bioihbjkbjnl/mcl2 huggingface dataset:
A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone Methyl
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to determine the effect of food on a single dose of 20 mg bardoxolone methyl
      administered to normal healthy adult subjects.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): bardoxolone methyl
Intervention type(s): Drug
Intervention description(s): oral, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel
      contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft
      contact lens wearers.
    


Intervention name(s): B&L Investigational Contact Lens; B&L PureVision Contact Lens
Intervention type(s): Device; Device
Intervention description(s): Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.; Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: contact lens
Study to Evaluate the Safety and Efficacy of Placulumab (CEP-37247) Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation
Condition: Sciatica
MeSH terms: Intervertebral Disc Displacement; Sciatica
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of the study is to evaluate the safety and efficacy of CEP-37247
      compared with placebo as assessed by the occurrence of adverse events, and the mean change in
      average pain intensity (API) in the affected leg.
    


Intervention name(s): CEP-37247; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.5-, 1-, 3-, 6-, and 12-mg doses of CEP-37247 will be administered by the transforaminal epidural route.; Matching placebo vials will be filled with the buffered solution for CEP-37247.
Other intervention name(s): placulumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sciatica; Pain
SOM230 Alone or in Combination With RAD001 in Patients With Medullary Thyroid Cancer
Condition: Medullary Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Carcinoma, Neuroendocrine; Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A mono centre study to evaluate the efficacy of SOM230 in patients with progressive
      metastatic or postoperative persistent medullary thyroid cancer.
    

Detailed description: 
      Medullary thyroid cancer (MTC) is a neuroendocrine tumor originating from thyroid C cells.
      Neuroendocrine tumors have been demonstrated to express somatostatin receptors as well as
      mTOR pathway. The somatostatin analogues now available (octreotide and lanreotide) act
      preferentially through the somatostatin receptor subtype 2 (sst2). In MTC, these compounds
      have been reported to exert anti-secretive effects on calcitonin but no anti-proliferative
      effects.SOM230 (pasireotide) is a new somatostatin analogue showing a peculiar binding
      profile with high affinity for sst1, sst2, sst3, sst5. Preliminary data show SOM230 to be
      effective in a phase II study on patients with metastatic carcinoid. RAD001 (everolimus) is a
      novel agent that interacts with mTOR. It was demonstrated to inhibit tumor growth in
      neuroendocrine tumor cell lines. Some clinical trials have explored the efficacy of a
      combined therapy with RAD001 plus octreotide in patients with digestive neuroendocrine
      tumors, highlighting encouraging results in term of tumor control.In particular, octreotide
      and RAD001 seem to show a synergistic activity in inhibiting neuroendocrine tumor
      proliferation.
    

Intervention name(s): SOM230 alone or in combination with RAD001.
Intervention type(s): Drug
Intervention description(s): SOM230 (pasireotide) 60 mg i.m. injection once every 28 days, +/- 2 days. RAD001 (everolimus) 10 mg per os daily.
Intervention MeSH terms: Everolimus; Pasireotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Progressive metastatic; postoperative persistent
The Impact of App-based Cognitive Training on Post-stroke Upper Extremity Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      To find out the impact of app-based cognitive training on upper extremity function in
      patients with sub-acute stroke.
    


Intervention name(s): traditional physical therapy; mobile app-based cognitive training
Intervention type(s): Other; Other
Intervention description(s): this group received conventional upper extremity active ROMs and stretches for 30 minutes three to five times a week for 6 weeks without using the app-based cognitive training.; This group received mobile app-based cognitive training of 30minutes session three to five times a week for 6 weeks which includes a few activities such as the memory, coordination and alertness along with conventional UE exercises for 15 minutes three to five times a week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: stroke, sub-acute stroke, cognitive impairment
a Pilot Study of Pramipexole to Treat Extrapyramidal Symptoms Induced by Antipsychotics
Condition: Extrapyramidal Syndrome
MeSH terms: Basal Ganglia Diseases; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is a pilot phased interventional clinical trial . The first stage will recruit 10
      patients with antipsychotic induced extrapyramidal symptoms.The patients will take
      pramipexole for 8 weeks. The inital dose of pramipexole will be 0.375 mg/d, and the
      adjustment of drug dose will be depended on the the doctor's decision and patients'
      condition.

      The second stage was a randomized, rater blindness and Antan controlled clinical study.
      Researchers will recruit another 40 patients with extrapyramidal symptoms (tradive dyskinesia
      will be excluded). The patients will randomly be divided into artane group or pramipexole
      group, and the efficacy and safety condition of pramipexole and artane for different kinds of
      EPS will be compared. The pramipexole group will have 20 cases, and 20 cases of artane group.
      The dose of pramipexole group group range from 0.375mg/d to 0.75mg/d dose .The dose of artane
      range from 2 mg/d to 4 mg/d,.The accurate drug doses can be adjusted by the doctor according
      to the patients' condition .

      Researchers will evualate patients' symptom at baseline, after three days' of baseline, 2
      weeks,4 weeks, 6 weeks and 8 weeks. The Simpson-Angus Scale(SAS) 、Barnes Akathisia Rating
      Scale（BARS）,Abnormal Involuntary Movement Scale (AIMS), Positive and Negative Syndrome
      Scale(PANSS), Calgary Depression Scale for Schizophrenia(CDSS), Clinical Global
      Impression-severity of Illness Scale(CGI-S) will be evualated by the trained raters indicated
      as the drug's efficacy of the extrapyramidal symptoms and schizophrenia .The adverse events,
      laboratory parameters, vital signs, ECG will be recorded as the safety indicators of the
      study drugs.
    


Intervention name(s): Pramipexole; Trihexyphenidyl hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): The dose of pramipexole range from 0.375mg/d to 0.75mg/d , The accurate dose of pramipexole can be adjusted by the patient's condition and tolerance .; he dose of Antan range from 2 mg/d to 4 mg/d , The accurate dose of pramipexole can be adjusted by the patient's condition and tolerance .
Other intervention name(s): SenForro; Antan
Intervention MeSH terms: Pramipexole; Trihexyphenidyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Extrapyramidal syndromes praminpexole pilot study
Implantable Loop Recorders in Post-atrial Fibrillation (AF) Ablation: RPAF-A
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      This is a randomized pilot study, of post pulmonary vein isolation (PVI) patients to
      determine the clinical utility of the Implantable Loop Recorder. These type of patients
      either are monitored with weekly transtelephonic monitoring (TTM) or implantable loop
      recorder (ILR). The Medtronic Reveal XT loop recorder will be implanted at the time of the
      PVI or at the 3-4 month PVI follow-up visit and patient care will be managed based on
      randomization to a blinded or unblinded group. Outcome measures will be compared to aid in
      decision making regarding anticoagulation and overall post ablation clinical management.
    

Detailed description: 
      This is a randomized pilot study, of post pulmonary vein isolation (PVI) patients to
      determine the clinical utility of the Implantable Loop Recorder. The Medtronic Reveal XT
      implantable Loop Recorder is a market released device indicated for patients with clinical
      syndromes or situations at increased risk of cardiac arrhythmias, and patients who experience
      transient symptoms that may suggest a cardiac arrhythmia. These type of patients either are
      monitored with weekly transtelephonic monitoring (TTM) or implantable loop recorder (ILR).
      Neither approach has been shown to be superior. As both approaches are currently being
      performed based on physician preference, the investigators propose to study and compare both
      approaches in a randomized fashion for evidence based practice. The Medtronic Reveal XT loop
      recorder will be implanted at the time of the PVI or at the 3-4 month PVI follow-up visit and
      patient care will be managed based on randomization to a blinded or unblinded group. Outcome
      measures will be compared to aid in decision making regarding anticoagulation and overall
      post ablation clinical management.
    

Intervention name(s): TTM and Holter monitor
Intervention type(s): Other
Intervention description(s): Standard of care visits recordings reviewed during clinical visits
Other intervention name(s): Transtelephonic monitoring
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients presenting for atrial fibrillation ablation
      
Keywords: atrial fibrillation; implantable loop recorder; TTM
Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Spray Dried BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the present study was to obtain information about the safety, tolerability and
      pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of
      spray-dried powder in healthy male and female volunteers. According to the original protocol,
      the primary objective was to investigate the safety and tolerability of single doses of a new
      spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of
      Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD
      II with and without concomitant administration of lactose
    


Intervention name(s): SD I; SD II; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a Phase 2/3, multi-center, randomized, double-blind, placebo-controlled study to
      assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult and
      adolescent patients with active eosinophilic esophagitis. Subjects who complete the
      randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses
      of open-label lirentelimab (AK002) through the OLE Period of the study.
    


Intervention name(s): Placebo; lirentelimab (AK002)
Intervention type(s): Other; Drug
Intervention description(s): Placebo; Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: EoE; Eosinophil; Esophagitis
Speckle-tracking Tricuspid Annular Plane Systolic Excursion
Condition: Ventricular Function, Right
MeSH terms: Systolic Murmurs
Study type: Observational

Summary: 
      The study is designed to validate the use of speckle-tracking echocardiography to measure
      tricuspid annular plane systolic excursion as a measurement of right ventricular function
      during transesophageal echocardiography.
    

Detailed description: 
      1. Use of speckle-tracking echocardiography to validate tricuspid annular plane systolic
           excursion measurements with transesophageal echocardiography.

        2. This study intends to validate the use of speckle-tracking echocardiography to measure
           the distance the tricuspid annulus moves during the systolic phase. The guideline
           articles regarding right ventricular function suggest m-mode measurements from the
           transthoracic approach and the same measurements may underestimate the actual distance
           on transesophageal echocardiography. This speckle-tracking technology will allow this
           distance to be measured despite its often non-parallel motion to the ultrasound beam,
           which otherwise limits the reliability of the valve recorded.

        3. All subjects undergoing a planned surgical procedure in which the use of transesophageal
           echocardiography would be used regardless for their management.

        4. No interventions, only evaluation of the measurements obtained with transthoracic
           echocardiography compared to transesophageal echocardiography.

        5. No follow-up, study will be completed at the time of image acquisition.
    

Intervention name(s): Concurrent TTE and TEE
Intervention type(s): Other
Intervention description(s): All subjects will undergo both transthoracic echocardiography and transesophageal echocardiography to compare the results of measurements obtained from both imaging locations.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All subjects will be scheduled to undergo a surgical procedure requiring general anesthesia
        and either due to subject factors or procedure factors, the use of intraoperative
        transesophageal echocardiographic monitoring will occur. These subjects will then have both
        transesophageal and transthoracic echocardiographic measurements of one variable of right
        ventricular function to validate the results from the transesophageal window.
      
Keywords: Speckle-tracking echocardiography; Transthoracic echocardiography; Transesophageal echocardiography
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium Chewable Tablets 5mg Under Fasted Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Montelukast Sodium chewable 5 mg tablet and Innovator's(Merck)Singulair chewable 5
      mg tablet. Dosing periods were separated by a washout period during fasted study.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Torrent's Montelukast Sodium Chewable Tablets 5mg; Singulair® (Montelukast Sodium) Chewable Tablets 5mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Iron Absorption From GDS Capsules II
Condition: Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Slow release iron capsules containing ferrous sulfate have been designed based on the gastric
      delivery system. Iron absorption from those capsules administered with and without meals will
      be measured using stable iron isotopes.
    


Intervention name(s): GDS capsule with meal; Ferrous sulfate with meal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): GDS capsule with meal; Ferrous sulfate with meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Iron absorption; Slow release iron; Gastric delivery system; Iron deficiency
Photobiomodulation Therapy Combined With Static Magnetic Field on the Subsequent Performance
Condition: Skeletal Muscle Performance
Study type: Interventional

Summary: 
      There is evidence about the effects of photobiomodulation therapy (PBMT) alone and combined
      with static magnetic field (PBMT-sMF) on skeletal muscle fatigue, physical performance and
      post-exercise recovery in different types of exercise protocols and sports activity. However,
      it is unknown the effects of PBMT-sMF to improve the subsequent performance after a first set
      of exercise. Therefore, the aim of this study was to investigate the effects of PBMT-sMF,
      applied between two sets of exercises, on the subsequent physical performance.
    

Detailed description: 
      A randomized, crossover, triple-blinded (assessors, therapist and volunteers),
      placebo-controlled trial was carried out. Healthy non-athletes' male volunteers were
      randomized and treated with a single application of PBMT-sMF and placebo between two sets of
      an exercise protocol performed on isokinetic dynamometer.

      The order of interventions was randomized.

      The primary outcome was fatigue index, measured by isokinetic dynamometer during the exercise
      protocol. The secondary outcomes were total work and peak torque measured by isokinetic
      dynamometer during the exercise protocol; and blood lactate, measured by blood samples
      collected before, 3 minutes after the first set of the exercise protocol, 3 minutes after the
      application of the intervention and 3 minutes after the second set of the exercise protocol.

      Statistical analysis:

      The findings were tested for normality using the Kolmogorov-Smirnov test and were determined
      to have a normal distribution. Data were expressed as the mean and standard deviation, and a
      two-way repeated measures ANOVA was performed to test between-group differences at each
      timepoint (treatment effects), mean difference (MD) and 95% confidence intervals (CI),
      followed by the Bonferroni post hoc test. The significance level was set at p < 0.05.
    

Intervention name(s): Active PBMT-sMF; Placebo PBMT-sMF
Intervention type(s): Device; Device
Intervention description(s): PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter. Six different sites of the knee extensor muscles (two medial, two lateral and two central points) were irradiated at the same time.; Placebo PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter, but without any emission of therapeutic dose. Placebo PBMT-sMF was applied at six different sites of the knee extensor muscles (two medial, two lateral and two central points).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Photobiomodulation Therapy; Static Magnetic Field; Subsequent performance
Effect of Global Postural Reeducation (GPR) Program With Hamstring Stretch for Patients With Low Back Pain
Condition: Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to find out the additional effect of global re-education program
      with hamstring stretching in patients with low back pain.
    

Detailed description: 
      Low back pain (LBP) is a very common health problem worldwide and a major cause of disability
      which affecting performance at work and general well-being. LBP is a complicated condition
      which affects the physiological and psychosocial aspects of the patient. The muscles of the
      low back provide the strength and mobility for all activities of daily living. The purpose of
      this study is to find out the additional effect of global re-education program with hamstring
      stretching in patients with low back pain.
    

Intervention name(s): Global Postural Reeducation Program; Hamstring Stretch Program
Intervention type(s): Other; Other
Intervention description(s): Global Postural Reeducation Program with hamstring stretch The lying posture with flexion of the legs aimed to stretch the posterior chain (upper trapezius, levator scapulae, sub occipital, erector spinae, gluteus maximus, ischio-tibial, triceps surae, and foot intrinsic muscles). The initial position will lying with the hip flexed and progression consisted of increasing hip flexion, knee extension, and dorsiflexion of the ankle All above exercises will be given and to be held for 15 minutes each. 40 min/session, 3 times/week for 6 weeks; Hamstring Stretch Program 3 times for 30 seconds hold, subjects rested for 15 seconds between stretches. Knee -flexor eccentric training to prevent hamstring muscle strain 10-15 rep 40 min/session, 3 times/week for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low Back Pain; Oswestry Disability Index; Numeric Pain Rating Scale; Stretch