bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy
Condition: Refractory Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      Treatment of chronic migraineurs who have failed more than 3 preventive drugs with Erenumab
      alone, to reduce frequency of monthly migraine days or as an add on therapy
    

Detailed description: 
      The investigators treated chronic migraineurs that have failed more than 3 preventive drugs
      with Erenumab alone or as an add on therapy to: Reduce the frequency of monthly migraine
      days, to evaluate If the add on of Erenumab to another preventive therapy is superior to
      Erenumab alone, and assess all adverse events related to the use of Erenumab.

      Migraineurs with 15-30 migraie days per month at baseline were clustered in 3 categories.
      Failure of Erenumab was defined as no improvement in the frequency of monthly migraine days.
      Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II:
      on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group
      III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort)
    

Intervention name(s): Erenumab Auto-Injector
Intervention type(s): Drug
Intervention description(s): Assess synergy of add on medication to Erenumab
Other intervention name(s): Botox, and oral migraine preventives
Intervention MeSH terms: Erenumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with more than 15 migraine days per month, receiving Botox, or an oral preventive
        treatment, or without any preventive therapy. Have failed more than 3 preventive treatments
        previously
Evaluating the Effect of Optical Zones on Correction for SMILE: Vector Analysis
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in
      small incision lenticular extraction.
    

Detailed description: 
      To retrospectively study whether different surgical optical zone sizes affect the correction
      of diopter and astigmatism in myopia patients. Divided into 2 groups according to the
      diameter of the optical zone. The vector analysis method was used to analyze the changes and
      errors of astigmatism in TR and SIR after operation. Generalized Estimation Equation (GEE)
      model is used for multiple regression analysis to evaluate the potential factors related to
      the error value.
    

Intervention name(s): small incision lenticular extraction
Intervention type(s): Procedure
Intervention description(s): In patients with the same degree of myopia, different optical zones were designed for operation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        age of patients between 18-45 years; spherical refraction of -3.00 to -6.00 diopters (D)
        with or without astigmatism (<-3.00 D); spherical equivalent, -3.00 to -6.00 D; corrected
        distant visual acuity (CDVA), >20/25
      
Keywords: small incision lenticule extraction; vector analysis
Newborn Cranial Somatic Dysfunction - An Observational Study
Condition: Somatic Dysfunction of Cranial Region; Somatic Dysfunction of Cervical Spine; Somatic Dysfunction of Lumbar Spine; Somatic Dysfunction of Sacrum
MeSH terms: Pathologic Processes
Study type: Observational

Summary: 
      Two prominent osteopathic physician researchers have studied cranial somatic dysfunction in
      newborns. Dr Viola Frymann published a paper in 1966 on the presence of somatic dysfunction
      involving 1250 infants. Dr. Jane Carreiro evaluated 1600 newborns in 1993 for cranial somatic
      dysfunction. This observational study is intended to continue their work in exploring the
      presence of cranial somatic dysfunction in newborns. The hypothesis is that there is an
      increased incidence of somatic dysfunction in newborns birthed by primigravid women and in
      newborns who experienced a longer second stage of labor.
    

Detailed description: 
      100 newborns will be assessed for somatic dysfunction of the head, cervical, lumbar, and
      sacral areas. These findings will be compared to the findings of a standard newborn physical
      exam and the newborn and maternal history. These records will be reviewed for maternal age,
      parity, gravity, anesthesia during labor, and estimated gestational age. Birth history and
      initial newborn assessments will be reviewed for labor augmentation, duration of labor,
      length of second stage of labor, presence of instrumental delivery(vacuum extraction, forceps
      delivery, etc.), multiple birth, and presentation at delivery (breech, transverse, or
      compound presentation). The purpose of the study is to quantify the presence of somatic
      dysfunction in the newborn. We will assess any relationships between the identified somatic
      dysfunctions and factors present in the mother's and newborn's medical history.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants born at the Northeast Regional Medical Center (NRMC) in Kirksville, MO, between
        August 1, 2011, and July 31, 2012. The infants must be greater than 6 but less than 72
        hours old to participate in the study.
      
Keywords: Newborn cranial somatic dysfunction; Newborn observational study; Somatic dysfunction; Cranial strain pattern; Osteopathy
The Effect of Continuous Sipping of a Glucose Solution on Markers of Oxidation in Men and Women
Condition: Cardiovascular Disease; Diabetes
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objective of this study is to determine the effect of reducing the rate of glucose
      absorption on oxidative stress after eating and to compare it with the effects of vitamin C.
      The hypothesis is that reducing the rate of glucose absorption will reduce oxidative stress
      to a similar extent as 1g vitamin C.
    

Detailed description: 
      Recently, much attention has been paid to evidence that abnormalities of the postprandial
      state (hyperglycemia) are important contributing factors to the development of chronic
      disease. This attention has increased interest in the role low glycemic index (GI) foods
      could potentially play in preventing postprandial oxidative burst/stress. GI is a means by
      which to categorize carbohydrate according to their postprandial glycemic response. Low GI
      foods promote slow intestinal absorption, prolonged and less pronounced postprandial
      glycemia, may decrease risk of chronic disease, as well as provide metabolic benefit to
      people living with glucose abnormalities as well as those with normal glucose. Few studies
      have been conducted looking at the potential relationship between GI and oxidation and are
      limited by dietary/lifestyle confounders. The proposed study has been developed to eliminate
      these confounders. Hypotheses (3): 1. Sipping glucose slowly over 3h will result in less
      oxidative stress than ingesting the same amount of glucose as a bolus over 5min. 2. Sipping
      glucose will reduce oxidative stress to the same extent as 1g of oral vitamin C. 3. The
      effect of sipping glucose on oxidative stress will occur sooner than that of vitamin C.
    

Intervention name(s): glucose bolus; Glucose sipping; Glucose bolus plus 1g vitamin C; Glucose sipping plus 1g vitamin C
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 50g anhydrous glucose dissolved in 300ml water consumed within 10min followed by a lunch (cheese sandwich, fruit and milk) at 4h.; 50g anhydrous glucose dissolved in 300ml water consumed at rate of 25ml per 15min followed by a lunch (cheese sandwich, fruit and milk) at 4h.; 50g anhydrous glucose dissolved in 300ml water consumed within 10min with 1g vitamin C followed by a lunch (cheese sandwich, fruit and milk) at 4h.; 50g anhydrous glucose dissolved in 300ml water consumed at rate of 25ml per 15min. 1g vitamin C taken with first 25ml. Followed by a lunch (cheese sandwich, fruit and milk) at 4h.
Intervention MeSH terms: Vitamins; Ascorbic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      To evaluate two toric contact lenses on the ocular physiology of existing contact lens
      wearers when used in an extended wear modality of days/six nights.
    


Intervention name(s): senofilcon A toric contact lens; balafilcon A toric contact lens
Intervention type(s): Device; Device
Intervention description(s): soft contact lens; soft contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men
Condition: Sarcopenia; Muscle Atrophy
MeSH terms: Sarcopenia; Muscular Atrophy
Study type: Interventional

Summary: 
      The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to
      investigate the effects of 12 weeks resistance exercise and whey protein supplementation on
      energy metabolism, markers of appetite, inflammation and hormonal response and body
      composition and strength and functional performance.

      Generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13
      per group). Participants will be randomised to either: a) control group, b) whey protein
      supplement group, c) resistance exercise + control group or d) resistance exercise + whey
      protein supplementation group.
    

Detailed description: 
      With demographics indicating that the world's population aged >60 years will increase from
      600 million reported in 2000, to >2 billion by 2050, there is an increasing interest in
      health issues related to ageing. One area of particular interest is sarcopenia, defined as
      the progressive loss of muscle mass, strength and physical function as a consequence of
      ageing. Sarcopenia has been associated with an increase in cardiovascular disease, poor
      metabolic and cognitive function, reduced quality of life and early mortality. Studies have
      reported beneficial effects of both resistance exercise and increasing protein intake
      independently and in combination on markers of sarcopenia (mostly increases in muscle mass,
      strength and physical function). However, little is known about the effects of combined
      intervention on energy metabolism, appetite and cognitive and endocrine function. This
      randomised, double-blind, placebo-controlled, parallel groups trial will investigate these,
      alongside assessing the effects of combined intervention on total lean tissue mass, muscular
      strength and functional performance.
    

Intervention name(s): Whey Protein; Control; Resistance Exercise
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 25 g whey protein supplementation twice daily (breakfast and lunch); 23.75 g maltodextrin twice daily (breakfast and lunch); 60 minutes of resistance exercise twice a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Sarcopenia; Resistance exercise; Protein
Study of [3H] BMS747158 in Healthy Male Subjects
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical study is to assess the safety, extent and route of [3H]
      BMS747158 radioactivity eliminated (mass balance) in urine and feces of healthy male
      subjects. The safety of [3H] BMS747158 administration will also be assessed, as well as
      pharmacokinetics of [3H] BMS747158 and metabolite identification.
    

Detailed description: 
      This Phase I, nonrandomized, open-label study will enroll up to seven healthy male subjects
      who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 100
      (±20) μCi of [3H] BMS747158. Subjects will undergo blood, urine, and fecal collections to
      evaluate [3H] activity for a minimum of 7 days post-dose. Safety will be assessed by
      monitoring of adverse events (AEs), vital signs, physical examinations, clinical laboratory
      tests, and electrocardiograms (ECGs).This Phase I, nonrandomized, open-label study will
      enroll up to seven healthy male subjects who meet all of the inclusion and none of the
      exclusion criteria. Subjects will receive 100 (±20) μCi of [3H] BMS747158. Subjects will
      undergo blood, urine, and fecal collections to evaluate [3H] activity for a minimum of 7 days
      post-dose. Safety will be assessed by monitoring of adverse events (AEs), vital signs,
      physical examinations, clinical laboratory tests, and electrocardiograms (ECGs).
    

Intervention name(s): [3H] BMS747158
Intervention type(s): Drug
Intervention description(s): Single bolus intravenous injection of [3H] BMS747158
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CAD; Pharmacokinetics; BMS747158
A Study of LY3473329 in Healthy Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3473329 in
      healthy Japanese participants. The study will also assess how fast LY3473329 gets into the
      blood stream and how long it takes the body to remove it. The study is open to healthy
      participants. The study will last up to about 71 days, inclusive of screening period.
    


Intervention name(s): LY3473329; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Evaluate the Efficacy of Riluzole in Children and Young Adults With Spinal Muscular Atrophy (SMA)
Condition: SMA
MeSH terms: Muscular Atrophy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multicentric, randomized, double-blind study versus placebo, with two parallel
      groups treated to evaluate the efficacy and the tolerance of Riluzole in children and young
      adults (6 to 20 years of age) with SMA. (Type II and Type III).
    

Detailed description: 
      ASIRI study should allow to evaluate the efficacy and the tolerance of Riluzole in children
      and young adults (6 to 20 years of age) with SMA. This is a multicentric, randomized,
      double-blind study versus placebo, with two parallel groups treated and followed during 2
      years. It has been preceded by a 7 days pharmacokinetic phase, concerning 14 patients, aiming
      to provide information on the kinetic profile of Riluzole in children. The drug could
      stabilize patients condition, and especially interrupt paralysis progression; those are the
      desired effects.

      There is an open-label study of the long term safety of riluzole therapy in spinal muscular
      atrophies types II and III, with patients previously enrolled in ASIRI double-blind study.
    

Intervention name(s): Riluzole
Intervention type(s): Drug
Intervention description(s): 50 mg per day during 24 months
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal muscular atrophies (SMA); Degeneration of the motor neurons; Anterior horn of the spinal cord; Riluzole
Pharmacokinetics and Safety of BI 695501 Administered Via Prefilled Syringe or Autoinjector
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501
      administered subcutaneously via prefilled syringe or autoinjector
    


Intervention name(s): BI 695501 prefilled syringe; BI 695501 autoinjector
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fumaric Acid Versus Fumaric Acid Plus Narrow Band Type B Ultraviolet (UVB) for Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of the study is to evaluate the additional effect of a narrow band Type B
      Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid
      esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the
      effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach
      Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate
      whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a
      positive predictive factor for the treatment response.
    


Intervention name(s): Full Body UV Therapy System UV 7002 plus fumaric acid esters; Fumaric acid esters
Intervention type(s): Device; Drug
Intervention description(s): Combination therapy of narrow band type B ultraviolet (UVB) therapy plus fumaric acid esters therapy.
Narrow band UVB therapy: 3 times a week for 6 weeks; Fumaric acid esters therapy: Capsules, schema therapy, 1 to 3 times a day for 6 months; Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months
Other intervention name(s): TL-01;; Irradiation therapy with narrow band UVB; Fumaric acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Photobiomodulation to Alter Cerebral Blood Flow and to Affect the Emotional Status of Patients With Major Depression
Condition: Major Depression; Anxiety Disorder; Post-Traumatic Stress Disorder; Substance Abuse Disorder
MeSH terms: Substance-Related Disorders; Depression; Depressive Disorder; Stress Disorders, Traumatic; Anxiety Disorders; Stress Disorders, Post-Traumatic; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      A pilot study to evaluate the ability of photobiomodulation to alter cerebral blood flow in
      the frontal poles and to affect the emotional status of patients with major depression.
    

Detailed description: 
      We wish to study whether photobiomodulation (PBM) with near infrared (NIR) light emitting
      diodes (LED), a non-ionizing phototherapy, in patients with major depression, can acutely
      alter frontal brain blood flow measured by near infrared spectroscopy (NIRS).

      Secondarily, we will examine whether PBM can improve emotional state immediately and over the
      following month.

      We see this as a pilot study to gather preliminary data that will guide future studies.
    

Intervention name(s): Photobiomodulation with a super-luminous light emitting diode
Intervention type(s): Device
Intervention description(s): The treatment will consist of applying PBM in the form of a super-luminous LED with an output of 250 mW/cm2 at a wavelength of 815 nm with a full width half maximum of 40 nm when applied at 4 mm from the skin. The treatment will consist of the exposure to the light for 4 minutes (total delivered fluence per spot of 60 J/cm2) at each of 4 sites on the forehead that correspond to the 10-20 EEG sites, F3, and F4.
Other intervention name(s): Near infra-red light
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major depressive disorder, anxiety disorders, treatments, photobiomodulation, near infra-red phototherapy, cerebral blood flow
Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.
Condition: Total Mesorectal Excision; Laparoscopic
Study type: Interventional

Summary: 
      The study involves the use of Retroperitoneal plane for TME for rectal anterior resection.
      Through a pilot prospective study, LR-TME will be assessed as one arm study.
    

Detailed description: 
      This study is based on our new suggested theory for a retro-peritoneal approach. After
      successful 2 cases of Laparoscopic extraperitoneal-TME. A pilot study for assessment of the
      feasibilty of the new approach.

      Data will be registered prospectively and the perioperative outcomes will be assessed.
    

Intervention name(s): LE-TME
Intervention type(s): Procedure
Intervention description(s): Retroperitoneal approach for total mesorectal excision
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LE-TME; Laparoscopic rectal resection; Retroperitoneal resection
Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra
Condition: Incontinence, Urinary
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      This study aims to evaluate the correlation of the ultrasonic functional length of the
      urethra and the incontinence urinary disorder (IUD). The goal is to predict the severity of
      the IU by measuring new static and dynamic ultrasound parameters of the urethra.
    

Detailed description: 
      The urinary incontinence is a disorder which affects 25 to 45% of women. Nowadays, the role
      of urethral tissue in IUD is not explored although well viewed in perineal ultrasound. Our
      actual knowledge demonstrates that urodynamic ultrasound is reliable to establish the bladder
      neck mobility. And the posterior urethral wall mobility was often associated to the stress
      urinary incontinence. Two elements appeared to indicate the elasticity of the urethral
      environment: functional length urethral variation and urethral closure angle variation during
      Valsalva manoeuvres compared to rest. This study aims to evaluate the correlation of the
      ultrasonic functional length of the urethra and the incontinence urinary disorder for the
      purpose to predict the severity of this syndrome.
    

Intervention name(s): Pelvic ultrasound / Urodynamic ultrasound
Intervention type(s): Other
Intervention description(s): Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic