bioihbjkbjnl/mcl2 huggingface dataset:
The Primary Objective of This Study Was to Investigate the Effect of Insulin on Myocardial Perfusion and Cardiac Function in Patients Undergoing Cardiac Surgery for CPB Using Transesophageal Echocardiography (TEE) to Detect CSBF
Condition: Insulin
Study type: Interventional

Summary: 
      The primary objective of this clinical trial was to investigate the effects of insulin on
      myocardial blood flow reflected by CSBF which was evaluated by TEE. The second aim was to
      observe the effect of insulin on cardiac function and markers of myocardial damage.
    


Intervention name(s): Glucose insulin potassium
Intervention type(s): Drug
Intervention description(s): After induction of anaesthesia,cardiac systolic-diastolic function was first measured by TEE, GIK solution was continuously pumped until the end of the procedure at a dose of 30 mU/kg/h of insulin, 0.12 g/kg/h of glucose and 0.06 mmol/kg/h of potassium chloride
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Insulin; Perioperative period; Blood glucose; Heart protection
Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether MOL4239 is effective in adult subjects with
      mild to moderate plaque psoriasis by comparing two target lesions in which each subject will
      apply MOL4239 ointment to one target lesion and placebo ointment to the contralateral target
      lesion twice a day for 28.5 consecutive days.
    

Detailed description: 
      This is a phase 2a, Randomized, Multi-center, Blinded, Paired Psoriasis Lesion, Comparative
      Placebo-Controlled study to evaluate the safety, preliminary efficacy and pharmacokinetics of
      MOL4239 in 30 adult subjects with mild to moderate plaque psoriasis. Eligible subject will
      have a diagnosis of mild to moderate plaque psoriasis affecting 9.9% body surface area (BSA)
      or less, and two designated similar target lesions with a Psoriasis Severity Score of at
      least 6 or higher. Each subject will apply 10% MOL4239 ointment to one target lesion and
      placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.
    

Intervention name(s): MOL4239; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days; placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis
Chemotherapy, Hormone Therapy, and Surgery to Remove the Prostate Gland in Patients With High Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      In men with prostate cancer who do not have evidence of spread to bone or other sites on
      computed axial tomography (CAT) scan/bone scan but are still at significant risk of failing
      treatment with surgery or radiation alone, a combination of chemotherapy and hormone therapy
      is being given for 6 months followed by surgery to remove the prostate.
    


Intervention name(s): Chemotherapy
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate cancer; chemotherapy; hormone therapy; surgery; PSA; Gleason score
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
Condition: Postmenopausal Women With Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to assess if there were any clinically meaningful differences in
      pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between
      GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).
    

Detailed description: 
      This was an international, multicenter, randomized, double-blind, parallel-group study with a
      total duration of up to 83 weeks.

      The study comprised a screening period of up to 5 weeks to assess a subject's eligibility and
      two treatment periods: Treatment Period 1 (TP1) from Day 1 to Week 52 and Treatment Period 2
      (TP2) from Week 52 to Week 78.

      Women with postmenopausal osteoporosis (PMO) were randomized on Day 1 in a 1:1 ratio to
      receive either two 60 mg subcutaneous (s.c.) doses at 26-week intervals of GP2411 (proposed
      biosimilar denosumab) or EU-Prolia (EU-authorized Prolia®) during TP1. At Week 52,
      participants in the EU-Prolia group were re-randomized 1:1 to either continue with a third
      dose of EU-Prolia or switch to GP2411 for TP2. Participants in the GP2411 group continued the
      treatment with a third dose of GP2411 in TP2. The End of Study was achieved at Week 78.
    

Intervention name(s): GP2411; EU-Prolia (EU-authorized Prolia®)
Intervention type(s): Biological; Biological
Intervention description(s): 60 mg /mL subcutaneous injection every 6 months; 60 mg /mL subcutaneous injection every 6 months
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prolia; GP2411; denosumab; postmenopausal osteoporosis
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain
Condition: Dysmenorrhea
MeSH terms: Pelvic Pain; Dysmenorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to evaluate the effects of treatment with Seasonique an
      extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the
      typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study
      duration will be approximately 9 months. Patients will be required to record menstrual pain
      in a daily diary.
    


Intervention name(s): levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets; levonorgestrel/EE 0.15/0.03 mg tablets and placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet daily; 1 tablet daily
Other intervention name(s): Seasonique; Portia
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cyclic pelvic pain; dysmenorrhea
Physiotherapy Treatment for Chronic Achilles Tendinopathy
Condition: Achilles Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      Laser treatment with the proper dosage has been found effective in the treatment of chronic
      Achilles tendinopathy, and animal research indicate that a combination of cryotherapy
      followed by LLLT could yield an even better result.

      Thus, the main purpose of this project is to test if the addition of low level laser therapy
      can enhance the treatment result of exercise and cryotherapy in patients with chronic
      Achilles tendinopathy, yielding less pain and higher function.
    


Intervention name(s): Low-level Laser Therapy; Sham Low-level Laser Therapy; Exercise therapy; Cryotherapy
Intervention type(s): Other; Other; Other; Other
Intervention description(s): LLLT, 904 nm wavelength, 3 Joules per treatment point in accordance with World Association for Laser Therapy (WALT) guidelines.; Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).; Concentric and eccentric exercises with a total duration of approximately 20 minutes.; Twenty minutes of cryotherapy applied to the Achilles tendon.
Other intervention name(s): Photobiomodulation; Sham Photobiomodulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic tendinopathy; Low-level Laser Therapy; LLLT; Photobiomodulation; Cryotherapy; Exercise therapy; Randomized Clinical Trial; RCT; Placebo-controlled
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands
Condition: Platysmal Bands
Study type: Interventional
Phase: Phase 2

Summary: 
      Interventional phase 2 study to evaluate safety and efficacy of abobotulinumtoxinA for the
      treatment of platysmal bands.
    


Intervention name(s): AbobotulinumtoxinA dose 1; Placebo; AbobotulinumtoxinA dose 2; AbobotulinumtoxinA dose 3
Intervention type(s): Biological; Other; Biological; Biological
Intervention description(s): Treatment of platysmal bands; Treatment of platysmal bands; Treatment of platysmal bands; Treatment of platysmal bands
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years
Condition: Encephalitis, Tick-borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW
      in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME
      IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years).
    


Intervention name(s): Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: tick-borne encephalitis
Obesity and Clinical Presentation of Hyperandrogenism
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism
Study type: Observational

Summary: 
      Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in reproductive
      women. It is estimated that 5 to 10% of women of reproductive age have PCOS. One of the major
      diagnostic criteria of PCOS was chronic anovulation which lead to irregular menstruation,
      amenorrhea, and infertility; the other diagnostic criteria was hyperandrogenism which lead to
      hirsutism, acne and alopecia. Furthermore, PCOS is thought as a metabolic disorder, the
      long-term consequence of PCOS were diabetes mellitus and cardiovascular disease, which are
      potentially dangerous in women health. Early diagnosis and prevention is very important to
      the PCOS patients.

      Obesity is the most potential risk of threat to health of populations. There is a major
      impact of obesity on the PCOS related disorders. Insulin resistance and distribution of
      adipose tissue were thought to be the important risk factors of cardiovascular and metabolic
      syndrome. To treat PCOS patients properly,Wan-Fang hospital had established a specific
      medical team. The investigators recently published in "Fertility and Sterility" about the
      clinical presentation of androgen excess in Taiwanese women. Hirsutism is much less
      prevalence (30%) in Taiwanese PCOS women than that previous reported (65-80%) in theWestern
      women. It is important to know that some clinical presentation of PCOS might have ethic
      variance. Insulin resistance was reported as another candidate that might have ethic
      variance. The investigators had reported about 40% women in PCOS women were obese, it is
      similar with previous literature reported. Obesity is a major factor that could be controlled
      during the treatment of PCOS.Weight reduction is one of our methods in PCOS treatment. The
      progressive results for obese PCOS women would be facing the risks of diabetes and metabolic
      syndrome. The investigators thought like to evaluate the benefit of weight reduction program
      to the prognosis of obese women with PCOS.

      Furthermore, it is known that Endothelial progenitor cells (EPC) be an early marker of
      cardiovascular disease, the investigators would like to know the role of EPC to predict
      metabolic syndrome in women with PCOS. Wan-Fang hospital has a professional team in PCOS
      treatment and research which including gynecological endocrinologist, cardiologist, medical
      endocrinologist, specialist in weight reduction. This team had been working well for more
      that 4 years.

      The investigators hope that we can make a contribution to the study and treatment of PCOS in
      Taiwan.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Polycystic Ovary Syndrome(PCOS)
      
Keywords: PCOS; Acne; Hirsutism
Augmentation in Tx-resistant OCD: an Open Label Trial
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive
      Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large
      percentage of patients fail to respond to medications and have residual symptoms. Such
      patients are referred to as having treatment resistant OCD.
    

Detailed description: 
      A patient will receive study drug for about 12 weeks. Throughout the study, the study doctor,
      on best medical judgment, may gradually increase or decrease the dose of the study
      medication. The adjustments will dependent on the subject's response and whether the subject
      has side effects. Once the subject has completed treatment under this study, the subject may
      resume standard treatment for his/her obsessive compulsive disorder by their regular doctor.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Psychiatry clinic
      
Keywords: obsessive compulsive disorder; OCD; treatment-resistant; SSRI
Radiation Therapy in Treating Young Patients With Gliomas
Condition: Brain Tumor; Central Nervous System Tumor
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may
      kill more tumor cells and cause less damage to normal tissue.

      PURPOSE: This phase II trial is studying how well radiation therapy works in treating young
      patients with gliomas.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the marginal-failure rate in young patients with low-grade gliomas treated
           with reduced-field conformal radiotherapy.

      Secondary

        -  Determine the progression-free survival, event-free survival, and overall survival rates
           of young patients treated with this regimen.

        -  Determine quality of life of patients treated with this regimen.

        -  Correlate MIB-1 labeling index with progression-free survival and overall survival of
           these patients.

      OUTLINE: This is a multicenter study.

      Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the
      absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline or 6 weeks after completion of study treatment and
      then at 2 and 5 years (closed as of 10/27/2010).

      After completion of study treatment, patients are followed every 3 months for 2 years, every
      6 months for 2 years, and then annually thereafter.
    

Intervention name(s): radiation therapy
Intervention type(s): Radiation
Intervention description(s): Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Other intervention name(s): 3-dimensional conformal radiation therapy; intensity-modulated radiation therapy; 3D conformal radiation therapy; 3D-CRT; IMRT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: childhood oligodendroglioma; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; childhood low-grade cerebral astrocytoma; recurrent childhood visual pathway and hypothalamic glioma; untreated childhood cerebellar astrocytoma; untreated childhood visual pathway and hypothalamic glioma
The Effects of Buprenorphine on Responses to Verbal Tasks
Condition: Basic Science
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In this study, the investigators will examine the effects of buprenorphine, as compared to
      placebo, upon physiological, subjective, and hormonal responses to a stressful speech task
      and a non-stressful control task in healthy adults. There is strong evidence in support of
      the role of endogenous opioids and opiates in mediating social behavior in humans and other
      animals, and particularly, in social distress. Recently it has been shown that buprenorphine,
      a partial mu-opioid agonist, reduces sensitivity to recognition of fearful facial expressions
      in humans. Here, the investigators propose to further explore the role of the opioid system
      in mediating stress responses in humans through the use of buprenorphine. The investigators
      hypothesize that buprenorphine with reduce both physiological and subjective measures of
      stress.
    


Intervention name(s): Buprenorphine 0.2 MG Sublingual Tablet; Placebo; Buprenorphine 0.4 MG Sublingual Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2); This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo; This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4)
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: opioid; subjective; stress; buprenorphine
Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's
      formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation
      (Plavix® 300 mg tablets) in healthy, adult, human, male subjects under fed conditions and to
      assess the bioequivalence.
    

Detailed description: 
      An open label, balanced, randomized, two treatment, two sequence, two period, single-dose,
      crossover oral bioequivalence study of Clopidogrel Bisulfate 300 mg Tablets of Dr. Reddy's
      Laboratories Ltd., India and Plavix® (Clopidogrel Bisulfate) 300 mg Tablets of Bristol-Myers
      Squibb/Sanofi pharmaceuticals partnership Bridgewater, NJ 0880750086441, USA, in healthy,
      adult, human male subjects under fed conditions.
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): Clopidogrel Tablets 300 mg
Other intervention name(s): Plavix
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the relative difference in Pharmacokinetics (PK)
      between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with
      desvenlafaxine SR and venlafaxine ER when a single dose is administered.
    


Intervention name(s): Desvenlafaxine Succinate Sustained-Release (DVS SR); Venlafaxine Extended Release (VEN ER)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Venlafaxine Hydrochloride; Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Subjects
Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Neurobehavioral Manifestations; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this pilot study is to evaluate, by means of a specific cognitive test battery
      (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the
      slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of
      treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate
      which test of the battery is the most sensitive in detecting differences between treatment
      groups.
    


Intervention name(s): Fingolimod; Interferon beta 1b
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg in capsules for oral administration once daily; 250 μg injected s.c. every other day
Intervention MeSH terms: Interferons; Interferon-beta; Fingolimod Hydrochloride; Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis; cognitive symptoms; relapsing-remitting multiple sclerosis (RRMS); fingolimod; Magnetic resonance imaging (MRI)
A Double-blind, Randomised Study to Assess the Influence of Tiotropium (Spiriva®)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate that tiotropium (Spiriva®) does not prolong the QT interval of the ECG more
      than placebo
    

Detailed description: 
      The objective of this study is to demonstrate that tiotropium does not prolong the QT
      interval more than placebo. This will be achieved by testing non-inferiority hypothesis.

      Study Hypothesis:

      There is one primary variable to be tested for non-inferiority: tiotropium high dose compared
      to placebo:

      H0: µ(TIO,12) - µ(PBO,12) >= 10 ms vs. H1: µ(TIO,12) - µ(PBO,12) < 10 ms where µ(TIO,12),
      µ(PBO,12) represent the mean change from baseline QTcF between 5 minutes and 2 hours after 12
      days of treatment (taking the mean of the time-matched differences between baseline and
      post-baseline values in each treatment period) with tiotropium 54 µg, or placebo,
      respectively.

      If the data suggest that the Fridericia correction is poor for the study population, an
      alternative correction will be explored (QTcN). The other correction formula would be used as
      a replacement for the Fridericia correction and would be defined before unblinding of the
      data.

      Comparison(s):

      Placebo, moxifloxacin as active control
    

Intervention name(s): tiotropium 18 mcg or 54 mcg qd; placebo matching tiotropium qd; moxifloxacin 200 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment