bioihbjkbjnl/mcl2 huggingface dataset:
Residence Time of Biomarkers of Semen Exposure
Condition: Semen Exposure
Study type: Observational

Summary: 
      The purpose of this study is to examine the vaginal residence time of certain semen
      biomarkers.
    

Detailed description: 
      The study will take approximately 2-3 months to complete. First, you will be screened to see
      if you are eligible for the study. At this visit the male partner will give a medical history
      and be asked to donate a semen sample for analysis, while the female will give a medical
      history, receive a physical exam, pelvic exam, pregnancy test, and will be tested for vaginal
      infection including Gonorrhea/Chlamydia. If you are eligible (as a couple), you will be
      called and randomized into one of four study groups. You will be allowed to choose whether
      you want to take certain samples yourself at home, or have them all taken by a nurse at the
      clinic. At this point you will either be asked to return home to have sexual intercourse, or
      the male partner will be asked to donate a semen sample, which will then be inserted into the
      female's vagina. Depending on which group you are in, you will next be asked to return to the
      clinic either 4 or 7 times over the next 2 weeks for vaginal swabs.

      Once you complete the main study, you will be offered the opportunity to participate in a
      substudy, where you will repeat the same visits, except that if you chose to have all your
      samples taken in the clinic for the main study, you will take certain samples at home for the
      substudy. If you chose to take certain samples at home for the main study, you will have all
      the samples taken at the clinic for the substudy. Also, you will not need to do another
      screening visit if you start the substudy within 9 weeks of the end of the main study.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      Vaginal swabs, semen
    
Keywords: Biomarkers; Semen Exposure
Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Pronation seems feasible and effective in improving blood oxygenation in patients with
      COVID-19 pneumonia. Data are lacking on the effects of pronation on clinical outcome in this
      subset of patients.
    


Intervention name(s): Prone position
Intervention type(s): Behavioral
Intervention description(s): Prone position maintained at least 3 hours/day
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients aged ≥18 and < 80 years old admitted to the two respiratory intensive care units
        for severe and critical COVID-19 pneumonia between March 1st, 2020 and June 1st, 2020.
      
Keywords: Spontaneous breathing; Awake pronation; COVID-19; Respiratory failure
Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse
Condition: Prolapse
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Uterine Prolapse; Prolapse
Study type: Interventional

Summary: 
      Urinary incontinence will develop after prolapse repair in approximately one quarter of
      patients with advanced pelvic organ prolapse who remain continent despite significant loss of
      anterior vaginal and pelvic organ support. Many women with advanced pelvic organ prolapse who
      choose to undergo surgical management also choose to undergo continence surgery in order to
      prevent new onset urinary incontinence.
    


Intervention name(s): Burch; Abdominal Sacrocolpopexy
Intervention type(s): Procedure; Procedure
Intervention description(s): polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve; By careful dissection (to avoid large veins in this region), expose the back of the pubic bone and the lateral aspects of the urethra.
The right-handed operator double gloves, and places the left hand in the vagina.
With fingers on either side of the catheter in the vagina, define the urethrovesical junction (at the balloon).
Place three Ethibond J-shaped sutures on either side of the urethrovesical junction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to characterize the safety and immunogenicity of the H1N1
      (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu
      vaccine in adults 19 to 40 years of age.
    

Detailed description: 
      Collaborators: United States Department of Health and Human Services, Office of Biomedical
      Advanced Research and Development Authority
    

Intervention name(s): GSK2340274A; GSK2340273A; Seasonal trivalent influenza vaccine (TIV); Saline placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Two intramuscular injections; Two intramuscular injections; Single intramuscular injection; Single intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: GSK Bio's influenza vaccine GSK2340274A; influenza infection; GSK Bio's influenza vaccine GSK2340273A
Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to study the effects of EARLY (no more than 24 four hours from
      injury) administration of extra amounts of oxygen on traumatic brain injury.
    

Detailed description: 
      Brain injury continues to be a major cause of death and disability throughout the world. Our
      investigations of hyperbaric oxygen treatment (HBOT) indicate that it is a relatively safe
      treatment that has promise as a potential therapy for patients with severe traumatic brain
      injury (TBI). The goals of the present proposal are to further elucidate the mechanisms of
      action of HBOT on severe TBI and to test hypotheses that are crucial to the possible future
      design of a Phase III clinical trial.

      Our initial prospective clinical trial to assess the effectiveness of HBOT in severe TBI
      documented very significant improvement in survival, particularly in certain subgroups of
      patients. In our second study, HBOT was found to improve cerebral aerobic metabolism in
      patients with severe TBI, reduce elevated intracranial pressure, and had a persistent
      positive effect for at least six hours following the treatment. Our work suggests that HBOT
      allows the brain to utilize increased amounts of oxygen more efficiently following treatment.

      Recently, increasing the inspired oxygen concentration (FiO2) to 100% has been proposed as an
      alternative way of delivering supranormal levels of oxygen to severe TBI patients.
      Experimental investigation in the fluid percussion rat model using HBOT at 1.5 ATA
      (atmospheres absolute) for 60 minutes followed by 3 hours of 100%fraction of inspired oxygen
      (FiO2) have given optimum results in terms of mitochondrial functional and neurobehavioral
      improvement.

      The clinical and experimental data together provide a strong basis for the restorative effect
      of the combination of hyper- and normobaric hyperoxia on severe TBI. The goal of this study
      is to evaluate the use of HBOT and 100% FiO2 separately and in combination.
    

Intervention name(s): Hyperbaric Oxygen Treatment (HBOT); Enhanced Oxygen Treatment (Enhanced FiO2)
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperbaric oxygen; cerebral metabolism; hyperoxia; traumatic brain injury
Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Observational

Summary: 
      Concomitant chemoradiotherapy improves overall survival in patients with locally advanced
      head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin
      100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late
      toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative
      but both chemotherapy regimens have not been compared prospectively. The aim of this study is
      to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC
      treated with concomitant cisplatin and carboplatin plus 5-FU.
    

Detailed description: 
      This is a retrospective comparison of patients with LA-HNSCC treated with chemoradiotherapy
      at 2 tertiary care centers in the Netherlands (UMCG and VUmc), where one center routinely
      gives carboplatin plus 5FU (UMCG) and the other center (VUmc) uses high dose cisplatin as
      standard of care.
    

Intervention name(s): cisplatin; carboplatin; 5-FU
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg/m2 day 1, 22 and 43; carboplatin 300-350 mg/m2 day 1, 22 and 43; 5-FU 600 mg/m2 days 1-4, 22-25 and 43-46
Intervention MeSH terms: Carboplatin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with locally advanced head and neck squamous cell carcinoma
      
Keywords: Head and neck squamous cell carcinoma; cisplatin; carboplatin; 5-fluorouracil
Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia
Condition: Primary Ciliary Dyskinesia; Kartagener Syndrome; Immotile Cilia Syndrome
MeSH terms: Ciliary Motility Disorders; Kartagener Syndrome; Dyskinesias; Syndrome
Study type: Interventional

Summary: 
      Impaired pulmonary function, decreased physical activity, functional capacity and depending
      on these factors are reported in patients with primary ciliary dyskinesia in recent studies.
      The purpose of this study to evaluate the effects of game based approach on pulmonary
      function, functional capacity and quality of life in patients with primary ciliary dykinesia.
    

Detailed description: 
      Primary ciliary dyskinesia (PCD) is an autosomal recessive hereditary disorder characterized
      by congenital structural abnormalities and impairment of respiratory function. Mucociliary
      clearance is affected by disorders in the structure and movement of cilia. That causes
      repeated infections in the upper and lower respiratory tract.In addition to mucociliary
      effects and impaired lung function, it is thought that there may be a decrease in respiratory
      muscle strength and functional capacity. One of the factors affecting functional capacity is
      the level of physical activity. For these reasons, the management of the respiratory system
      in patients with PCD is very important. In addition to airway clearence techniques,
      approaches to increase physical activity are also important. It was thought that severe
      physical activity could be an important determinant of cardiopulmonary functional capacity in
      patients with mild to moderate PCD. The level of physical activity is known to be associated
      with quality of life.

      In literature no study investigated the effects of game based approach on oxygenation,
      functional capacity and quality of life in patients with PCD. Game based approach is a new
      method lead to increase physical activity. In literature there is no study investigated the
      effects of game based approach on oxygenation, functional capacity and quality of life in
      patients with PCD.
    

Intervention name(s): Home based therapy; Game and home based therapy
Intervention type(s): Other; Other
Intervention description(s): Airway clearence techniques; Game based approach programme and airway clearence techniques
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary Ciliary Dyskinesia; Kartegener Syndrome; Immotile Cilia Syndrome; Pulmonary Rehabilitation; Airway Clearance Techniques; Exergame
Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation
Condition: Menopause
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to determine the equivalence of 3 new formulations of a
      Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed
      dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women.
      Each subject will participate in the study for approximately 14 weeks, including a screening
      evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with
      at least a 21-day washout interval between each dose administration.
    


Intervention name(s): Premarin®/MPA formulation A; Premarin®/MPA formulation B; Premarin®/MPA formulation C; Premarin®/MPA currently marketed product
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Premarin®
A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90
      mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate)
      Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild
      Asthma
    


Intervention name(s): Zero-dose; 90 mcg of PROAIR® HFA; 180 mcg of 90 mcg of PROAIR® HFA; 90 mcg of albuterol sulfate inhalation aerosol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A; Treatment B; Treatment C; Treatment D
Intervention MeSH terms: Albuterol; Procaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities
Condition: Immunizations; Vaccination; Influenza; School Health
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      Purpose of the study. The purpose of the project is to evaluate the feasibility,
      acceptability, and cost effectiveness of providing influenza vaccine in schools to children
      in grades Kindergarten through 6th grade.

      Hypothesis 1: School based influenza vaccination (SIV) will increase the overall rate of
      influenza vaccination in school children.

      Hypothesis 2: Higher intensity parent notification about school based influenza vaccination
      does not increase immunization rates compared to low intensity.

      Hypothesis 3: School based vaccination from the perspective of mass vaccinators is cost
      neutral.
    

Detailed description: 
      Background. The ACIP (American Committee on Immunization Practices) has now recommended
      influenza vaccination for all children 6 months to 18 years of age. While many school-aged
      children will be vaccinated in the medical home, the large number of children for whom the
      vaccine is now recommended exceeds the capacity of many primary care settings. Schools have
      been recommended as potential sites for influenza vaccination, yet little is known about the
      feasibility, implementation requirements, costs, or effectiveness of school-based influenza
      vaccination (SIV) programs. This project will implement and rigorously evaluate the
      feasibility, acceptability, billing and reimbursement components, costs, cost-effectiveness,
      and overall effectiveness of an SIV program that targets diverse populations and different
      intensity of interventions.
    

Intervention name(s): School based flu vaccine: Low intensity; School based flu vaccine: High intensity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interventions: Parents of children in Low Intensity Notification schools got less than 3 communications from schools describing influenza vaccine and the clinics, and consent forms sent home one.; Interventions: Parents in high intensity schools have 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.
Other intervention name(s): Trivalent injectable influenza vaccine; Live Attenuated Influenza vaccine; School based vaccines; Trivalent injectable influenza vaccine; Live Attenuated Influenza vaccine; School based vaccines
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: seasonal influenza vaccine; school-based clinics; economic analysis of school based influenza vaccine delivery; pediatric influenza vaccine rates; Influenza vaccine information for parents
Evaluation of Carbohydrates
Condition: Glycemic Index
Study type: Interventional

Summary: 
      The study is open-label with a randomized, cross-over design using standard Gl methodology.
    


Intervention name(s): CHO Control 1 and 2 Glucose; CHO Experimental 1 Slowly Digested; CHO Experimental 2 Digestion Resistant; CHO Experimental 3 Low Sugar; CHO Experimental 4 Maltodextrin
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption; mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption; mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption; mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption; mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
Condition: Purpura, Thrombocytopaenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down
      in the body by healthy subjects versus subjects with mild, moderate or severe liver problems.
      The study is also being done to 1) check on how well the study drug is tolerated by healthy
      subjects versus those with liver problems and 2) to check if liver impairment affects how the
      study drug binds to protein in the blood.
    


Intervention name(s): eltrombopag
Intervention type(s): Drug
Intervention description(s): Subjects will be administered a single oral dose of 50 mg eltrombopag.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis C-associated thrombocytopenia; chemotherapy induced thrombocytopenia; thrombocytopenia; hepatic impairment; chronic immune thrombocytopenia purpura
Study to Examine the Effect of Ulimorelin on the Pharmacokinetics of Midazolam in Healthy Volunteers
Condition: Digestive System Disorders
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, single centre, randomised, cross-over study to examine the effect of
      ulimorelin on the pharmacokinetics of midazolam after repeat dose administration of
      ulimorelin in healthy volunteers.
    

Detailed description: 
      Ulimorelin is a first-in-class new chemical entity. It is a ghrelin agonist with
      gastroprokinetic activity being developed as an intravenous therapy to be used in the
      treatment of gastrointestinal (GI) hypomotility disorders such as post-operative ileus (POI)
      and gastroparesis.

      POI is a transient disruption of co-ordinated bowel motility that contributes to patient
      morbidity, discomfort and prolonged recovery times. POI most commonly occurs after abdominal
      surgery and annually, POI is the main determinant of length of hospital stay after major
      abdominal surgery and a factor in patient hospital re-admissions, increased healthcare
      resource use and cost, and decreased patient satisfaction. Current strategies to attenuate
      POI are aimed at enhanced recovery after surgery (ERAS) or "fast track". These are multimodal
      care protocols designed to reduce the impact of external and internal factors on POI
      duration. Recently, fewer complications and a quicker return to work and normal activities
      for patients who have had ERAS programmes implemented have been reported. In spite of these
      strategies only up to 20% of subjects undergoing partial bowel resection recover GI function
      within 72 hours after surgery.
    

Intervention name(s): Midazolam; Ulimorelin
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration on Day 1 or Day 5; Intravenous infusion of 480 micrograms/kg on Days 1 to 5
Other intervention name(s): TZP101
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic