bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate How Well Single and Multiple Doses of GLPG3121-modified Release Formulation Are Tolerated in Healthy, Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to examine the safety and tolerability of GLPG3121-modified release
      formulation when given to healthy male subjects once as a single dose or multiple times over
      a period of 14 days in fasting condition or after a standard breakfast.

      The study will evaluate how the body absorbs and breaks down GLPG3121, and how GLPG3121 and
      the major breakdown product of GLPG3121 are eliminated from the body. In addition, the study
      will investigate the effect of food (high-fat) after a single oral dose of GLPG3121 as
      modified release tablet.
    


Intervention name(s): GLPG3121; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GLPG3121 modified-release tablet; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD) are randomized, double-blind, placebo-controlled; Part 3 Food-effect (FE) is randomized, open-label, crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Oral Aripiprazole Open-Label Rollover Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the long-term safety and tolerability of oral
      aripiprazole in adolescent patients with schizophrenia.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Flexible dose between 5 mg and 30 mg Aripiprazole tablets.
Other intervention name(s): ABILIFY®
Intervention MeSH terms: Aripiprazole
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open Label; Aripiprazole
Dose-finding Study of ASP2151 in Subjects With Herpes Zoster
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the efficacy and safety of three different doses of ASP2151, as compared to
      valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended
      clinical dose.
    


Intervention name(s): ASP2151; Valacyclovir hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Valacyclovir hydrochloride; herpes zoster; ASP2151
Ultra-high Dose Vitamin D for HSCT
Condition: Hematopoietic Stem Cell Transplant
Study type: Interventional

Summary: 
      This is a pilot study to investigate the effects of achieving adequate vitamin D levels via
      ultra-high-dose vitamin D supplementation given prior to hematopoietic stem cell transplant
      on transplant-related complications and inflammatory biomarkers.
    

Detailed description: 
      Up to 70% of patients have vitamin D deficiency prior to hematopoietic stem cell transplant
      (HSCT). Patients with sufficient Vitamin D levels (>50nm/L) prior to allogeneic transplant
      have significantly better overall survival (OS) and lower rates of rejection and relapse.
      Vitamin D inhibits Th1 and augments Th2 cell development. Patients who receive vitamin D
      supplementation during allogeneic transplant have less inflammatory-mediated processes such
      as chronic graft versus host disease (GVHD) and lower levels of naïve CD8+ cells and CD40
      ligand. Multiple studies have raised concern regarding the adequacy of standard and high-dose
      vitamin D dosing for vitamin D deficiency. A single oral ultra-high dose of Vitamin D given
      prior to HSCT has been shown to be a safe and well tolerated method of sustaining therapeutic
      Vitamin D levels for 6-19 weeks.

      This is a pilot study to investigate the dynamic changes in inflammatory biomarkers following
      ultra-high-dose vitamin D supplementation. The study population is patients with total
      vitamin D level </=50ng/mL prior to HSCT.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): A single dose of ultra-high-dose vitamin D (cholecalciferol) will be given prior to hematopoietic stem cell transplant. Research labs including inflammatory biomarker panels will be obtained prior to and after the dose is given.
Other intervention name(s): vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: vitamin D; cytokines
Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity.
Condition: Childhood Obesity
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      Evaluate the feasibility and effectiveness of a multi-component school-based intervention to
      promote healthy eating and physical activity with school children ages 9 to 11 years in
      Lebanon.
    


Intervention name(s): Health-E-PALS-
Intervention type(s): Other
Intervention description(s): Intervention to promote Healthy Eating and Physical Activity in Lebanese School-Children It comprises in class-activities, meetings with parents, improvement of school food service
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: School-based intervention
Deep Brain Stimulation of Nucleus Accumbens for Chronic and Resistant Major Depressive Disorder
Condition: Major Depressive Disorder, Recurrent, Unspecified
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      Depression is a common, recurrent and disabling disorder. Among patients with a chronic
      course of the disease, 20 to 30% are resistant to antidepressant medications. Among those
      patients, 50% would not benefit from electroconvulsive therapy (ECT). For such patients, deep
      brain stimulation (DBS) of nucleus accumbens is considered.
    

Detailed description: 
      Depression is a common (12-Month Prevalence in the general population: 6%), recurrent and
      disabling disorder.

      Among patients with a chronic course of the disease, 20 to 30% are resistant to
      antidepressant medications. Among those patients not responding favorably to antidepressant
      medications, 50% would not benefit from ECT. For such patients, surgical interventions have
      been proposed in the past.

      Many results support the hypothesis of a dysfunction of the functional loops between cortical
      and subcortical structures underlying the expression of depressive disorders.

      Thus, therapeutic intervention focusing on these loops, in patients with chronic depression
      resistant to treatment, should be an issue and could improve prognosis of these patients.

      As part of a maximal resistance to antidepressant drug, after failure of a series of
      bilateral ECT, a surgical functional intervention using DBS of nucleus accumbens is
      considered.

      This open-label trial proposes to assess feasibility, safety and efficacy of DBS of nucleus
      accumbens in patients with chronic depression.
    

Intervention name(s): Deep brain stimulation of nucleus accumbens
Intervention type(s): Procedure
Intervention description(s): Day0 : surgical placement of electrodes
M1 : stimulation of nucleus accumbens
M5 : stimulation of nucleus accumbens or associative territory of caudate nucleus (if no response observed with nucleus accumbens stimulation)
Other intervention name(s): Non applicable.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a chronic and resistant major depressive disorder.
      
Keywords: chronic and resistant major depressive disorder; deep brain stimulation
Intermittent Mechanical Compression For Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The study tests the use of a portable mechanical compression device (FM220, Flowmedic, USA)
      for the treatment of claudication and peripheral arterial disease.

      Major endpoints are improved exercise tolerance and relevant blood pressure ratios
    


Intervention name(s): Intermittent Mechanical Compression; Control
Intervention type(s): Device; Drug
Intervention description(s): FM220 device; Standard medical treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Claudication; Peripheral Arterial Disease; Intermittent Compression; Mechanical Compression; Flowmedic
Methylene Blue for Cognitive Dysfunction in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      While many bipolar patients treated with mood stabilizing medications experience improvement
      in their symptoms, some continue to have ongoing difficulties with concentration and memory.
      The purpose of this study is to look at whether these symptoms can be improved by adding the
      compound methylene blue to the treatment plan of patients who are already taking lamotrigine.

      Methylene blue is an available 'over the counter medication' in Canada. It has been studied
      in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies
      done in bipolar disorder report that methylene blue has had positive effects on both
      cognition and mood. It is important to do further research in this area as we know that, for
      patients who continue to have ongoing cognitive difficulties, there is no recognized standard
      of care for bipolar patients who experience these type of deficits.
    

Detailed description: 
      This is a double blind cross-over study. There are two dose ranges in this study. A cross
      over design means that some patients will start at one dose range and others with another.
      About half way through the study, patients will then be switched over to the other dose
      range. Patients partially stabilized on lamotrigine will be randomized to either
      subtherapeutic (16mg) or therapeutic (200mg) dose of methylene blue. This design is necessary
      because methylene blue stains urine and thus it is not possible to use a traditional placebo.
      Double-blind means that neither the doctor nor the patient will know which strength of study
      drug the patient will be on at what point in the study. The study will be conducted in three
      centres, each recruiting 20 subjects over a two-year period. The duration of the study is 6
      months.
    

Intervention name(s): Methylene Blue
Intervention type(s): Drug
Intervention MeSH terms: Methylene Blue
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: methylene blue for cognitive dysfunction in bipolar disorder
Ureteric Jet Doppler Waveforms in Patients With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      Urinary dysfunction is very common in individuals with spinal cord injury. The urine flowing
      from the collecting ducts to the renal calyx stretches the calyces. ANS controlled
      peristaltic contractions originate in the proximal renal pelvis and travel down the ureters,
      pushing urine from the renal pelvis towards the bladder. The urine bolus delivered from the
      kidneys through the peristaltic contraction of the ureter creates an image called ureteric
      jet. Using the Doppler analysis of ureteral jets, previous studies have examined the changes
      in the ureteric jet pattern in pathological conditions such as the diagnosis of normal
      ureteral physiology.
    

Detailed description: 
      This cross-sectional study was conducted at a tertiary rehabilitation center. Eighteen spinal
      cord injury patients who met the inclusion criteria and 24 healthy volunteers were included
      in the study. The appearance of üreteric jet form and bladder wall thicknesses were obtained
      by urinary Doppler ultrasound both in patient and control groups. Detrusor pressure and
      bladder volume were measured only in patient group during urodynamic assessment.
    

Intervention name(s): Doppler ultrasound, Urodynamic assessment.; Urodynamic assessment.
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): The patients included in the study group were given 600 cc of water in the morning and the Doppler ultrasound was performed 30 minutes later; A transurethral double lumen catheter was used to measure intravesical pressure in the urodynamic unit for the patients in the study group immediately after the use of the Doppler USG
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Spinal cord injury patients who were hospitalized in the spinal cord injury Rehabilitation
        Unit of our rehabilitation center and 32 no spinal cord injury who presented at outpatient
        clinics.
AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of treatment with AICS is weaning from oral corticosteroids, i.e. a reduction of the
      oral corticosteroid dose. An anticipated treatment benefit of AICS is a reduction of oral
      corticosteroid dose and stability/improvement of clinical parameters related to asthma in the
      targeted subject population. Ultimately, the goal is to free subjects with severe asthma from
      the burden of chronic oral steroid therapy.
    


Intervention name(s): Budesonide; Budesonide; Budesonide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Budesonide
Keywords: Severe Asthma, requiring chronic oral steroid use
CyclASol® Phase 1 Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to investigate the tolerability and the safety of Cyclosporine A
      containing CyclASol® eye drops compared to Placebo (vehicle) in a cohort of healthy
      volunteers. Subjects will be randomly assigned to dosing with CyclASol® eye drops or Placebo
      (vehicle) in the first part (first period) of the study, and switched to the alternative
      dosing in the second part (second period) of the study. An ophthalmological assessment of the
      eyes will be performed, and a questionnaire will be issued in the beginning and after each
      dosing. Additionally physical examinations, safety laboratory and ECGs will be performed, and
      blood samples will be analyzed for Cyclosporine A and Placebo (vehicle).
    


Intervention name(s): CyclASol®; Placebo (vehicle)
Intervention type(s): Drug; Drug
Intervention description(s): Cyclosporine A Solution; Vehicle Solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: phase I study; tolerability; safety; CyclASol®; eye drops
Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are:

      To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine
      to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.
    


Intervention name(s): Phentolamine Opthalmic Solution 0.75%; Placebo; Low dose pilocarpine; Low dose pilocarpine vehicle
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist; Vehicle for Phentolamine Ophthalmic Solution; Pilocarpine hydrochloride ophthalmic solution 0.4%; Vehicle for low dose pilocarpine
Other intervention name(s): Nyxol; Phentolamine Ophthalmic Solution Vehicle; Pilocarpine; LDP
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions; Pilocarpine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nyxol; Presbyopia; Pilocarpine
Efficacy of Patellar Taping and Electromyographic Biofeedback Training at Various Knee Angles on Quadriceps Strength and Functional Performance in Patellofemoral Pain Syndrome
Condition: Patellofemoral Disorder; Anterior Knee Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      This study compared the effects of patellar taping and electromyographic-biofeedback (EMG-BF)
      guided isometric quadriceps strengthening at different knee angles in patello-femoral pain
      syndrome (PFPS).
    

Detailed description: 
      A total of 60 adult male athletes aged 18 to 45 years were recruited. Subjects will be
      included with the history of knee pain during activities such as descending and ascending
      stairs, squatting, and running, had positive J sign (lateral tilt of patella), and a sign of
      patellar malalignment on the radiograph. Individuals with a history of fracture around the
      knee, patella dislocation, knee deformity (e.g., genu varum), flexion contracture,
      ligaments/meniscal injuries, and osteoarthritis of the knee will be excluded from the study.
      The protocol was submitted to and approved by the ethical sub-committee of the College of
      applied medical science, Majmaah, Saudi Arabia (Ethics number: MUREC-Nov./COM-2O20/11-2).
      Participants were requested to sign a written informed consent form approved by the
      institution ethics committee.

      Participants were randomly assigned to Group A (experimental group): electromyography
      biofeedback (EMG-BF) guided maximum voluntary isometric contraction exercise with patellar
      taping; Group B (control group): sham EMG-BF guided maximum voluntary isometric contraction
      without patellar taping. The outcome measure for this study will be the mean changes in
      maximum voluntary isometric contraction (MVIC) of the quadriceps muscle at different angles,
      pain intensity, single-leg triple hop test (SLTH), and functional status up to 6 weeks.
    

Intervention name(s): Electromyographic-biofeedback guided (EMG-BF) isometric quadriceps strengthening with patellar taping five days a week for six weeks.
Intervention type(s): Other
Intervention description(s): Patellar Taping, electromyography biofeedback (EMG-BF), Strength Training
Other intervention name(s): Control group will receive Sham EMG-BF guided isometric quadriceps strengthening without patellar taping five days a week for six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental: Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training along with patellar taping at 30, 60, and 90-degree angles.
No Intervention: Control: Participants in this group will receive Sham EMG-BF guided strength training without patellar taping at 30, 60, and 90-degree angles.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Strength; Function; PFPS; Athletes; SLTHT
Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 and Insulin Glargine and Insulin Glulisine Therapy in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to compare the 24-hour
      pharmacodynamics/ pharmacokinetics of biphasic insulin aspart 30 (BiAsp 30) thrice daily
      treatment with that of a basal-bolus treatment with insulin glargine and insulin glulisine in
      type 2 diabetic subjects.

      Pharmacodynamics is the glucose-lowering effect of the study medication over the entire
      observation phase from the time of administration and the efficacy period while the
      pharmacokinetics is the amount of the study insulin that can be determined in the blood.
    


Intervention name(s): biphasic insulin aspart 30; insulin glargine; insulin glulisine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects
Condition: Healthy
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The
      primary purpose of this trial is to evaluate the safety and tolerability, and
      pharmacodynamics, of multiple oral doses of PF-04620110.
    


Intervention name(s): PF-04620110; PF-04620110; PF-04620110; PF-04620110; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Multiple oral doses of 5 mg of PF-04620110 will be given once daily for 2 weeks.; Multiple oral doses of 1.5 mg of PF-04620110 will be given twice daily for 2 weeks.; Multiple oral doses of 3 mg of PF-04620110 will be given once daily for 2 weeks.; Multiple oral doses of 2.5 mg of PF-04620110 will be given twice daily for 2 weeks.; Multiple oral doses of placebo will be given once daily for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Multiple Dose Study in Overweight Healthy Subjects; body weight