bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes
      post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe
      ED
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Tadalafil
Intervention type(s): Drug; Drug
Intervention description(s): Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse; Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse
Intervention MeSH terms: Tadalafil; Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Vardenafil
Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects
Condition: Obesity; Postprandial Lipemia; Atherosclerosis; Inflammation; Postprandial Incretins
MeSH terms: Atherosclerosis; Hyperlipidemias; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of dietary protein on blood lipids and
      gut hormones after a fat-rich meal.

      Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream
      following a fat rich meal. The effect is dependant of both the quality and the quantity of
      protein ingested.
    


Intervention name(s): Caseine; Cod; Gluten; Whey Isolate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Postprandial Period; Postprandial Lipaemia; Incretins; Subclinical Inflammation; Obesity; Atherosclerosis; Triglyceride; Lipoproteins; Postprandial inflammation
FFOCT for the Diagnosis of Prostate Cancer
Condition: Patients With PSA Level 4.0 ng/mL
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Primary objective :

      The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection
      in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation.

      Secondary objective:

        -  Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores

        -  Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores

        -  Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy
           cores

        -  Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores

        -  Evaluate FFOCT procedure time
    

Detailed description: 
      Research in optical imaging has led to the development of the Full Field Optical Coherence
      Tomography (FFOCT) technology, which allows to image fresh tissues up to a depth of a few
      hundreds microns. The system is a microscope coupled with an interferometer. A halogen light
      source is used to illuminate the tissue specimen and a reference mirror. The light retro
      diffused by the specimen is combined with the light reflected by the mirror, and the
      interference signal is measured. Multiple Grey scale images are obtained and automatically
      stitched to obtain a complete slide throughout the specimen. The feasibility of the technique
      has been reported in various pilot studies, as well as the absence of any potential tissue
      harm and subsequent pathological artifact caused by the process.

      FFOCT could be used as an additional detection tool for prostate cancer screening. The use of
      extended systematic trans-rectal ultrasound-guided (TRUS) prostate biopsies has led to
      over-diagnosis and over-treatment. Also, the number of unnecessary biopsies has increased,
      along with the morbidity of the procedure. Performing a "pre-pathological" evaluation of
      biopsy cores during the biopsy procedure would be of significant help to determine the nature
      of targeted areas and guide the number of biopsies to perform.

      We hypothesize that FFOCT imaging of prostate biopsy cores would allow a cancer detection
      rate not statistically different from pathological analysis.
    

Intervention name(s): Full Field Optical Coherence Tomography (FFOCT) procedure
Intervention type(s): Procedure
Intervention description(s): TRUS Prostate biopsy are performed under the care procedure Pathological examination of these prostate biopsy with FFOCT procedure, as compared to standard pathological evaluation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 45 to 75 years old, with PSA level 4.0 ng/mL
      
Keywords: Cancer; Prostate; PSA; Biopsies; FFOCT procedure
Intravenous Mepolizumab In Children With Eosinophilic Esophagitis
Condition: Oesophagitis, Eosinophilic
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.
    


Intervention name(s): mepolizumab
Intervention type(s): Drug
Intervention description(s): Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg), 2.5 mg/kg , or 10 mg/kg by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: eosinophilic; mepolizumab; esophagitis
P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, multi-center, double-blinded study in subjects with moderate to severe
      acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2
      concentrations of a topical drug in development or a vehicle. Subjects will be treated for up
      to 12 weeks.
    

Detailed description: 
      A randomized, multi-center, double-blinded study in subjects with moderate to severe acne
      vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2
      concentrations of a topical drug in development or a vehicle. Subjects will be treated for up
      to 12 weeks.
    

Intervention name(s): SB204 2%; SB204 4%; Vehicle Gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Applied topically twice daily; Applied topically daily; Applied topically twice and once daily
Other intervention name(s): NVN1000; NVN1000; Placeco
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acne
A Study to Evaluate the Safety and Efficacy of SYB Filler(SF-01) in the Correction of Nasolabial Folds
Condition: Nasolabial Folds
Study type: Interventional

Summary: 
      The objective of this clinical trial is to verify the safety and efficacy of SYB Filler
      (SF-01) in the temporary improvement of Nasolabial Folds.
    


Intervention name(s): SYB Filler (SF-01); Ellansé M
Intervention type(s): Device; Device
Intervention description(s): Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold.; Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Subject & Evaluator-blind, Matched pairs, Prospective Study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Minimal Erythema Dose of UV-B in Normal Population of Taiwan
Condition: Human Volunteers
MeSH terms: Erythema
Study type: Observational

Summary: 
      There is no previous study on the minimal erythema dose of UVB irradiation in Chinese people.
      We will investigate the correlation of skin phototype, constitutive skin color, facultative
      skin color and minimal erythema dose in Taiwanese.
    

Detailed description: 
      The skin phototype will be obtained from a structuralized questionaire. The constitutive skin
      color and facultative skin color will be obtained by chromameter. The minimal erythema dose
      will be obtained by physician's assessment.
    

Time perspective: Other
Keywords: minimal erythema dose; UVB; normal
Intranasal Remimazolam for Premedication in Pediatric Patient
Condition: Sedative; Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Anesthetic inhalation induction could be one of the most stressful experiences for children
      during the perioperative period, with almost 50% of them showing anxiety. It is an essential
      challenge for pediatric anesthesiologists on how to decrease anxiety for children in the
      operating room (OR) environment and to facilitate a smooth induction of anesthesia. Various
      factors like parental separation, unfamiliar surroundings, fear of physicians and needle
      injections can increase their preoperative anxiety. The researchers conducted the current
      study to investigate whether intranasal remimazolam can reduce anxiety in children before
      surgery.
    

Detailed description: 
      children aged 2-5 years old were randomly allocated into three equal groups based on the
      premedication routes: Group R with intranasal remimazolam, Group D with intranasal
      dexmedetomidine and Group P with intranasal placebo, respectively.
    

Intervention name(s): Remimazolam; Distilled water for injection; Dexmedetomidine
Intervention type(s): Drug; Other; Drug
Intervention description(s): intranasal remimazolam; intranasal distilled water for injection; Intranasal dexmedetomidine
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: remimazolam
Impact of Video Intervention on Postabortal Uptake of Long Acting Reversible Contraception (LARC)
Condition: Abortion
Study type: Interventional

Summary: 
      Primary: To compare rates of immediate postabortal LARC uptake between women exposed to a
      brief, theory-based, video intervention prior to standard contraceptive counseling and women
      exposed to standard counseling alone.

      Secondary: To identify predictors of immediate postabortal LARC uptake among all participants
      including the role of:

        -  Demographic and reproductive health history variables

        -  Baseline decisional balance, self-efficacy and stage of change for contraceptive
           initiation
    

Detailed description: 
      This is a randomized controlled trial evaluating the effect of a brief video intervention on
      postabortal uptake of long acting reversible contraception.
    

Intervention name(s): Video intervention
Intervention type(s): Behavioral
Intervention description(s): Brief 7 minute video of physician describing LARC methods followed by two patient testimonials about their own postabortal LARC experience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: Abortion; LARC; Contraception; IUD; Contraceptive implant; behavioral change; video intervention
Enhancing Diagnosis and Prevention of Cardiovascular Disease in Newham by Integrated Use of Electronic Health Records
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The investigators will develop a "risk report" within the primary care electronic health
      record (EMIS) for patients attending for their National Health Service Health Check. The
      value of the report for reducing cardiovascular risk will be assessed qualitatively and also
      quantitatively in a non-randomised comparative trial.
    

Detailed description: 
      The investigators will design a template within the primary care electronic health record
      (EMIS) that draws on Health Check data to provide a contemporary "risk report". Included in
      the report will be clear description of life-time cardiovascular risks, the factors driving
      those risks and how risk might be reduced through life-style and risk factor modification.
      The investigators will evaluate the benefits of providing patients with a risk report
      qualitatively by patient and clinician interviews. Quantitative analysis of the benefit of
      the risk report will be provided by a non-randomised comparative trial. First, a group of
      patients undergoing a conventional Health Check will be recalled after three months for a
      second Health Check, allowing measurement of the change in "Heart Age" - a convenient index
      of life-time cardiovascular risk. Following introduction of the risk report the investigators
      will recall a further group of patients for a second Health Check, allowing measurement of
      the change in "Heart Age". The effect of the risk report will be determined by comparing the
      change in Heart Age between the two groups of patients.
    

Intervention name(s): Enhanced Health Check
Intervention type(s): Other
Intervention description(s): National Health Service Health Check enhanced by risk report
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary prevention; National Health Service Health Check
Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      In the present project the investigators will evaluate whether glucagonotropic properties of
      the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be
      utilized as a safeguard against hypoglycemia in patients with T1D.
    


Intervention name(s): glucose-dependent insulinotropic peptide; Glucose-Dependent Insulin-Releasing Hormone[3-30]; Saline Solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Infusion of GIP; Infusion of GIP antagonist GIP[3-30]; Infusion of Saline
Other intervention name(s): Placebo
Intervention MeSH terms: Gastric Inhibitory Polypeptide; Hormones; Incretins
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blinded, randomized, cross-over study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Diabetes Mellitus, Type 1; Hypoglycemia; Gastric Inhibitory Polypeptide; Glucagon; Incretin
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fasting condition in
      normal, healthy, adult, human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India
      and the corresponding Reference Product: Zestoretic® 20/25 lisinopril/hydrochlorothiazide
      Tablets of M/s AstraZeneca Pharmaceuticals LP, USA under fasting condition in normal,
      healthy, adult, human subjects in a randomized crossover study.

      The study was conducted with 48 healthy adult subjects. In each study period, a single
      Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of either test or reference was
      administered to the subjects as per the randomization schedule in each study period with
      about 240 mL of water at ambient temperature in sitting position.

      The duration of clinical phase was 12 days, including the washout period of 7 days between
      each study period.
    

Intervention name(s): Lisinopril and Hydrochlorothiazide Tablets (20+25) mg; Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Lisinopril and Hydrochlorothiazide (20+25) mg Tablets once a day; Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets once a day
Other intervention name(s): Test product; Reference product
Intervention MeSH terms: Hydrochlorothiazide; Lisinopril; Hydrochlorothiazide, lisinopril drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between Functional and Analytic Methods to Strengthen Shoulder Rotators and Scapular Muscles
Condition: Strength
Study type: Interventional

Summary: 
      The objective of the study was to compare analytic, functional and mixed
      (analytic/functional) methods in strengthening rotator cuff and scapular stabilizers muscles.
      For that purpose, participants had to follow a strengthening program 3 times a week during 8
      weeks.
    

Detailed description: 
      Each participant was allocated to a group (analytic, functional and mixed groups) in a random
      way while assuring that the groups were quite similar in morphological data or in
      performance. The strengthening program has to be performed three times a week during eight
      weeks by each participant.

      The exercises included in the program were chosen among the bests exercises described in
      literature to active shoulder rotators as well as scapular stabilizing muscles. The analytic
      group has to perform the following exercises: prone rowing with dumbbell, prone external
      rotation at 90° of abduction, prone extension, bilateral scapular protraction with dumbbells,
      eccentric internal rotation at 90° of abduction, external rotation diagonal exercise and
      single arm shot put medicine ball throw. The functional group performed the same exercises
      but with a functional component: standard plank rowing, swissball external rotation at 90° of
      abduction, standard plank extension, bilateral scapular protraction (standard plank + raised
      feet), eccentric internal rotation 90° of abduction with unipodal glute bridge, external
      rotation diagonal in an unipodal position and single arm shot put throw with medicine ball in
      and single arm shot put medicine ball throw. Then, for the mixed group, the program included
      exercises from the analytic group and other ones from the functional group in equal parts.
      For all the groups, the exercises aimed to strengthen shoulder rotators were performed five
      times in a row and the others aimed to strengthen scapular stabilizing muscles were performed
      fifteen times in a row. The only exception was for the single arm shot put medicine ball
      throw that was performed ten times. Two series of each exercises were performed during each
      session, which represent a mean duration of thirty minutes.

      At the beginning and at the end of the intervention, three different evaluations were
      performed :

        -  Measurement of shoulder rotators strength (with an isokinetic device)

        -  Measurement of scapular stabilizers strength (with an isokinetic device)

        -  Measurement of functional performance (with Medicine Ball Throw, CKCUEST, Y Balance Test
           and a core stability test)
    

Intervention name(s): Strengthening exercises
Intervention type(s): Other
Intervention description(s): The participants had to perform specific exercices 3 times a week during 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration
Condition: Diabetes
Study type: Observational

Summary: 
      A data collection of blood glucose values, insulin, meal composition will be performed for a
      period of two months, to evaluate the performances of an automated insulin titration
      algorithm
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 diabetic patients
      
Keywords: Diabetes; Functional insulin therapy
Nocturnal Hypertension and Non-Dipping Blood Pressure
Condition: Hypertension; Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to determine if high salt diet contributes to high nighttime
      blood pressure. The investigators will determine if high compared to low salt diet increases
      24-hour blood pressure levels. The investigators will also determine if high salt diet
      affects blood vessel stiffness, cardiac output, and sleep apnea. The study will also
      determine how high salt diet affects the activity of certain genes related to control of
      blood pressure. A total of 60 participants will be enrolled in the study.
    


Intervention name(s): Dietary sodium
Intervention type(s): Dietary Supplement
Intervention description(s): High (6 g) versus low (1.5 g) sodium diet
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover study of high (6 g) and low (1.5 g) sodium diet
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nocturnal hypertension; non-dipping blood pressure; obstructive sleep apnea
Long-term Paired Associative Stimulation as a Treatment for Incomplete Spinal Cord Injury of Non-traumatic Origin
Condition: Spinal Cord Diseases; Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Spinal Cord Diseases; Wounds and Injuries
Study type: Interventional

Summary: 
      The investigators have recently shown in incomplete SCI patients that long-term paired
      associative stimulation is capable of restoring voluntary control over some paralyzed muscles
      and enhancing motor output in the weak muscles (1). In this study, the investigators will
      administer long-term paired associative stimulation to patients with incomplete SCI of
      non-traumatic origin.
    


Intervention name(s): long-term paired associative stimulation
Intervention type(s): Device
Intervention description(s): Paired associative stimulation (PAS) administered several times per week for 6 weeks to one hand. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment