bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).
Condition: Complicated Intra-abdominal Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety , efficacy and pharmacokinetics of ceftazidime avibactam
      and metronidazole versus meropenem in paediatric population (from 3 months to less than 18
      years of age )with complicated intra-abdominal infections (cIAIs)
    

Detailed description: 
      This is a multicentre, multinational, single blind, randomised and active controlled trial of
      intravenous ceftazidime avibactam in combination with metronidazole versus meropenem.
      Patients will receive intravenous (IV) treatment for a minimum of 72 hours (3 full days, ie,
      9 doses) before having the option to switch to an oral therapy. The decision to switch to
      oral therapy is entirely at the Investigator's discretion, if the patient has good or
      sufficient clinical response, and the patient is tolerating oral fluids or food.Patients will
      be assessed for safety and efficacy throughout the study, and blood samples will be taken for
      pharmacokinetic (PK) assessment. The duration of each patient's participation in the study
      will be a minimum of 27 days to a maximum of 50 days after start of study treatment (defined
      as the time point at which first dose of study treatment is administered) at which time there
      will be a late follow up (LFU) assessment visit. The LFU is to be performed 20 to 35 days
      after the last dose of any treatment.The assessments at the test of cure (TOC) visit should
      be performed in person 8 to 15 days after last dose of any study drug (IV or oral). The
      maximum duration of IV study drug or oral switch therapy is up to Day 15.
    

Intervention name(s): Ceftazidime -avibactam; Meropenem; Metronidazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment; Randomisation (3:1) to CAZ AVI plus metronidazole or meropenem treatment; Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment
Intervention MeSH terms: Metronidazole; Meropenem; Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Combination Alexandrite Laser and Topical Therapy vs Topical Therapy Alone for Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of a combination of
      non-hydroquinone topical therapy and a 755nm Alexandrite compared to topical therapy alone
      for the treatment of facial melasma.
    


Intervention name(s): 755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy); Lytera Skin Brightening System (Non-hydroquinone topical therapy)
Intervention type(s): Other; Other
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Photo Evaluation
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of photoirritation and
      photosensitization potential of the product Dermacyd PHDETINLYN Tangerine Mix (Lactic Acid).
    


Intervention name(s): Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)
Intervention type(s): Drug
Intervention description(s): Lactic Acid (Dermacyd PH_DETINLYN Tangerine Mix)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
Condition: Infections, Papillomavirus
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter study in which women are planned to receive either the HPV vaccine or
      control. Study participation will last approximately 72 months and involves a total of
      thirteen or fourteen scheduled visits.

      Originally, the study was planned for 24 months. It was then extended for 2 more years with 4
      additional visits (study end at Month 48).

      The protocol posting has been updated as the study was extended by additional 2 years with
      two or three additional visits (study end at Month 72) for subjects who consent to
      participate in the extension.
    

Detailed description: 
      This protocol posting has been updated following protocol amendment 6 dated 24 April 2014.
    

Intervention name(s): HPV GSK 580299 vaccine; Placebo control
Intervention type(s): Biological; Biological
Intervention description(s): Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.; Subjects were planned to receive three doses of the placebo control administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human papillomavirus; vaccine; cervical cancer; cervical infection
Arthroscopic Versus Conservative Treatment of Degenerative Meniscal Tear in Middle Aged Patients in Regard to Pain & Knee Function
Condition: Knee Pain Chronic
Study type: Interventional

Summary: 
      The study is prospective comparative study, conducted in Erbil teaching hospital on 60
      patients, their age ranging between 40 and 60 years. All were clinically diagnosed to have
      degenerative medial meniscal tear then confirmed by MRI. Thirty patients were treated
      conservatively, thirty patients were treated arthroscopically.
    


Intervention name(s): Arthroscopic menisctomy
Intervention type(s): Procedure
Intervention description(s): Arthroscopic medial menisctomy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arthroscopic meniscectomy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Degenerative meniscal tear; arthroscopic partial meniscectomy; conservative treatment; medial meniscal tear
Temporomandibular Joint Problems and Core Stabilization
Condition: Temporomandibular Joint Disorders; Core Stability
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      This study aimed to investigate the relationship between temporomandibular joint problems,
      head posture, tongue strength, and endurance with core stabilization.
    

Detailed description: 
      This cross-sectional study was conducted on university students aged 18-31 between September
      2022 and February 2023. In the evaluation of the students were used that the Fonseca's
      Anamnestic Questionnaire for temporomandibular joint dysfunction, Research Diagnostic
      Criteria for Temporomandibular Disorders Examination Form for maximum pain-free mouth
      opening, presence of sound in temporomandibular joint movements, and palpation parameters of
      temporomandibular joint and surrounding muscles, Craniovertebral Angle for forward head
      posture, and Iowa Oral Performance Instrument for tongue strength and endurance. In addition,
      the Trunk Flexor Endurance Test and Biering Sorenson Test were used for static endurance of
      the core muscles, and Sit-ups Test and Modified Push-ups Test were used for dynamic endurance
      of the core muscles.
    

Intervention name(s): TMJ dysfunction; Maximum pain-free mouth opening (MMO); Forward head posture; Tongue strength and endurance; Static endurance evaluation of the trunk muscles; Dynamic endurance evaluation of the core muscles
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Fonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The diagnostic accuracy of the FAQ was found to be high in identifying pain-related and intra-articular TMDs, and the cut-off point was set as 25 points. A score of 25 and above was accepted as the presence of TMD.; The maximum pain-free mouth opening was recorded using a 15 cm ruler; Forward head posture was evaluated by CVA using a goniometer. CVA was measured in degrees as the angle between the horizontal plane, the seventh cervical vertebra and the ear hole; Tongue strength and endurance were evaluated with IOPI (Medical LLC, Redmond, WA), which has been clinically validated and reliable; The Trunk Flexors Endurance Test and the Biering Sorenson Test were used. These static tests are measurements targeting the local core muscles.; The Sit-ups and the Modified Push-ups Tests were used. These dynamic tests are measurements targeting the global core muscles.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        University students
      
Keywords: temporomandibular disorders; core stability; head posture; tongue strength
The Effect of Post-Cesarean Section Acupressure on the Severity of Pain and First Mobilization Distance
Condition: Pain; Mobilization
Study type: Interventional

Summary: 
      This randomized controlled trial evaluates the effect of acupressure application on
      cesareans' pain and the number of steps in the first mobilization. This study hypothesizes
      that acupressure reduces pain and improves number of steps.
    

Detailed description: 
      Methods: In the study, 64 cesareans will randomly assigned to acupressure and placebo
      acupressure groups. To the acupressure group (n = 32), an average of 15 minutes will be
      applied to the LI4 (liver), P6 (pericardium) and the Sanyinjia points on the splenic meridian
      (SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the
      tibia. In the placebo acupressure group (n = 32), the points 1.5 cm away from the LI4, P6 and
      SP6 points (four points in total) will be applied for an average of 15 minutes. The primary
      outcome of the research is the effect of acupressure on the pain of cesareans. The secondary
      outcome of the study is to determine the effect of acupressure on the number of steps. The
      pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo
      acupressure administration. The number of steps will be collected 4th hour after acupressure
      and placebo acupressure administration.
    

Intervention name(s): Acupressure; Plasebo acupressure
Intervention type(s): Other; Other
Intervention description(s): The experimental group will start with LI4 points, and continue with P6 and SP6 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.; In the control group, the application will start with the points 1.5 cm around the LI4, P6 and SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.
Other intervention name(s): Acupress; Placebo Acupress
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, two-arm, randomized controlled clinical trial, double blind
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Post-cesarean; Acupressure; Pain; Step; Mobilization
Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Condition: Asthma
MeSH terms: Bronchial Spasm
Study type: Interventional

Summary: 
      Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve
      bronchodilator response during nocturnal bronchospasm.
    


Intervention name(s): anti-static then static; Static then anti-static chamber
Intervention type(s): Device; Device
Intervention description(s): Albuterol using static chambers; albuterol with Static then anti-static chambers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis
Condition: Mastitis
MeSH terms: Mastitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of
      Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for
      4 weeks. The three lactobacilli strains were originally isolated from milk of healthy women.
      On days 0 and 28, milk samples will be collected, and staphylococci/streptococci and
      lactobacilli will be counted and identified. Evolution of clinical signs will be recorded by
      midwifes on days 0, 7, 14 and 28.
    


Intervention name(s): Lactobacillus salivarius HN6; Lactobacillus reuteri CR20; Lactobacillus fermentum LC40; Beta-lactam antibiotic
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): 9 log colony-forming units, capsules, daily, four weeks; 9 log colony-forming units, capsules, daily, four weeks; 9 log colony-forming units, capsules, daily, four weeks; Use of amoxicillin, cloxacillin or amoxicillin/clavulanic acid(500-750 mg), orally, every 8-12 h, for 2-3 weeks (as prescribed by the physician responsible for the clinical diagnosis of lactational mastitis)
Other intervention name(s): Amoxicillin (generic), Cloxacillin (generic), Amoxicillin/clavulanic acid (generic), Clamoxyl, Orbenin, Augmentine
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Clavulanic Acids; Clavulanic Acid; Lactams; beta-Lactams; Cloxacillin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mastitis; Staphylococcus; Streptococcus; lactation; breastfeeding
XTR003 PET Radiotracer for the Detection of Viable Myocardium
Condition: Ischemic Heart Disease (IHD)
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was designed to explore the clinical feasibility of XTR003, a PET myocardial
      fatty-acid tracer, for the detection of viable myocardium in patients with ischemic heart
      disease (IHD).
    

Detailed description: 
      The incidence of IHD is increasing in China and globally. However, the 18F-FDG-PET patient
      preparation protocols present challenges in certain patients such as patients with type I and
      II Diabetes Mellitus. XTR003 is a PET fatty-acid analog used in the imaging of myocardial
      fatty-acid metabolism. The combination of fasting XTR003/18F-FDG PET imaging may overcome the
      shortness of glucose-loaded 18F-FDG PET imaging protocol and effectively identify viable
      myocardium.

      This is an exploratory, single-arm, open-label, phase II clinical study with the following
      objectives:

        1. To explore the clinical feasibility of XTR003 for the detection of viable myocardium in
           patients with NSTEMI, old myocardial infarction, or total occlusions of coronary
           arteries.

        2. To evaluate the safety and adverse events incidence of XTR003 in patients with known
           IHD.

        3. To evaluate the sensitivity and specificity of fasting 18F-FDG/XTR003 PET combining
           imaging in detecting viable myocardium.
    

Intervention name(s): XTR003
Intervention type(s): Drug
Intervention description(s): Enrolled subjects were required to fast for ≥ 6 hours before drug administration at rest;
Initial intravenous injection of 18F-FDG to each subject with a dose range of 2.0-3.0 mCi (74-111 MBq). Each patient will be imaged with PET for 10 minutes at 50-70 minutes after the injection.
In few minutes, a single intravenous bolus injection of XTR003 will follow and administer to each patient with a dose range of 6.0-8.0 mCi (222-296 MBq). Each patient will be immediately imaged with PET for 15 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Coronary Artery Disease (CAD); Positron Emission Tomography (PET); XTR003 PET myocardial fatty-acid tracer; 18F-Fluorodeoxyglucose (18F-FDG); Non-ST-Segment Elevation Myocardial Infarction (NSTEMI); Old Myocardial Infarction (OMI); Total Coronary Occlusions (TCO)
Profiling Children and Youth With Cerebral Palsy in Relation to Feeding and Nutrition
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      HCPs will complete questionnaires about their patients with Cerebral Palsy (CP) and invite
      parents/caregivers of these patients to fill in questionnaires as well. Questionnaires
      include questions on individualized treatment, nutritional profile and management, and
      patient characteristics.
    

Detailed description: 
      Coordinating health care professionals (HCPs; e.g. paediatric neurologists, physiotherapists)
      in different centres across different countries will be asked to participate in this
      cross-sectional study.

      A) for the HCP to fill out a questionnaire about their CP child, related to general subject
      characteristics, motor function, co-morbidities, type of therapies, anthropometry, feeding
      mode and nutritional status; and B) for parents (/legal representatives) to receive and fill
      out questionnaires about their CP child and themselves, related to general subject
      characteristics, motor function, co-morbidities, type of therapies, anthropometry, feeding
      mode and nutritional status, participation and (their own) quality of life.

      If parents (/legal representatives) agree to "A)", but not "B)" then a subject will still
      enter the study, but without the parental assessment.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects between 1 month and 18 years of age with Cerebral Palsy
      
Keywords: Cerebral Palsy
Cholesterol Absorption Inhibition Study
Condition: Cholesterol Absorption Inhibition
Study type: Interventional

Summary: 
      Rationale: Consuming Plant Sterols (PS) fortified foods is widely accepted as easy to apply,
      life-style change to combat modestly elevated plasma cholesterol concentrations. PS are
      typically formulated as PS fatty acid ester (PSE) from margarines. In this study, PS will be
      formulated in a new innovative type spread. To confirm that the new spread results in a
      comparable cholesterol absorption inhibition as the reference product a dual isotope
      cholesterol study is planned, prior to any larger efficacy study.

      Primary objective: Cholesterol absorption inhibition (%) calculated from plasma concentration
      vs. time curves from labeled cholesterol, for the PS or PSE containing products, compared to
      a control product without PS or PSE.

      Secondary objectives: PK parameters for cholesterol as derived from the plasma concentration
      vs. time curves.

      Study design: Acute, single dose, double-blind, randomized, cross-over. Study population: 18
      healthy, non-obese men (BMI 20-27 kg∙m-2, age range 20 - 65 yr) Test products: PS (2250 mg)
      formulated in innovatively processed spread (30 g); PSE (2250 mg PS) reference product (30
      g); Control product without PS or PSE (30 g) Intervention: Three study periods during which a
      single dose of either Test, Reference or Control (regular light spread) spreads will be
      consumed together with standard breakfast. At each study period, 50 mg of D7-cholesterol is
      added to the meal and 30 mg of 13C-cholesterol is injected to measure cholesterol absorption.
      Before and four times after consumption of each spread, blood samples will be taken at 24 h
      intervals up to 7 days.

      Key parameters: Enrichments of labeled cholesterol isotopes as determined by GCMS and IRMS.
      Fractional absorption is determined by the ratio of the two isotopes in plasma cholesterol
      after 7 days.
    


Intervention name(s): Reference spread; Placebo spread; Test spread
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Single dose (30 gr) of spread, containing 2250 mg PS; Single dose (30 gr) of regular light margarine; Single dose (30 gr) of innovatively processed spread containing 2250 mg PS.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
24-Hour Intraocular Pressure (IOP) And Blood Pressure Control In Glaucoma And Ocular Hypertension Patients
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the short-term mean 24-hour intraocular pressure
      control, 24-hour blood pressure effect and safety of Latanoprost/Timolol fixed combination
      given once in the evening with placebo once in the morning versus timolol maleate 0.5% given
      twice daily in patients with ocular hypertension and primary open-angle glaucoma.
    


Intervention name(s): timolol maleate 0.5%; latanoprost/timolol fixed combination; placebo (artificial tears)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Timolol; Latanoprost; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment