT-prescription of
           metallic brackets.
    

Detailed description: 
      Most adult patients do not prefer traditional fixed appliances for aesthetic reasons, long
      treatment duration, and relatively difficult oral care. The current study came in order to
      evaluate the Efficiency of a new single aligner appliance that is both aesthetic and
      economical.
    

Intervention name(s): Modified aligner appliance; Traditional fixed appliance
Intervention type(s): Device; Device
Intervention description(s): Patients will be treated using a single aligner appliance with NiTi Springs in order to align their crowding teeth.; Patients will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild crowding; Aligner; Orthodontic treatment; Crowded anterior teeth
Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Stroke Patients With Hemiplegia
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      This trial is a multi center, randomized, controlled, excellent effect, open and loading
      trial design. The subjects are randomly assigned to the experimental group and the control
      group. The experimental group adopts litestepper single lower limb rehabilitation training
      robot walking training on the basis of routine rehabilitation management of stroke patients
      with hemiplegia, walking training once a day, 40 ± 5 minutes each time; The control group was
      treated with routine rehabilitation management of stroke patients with hemiplegia. The trial
      was an open design. Both researchers and subjects knew the treatment allocation and conducted
      three evaluations within 21 days to evaluate the effectiveness and safety of litestepper
      single lower limb rehabilitation training robot in the training of lower limb motor function
      of stroke patients with hemiplegia.
    

Detailed description: 
      By collecting the movement gait information of the patient's healthy side limb, judging the
      patient's movement intention, analyzing and learning the gait characteristics of the
      patient's healthy side, so as to drive the movement of the single lower limb rehabilitation
      training robot and drive the patient's affected side limb to carry out the rehabilitation
      training suitable for the healthy side limb, which can enable the patient to complete the
      normal walking process and achieve the purpose of auxiliary rehabilitation. Through long-term
      walking rehabilitation, patients can gradually recover their normal walking gait.
    

Intervention name(s): litestepper single lower limb rehabilitation training robot
Intervention type(s): Device
Intervention description(s): The experimental group adopts litestepper single lower limb rehabilitation training robot walking training on the basis of routine rehabilitation management of stroke patients with hemiplegia, walking training once a day, 40 ± 5 minutes each time; The control group was treated with routine rehabilitation management of stroke patients with hemiplegia. The trial was an open design. Both researchers and subjects knew the treatment allocation and conducted three evaluations within 21 days to evaluate the effectiveness and safety of litestepper single lower limb rehabilitation training robot in the training of lower limb motor function of stroke patients with hemiplegia.
Intervention model: Single Group Assignment
Intervention model description: multicenter, randomized, controlled, excellent effect, open trial design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemiplegia
The Acute Effect Of Different Kinesiological Tape
Condition: Chronic Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      This study aims to compare the acute effects of different kinesiology tapes on pain,
      functional performance and trunk endurance in young adults with chronic low back pain.
      Seventy young adults with chronic low back pain between the ages of 18-40 were included in
      our study. The individuals included in our study were divided into two groups by a simple
      randomization method. Star-shaped kinesiology taping was applied to the 1st group, and
      I-shaped kinesiology taping was applied to the 2nd group. The demographic and physical
      characteristics of the individuals who agreed to participate in the study were recorded.
      Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4
      days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability
      level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional
      performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending
      test with weight and trunk endurance.
    

Detailed description: 
      Star-shaped kinesiology taping was applied to the 1st group, and I-shaped kinesiology taping
      was applied to the 2nd group. The demographic and physical characteristics of the individuals
      who agreed to participate in the study were recorded. Visual Analogue Scale (VAS) to evaluate
      pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain
      disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test,
      Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test
      was applied to evaluate the forward bending test with weight and trunk endurance.
    

Intervention name(s): The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain
Intervention type(s): Device
Intervention description(s): The Acute Effect Of Different Kinesiological Tape Application On Pain, Functional Performance And Trunk Endurance In Young Adults With Chronic Back Pain
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Kinesiology Taping; Visual Pain Scale; Oswestry; Chronic Low Back Pain; Functional Performance
Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one
      dose of four different formulations of the MenACWY conjugate vaccine when given to healthy
      children aged 12-14 months and 3-5 years. The selection of the best formulation will be based
      on data obtained up to one month after the vaccine dose.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age.
      3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind
      manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or
      the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. The study
      will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study
      will include all subjects; the second (booster/persistence) phase of the study (Study Stage
      2) will include subjects in the active control groups and in the group which was primed with
      the selected MenACWY formulation.

      The study will be conducted in a double-blind manner for groups receiving formulations A, B,
      C and in single blind manner with respect to the group receiving formulation D. The control
      vaccines will be administered in an open manner with respect to the investigational
      vaccination regimens.

      Each group will have one blood sample prior to and one blood sample one month after the first
      vaccine dose.
    

Intervention name(s): Conjugated meningococcal ACWY-TT (vaccine); DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™); Meningitec™; Mencevax™ACWY
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): One intramuscular dose during the primary vaccination; One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only; One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only; One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age; One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
Intervention MeSH terms: Edetic Acid; Vaccines; Pentetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Safety; Meningococcal vaccine; Dose selection; Toddlers; Immunogenicity; Conjugate vaccine; Reactogenicity; Children
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This open label extension study is designed to provide continued access to ANAVEX 2-73 for
      eligible subjects with mild to moderate Alzheimer's Disease who have previously participated
      in the Anavex sponsored study ANAVEX2-73-002.
    


Intervention name(s): ANAVEX2-73
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immune Response to Covid-19 in 300 Health Care Workers With Mild Symptoms
Condition: COVID-19; Serology
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      Three hundred healthcare workers with mild symptoms for Covid-19 will be followed during
      three months. Each two weeks, serological tests will be performed. Re-infection will be
      monitored by saliva-swabs.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HCW previous tested for Covid-19 with mild symptoms in Jessa Ziekenhuis, Belgium
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
Condition: Chronic Sinusitis; Polyposis
MeSH terms: Sinusitis; Colorectal Neoplasms; Nasopharyngeal Neoplasms; Chronic Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      That high-dose steroid applied to the nasal cavity immediately post-operatively will improve
      olfaction and healing following endoscopic sinus surgery.
    


Intervention name(s): pulmicort
Intervention type(s): Drug
Intervention description(s): applied to nasal packing after surgery
Other intervention name(s): budesonide
Intervention MeSH terms: Budesonide
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of the Product QGC001 as a Single Dose and Multiple Doses Administered Orally to Healthy Adult Subjects
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      1QG2 is a Phase 1 study aiming to assess the safety and tolerability of ascending
      single/multiple oral doses (SAD & MAD) in healthy young subjects, the preliminary food
      interaction and the effect of QGC001 on blood pressure and heart rate, but also to determine
      pharmacokinetic preliminary profiles of QGC001 and its metabolite EC33 and pharmacodynamic
      preliminary profiles of QGC001 and its metabolite EC33 especially effects on the
      renin-angiotensin-aldosterone and copeptin systems.
    


Intervention name(s): QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Contains magnesium stearate, silica dental type, anhydrous lactose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
PHYSIOFLOW/Comparison of Cardiac Output Measurement
Condition: Pediatric Disorders
Study type: Observational

Summary: 
      PhysioFlow® (PF®) is a new cardiac output (CO) monitoring method by impedance cardiography
      (IC), never studied in pediatric intensive care unit (PICU). The aim of the study was to
      compare CO and cardiac index (CI) measurements (IC) by trans-thoracic Doppler
      echocardiography (TTE) (COTTE and CITTE) and PF® (COIC and CIIC) in PICU.
    

Detailed description: 
      In this monocentric prospective study in PICU of the CHRU of Lille, simultaneous sets of
      three measurements were realized by TTE and PF® in 43 patients.

      In the study, the patient will receive a measure of CF by impedancemetry chest. This
      electrode will be glued on the torso and the neck of the child. We will collect information
      obtained through IT, to compare the results obtained by the ETT, carried out under the
      support of the child. The study will last 15 minutes maximum. No blood sampling will be
      conducted for the purpose of the study, apart from the exams necessary to its support and its
      treatment. At no time, the results of the impedance will affect support. The study will use
      only the data contained in the medical file of the child and would involve no additional
      intervention (no examination, no further treatment). The use of these data will then be
      anonymous. After anonymization, information recorded will computer processing of the data
      collected.

      Concordance correlation coefficient (CCC) and Bland-Altman analysis with log-transformed data
      were used to compare CO, CI, stroke volume (SV) and systemic vascular resistance (SVR)
      measurements.
    

Intervention name(s): PHYSIOFLOW - PF05 Lab1TM
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Child hospitalized in pediatric intensive care unit aged from 28 days to 10 years. Any
        change of treatment was performed during inclusion
      
Keywords: Hemodynamic monitoring; cardiac output; Transthoracic echocardiography; Impedance cardiography; Child; Physioflow; pediatric intensive care unit