bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
Condition: Skin Diseases, Infectious
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Infectious; Skin Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess
      the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to
      17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by
      Gram-positive pathogens.
    

Detailed description: 
      This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess
      the safety, efficacy, and PK of daptomycin in pediatric participants ages 1 to 17 years,
      inclusive, with cSSSI caused by Gram-positive pathogens. Participants will be enrolled into
      age groups and given age-dependent doses over a period of up to 14 days. Participants will be
      stratified by age group to receive either daptomycin or SOC (recommended as vancomycin,
      clindamycin or semisynthetic penicillin) in a ratio of 2:1, respectively. Participants may
      continue on oral therapy following completion of IV study drug administration and provided
      that the participant meets all criteria for conversion to oral therapy, including clear
      clinical improvement and availability of an oral agent to which the pathogen is susceptible.
      The choice of oral therapy will be left to the discretion of the Investigator. February 11,
      2015 released from post marketing requirement to include subjects aged 3 months - < 1 year.
      Ref ID: 3701325
    

Intervention name(s): Daptomycin; Standard of Care (SOC)
Intervention type(s): Drug; Drug
Other intervention name(s): Cubicin; nafcillin, oxacillin, cloxacillin
Intervention MeSH terms: Daptomycin; Cloxacillin; Oxacillin; Nafcillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Complicated; Skin; Structure
An Open-Label, Single-Dose, Mass-Balance Study to Assess the Disposition of 14C-Labeled PRT054021 in Healthy Male Subjects
Condition: Health Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open label, single center, single oral dose, study of PRT054021, in healthy
      subjects.
    


Intervention name(s): Betrixaban single oral dose
Intervention type(s): Drug
Intervention MeSH terms: Betrixaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Betrixaban; Healthy; Mass Balance
Does Pregnancy Increase Risk of Ventral Hernia Recurrence?
Condition: Recurrent Hernia of Anterior Abdominal Wall
MeSH terms: Hernia; Recurrence; Hernia, Ventral
Study type: Observational

Summary: 
      The investigators will examine if pregnancy increases risk of ventral hernia recurrence
    

Detailed description: 
      The investigators will establish a cohort of female fertile patients who underwent ventral
      hernia repair (Umbilical, Epigastric and Incisional hernia repair) registered in the Danish
      Hernia Database. The investigators will link these data at an individual level with the
      Danish National Patient Registry (DNPR), Danish Medical Birth Registry (DMBR) and the Danish
      Civil Registry (CPR).

      From DMBR, subsequent pregnancies in the study cohort will be noted. From DNPR, ventral
      hernia recurrence, defined as clinical recurrence and/or reoperation for recurrence will be
      noted. Cases registered with both clinical recurrence and reoperation for recurrence, the
      date of the earliest registration will be defined as the date of ventral hernia recurrence.

      From CPR, date of death or emigration will be noted.

      Through an extended Cox regression analysis, handling pregnancy as a time-dependent variable,
      the investigators will examine whether pregnancy is associated with an increased risk of
      ventral hernia recurrence.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Fertile female patients who have undergone ventral hernia repair
Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days?
Condition: Acute Cholecystitis
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
Study type: Interventional

Summary: 
      Objectives: To compare the safety of early (≤72h) versus late (>72h-7days) laparoscopic
      cholecystectomy (LC) from symptom onset for acute cholecystitis (AC).

      Background: As LC within 72h of symptom onset was considered the optimum time, sometimes
      there was a delay in diagnosis and management. So, we raised the question of safety and
      feasibility of performing LC to patients with AC who failed to have LC within 72h of acute
      attack.

      Patients and Methods: This was a prospective, randomized, double-blind, clinical trial;
      carried out on 120 patients presented with AC between September 2017 and April 2019. Patients
      were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom
      onset, and group L: after 72h up to seven days from symptom onset.
    


Intervention name(s): Early laparoscopic cholecystectomy; Late laparoscopic cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): within 72h from symptom onset; after 72h up to seven days from symptom onset
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute cholecystitis; Early laparoscopic cholecystectomy; Gallbladder disease; Late laparoscopic cholecystectomy
Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial
Condition: Cold Hypersensitivity
MeSH terms: Cryopyrin-Associated Periodic Syndromes; Hypersensitivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold
      Hypersensitivity in the Hands and Feet
    


Intervention name(s): Ucha-Shinki-Hwan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Product name : Bosinji Granule Manufacturer : Tsumura & Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g)
Bosinji extract is composed of following proportion of ingredient
Rehmannia Root 1.7g Achyranthes Root 1.0g Cornus Fruit 1.0g Dioscorea Rhizome 1.0g Psyllium Husk 1.0g Alisma Rhizome 1.0g Hoelen 1.0g Moutan Root Bark 1.0g Cinnamon Bark 0.3g Pulvis Aconiti Tuberis Purificatum 0.3g; placebo granule
Other intervention name(s): Bosinji
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cold Hypersensitivity; Korean medicine; Ucha-Shinki-Hwan
KP-10 and Insulin Secretion in Men
Condition: Kisspeptin Action on Insulin in Healthy Normal Men; Kisspeptin Action on Insulin in Obese Diabetic Men
Study type: Interventional
Phase: Phase 3

Summary: 
      Induction of insulin secretion by kisspeptin is observed in mouse, pig, rat, and human islets
      in vitro and in rats, mice and monkeys in vivo, but its mechanism is not fully clear. The
      present study was designed to investigate the role of KP-10 on insulin secretion in adult
      healthy and obese men with insulin resistance. The aim of selection of obese persons for the
      present study was to investigate the effect of acute KP-10 administration in a metabolically
      challenged condition where the pancreatic beta cells are already highly activated. The
      long-term objective of this study was to understand the physiological role of kisspeptin
      signalling in the regulation of insulin secretion in human health and disease.
    


Intervention name(s): Kisspeptin-10
Intervention type(s): Biological
Intervention description(s): Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fourteen volunteers (aged 20-45 years), including seven adult normal weight healthy men (mean body weight and BMI 75.5±4.8 kg and 23±0.7 kg/m2, respectively) and seven obese men (mean body weight and BMI 115±15 kg and 34±2 kg/m2, respectively), participated in this clinical study
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of a New Design of Crowns in the Posterior Teeth
Condition: Broken Down Molars; IPS-emmax Crowns
Study type: Interventional

Summary: 
      Background: no randomized controlled trial has tried to compare treatment outcomes between
      the IPS.emmax endocrowns and the IPS.emmax conventional crowns .

      Objective: to investigate the clinical performance of the IPS.emmax endocrowns and the
      IPS.emmax conventional crowns Design and setting: Parallel-groups randomized controlled trial
      on patients with one or more intensive damaged molars requiring crowning and being treated at
      the University of Damascus, Dental School in Damascus, Syria .All molars will be examined at
      the baseline assessment using a modified US Public Health Service (USPHS) criteria.

      Participants: Incoming patients to the Fixed Prosthetic and Endodontic Departments will be
      examined to find any excessively damaged molars requiring crowning. Forty patients will be
      recruited according to specific inclusion criteria. Randomization will be performed using
      computer-generated tables; allocation will be concealed using sequentially numbered opaque
      and sealed envelopes.The included 40 patients will be analyzed (age range between 20-60
      years). They will be randomly distributed into two groups with 20 patients in each group (1:1
      allocation ratio).

      Intervention: Excessively damaged and endodontically treated molars will be restored with
      IPS.emmax endocrowns or IPS.emmax crowns supported with composite core.

      Main outcome measure: marginal adaptation and anatomic form will be investigated clinically
      and by apical radiographs at the baseline assessment using the modified (USPHS) at six
      assessment times during an 18-month observation period.

      Assessor blinding will be employed.
    


Intervention name(s): IPS.emmax endocrown
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: endocrown; marginal adaptation; anatomic form; retention loss; IPS.emmax crowns
A Study To Estimate The Effects Of Itraconazole On Pharmacokinetics Of Pf-06649751 In Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the impact of CYP3A4 inhibitor, itraconazole, on
      plasma concentration of PF-06649751 in healthy subjects
    


Intervention name(s): PF06649751, Itraconazole
Intervention type(s): Drug
Intervention description(s): PF-06649751 0.25 mg on Days 1,2,3 PF-06649751 0.5 mg on Days 4,5,6 PF-06649751 1 mg on Days 7 to Day 25 Itracoanzole 200 mg on Days 12 to Day 25
Intervention MeSH terms: Itraconazole
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug drug interaction, CYP3A4, itraconazole
New Version Pulmicort Turbuhaler USA Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently
      approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents
      who have asthma. In addition the study evaluated the functionality of the new inhaler at the
      end of its intended life.
    


Intervention name(s): budesonide
Intervention type(s): Drug
Other intervention name(s): Pulmicort
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Pulmicort; Children; Paediatrics; budesonide; Flexhaler
Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products
Condition: Urinary Tract Infection
MeSH terms: Urinary Tract Infections
Study type: Interventional

Summary: 
      This protocol is a clinical trial to validate proanthocyanidin A2 (PAC-A2) as a useful marker
      of cranberry intake. We hypothesize the consumption of this cranberry beverage in a
      progressive dosing schedule will increase PAC-A2 excretion in urine. Five generally healthy,
      nonsmoking, pre-menopausal women (absent major chronic diseases including cardiovascular,
      endocrine, gastrointestinal, and renal conditions), age 20-40 years, with a body mass index
      (BMI) of 18.5-25 kg/m2 will be recruited from the Boston area because sexually active women
      in this age range are particularly vulnerable to urinary tract infection. Volunteers will be
      asked to consume their assigned cranberry beverage at a dose of 8 oz/day according to a
      weekly dosing schedule. Relevant clinical information and eleven 24-hour and morning spot
      urine samples each will be collected from subjects during the study. Urinary PAC-A2
      concentration will then be determined to validate if it can serve as a marker of compliance
      of cranberry juice consumption.
    

Detailed description: 
      People who frequently eat whole grains, fruits and berries, vegetables, beans and legumes,
      nuts, seeds, cocoa, tea, wine, and fruit or vegetable juices may have decreased risk of
      diseases. It is believed that some of these health benefits are due to phytochemicals present
      in these foods and beverages. Phytochemicals are nutrients that are naturally present in
      plant-based foods and beverages. Recently, cranberry containing foods and beverages are
      believed to prevent urinary tract infection. However, how cranberry decrease urinary tract
      infection is not very clear. To better understand how phytochemicals in cranberries may
      benefit health, we want to learn how they are absorbed and eliminated from the body. Thus,
      the purpose of the main study is to see whether we can measure phytochemicals from
      cranberries in health volunteers after they drink cranberry juice.
    

Intervention name(s): cranberry juice
Intervention type(s): Other
Intervention description(s): 27% cranberry juice
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: compliance, proanthocyanidin, phenoic acids, cranberry
Diaphragm Movement During Its Postural Function
Condition: Diaphragm Movement
Study type: Observational

Summary: 
      The aim of this study is to describe the movement of the diaphragm during postural activation
      of the trunk muscles in comparison with tidal breathing.
    

Detailed description: 
      Diaphragm movement will be measured by m-mode ultrasonography in a standing position. 30-35
      healthy subjects will participate in the study. The movement of the diaphragm will be
      measured during tidal breathing then, during holding a load corresponding to 20% of the
      subject´s body weight and finally, during voluntary contraction of the trunk muscles. Trunk
      muscles contraction will be measured by a special device with pressure sensors placed on a
      trunk surface. Breathing activity will be measured by spirometry.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy Subjects
      
Keywords: diaphragmatic motion; m-mode ultrasonography; postural function
Study to Evaluate Safety and Efficacy of PreCrea® on Subjects With Higher Than Normal Blood Sugar Levels
Condition: Diabetes Mellitus; Pre-Diabetes; Hyperglycemia; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Hyperglycemia; Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with
      higher than normal blood sugar levels.
    

Detailed description: 
      A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate
      the efficacy and safety of PreCrea®, a twice-daily dietary supplement in people with higher
      than normal blood sugar levels.
    

Intervention name(s): Study dietary supplement (PreCrea 600 mg capsules); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Study dietary supplement (PreCrea 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with life style modification.
Other intervention name(s): PreCrea, Natural Sugar Lowerig Supplement, Predisease; Placebo 600mg capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High blood sugar; High HbA1C; hyperglycemia; Pre-Diabetes; Natural Supplement for Diabetes
Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation
Condition: Tracheal Intubation; Difficult Airway
Study type: Interventional

Summary: 
      The study is in two parts

      Part one of the study describes the use of the new single-use flexible video-scope for
      intubation of patients with predicted normal airways.

      Part two compares the performance of the single-use flexible video-scope with that of a
      conventional flexible video-scope for awake intubation of patients with predicted difficult
      airways.

      The hypothesis is that the new single-use flexible video-scope for intubation performs as
      well as the traditional scope.
    


Intervention name(s): tracheal intubation with a single use flexible videoscope
Intervention type(s): Procedure
Intervention description(s): tracheal intubation with a single use flexible videoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of the Effects of Two Different Treatment Programs on Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study was planned to examine the effects of two different treatment programs on pain
      intensity, back awareness, functional and psychosocial factors in patients with chronic low
      back pain.
    

Detailed description: 
      Recent study will be carried out on volunteer patients who applied to the Physical Therapy
      Clinic of "Mugla Sitki Kocman University" Training and Research Hospital, who were diagnosed
      with chronic non-specific low back pain and who comply with the study criteria.

      The sample size has been calculated that 80% power can be obtained at 95% confidence level.
      It was found that at least 21 cases, a total of 44 cases, were required for each group.

      Volunteers will be divided into 2 groups by randomization. Conventional physiotherapy
      applications will be applied to the control group. In addition to conventional physiotherapy
      methods, kinesio-taping (KT) will be applied to the study group. Patients in both groups will
      be treated 5 days a week for a total of 10 sessions for 2 weeks. KT will be renewed in each
      session on weekdays.
    

Intervention name(s): conventional physiotherapy; conventional physiotherapy plus kinesiotaping
Intervention type(s): Other; Other
Intervention description(s): Classical electrotherapy method consisting of tens, hotpack and ultrasound.; Conventional physiotherapy plus kinesiotaping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic low back pain, kinesiotape, physiotherapy, awareness
A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the
      treatment of PCOS with elevated LDL cholesterol.
    

Detailed description: 
      The investigators hypothesize that improving the lipid profile with atorvastatin will improve
      vascular function, increase the frequency of ovulation, decrease androgen levels, improve
      insulin sensitivity, and improve the lipid profile more efficiently than placebo.
    

Intervention name(s): Lipitor; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40mg caplets per day for six weeks; 1 placebo caplet per day for six weeks.
Other intervention name(s): Atorvastatin; Sugar Pill
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome
Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers
Condition: Neisseria Meningitidis
Study type: Observational

Summary: 
      This is an observational cross sectional study to evaluate the impact of a 4CMenB vaccination
      program on oropharyngeal N. meningitidis carriage in vaccinated and unvaccinated school
      leavers.
    

Detailed description: 
      This carriage study of a cohort of school leavers in South Australia (SA) will provide an
      opportunity to assess carriage rates in the young adult population (school leavers) following
      introduction of a 4CMenB vaccination program in senior school students from 2017-2018.This
      will allow a comparison of carriage prevalence in the two years (2018 and 2019) following
      implementation of the school program to assess impact on carriage at a population level and
      compare carriage prevalence in vaccinated versus non-vaccinated groups. Assessment of any
      association between risk factors and prevalence of nasopharyngeal carriage in school leavers
      will be made and compared between vaccinated and unvaccinated students.

      School leavers are defined as students who were enrolled in year 12 at school in the
      preceding year of recruitment and have been chosen as they are likely to have the highest
      carriage rates. A high proportion (approximately two thirds) of students will be immunised by
      the time of throat swab collection in years 2018 and 2019. Assessing carriage in both
      vaccinated and unvaccinated cohorts will further inform the effect of 4CMenB vaccine on
      carriage at a population level. This will help determine any herd immunity impact of 4CMenB
      vaccine and persistence of any effect.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        School leavers recruited through tertiary education sites and mail out through schools.
      
Biospecimen description: 
      Oropharyngeal throat swabs