bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated
      Doses for 3 days in Subjects with Type 2 Diabetes Mellitus
    

Detailed description: 
      A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to
      Assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3
      days in Subjects with Type 2 Diabetes Mellitus
    

Intervention name(s): AR-C165395XX; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral dose of AR-C165395XX (tablets); Oral dose of placebo for AR-C165395XX (tablets)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: patients; glycaemic control on metformin
Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety
      and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive
      sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.

      This is a 2-arm placebo and Lybridos (0.5 mg testosterone + buspirone 10 mg) extension to
      study EB90 (Clinical Study Protocol EB90a, version 3.0, 07 June 2013).

      In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in
      healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s).
      Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours
      after each sexual activity. The following hypotheses will be tested:

      Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual
      events.

      Objectives:

      To investigate the efficacy of Lybridos as compared to placebo in increasing the number of
      satisfactory sexual episodes in healthy female subjects with hypoactive sexual desire
      disorder (HSDD) and maladaptive activity of sexual inhibitory mechanisms

        -  To identify the optimal dose of Lybridos to take into phase 3 clinical development

        -  To confirm that Lybridos has superior efficacy as compared to testosterone alone and to
           buspirone alone

        -  To evaluate the effect of Lybridos as measured by scales of sexual satisfaction and/or
           sexual desire/arousal

        -  To evaluate the safety profile of Lybridos
    

Detailed description: 
      None entered
    

Intervention name(s): Placebo; 0.5 mgTestosterone + 10 mg Buspirone
Intervention type(s): Drug; Drug
Intervention description(s): A total of 28 doses will be provided. Subjects are required to take a minimum of 8 doses over the 8-week treatment period (1 dose/week). The other 20 doses may be taken as desired (ie, "on demand") throughout the 8-week treatment period; dosing is permitted every 2 days (ie, on alternate days).
Other intervention name(s): Solid Oral Dosage. Maximum every other day (on an as needed basis); Solid Oral Dosage. Maximum every other day (on an as needed basis)
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HSDD
NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes
Condition: Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies
Study type: Observational

Summary: 
      The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR
      and impedance.
    

Detailed description: 
      The aim of the study is to examine how suitable a hand-held measuring probe (DDD-probe) using
      NIR (near infrared light) as well as impedance (conductivity), is to detect early signs of
      diabetic neuropathy.

      The DDD-probe is put directly on the skin and is measuring by the use of light and impedance.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Control group men without diabetes Type1 diabetic men without neuropathy complications Type
        1 diabetic men with neuropathy complications
      
Keywords: Near infrared light; Diabetic neuropathy; Sensory neuropathy; Autonomic neuropathy; Vagus; Sudomotor function; Monofilament; Impedance
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the healing rate and safety of Lafutidine in erosive esophagitis
    


Intervention name(s): Lafutidine; Famotidine; Omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lafutidine 20mg/day; Famotidine 40mg/day; Omeprazole 20mg/day
Intervention MeSH terms: Omeprazole; Famotidine; Lafutidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Grid Laser for Diffuse Diabetic Maculopathy
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Macular Degeneration
Study type: Observational

Summary: 
      Diabetic related complications are increasing day by day due to increse in the number of
      diabetic patients all over the world. Diabetic macular edema is one of them and a major cause
      of vision imparment. Various kind of treatment modalities are preent to treat this
      coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive
      procedure.Laser power if kept to aminimum can get the desired results without severe
      destruction to the retina . In this study, the investigators are going to document the effect
      of minimal grid laser tn loss o overcome the visioe to diabetic macular edema.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetic patients having diffuse diabetic macular edema.
      
Keywords: Macular grid; Subthreshold; diabetic macular edema; decrease in visual acuity
Acute Physiological and Perceptual Responses to Novel Forms of High-intensity Interval Exercise
Condition: High-intensity Interval Exercise; Heart Rate; Rating of Perceived Exertion; Blood Pressure; Acute Mood; Physical Activity Enjoyment
Study type: Interventional

Summary: 
      Randomised cross-over study seeking to explore the acute physiological and perceptual
      responses to three novel forms of high-intensity interval training (HIT).
    

Detailed description: 
      Randomised cross-over study seeking to explore the acute physiological (heart rate and blood
      pressure) and perceptual responses (rating of perceived exertion, mood and enjoyment) to
      three novel forms (non-contact boxing, stair stepping and stair climbing) of high-intensity
      interval training (HIT).
    

Intervention name(s): Boxing; Stair stepping; Stair climbing
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): as already discussed; as already discussed; as already discussed
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Using a randomised crossover trial design participants will be randomised computer assisted random sequence generation to sequences in which they are exposed to each experimental condition (exercise modality: stair stepping, stair climbing and non-contact boxing).
Masking: None (Open Label)
Primary purpose: Other
Antibiotic Irrigation for Pancreatoduodenectomy
Condition: Surgery; Infection
MeSH terms: Infections
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the routine use of antibiotic irrigation during
      pancreas surgery (Whipple procedure) will decrease superficial and organ space infections.
    

Detailed description: 
      The primary aim of this study is to test the efficacy of routine antibiotic irrigation in
      reducing superficial and organ space infections among patients undergoing
      pancreatoduodenectomy.
    

Intervention name(s): Polymyxin B in Normal Saline; Placebo: Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): Antibiotic irrigation via peritoneal lavage; Placebo irrigation via peritoneal lavage
Other intervention name(s): Antibiotic; Placebo
Intervention MeSH terms: Anti-Bacterial Agents; Polymyxins; Polymyxin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Pancreatoduodenectomy; Whipple
The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function
Condition: Urinary Incontinence,Stress
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The purpose of this study is to assess the influence of the body posture correcting therapy
      on pelvic floor muscles function and urinary incontinence problem.
    

Detailed description: 
      This randomized, controlled study was aimed to asses influence of a six week global posture
      correction therapy on pelvic floor muscles function and urinary incontinence problem.
      Participants were randomly divided into two groups. All subjects overcame assessment of
      pelvic floor muscles (sEMG, manometry and digital) and completed questionnaire about urinary
      incontinence problem and general health condition connected with lower tract symptoms. Both
      groups had a pelvic floor education (what is it, where are the pelvic floor muscle, how to
      correct contract them etc.) Additionally, the study group had a six week therapy focused on
      body posture correction. Therapy consisted of manual therapy (once per week) and correction
      exercises.
    

Intervention name(s): Manual therapy, exercises and education program; Education program
Intervention type(s): Other; Other
Intervention description(s): a six week body posture therapy consisted of manual therapy (once per week) and home exercises; education about pelvic floor; education about pelvic floor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants divided into two groups (the study and the control)
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Exercise on Cognition in Older Adults At-risk for Diabetes: A Feasibility Pilot Study
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Older adults with type 2 diabetes experience cognitive decline and are at higher risk for
      developing dementia. Consequently, older adults at-risk for developing type 2 diabetes (based
      on body mass, glucose levels) are at higher risk for cognitive decline, and intervening at
      this point may prevent or delay the onset of such decline. One promising lifestyle
      intervention that has been shown to improve cognitive function in other populations is
      exercise. However, before investigators can examine whether exercise will improve cognitive
      function and brain health (structure and function) in this at-risk population, a feasibility
      pilot study is needed to determine whether a larger-scale trial would be viable.
    

Detailed description: 
      Investigators will conduct a six-month randomized control trial (RCT) exercise intervention.
      Thirty older adults (aged 60-80) at-risk for diabetes will be randomly assigned into one of
      two groups: 1) Resistance training, or 2) Balance and Tone training (control). All
      participants will engage in three one-hour exercise classes per week. Once a month, a neutral
      assessor will visit the classes to evaluate the quality of the classes for participants.
      Assessments will be made at baseline, midpoint (three months) and trial completion (six
      months), and will include cognitive testing, health questionnaires, physical testing, and
      magnetic resonance imaging (MRI; to assess structural and functional brain changes).
      Throughout the study, investigators will examine data for trends in successful recruitment
      strategies and rates of recruitment and adherence to inform future clinical trials in this
      population. Research assistants (n = 30) in the study will complete an anonymous feedback
      survey upon completion of their volunteer term, to assist in improving the study for future
      participants and volunteers.
    

Intervention name(s): Resistance Training; Balance and Tone Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six months of thrice-weekly resistance training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down). Classes will be group classes, with up to five participants in each.; Six months of thrice-weekly stretching and relaxation exercises. Each session will be 60 minutes. Classes will be group classes, with up to five participants in each.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive assessment; cognitive function; community dwelling older people; pre-diabetes; randomized control trial; exercise; pilot study; feasibility study
Dietary Impact on Intestinal Sulfate Metabolism
Condition: Healthy Nutrition
Study type: Interventional

Summary: 
      This is a 5-week crossover pilot study of 15 highly motivated healthy volunteers who will
      consume two 7-day intervention diets: 1) a diet low in sulfur-containing amino acids (Low-S
      diet), emphasizing plant-based foods and fat sources; and 2) a diet high in sulfur-containing
      amino acids (High-S diet), emphasizing animal protein and fat sources. A 14-day washout
      period will follow each intervention, in which participants will eat their typical diets.
    


Intervention name(s): Plant-Based Diet then animal-based diet; Animal-based diet then plant-based diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants started with plant based diet: high in fiber, low in animal products for 7 days, with 14 day washout period between interventions. Following that, participants were switched to animal-based diet: high in animal products, low in fiber for 7 days.; Participants were started with animal-based diet: high in animal products, low in fiber for 7 days, with 14 days washout period between interventions. Following that, participants were switched to plant-based diet: high in fiber, low in animal products for 7 days
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: 5-week crossover pilot study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Animal-based; Plant-based; Microbiome; Hydrogen sulfide; Ulcerative colitis
Aging and Cellular Mechanism for Insulin Action After Exercise Training
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study will determine whether the metabolic and cellular mechanisms contributing to
      improved insulin action after aerobic or resistive exercise are different in older, obese,
      insulin resistant veterans. The hypothesis is that regular exercise, whether aerobic or
      resistive, will improve whole body insulin action, but the nature and magnitude of changes in
      skeletal muscle will differ between the two types of exercise.
    

Detailed description: 
      Veterans will be of comparable body composition and age, and randomly assigned to either
      aerobic or resistive exercise. They will be instructed in a weight maintenance diet prior to
      beginning the exercise program, and maintain this diet throughout the study. Metabolic
      testing will be performed at baseline and after 6 months of exercise training. Testing will
      include measurement of body composition (anthropometry, dual-energy Xray absorptiometry,
      computed tomograph scan), maximal oxygen consumption, and muscle strength, glucose tolerance
      (oral glucose tolerance test), insulin sensitivity (euglycemic-hyperinsulinemic clamp), and
      muscle biopsies to examine skeletal muscle metabolic characteristics (fiber type
      distribution, capillary density, oxidative and glycolytic enzyme activities, and levels of
      key proteins important in insulin signaling and glucose transport). Data will be analyzed
      using analysis of variance to determine differences between the two exercise groups, and
      multiple regression analysis to determine the primary adaptations that are associated with
      the improvements in whole body insulin action.
    

Intervention name(s): Exercise
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
A Study to Test the Potential of Brillouin Microscopy for Biomechanical Properties Measurements in Human Cornea
Condition: Pellucid Marginal Corneal Degeneration; Keratoconus; Keratectasia
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      The purpose of this research study is to find out if the new Brillouin Ocular Scanner can
      measure the variation (difference) of the corneal elastic changes involved in the onset of
      corneal ectasia, induced by LASIK surgery and cornea collagen crosslinking (CXL) treatment.
      Ectasia refers to the thinning and bulging of the cornea and results in severe vision
      degradation (loss), which may occur because of a progressive disease (keratoconus) or because
      of LASIK surgery. It is believed that the structural weakening of the cornea plays a major
      role in developing ectasia. CXL is a treatment that is able to halt the progression of
      ectasia.

      The Brillouin Ocular Scanner is a technique based on the principles used in the laser speed
      measuring of a car (radar gun). When laser light illuminates a moving sample, a portion of
      the light slightly changes color. In our body, e.g in eye and corneal tissue, very weak sound
      waves are naturally present and they can induce a similar color shift. Measuring this color
      shift with a sensitive light color meter (spectrometer), we will measure the sound speed in
      the tissue.
    


Intervention name(s): Brillouin Ocular Scanner
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Median Nerve Excursion During Neurodynamic Mobilization
Condition: CTS
MeSH terms: Carpal Tunnel Syndrome
Study type: Observational

Summary: 
      This study will compare changes in longitudinal median nerve excursion when neck flexion and
      ipsilateral rotation are added to the standard Median neurodynamic test1 (MNT1) position in
      patients with carpal tunnel syndrome (CTS) and normal controls.
    

Detailed description: 
      Median nerve excursion will be assessed by ultrasonography during three positions: standard
      MNT1, neck flexion with MNT1, and ipsilateral rotation combined with MNT1. Both arms will be
      tested.

      Arm will be held in abduction to 90° - 110° and external rotation to 90°, forearm supination,
      elbow extension and wrist and fingers extension using a custom made splint.

      The standard MNT1 includes neck contralateral side flexion. Then, the researcher will move
      the neck passively into rotation and flexion. Passive range limit will be determined prior to
      testing using a goniometer and passive end feel. Movement order will be randomized using an
      excel random function.

      Every position will be tested three times. A single researcher will do all movements
      passively. Nerve excursion will be measured in real time by the same ultrasonographer who is
      blinded to patients grouping.
    

Intervention name(s): MNT1
Intervention type(s): Procedure
Intervention description(s): Participants will in supine. Arm will be position in standard MNT1. Shoulder, elbow, wrist and fingers will be maintained in the required position using a costumed splint throughout all testing.
All movements will be limited to the range where pain or other symptoms are not provoked. Passive neck flexion and rotation will be added to MNT1 and will be applied as tensioning movements at level 3. All movements will be repeated three times and an average will be calculated. Myrin goniometer will be used to assess neck flexion and rotation. The movements order will be randomized using excel random generation function. Movements will be done by a single trained therapist. The end position will be held up to 10 seconds until median nerve excursion is recorded by US. For US capturing, the transducer will be positioned perpendicularly and aligned longitudinally with the median nerve at the wrist. Assessor will be blinded to participants grouping.
Other intervention name(s): Neurodynamic tension test
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients will be selected from primary care clinics.
      
Keywords: Median nerve,; Carpal tunnel syndrome; Neurodynamic mobilization
A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of gefitinib in patients who
      have progressed on first line gefitinib, comparing continuing gefitinib in addition to
      cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed
      combination chemotherapy alone.
    

Detailed description: 
      A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to
      Assess the Efficacy and Safety of continuing IRESSA 250 mg in addition to Chemotherapy versus
      Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation
      Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have
      progressed on First Line IRESSA.
    

Intervention name(s): Gefitinib; Placebo; Pemetrexed; Cisplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Investigational Drug; Matching placebo as comparator; Chemotherapy (concomitant therapy); Chemotherapy (concomitant therapy)
Intervention MeSH terms: Pemetrexed; Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non Small Cell Lung Cancer; Gefitinib; Pemetrexed; Treatment Beyond Progression