bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers
Condition: Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the safety and tolerability of a single day
      dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the
      study having a different set of healthy male and female volunteers.
    

Detailed description: 
      This is a Phase 1, double-blind, randomized, placebo-controlled, single day and multiple day
      dosing, in healthy, non-smoking, male and female volunteers.

      Part 1: Single Ascending Dose (SAD)

      Seven (7) healthy male and female volunteers will be randomly assigned to receive either
      18-MC HCl (n=5) or placebo (n=2) in each cohort. These volunteers will receive 18-MC HCl
      twice in 1 day (bid).

      There are 3 phases: Screening, Enrollment and Follow-Up. All participants will be assessed
      for safety and tolerability for 28 days. Screening begins when a participant reports to the
      clinical unit (CU) for a screening visit to undergo safety and compliance assessments on this
      day. Participants that meet all eligibility criteria will be admitted to the CU on the day
      prior to receiving study drug. Enrollment begins on Day 1 where participants will receive two
      doses of study drug for 1 day, will be assessed for 18-MC PK up to 48 hours, and will remain
      admitted at the CU until Day 3, at which time they will be discharged. For follow-up the
      participants will return for safety and tolerability assessments at Days 7, 14, 21 and Day
      28.

      Part 2: Multiple Day Ascending Dose (MAD)

      Seven (7) healthy male and female volunteers will be randomly assigned to receive either
      18-MC HCl (n=5) or placebo (n=2) in each cohort. These volunteers will receive 18-MC HCl
      twice over 7 days (bid).

      There are 3 phases: Screening, Enrollment and Follow-Up. All participants will be assessed
      for 42 days. Screening begins when a participant reports to the clinical unit (CU) for a
      screening visit to undergo safety and compliance assessments on this day. Participants that
      meet all eligibility criteria will be admitted to the CU on the day prior to receiving study
      drug. Enrollment begins on Day 1 where participants will receive two doses of study drug
      every day for 7 days, will be assessed for 18-MC PK up to 48 hours on Day 1 and Day 7, and
      will remain admitted at the CU until Day 9, at which time they will be discharged. For
      follow-up the participants will return for safety and tolerability assessments at Days 14,
      21, 28, 35 and Day 42.
    

Intervention name(s): 18-MC Compound
Intervention type(s): Drug
Intervention description(s): 18-MC
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: opioid use disorder (OUD)
A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy
Condition: Glomerulonephritis
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranous
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Membranous Nephropathy (MN) is an immune-mediated kidney disease that affects the glomerulus
      or the filter that removes toxins from the blood. Damage to the membrane that separates blood
      from urine results in loss of protein into the urine (proteinuria) and in some cases loss of
      kidney function.There is no standard specific treatment for MN.

      ACTH has a pronounced lipid-lowering effect in healthy individuals, in steroid-treated
      patients with renal disease and in hemodialysis patients Some studies suggest that prolonged
      synthetic ACTH therapy may represent an effective therapy in patients with idiopathic MN,
      more extensive randomized studies with longer follow-up are needed before therapeutic
      recommendations can be made.

      We propose to do a pilot study to test the hypothesis that biologic ACTH, a slow-release
      formulation of corticotropin extracted from porcine pituitary glands (H.P. Acthar gel) will
      be effective in reducing proteinuria and improving lipid profile in patients with idiopathic
      MN.
    


Intervention name(s): Adrenocorticotrophic hormone ACTH
Intervention type(s): Drug
Intervention description(s): There will be two arms to the study: one arm receive 40 units and the second arm 80 units of the ACTH gel subcutaneously both given in a dose escalating frequency beginning at once every two weeks escalating to a maximum of twice per week over a total of three months exposed.An ammendment(approved by Health Canada and the UHN IRB allows an additional 1 month of the perscribed therapy of ACTH )if there is an improvement in proteinuria at the end of the 3 month exposure.
Other intervention name(s): HP Acthar gel
Intervention MeSH terms: Hormones; Adrenocorticotropic Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney disease, Glomerulonephritis
Short-term Effect of Patellar Taping and Electromyographic Biofeedback Strength Training on Quadriceps Strength
Condition: Patello Femoral Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Interventional

Summary: 
      Patellofemoral pain syndrome is one of the most common young adult female complaints, caused
      by changes in the patellofemoral joint's physical and biomechanical properties. This study
      compared the Short-term effects of patellar taping and electromyographic-biofeedback (EMG-BF)
      guided maximum voluntary isometric contraction of quadriceps muscle strengthening at 900 or
      600 knee angles on quadriceps strength and functional performance in a female patient with
      patello-femoral pain syndrome (PFPS)
    

Detailed description: 
      Quadriceps muscle strength Pain intensity Knee function
    

Intervention name(s): EMG-BF guided patellar taping; sham patellar taping without EMG-BF guided stimulation; maximum voluntary isometric contraction exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): EMG-BF guided patellar taping Maximum voluntary isometric contraction exercise at 60, and 90 degrees angle.; sham patellar taping without EMG-BF guided stimulation; maximum voluntary isometric contraction exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental group Control group
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Patello-femoral pain syndrome; pain; strength; Maximum voluntary Isometric contraction (MVIC).
Study of Oral Anthocyanins on Insulin Resistance
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      Dietary strategies for alleviating the metabolic complications such as diabetes associated
      with obesity are actively being pursued as alternatives to pharmaceutical interventions The
      genus Vaccinium (e.g. blueberry, blaeberry, cranberry) has been used traditionally as a
      source of folk remedies for established diabetic symptoms, primarily as leaf or stem
      infusions or decoctions. Berries from this family such as blaeberry (BL) and blueberry (BB)
      are enriched in anthocyanins, polyphenolics recognized for their ability to provide and
      activate cellular antioxidant protection, inhibit inflammatory gene expression, and
      consequently protect against oxidant-induced and inflammatory cell damage and cytotoxicity.
      The association of obesity with adipose tissue stress, macrophage recruitment, and
      inflammatory gene expression suggests that eating edible berries from this genus might
      provide an effective alternative or supplementary intervention to attenuate obesity-
      associated inflammation and the associated insulin resistance.

      The aim of this study is to determine the effects of anthocyanin supplementation in the form
      of a concentrated blaeberry extract on insulin resistance and inflammation particularly in
      the adipose tissue following a three week supplementation period.
    


Intervention name(s): Mirtoselect
Intervention type(s): Dietary Supplement
Intervention description(s): Male subjects (BMI > 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.
Volunteers will be given either a total daily dose of 1.4 grams of concentrated blaeberry extract (mirtoselect provided by Indena S.p.A. (http://www.mirtoselect.info/) in a hard gelatin capsules or control capsules containing lactose administered thrice a day for 21 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anthocyanin; blaeberries; bilberries; blueberries; mirtoselect; type 2 diabetes; insulin resistance; Adipose tissue; inflammation
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effect and safety of KHK7791 in combination with phosphate binders to treat
      Hyperphosphatemia in ptatients on HD.
    


Intervention name(s): KHK7791; Placebp
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tenapanor; Hyperphosphatemia; Hemodialysis
Clinical, Meibographic and Interferometric Evaluation of Phlyctenular Keratitis in Children - MEIBO-ROSACEE
Condition: Ocular Rosacea; Keratoconjunctivitis; Meibomian Gland Dysfunction
MeSH terms: Keratitis; Meibomian Gland Dysfunction; Keratoconjunctivitis; Rosacea
Study type: Observational

Summary: 
      The aim of this study is to describe the clinical, meibographic and interferometric
      manifestations of phlyctenular keratitis in children.
    

Detailed description: 
      The investigators are conducting a monocentric, transversal, epidemiologic study. 100
      patients should be included: 50 children suffering from ocular rosacea, and 50 children with
      no palpebral or Meibomian disease. Witnesses will be matched on the age of the cases.

      Patient and controls will undergo a classic ophthalmologic examination with visual acuity
      measurement and slit lamp examination of both eyes and eyelids. Then, the child will go
      through a meibographic and interferometric evaluation of his two inferior eyelids. This
      evaluation is made by an optometrist with the Lipiview device, and lasts a few minutes.
    

Intervention name(s): Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)
Intervention type(s): Procedure
Intervention description(s): Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged between 2 and 16 : Cases, suffering from ocular or oculo-cutaneous rosacea
        and Witnesses without any present or past palpebral or meibomian disease
      
Keywords: Ocular Rosacea; Keratoconjunctivitis; Meibomian Gland; Interferometry; Child
Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and
      Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who
      completed a phase 2/3 Thiazolidine add on study.
    

Detailed description: 
      Both insulin hyposecretion and insulin-resistance are considered to be involved in the
      development of type 2 diabetes mellitus.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2
      peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of DPP-IV will improve glycemic control in patients with type 2 diabetes.

      To evaluate the long-term safety and efficacy of alogliptin, participants in the present
      study were enrolled from a core phase 2/3 thiazolidine add on study (SYR-322/CCT-004;
      NCT01318070).
    

Intervention name(s): Alogliptin and pioglitazone; Alogliptin and pioglitazone
Intervention type(s): Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.; Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Other intervention name(s): SYR-322; Actos; SYR-322; Actos
Intervention MeSH terms: Pioglitazone; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus - Type 2; Diabetes Mellitus; Drug Therapy
Gene Expression Correlates of Post-Traumatic Stress Disorder (PTSD) Symptom Change After EFT (Emotional Freedom Techniques)
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of the study is to measure the change in psychological symptoms and gene
      expression in war veterans after a series of 10 EFT coaching sessions. Outcome studies have
      shown statistically significant reductions in depression, anxiety, and PTSD in veterans after
      EFT, and this study extends earlier research using biological sampling. EFT is a form of
      Energy Psychology (EP) that is sometimes referred to as "emotional acupuncture." It involves
      self-stimulation of 14 acupuncture points at the end of meridians with the fingertips, while
      recalling an emotional event such as a combat trauma. It is typically effective in 6 to 15
      coaching sessions, making it an efficient clinical technique for reducing affect.
    

Detailed description: 
      There is peer-reviewed published experimental evidence showing that (a) acupuncture reduces
      the fear response in the brain, especially the limbic system, and most particularly the
      amygdala; that (b) tapping or rubbing acupuncture points (acupressure) can be as effective as
      needling them; that (c) EFTs use of such acupressure is efficacious in reducing anxiety, PTSD
      and other mood disorders; that (d) EFT reliably reduces emotional intensity associated with
      traumatic memories, is safe and low-risk; that (e) all EP studies that included a long-term
      follow-up show that patient gains are maintained over time; that (f) the psychological
      questionnaires used in this study are validated and safe; and that for all these reasons (g)
      EP is a treatment of choice among therapists when dealing with the traumatic memories of
      clients. This study extends these findings by noting changes in gene expression associated
      with the remission of PTSD symptoms.
    

Intervention name(s): EFT (Emotional Freedom Techniques)
Intervention type(s): Behavioral
Intervention description(s): 10 EFT sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Visual Perceptual Learning for the Treatment of Visual Field Defect
Condition: Stroke; Visual Field Defect
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study will test the hypothesis whether visual field defect caused by chronic stroke
      could be improved by visual perceptual learning. The secondary hypothesis is that improvement
      of visual field defect would be accompanied by connectivity changes in visual networks. In
      addition, investigators will evaluate whether improvement of visual field defect could
      achieve improvement of subjective visual function.
    

Detailed description: 
      Study design: A PROBE (Prospective, Randomized, Open-label, Blinded-endpoint) design

      Methods:

        1. Visual perceptual learning (VPL) group

             1. Visual perceptual learning (24 times for 2 months, 3 times per week) in visual
                field defect areas

             2. At baseline and post-VPL evaluations (2 months after): Structural & Functional
                MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests,
                Subjective visual function questionnaires

        2. Control group

             1. At baseline and 2-months later: No VPL, Structural & Functional MRIs, Visual field
                tests, Visual evoked potential, Visual cognitive tests, Subjective visual function
                questionnaires

             2. Visual perceptual learning after 2-month follow-up evaluation (24 times for 2
                months, 3 times per week)

           (The patients who were stratified by age (over 65 years old or not) and degree of visual
           field defect (quadrantanopia or complete hemianopia) will be randomly assigned into the
           learning and control group.)

        3. Investigations

             1. Improvement of visual field test scores between VPL group and control group

             2. Analysis of brain network changes in MRI data

             3. Correlation analysis of improvement of visual field defect and MRI data

             4. Correlation analysis of improvement of visual field defect and visual evoked
                potential (VEP) data

             5. Correlation analysis of improvement of visual field defect and neuropsychological
                data
    

Intervention name(s): Visual perceptual learning
Intervention type(s): Behavioral
Intervention description(s): 24 times of training for visual perceptual learning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Visual Field Defect; Visual perceptual learning; Brain connectivity
Evaluating the Effect of Mucinex 1200mg on Mucociliary and Cough Clearance During an Acute Respiratory Infection
Condition: Acute Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to explore the mechanism of action of Mucinex, an oral,
      over-the-counter, FDA approved expectorant in patients with acute respiratory tract
      infections.
    


Intervention name(s): Mucinex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study; Placebo given as 2 tablets
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute Respiratory Infection; Mucociliary; Cough Clearance; Guaifenesin
Study to Evaluate the Mass Babance and Biotransformation of [14C]SHR6390 in Healthy Adult Male Volunteers
Condition: Healthy Adult Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Evaluate the mass balance and biotransformation of single dose [14C]SHR6390 in
      Chinese healthy adult male volunteers.
    


Intervention name(s): [14C]SHR6390
Intervention type(s): Drug
Intervention description(s): Patients will receive single dose of orally [14C]SHR6390 on Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Electronic Cleansing Toilet System (Bidet) on Anal Resting Pressure
Condition: Anorectal Physiology
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study was to evaluate the effect of Bidet on anal resting pressure with
      regards to various flow rates and temperatures.
    

Detailed description: 
      Bidet is an electronic device spraying stream of the water for cleansing the anus and
      sometimes to aid defecation. It is widely used in Korea and Japan, with the flow rate
      (pressure) and temperature of water varying widely among the manufacturers. However, the
      effects of Bidet on anorectal function have not been studied in detail with regards to these
      variables.
    

Intervention name(s): Bidet (electronic cleansing toilet system)
Intervention type(s): Device
Intervention description(s): The volunteers underwent rectal examinations and baseline manometry at lateral decubitus position. Subjects were then placed on a toilet with Bidet attached and manometry catheter was inserted and fixed placing the channels of the catheter at the high pressure zone (HPZ) of the anal canal. Anorectal pressures were measured before and after using the Bidet under different water pressures (4, 8, 16, 20 gram force, gf), types of water stream (narrow vs. wide), and different temperatures (24oC vs. 38oC).
Other intervention name(s): Bidet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Electronic toilet; Bidet; Anorectal resting pressure
A Food Effect Study of TS-142 in Healthy Subjects
Condition: Effect of Food
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the food effect of TS-142 preliminary market formulation tablet in
      healthy subjects
    


Intervention name(s): TS-142 10 mg
Intervention type(s): Drug
Intervention description(s): Single-dose of 10 mg of TS-142
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment