bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of WRSS1, a Shigella Sonnei Vaccine Candidate
Condition: Dysentery; Shigella; Diarrhea
MeSH terms: Dysentery, Bacillary; Dysentery; Diarrhea
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is an inpatient trial to determine the safety, immunogenicity and efficacy of the
      WRSS1 candidate vaccine in healthy Thai adult volunteers.
    

Detailed description: 
      This study is designed as 2 parts.

        -  Part 1 is a blinded, placebo-controlled inpatient trial in a total of 20 volunteers (14
           vaccinees and 6 controls) to determine the safety and immunogenicity. Volunteers will be
           vaccinated with a single oral dose of 104 colony forming unit (cfu) of WRSS1 or placebo
           given with bicarbonate buffer.

        -  Part 2 will be started approximately 60 days after WRSS1 vaccination. This part is an
           inpatient phase II efficacy trial involving a challenge with the S.sonnei 53G of 10
           vaccinees from the first part and 10 naïve controls.
    

Intervention name(s): Part 1/Arm 1 of Study: WRSS1 vaccine; Part 1/Arm 2 of Study: Placebo vaccine; Part 2/Arm 1 of Study: S. sonnei 53G; Part 2/Arm 2 of Study: S. sonnei 53G
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Single, oral dose of WRSS1; Placebo vaccine; Subject from Part 1/Arm 1 of Study are given 53G S. sonnei; 10 naïve controls are given S. sonnei 53G
Intervention MeSH terms: Vaccines; Complement Factor H
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal
      patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of
      povidone-iodine and normal saline irrigation at reducing bacterial contamination of the
      surgical wound will be measured by collecting cultures before and after irrigation.
    

Detailed description: 
      Previous research has shown there is baseline bacterial contamination of surgical spinal
      wounds prior to closure. While this bacterial contamination may or may not lead to infection,
      recent adult studies demonstrated reduced infection rates by using povidone-iodine irrigation
      before closure. This study will determine the safety of using povidone-iodine irrigation in
      pediatric spinal patients and how effective it is at reducing bacterial contamination of the
      spinal surgical wound prior to closure, compared with normal saline. The investigators
      hypothesize povidone-iodine is both safe and effective. Understanding techniques that reduce
      the local bacterial load in the wound prior to closure after spinal fusion will give data to
      support measures that will ultimately reduce the rate of postoperative infections.
    

Intervention name(s): Povidone-Iodine; Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine; Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
Other intervention name(s): Betadine; NSS, NS or N/S
Intervention MeSH terms: Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Scoliosis; Spine fusion; 0.35% povidone-iodine
Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction
Condition: Contrast-Induced Nephropathy; Acute Myocardial Infarction
MeSH terms: Kidney Diseases; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Patients with acute myocardial infarction undergoing primary angioplasty are at high risk for
      renal injury due to the toxic effect of contrast agents. Patients developing renal
      dysfunction after primary angioplasty have worse outcome. To investigate the role of the
      antioxidant N-acetylcysteine (NAC) in preventing renal injury in angioplasty, we randomized
      352 consecutive patients undergoing primary angioplasty into three groups: the first group
      received NAC at standard dose (NAC group, 600 mg i.v. bolus before primary angioplasty,
      followed by oral 600 mg twice daily for the following 48 hours; n=115), the second group
      received NAC at double dose (DD-NAC group; 1,200 mg i.v. bolus and oral 1,200 mg twice daily
      for 48 hours; n=118), and the last group received placebo (controls; n=119).
    


Intervention name(s): intravenous and oral N-acetylcysteine
Intervention type(s): Drug
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Contrast-induced nephropathy; Acute myocardial infarction; Primary coronary angioplasty
Comparing French Ambulatory and MISGAV-LADACH C-Section Techniques
Condition: Cesarean Section
Study type: Interventional

Summary: 
      In the last decades cesarean section rates are getting higher in many countries. The rise in
      those rates encourages obstetricians to improve operative techniques for a better maternal
      and fetal outcome.

      Despite its worldwide spread, a general consensus on the most appropriate technique to use
      has not yet been reached.

      The most known surgical technique is the MLC . A modified extraperitoneal method of caesarean
      section :" French Ambulatory Cesarean Section ( FAUCS) was described in the middle of the
      90's by "Denis Fauck" and "Jacques Henri Ravina " However, no study comparing these two
      cesarean techniques was conducted. From where the investigators initiate this study .
    

Detailed description: 
      Caesarean Section (CS) is one of the most commonly performed operations worldwide The rate of
      CS continues to rise, despite initiatives to counter this trend. Cesarean sections have a
      higher morbidity rate than vaginal deliveries, with a substantial care and cost measurable by
      the mean hospital stay, the use of analgesics, and the potential for complications .
      Crucially, the birth of a new baby is an unique incentive to return quickly to "normal"
      function. Improving the cesarean section techniques is therefore of considerable importance
      in modern obstetrics.

      One of the most widely used cesarean section techniques is the MLC method developed by
      Michael Stark et al. This approach is indicated as the optimal technique in view of its
      characteristic of reducing lower pelvic discomfort and pain, thus improving quality of life
      However, this intraperitoneal C-section interfere at least with future fertility desire.

      The French Ambulatory Cesarean Section (FAUCS) technique has been employed by 10
      practitioners in France for approximately 20 years. In a retrospective study over 3000 cases
      this innovative approach seems to provide a shorter recovery time with a Hospital discharge
      the day after surgery . Investigators introduced this technique in "Mongi Slim" university
      hospital in January 2018. In this study, investigators compare the FAUCS and the MLC
      techniques in termes of mother and child outcomes
    

Intervention name(s): FAUCS; MLC
Intervention type(s): Procedure; Procedure
Intervention description(s): extraperitoneal cesarean with a paramedian left section; Gold standard
Other intervention name(s): French Ambulatory Cesarean section; "Misgav Ladach" Method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Cesarean; Surgery; Birth; Recovery; Outcomes
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)
Condition: Overactive Bladder; Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics (PK) of mirabegron oral
      suspension after single dose administration in children with neurogenic detrusor overactivity
      (NDO) or overactive bladder (OAB).

      This study will also evaluate the safety and tolerability as well as the acceptability and
      palatability of mirabegron oral suspension after single dose administration in children with
      NDO or OAB.
    


Intervention name(s): mirabegron
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Myrbetriq; Myrbetric; Betanis; YM178; Betmiga
Intervention MeSH terms: Mirabegron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: OAB; overactive bladder; Myrbetric; neurogenic detrusor overactivity; Betanis; Myrbetriq; NDO; YM178; mirabegron; Betmiga
Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to provide data about the 24 hours FEV1 profile, safety and
      tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using
      fluticasone/salmeterol as an active control.
    


Intervention name(s): fluticasone propionate/salmeterol; indacaterol maleate / mometasone furoate; placebo to indacaterol/mometasone; placebo to fluticasone propionate/salmeterol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI.; Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device.; Placebo to indacaterol maleate/mometasone furoate delivered via the TWISTHALER device.; Placebo to fluticasone propionate / salmeterol delivered via MDDPI.
Other intervention name(s): Advair®; Seretide®; QMF149
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; QMF; Indacaterol; Mometasone
Adipose Tissue Gene Expression Profiles in Women With Polycystic Ovary Syndrome (PCOS) Versus Controls
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Adipose tissue is a central organ in mediating metabolic health. There is some evidence that
      women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction which
      may negatively affect their metabolic health. The aim of this study was to assess
      transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with
      a control population matched on the basis of age and body mass index (BMI). A secondary aim
      was to then relate these gene expression profiles to the biochemical environment.
    

Detailed description: 
      Adipose tissue is a central organ in mediating metabolic health. There is some evidence that
      women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction which
      may negatively affect their metabolic health. The aim of this study was to assess
      transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with
      a control population matched on the basis of age and body mass index (BMI). A secondary aim
      was to then relate these gene expression profiles to the biochemical environment.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women with PCOS and a control population of women matched for age and body mass index (BMI)
      
Biospecimen description: 
      Plasma
    
Keywords: PCOS
A Prospective, Two-arm, Non-interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis
Condition: Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Study type: Observational

Summary: 
      This was a prospective, two-arm, non-interventional study of JAKAVI® (Ruxolitinib) in
      patients with myelofibrosis
    

Detailed description: 
      The purpose of this NIS was to gather data from the daily clinical practice of the
      Jakavi®-treatment in a broad patient population. In order to evaluate the direct effect of
      Jakavi®, only JAK inhibitor naive patients were documented in the first study arm; patients
      pretreated with JAK inhibitors were documented in the second study arm to evaluate the
      long-term efficacy of Jakavi® in this subpopulation.

      The documentation of all patients was carried out prospectively and began after the baseline
      visit. The medical decision on which therapeutic and diagnostic measures to take was made
      solely by the responsible physician. The observational period per patient was 36 months. The
      visit schedule after the baseline visit was set by the responsible physician according to
      standard clinical care, the clinical condition of the respective patients and the SmPC.
    

Intervention name(s): Jakavi
Intervention type(s): Other
Intervention description(s): Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.
Other intervention name(s): Ruxolitinib
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients with primary myelofibrosis (PMF), post-polycythemia vera
        myelofibrosis (PPV-MF), or post-essential thrombocythemia Myelofibrosis (PET-MF), for whom
        Jakavi® therapy is indicated.
      
Keywords: Primary Myelofibrosis; PMF; post-polycythemia vera myelofibrosis; PPV MF; post-essential thrombocythemia myelofibrosis; post ET MF; Ruxolitinib; Jakavi
Research Study to Determine Sensitivity to Gentle Touch and Pressure During an Active Migraine Attack.
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a
      heightened skin sensitivity during an active migraine attack. Migraine attacks in patients
      who experience allodynia are more difficult to treat. This study intends to collect and
      evaluate data on the phenomenon of allodynia in patients with episodic migraine during an
      actual attack. The results of this study may help clinicians better understand allodynia,
      thereby helping them diagnose and more effectively manage patients with migraine and
      allodynia.
    


Intervention name(s): No intervention: We are testing for the presence of allodynia
Intervention type(s): Other
Intervention description(s): We are testing for the presence of abnormal sensation (allodynia) during a migraine attack.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with episodic migraine, as defined by the International Headache Society,recruited
        from our office practice and the communitiy
Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of our study is to assess the value of concomitant surgical correction of
      asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling
      for treatment of female patients with stress incontinence
    

Detailed description: 
      female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal
      wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and
      group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.
    

Intervention name(s): trans-obturator tape inside-out usingsoft tapes.; anterior colporraphy
Intervention type(s): Procedure; Procedure
Intervention description(s): trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.
Other intervention name(s): anterior colporrhaphy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy .
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asymptomatic cystocele.; stress urinary incontinence
Sildenafil in Acute Pulmonary Embolism
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular
      function in patients with acute intermediate-high risk pulmonary embolism (PE).
    

Detailed description: 
      Patients with PE randomized to a single oral dose of sildenafil 50mg (n=10) or placebo (n=10)
      as add-on to conventional therapy. Right ventricular function evaluated immediately before
      and shortly after (0.5-1.5h) randomization by right heart catheterization (RHC),
      trans-thoracic echocardiography (TTE), and cardiac magnetic resonance (CMR). The primary
      efficacy endpoint was cardiac index measured by CMR.
    

Intervention name(s): Sildenafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg sildenafil, one dose; Placebo
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients
Condition: Pain
MeSH terms: Abdominal Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Compared with performing each procedure individually, performing two combined procedures such
      as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal
      distension and post-procedure pain because of longer procedure time related to more bowel
      insufflated gas than one procedure. To the best of the investigators knowledge, there has
      been no randomized controlled trial of CO2 versus air for insufflations during combined two
      procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials
      concerned CO2 insufflation in patients receiving sedation during colonoscopy.

      The aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural
      abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of
      CO2 insufflation when it is used during procedure in sedated outpatients.
    


Intervention name(s): bowel insufflation gas; bowel insufflation gas
Intervention type(s): Other; Other
Intervention description(s): air insufflation, during colonoscopy and esophagogastroduodenoscopy; CO2 insufflation, during colonoscopy and esophagogastroduodenoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Carbon dioxide insufflation; Colonoscopy; Esophagogastroduodenoscopy; Bowel insufflation; Postprocedure pain; Pain Due to Certain Specified Procedures
Community-Onset Bacteremia Due to ESBL Producing E.Coli or K.Pneumoniae in China: Prevalence, Risk Factors and Prognosis
Condition: Community Acquired Infection
MeSH terms: Pneumonia; Bacteremia; Community-Acquired Infections
Study type: Observational

Summary: 
      Escherichia coli is the leading cause of community-onset gram-negative bloodstream
      infections. There has been a dramatic increase in the prevalence of extended-spectrum
      b-lactamases producing E. coli and K.pneumoniae in the community, which was considered to be
      exclusively a nosocomial pathogen in recent years. As a result, the treatment options for
      community-onset infections due to ESBL-producing E. coli or K.pneumoniae are limited and the
      initial empirical therapy is often ineffective and associated with increased mortality.
      Although there were some reports of the risk factors of community-onset ESBL producing E.
      coli in Spain, Korea, and Canada, few empirical data were available about China. Therefore,
      the investigators aim was to investigate the epidemiology, risk factors, and the hospital
      outcomes for patients with community-onset bacteremia caused by ESBL producing E. coli or
      K.pneumoniae in China.
    

Detailed description: 
      Eligibility criteria:

        1. Inclusion criteria:Blood cultures demonstrated E.coli or K.pneumoniae among
           nonhospitalized patients or within 48 h after hospitalization.

        2. Exclusion criteria:Patients with hospitalization in the past 1 month.

      Outcome measures:

        1. Risk factors for community-onset bacteremia due to ESBL producing E. coli or
           K.pneumoniae

        2. Microbial and clinical efficacy of commonly used antibiotics for community-onset
           bacteremia due to ESBL producing E. coli or K.pneumoniae
    

Intervention name(s): bacteremia caused by ESBL producing E.coli or K.pneumoniae
Intervention type(s): Other
Intervention description(s): community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All adult patients visited any of the 28 particitant hospitals during the study period were
        screened. Patients with community-onset bacteremia caused by E.coli or K. pneumoniae and
        without a recent hospitalization in any hospital will be included
      
Biospecimen description: 
      bacterial strains