bioihbjkbjnl/mcl2 huggingface dataset:
Human Factors Usability Study of Ib2C Conception System
Condition: Cervical Cap Insemination
Study type: Observational

Summary: 
      The purpose of this study is to obtain subjective feedback in a home use environment
      regarding usability and ease of use of the applicator and conception cap and the instructions
      for use. Data will be collected and evaluation to determine if the usability requirements of
      the conception system as determined by the usability specification have been met. The study
      will not involve sexual intercourse or delivery of any fluids to the cervix. The study will
      only involve use of the applicator to insert the cervical cap into the vagina, track it to
      the cervix and prepare and release the cervical cap (with removal string attached) onto the
      cervix. The conception cap will remain in place for no more than 6 hours.
    

Detailed description: 
      The purpose of this study is to obtain subjective feedback in a home use environment
      regarding usability and ease of use of the applicator and conception cap and the instructions
      for use. Data will be collected and evaluation to determine if the usability requirements of
      the conception system as determined by the usability specification have been met. The study
      will not involve sexual intercourse or delivery of any fluids to the cervix. The study will
      only involve use of the applicator to insert the cervical cap into the vagina, track it to
      the cervix and prepare and release the cervical cap (with removal string attached) onto the
      cervix. The conception cap will remain in place for no more than 6 hours.
    

Sampling method: Probability Sample
Study population: 
        Females between the ages of 20 and 45.
      
Keywords: Cervical cap insemination; Usability Study
Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)
Condition: X-linked Hypophosphatemia
MeSH terms: Familial Hypophosphatemic Rickets; Hypophosphatemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of the study are to:

        -  Identify a dose and dosing regimen of burosumab, based on safety and pharmacodynamic
           (PD) effect, in pediatric XLH participants

        -  Establish the safety profile of burosumab for the treatment of children with XLH
           including ectopic mineralization risk, cardiovascular effects, and immunogenicity
           profile

        -  Characterize the pharmacokinetic (PK)/PD profile of the KRN23 doses tested in the
           monthly (Q4) and biweekly (Q2) dose regimens in pediatric XLH patients

        -  Determine the PD effects of burosumab treatment on markers of bone health in pediatric
           XLH patients

        -  Obtain a preliminary assessment of the clinical effects of burosumab on bone health and
           deformity, muscle strength, and motor function

        -  Obtain a preliminary assessment of the effects of burosumab on participant-reported
           outcomes, including pain, disability, and quality of life in pediatric XLH patients

        -  Evaluate the long-term safety and efficacy of burosumab
    


Intervention name(s): burosumab
Intervention type(s): Biological
Intervention description(s): solution for SC injection
Other intervention name(s): KRN23; Crysvita®; UX023
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: X-linked hypophosphatemia; XLH; FGF23; KRN23
Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD
Condition: Morbid Obesity; NAFLD
MeSH terms: Non-alcoholic Fatty Liver Disease; Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      Pediatric obesity has become a critical health problem worldwide, increasing the premature
      onset of obesity-related morbidities. This phenomenon has induce an increase in the incidence
      of serious health complications starting in childhood and adolescence. Lifestyle
      interventions, including diet and regular physical activity, are the cornerstone of current
      medical management. Unfortunately, these interventions are often ineffective in providing a
      meaningful and long-lasting weight loss necessary to change health outcomes. It has been
      demonstrated that an early intervention in obesity in children and adolescents, inducing
      weight loss by performing bariatric surgery in carefully selected patients, can dramatically
      reduce the risk of adulthood obesity and obesity-related diseases, including non-alcoholic
      fatty liver disease (NAFLD).

      Recent evidence suggest that bariatric surgery can improve metabolic complications and liver
      involvement in patients affected by morbid obesity.
    


Intervention name(s): Laparoscopic Sleeve gastrectomy (LSG); Lifestyle Intervention
Intervention type(s): Procedure; Behavioral
Intervention description(s): These patients (no. 20) are assessed by clinical and psychological evaluation (auxological parameters, blood pressure and personal and family history), blood tests (liver function test's (LFT's), uric acid, lipid and gluco-insulinemic profile with oral glucose tolerance test (OGTT)), abdominal ultrasound at time of enrollment.
They are treated with laparoscopic sleeve gastrectomy associated to lifestyle intervention. Concomitantly to surgical intervention, liver biopsy is performed.
At 6 and 12 months after LSG the patients are evaluated with laboratory, clinical and echographic assessment. Moreover, one year after LSG liver biopsy is repeated.; These patients (no. 20) are assessed by clinical and psychological evaluation (auxological parameters, blood pressure and personal and family history), blood tests (liver function test's (LFT's), uric acid, lipid and gluco-insulinemic profile with oral glucose tolerance test (OGTT)), abdominal ultrasound at time of enrollment.
They are treated with lifestyle intervention. At 6 and 12 months after enrollment the patients are evaluated with laboratory, clinical and echographic assessment.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bariatric surgery; sleeve gastrectomy
A-line/CareTaker Comparison Study in ICU Patients
Condition: Blood Pressure
Study type: Observational

Summary: 
      Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and
      Intra-Arterial Catheters in ICU Patients
    

Detailed description: 
      The object of the work presented here was to validate a new approach to tracking blood
      pressure that is based on the pulse analysis of the peripheral arterial pressure pulse. The
      approach, referred to as the Pulse Decomposition Analysis (PDA) model, goes beyond
      traditional pulse analysis by invoking a physical model that comprehensively links the
      components of the peripheral pressure pulse envelope with two reflection sites in the central
      arteries.

      In these experiments, approved by the University of Virginia Institutional Review Board, the
      arterial blood pressures of patients (23 m/11 f, mean age: 44.05 y, SD: 13.9 y, mean height:
      173.3 cm, SD: 9.4 cm, mean weight: 95.3 kg, SD: 27.4 kg) hospitalized in University of
      Virginia Medical Intensive Care Units (MICUs) were monitored using radial intra-arterial
      catheters, while the CareTaker system collected pulse line shapes at the lower phalange of
      the thumb of the ipsilateral hand.

      Systolic and diastolic blood pressures continuously collected from the arterial catheter and
      CT were compared. Pearson correlation coefficients were calculated between arterial catheter
      and CT blood pressure measurements and a Bland-Altman analysis was created. Results were
      within the limits established for the validation of automatic arterial pressure monitoring
      (AAMI/ANSI/ISO 81060-1:2013).
    

Intervention name(s): continuous non-invasive blood pressure monitor
Intervention type(s): Device
Intervention description(s): continuous blood pressure monitoring using device in parallel with Gold Standard (A-line)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        (23 m/11 f, mean age: 44.05 y, SD: 13.9 y, mean height: 173.3 cm, SD: 9.4 cm, mean weight:
        95.3 kg, SD: 27.4 kg) hospitalized in University of Virginia Medical Intensive Care Units
        (MICUs)
      
Keywords: continuous, non-invasive
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Fat-based Breakfast
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether the addition of whey protein to a
      breakfast high in fat content will influence acute metabolic and appetite responses, as well
      as responses to a subsequent lunch meal.
    

Detailed description: 
      Participants will be asked to report to the lab for their first main trial, having not eaten
      for 12 hours, and refrained from caffeine and alcohol intake and strenuous exercise for 24
      hours. Both trials will take place at the same time of day.

      Upon arrival height and body mass will be recorded and a cannula will be inserted into a vein
      in the back of the hand and a 10 ml blood sample will be taken.A visual analogue scale (VAS)
      will then be used to subjectively measure the participant's appetite pre-breakfast.

      Participants will then be provided with one of the two breakfast meals that are being tested
      in a randomised order. The two breakfasts consist of a high fat breakfast or high fat plus
      additional whey protein. A drink of water shall also be consumed, the volume of which depends
      on the trial being carried out. The high fat breakfast will consist of scrambled egg yolks
      made with single cream and butter (Tesco, Hertfordshire, UK). The macronutrient distribution
      of the breakfast is 12% protein, 3% carbohydrate, 85% fat (1771 kJ; 423 kcal total). For the
      whey protein trial, 23.9g whey protein isolate (Lacprodan DI-9224, Arla Foods, Denmark) shall
      be added to water and incorporated into each meal as a drink on the side, in order to provide
      20g whey protein.

      A timer shall be set when the participant takes their first mouthful of breakfast, and they
      will be required to rest for the following 3 hours. At 15, 30, 45, 60, 90, 120, 150 and 180
      minutes post-breakfast 10 ml blood samples shall be collected. Every 30 minutes during this
      period the appetite VAS will also be completed. After this participants will be provided with
      a standardised lunch meal which shall consist of pasta with a tomato and basil sauce, olive
      oil and cheddar cheese, along with a 350 ml drink of water. The macronutrient distribution of
      the lunch is 13% protein, 49% carbohydrate, 38% fat. Following this, the post-breakfast
      procedure shall be repeated for another period of 3 hours.
    

Intervention name(s): Whey Protein; High Fat Breakfast Meal
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 20 g whey protein isolate (Arla Foods Ingredients Group) added to breakfast meal; A standardised high fat breakfast served to all participants. The macronutrient distribution of the breakfast is 12% protein, 3% carbohydrate, 85% fat (1771 kJ; 423 kcal total)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Postprandial glycemia; Metabolic health measures
Vfend Special Investigation For Pediatric - Observational
Condition: Pediatric Safety and Effectiveness
Study type: Observational

Summary: 
      Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general
      clinical practices.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The subjects who have been treated with voriconazole for severe mycosis
Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula
Condition: Anal Fistula
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      Patients with simple anal fistula will undergo fistulotomy operation and will be divided into
      two groups: the first will undergo marsupialization of the laid open fistula track and second
      group will not undergo marsupialization. The effect of marsupialization on healing of anal
      fistula will be compared postoperatively.
    


Intervention name(s): Fistulotomy; Marsupialization
Intervention type(s): Procedure; Procedure
Intervention description(s): The fistula track is laid open after complete probing till the internal opening; The laid open track will be marsupialized using interrupted absorbable sutures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Condition: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out if an investigational drug, called RT001 Botulinum
      Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and
      hairline called crow's feet, also known as lateral canthal lines.
    

Detailed description: 
      RT001, a new drug, may be effective for the temporary improvement in the appearance of
      moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study,
      researchers want to find out if RT001is more effective than placebo gel by examining the
      effect on the improvement of crow's feet by both the patient and physician.
    

Intervention name(s): Botulinum Toxin Type A; Placebo (Dose B)
Intervention type(s): Drug; Drug
Intervention description(s): RT001 (Botulinum Toxin Type A Topical Gel, Dose A) applied topically at Baseline (Day 0) to the lateral canthal lines; Placebo (Dose B), applied topically at Baseline (Day 0) to the lateral canthal lines
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lateral Canthal Lines; Crow's Feet Wrinkles; Facial Wrinkles
Study to Evaluate the Effect of Multiple Doses of Rifampicin on the Multiple-dose Pharmacokinetics of Linagliptin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of the bioavailability of linagliptin after concomitant multiple oral
      administration of 5 mg linagliptin tablets and 600 mg rifampicin (Treatment A) in comparison
      to multiple oral administration of 5 mg linagliptin tablets given alone (Treatment B)
    


Intervention name(s): Rifampicin; Linagliptin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin; Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MK-8189 Multiple Dose Study in Healthy Volunteers and Schizophrenia Participants (MK-8189-003)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This 3-part dose titration study will assess MK-8189 safety, tolerability, pharmacokinetics
      (PK), and central nervous system activity. Part 1 (Panels A and B) will assess MK-8189
      administered as monotherapy in participants with schizophrenia. Part 2 (Panel C) will assess
      MK-8189 administered as add-on to atypical antipsychotic treatment in participants with
      schizophrenia. Part 3 (Panel D) will assess monotherapy with MK-8189 in healthy participants,
      including those of Japanese descent. The primary hypothesis is that there is at least one
      dose of MK-8189 that is generally safe and well-tolerated which will have the desired PK
      parameters in participants with schizophrenia.
    

Detailed description: 
      As specified by Phase 1 protocol-flexible language in the protocol, modifications to the dose
      or dosing regimen can be made to achieve the scientific goals of the trial objectives and/or
      ensure appropriate safety of the trial participants. The proposed doses for each Part may be
      adjusted downward based on evaluation of safety, tolerability, and pharmacokinetic data
      observed in previous panels.
    

Intervention name(s): MK-8189; Placebo; Base Monotherapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK-8189, oral, 2 mg and/or 10 mg tablets, taken QD for a total daily dose of 2 mg, 4 mg, 8 mg, 10 mg, 12 mg, 14 mg, 16 mg, 20 mg, or 40 mg; Placebo matching oral 2 mg and/or 10 mg MK-8189 tablets, taken QD; For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone, Aripirprazole, Lurasidone, Risperidone [not to exceed daily dose of 6 mg], or Ziprasidone.) The participant should be on a stable and well tolerated treatment regimen for at least 2 months prior to screening. NOTE: Clozapine is not allowed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
New Multiplex Real-time PCR for Genital Ulcer Disease
Condition: Genital Ulcer Disease (GUD)
MeSH terms: Ulcer
Study type: Observational

Summary: 
      (i) To compare a new diagnostic PCR with established diagnostic procedures for T. pallidum
      (serology, dark field microscopy), H. ducreyi (cultivation), HSV types 1 and 2 (cultivation,
      PCR).

      (ii) To assess the frequency of infections with T. pallidum, H. ducreyi and HSV types 1 and 2
      in patients with genital, anal and oropharyngeal ulcers by a new PCR.
    


Intervention name(s): Diagnostic swab
Intervention type(s): Procedure
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with genital, anal or oropharyngeal ulcers
A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287
      in Subjects with Mild-to-Moderate Ulcerative Colitis.
    

Detailed description: 
      This is a Phase 1b multicenter, randomized, double-blind, placebo-controlled multiple dose
      study designed to evaluate the safety and tolerability of SER-287, and to evaluate the
      microbiome alterations and pharmacodynamics associated with two dosing regimens of SER-287 in
      adult subjects with active mild-to-moderate ulcerative colitis (UC).
    

Intervention name(s): SER-287; Placebo; Placebo Pre-Treat; Vancomycin Pre-Treat
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Eubacterial Spores, Purified Suspension, Encapsulated
Intervention MeSH terms: Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854
      administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
    

Detailed description: 
      This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study
      to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80
      mg) compared to placebo, administered once daily. The study design includes a double-blind,
      placebo-controlled treatment period for 6 weeks and a double-blind NBI-98854 treatment period
      for an additional 42 weeks, for a total of 48 weeks of treatment. Final follow-up assessments
      will be conducted 4 weeks after the last dose of the study drug.
    

Intervention name(s): NBI-98854; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NBI-98854 40 mg capsules; NBI-98854 placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Scoliosis and Quality of Life of Adolescents
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      Around the scoliosis surgery, the pain (pre or post operative, physical, psychological,
      fantasy or real) is a major concern for adolescents and their families. She is also a key
      concern of caregivers, both its assessment and management is complex. this pain involved
      predominantly in the quality of life of these teenagers today who will become the adults of
      tomorrow.

      To date in France, no study aims to describe and evaluate the effect of a multidisciplinary
      approach and its impact on the quality of life of these young people made.

      The present study wish to prevent, anticipate and limit the short, medium and long-term
      morbidity. Focus will be on pain and its management, on preparing for surgery,
      hospitalization, follow-up after surgery, rehabilitation until recovery.

      Help teens reclaim their bodies after the changes caused by the intervention is a major
      issue.

      This study believe that support good quality, adapted to patient needs will limit operating
      and postoperative pain in the medium and long term.

      Medical team developed special attention around the teenagers that are operated for scoliosis
      (teen groups and parent groups, interview before the operation and counseling, physiotherapy
      support ...).

      The present study would systematize data collections in order to have a comprehensive and
      accurate assessment of the care.

      The qualitative research will focus on the multidisciplinary care in an effort to evaluate
      the whole course of these teenagers, their experience and to identify efforts to put in place
      to optimize the current care.
    


Intervention name(s): First time measure; Second time measure; Third time measure
Intervention type(s): Other; Other; Other
Intervention description(s): Initial Interview
Initial Survey,
Quality of life Scale
Kinesitherapy Review
Anxiety Scale; Kinesitherapy review
Second survey including numeric scale of pain
Anxiety scale
Scoliosis Research Society 22 quality of life scale; Scoliosis Research Society 22 quality of life Scale
Anxiety scale
Numeric scale of pain
Kinesitherapy review
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Teenagers with diagnosis of idiopathic scoliosis
      
Keywords: Teenagers; Multidisciplinary approach; Pain; Surgery