bioihbjkbjnl/mcl2 huggingface dataset:
Double-Blind Study of Miglitol in Japanese With type2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the efficacy and safety of miglitol in Japanese patients with type 2 diabetes
      that is insufficiently controlled diet alone.
    


Intervention name(s): miglitol
Intervention type(s): Drug
Intervention MeSH terms: Miglitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: alpa-glucosidase inhibitor
Aerobic Training for Management of Post-Concussion Syndrome in Adolescents
Condition: Concussion; Post-concussion Syndrome; Sports Injury
MeSH terms: Post-Concussion Syndrome; Syndrome; Athletic Injuries
Study type: Interventional

Summary: 
      Sports-related concussions are common in adolescent-athletes. Prolonged recovery after
      concussion or post-concussion syndrome (PCS) is a public health problem. This project will
      determine the effectiveness of an aerobic exercise program for management of PCS and it will
      evaluate the influence of exercise on biologic correlates of PCS.
    

Detailed description: 
      Concussion or mild traumatic brain injury (mTBI) is a public health problem and it is
      imperative that efficacious treatment protocols be developed to reduce the morbidity
      associated with PCS in adolescents. In adolescent athletes, timely return of normal
      neurocognitive function and return to sports safely is critical to normal development. The
      proposed study will fill a critical gap by systematically evaluating the potential efficacy
      of an aerobic training intervention for management of PCS in adolescents. To our knowledge,
      this will be the first randomized controlled study to evaluate the efficacy of aerobic
      training for treatment of PCS in adolescents as soon as four weeks after injury. The study
      will also improve our understanding of the pathophysiology of PCS and the biologic influence
      of aerobic training on PCS. The proposed study will fill a critical gap and inform the
      development of larger studies to assess the efficacy, and if proven efficacious, optimize the
      timing and intensity of aerobic training treatment protocols, thus transforming the care and
      limiting the adverse public impact of this condition.
    

Intervention name(s): Aerobic Training Intervention; Stretching Intervention
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: concussion; mild traumatic brain injury; post-concussion syndrome; adolescents; sports injury; aerobic training; stretching training
Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects
Condition: Cardiodynamics; Safety; Tolerability; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, double-blind, randomized, placebo- and positive-controlled,
      double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over
      comparison between moxifloxacin and placebo in healthy male and female subjects. The primary
      objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an
      effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally
      administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects.
      Moxifloxacin is included as a positive control.
    


Intervention name(s): selexipag; placebo for selexipag; moxifloxacin; moxifloxacin-matching placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin; Selexipag; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Selexipag; ACT-333679
Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter study will be divided into 2 phases. The first phase will be an open label,
      dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled,
      parallel-group, dose-response phase. The second phase will only start if the first phase
      succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne
      vulgaris in the face will be included.The results from part 2 has been presented in the
      result section.
    

Detailed description: 
      For the second part: All patients will receive 4 PDT sessions 2 weeks apart using a light
      dose of 37 J/cm2. One treatment group will receive vehicle cream, while the other 2 groups
      will receive MAL cream with a concentration of 40 mg/g and 80 mg/g, respectively. The MAL and
      vehicle cream will be applied in a thin layer on clean skin and left for 1.5 hours under
      occlusion before illumination.
    

Intervention name(s): Methyl aminolevulinate (MAL) PDT
Intervention type(s): Drug
Intervention description(s): Cream application followed by illumination with red light
Intervention MeSH terms: Aminolevulinic Acid; Methyl 5-aminolevulinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Peripheral Endothelial Function in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of the study is to assess the peripheral endothelial function in adult COPD (chronic
      obstructive pulmonary disease) patients and the relationship between the peripheral
      endothelial function and the pulmonary function.
    

Detailed description: 
      The primary criteria is the peripheral endothelial function that will be assessed by the
      measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The
      pulmonary function will be assessed by the measures of the FEV1 (forced expiratory volume in
      one second), the forced vital capacity (FVC) and the expiratory flow between 25% and 75%
      (FEF25-75%). The relationship between these parameters of the pulmonary function and the
      peripheral endothelial function will be analyzed. In addition, a relationship between
      peripheral endothelial function and the severity of COPD (classification according to GOLD
      (Global Initiative for Chronic Obstructive Lung Disease) 2010 and GOLD 2011 and the COPD
      assessment test, the cardiovascular risk factors (SCORE INdex) and the smoker status will be
      also assessed.
    

Intervention name(s): COPD patients
Intervention type(s): Device
Intervention description(s): measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (EndoPAT®)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: endothelial function; COPD; pulmonary function
Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The metabolic effect of three different doses of insulin aspart and human insulin are
      investigated with the euglycaemic glucose clamp technique.
    

Detailed description: 
      Double-blind, randomized, 6-period cross-over study in 16 healthy subjects. Each patient
      participates in 6 euglycemic glucose clamp experiments each.

      The time interval between the study days is 2 to 28 days. At the clamp visits, subjects are
      connected to a Biostator (MTB Medizintechnik, Ulm, Germany) and receive an intravenous human
      insulin infusion (rate of 0.15 mU/kg/min) over the duration of each experiment to prevent a
      rise in endogenous insulin secretion. After a baseline period of 2 h the trial drug (6, 12,
      or 24 U of either Insulin Aspart or regular human insulin in random order) are administered
      s.c. with a syringe into the abdominal wall. Glucose infusion rates (GIR) necessary to keep
      blood glucose concentrations close to the clamp level of 90 mg/dl (5 mmol/l) are administered
      and recorded by the Biostator every minute for a period of 12 h post-dosing. Blood samples
      are drawn at regular intervals for the analysis of C-peptide and (depending on the trial drug
      administered) serum insulin or serum Insulin Aspart concentrations (measured with specific
      ELISAs).
    

Intervention name(s): insulin aspart; human regular insulin
Intervention type(s): Drug; Drug
Intervention description(s): 6, 12, 24 U s.c.; 6, 12 and 24 IU sc
Other intervention name(s): Novorapid; Actrapid
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: euglycaemic glucose clamp; duration of action; late metabolic activity; hypoglycaemia
Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement
Condition: Hip Osteoarthritis; Pain, Acute; Pain, Postoperative; Opioid Use
MeSH terms: Osteoarthritis, Hip; Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      The nerves from lumbar plexus (LP) are the current target to achieve analgesia after a total
      hip arthroplasty (THA). Lumbar plexus block (LPB) is an alternative that provides optimal
      postoperative analgesia. However, many adverse effects and complications have been reported
      due to its proximity to vital structures. Because of these shortcomings, an alternative to
      block the LP nerves is required.

      In a recent trial suprainguinal Fascia Iliaca Block (SFIB) was reported to provide reliable
      analgesia in THA. SFIB may carry a lower risk profile, however, no study has compared the
      efficacy of LPB and SFIB in this setting.

      Thus, this randomized trial is set out to compare US guided LPB and SFIB for analgesia after
      THA. The hypothesis is that both blocks would result in similar postoperative opioid
      (morphine) consumption at 24 hours and, therefore, designed the study as an equivalence
      trial.
    


Intervention name(s): lumbar plexus block; suprainguinal fascia iliaca block
Intervention type(s): Procedure; Procedure
Intervention description(s): Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, in the posteromedial quadrant of psoas muscle; Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, underneath the fascia iliaca at the suprainguinal level
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nerve block; fascia iliaca; hip replacement; lumbar plexus
Nicotinamide Riboside and Metabolic Health
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This study will investigate the effects of 6 week Nicotinamide Riboside supplementation (1000
      mg/day) on metabolic health in healthy (pre)obese humans. The primary objective will be
      hepatic and whole body insulin sensitivity. Secondary objectives, to provide information
      about the underlying mechanism, will be muscle mitochondrial function, brown fat activity,
      ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body
      composition and acetylcarnitine levels.
    


Intervention name(s): Nicotinamide Riboside (Niagen); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nicotinamide Riboside; Obesity; Metabolic health; Insulin resistance; Mitochondrial function; Brown adipose tissue; Energy expenditure; Ectopic lipid accumulation; Cardiovascular risk; Acetylcarnitine
A Epidemiological Survey of Preoperative Pain Perception and Postoperative Pain in Chinese Population
Condition: Pain; Surgery
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      Object: Every person's pain perception and possible postoperative pain is different. As the
      investigators know, they are affected by many factors. However, the investigators don't know
      whether the smoking factors, alcohol factors, surgery type, education background, etc. will
      affect individual pain perception and possible postoperative pain in Chinese population. This
      study was conducted to investigate the power of these possible affect factors. Method:
      Patients receiving elective surgery under general anesthesia were recruited into this study.
      The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain
      tolerance (PTO)and also investigated the patient's personal information of smoking factors,
      alcohol factors, surgery type, education background, etc. In addition, we retrospectively
      investigated the visual analog scale (VAS) during patient-controlled analgesia (PCA)
      treatment 0 to 48 h after operation as well as the PCA press frequency and drug consumption
      of those patients who received PCA administration.
    

Detailed description: 
      Patients with the following diseases were excluded: known history of chronic pain,
      psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular
      diseases, kidney or liver diseases with poor hepatic function, alcohol or pregnancy or at the
      lactation period.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Chinese patients receiving elective surgery under general anesthesia
      
Keywords: pain perception; postoperative pain; demography; smoking; alcohol
Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Intravenous (IV) Catheterization in Children
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is a comparison of the anesthetic effectiveness of J-Tip needle-free jet injection
      of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ELA-Max for peripheral
      intravenous catheter (PIV) insertion. The researchers hypothesize that the jet injection of
      lidocaine will provide superior anesthesia to the ELA-Max prior to PIV insertion.
    

Detailed description: 
      A prospective, block-randomized, controlled trial comparing J-Tip jet injection of 1%
      buffered lidocaine to a 30-minute application of 4% ELA-Max for topical anesthesia in
      children 8-15 years old presenting to a tertiary care pediatric emergency department for PIV
      insertion. All subjects recorded self-reported Visual Analogue Scale (VAS) scores for pain at
      time of enrollment and pain of PIV insertion. Jet injection subjects also recorded pain of
      jet injection. Subjects were videotaped during jet injection and PIV insertion. Videotapes
      were reviewed by a single blinded reviewer for observer-reported VAS pain scores for jet
      injection and PIV insertion.
    

Intervention name(s): J-tip jet injection of 1% buffered lidocaine
Intervention type(s): Procedure
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: local anesthesia; analgesia; peripheral IV; Local anesthesia prior to peripheral IV insertion
A Study To Determine The Effect Of SB-480848 On Asthma
Condition: Atherosclerosis
MeSH terms: Asthma; Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the effects of SB-480848 with placebo in subjects
      with asthma.
    


Intervention name(s): SB 480848, tablets
Intervention type(s): Drug
Other intervention name(s): SB 480848; tablets
Intervention MeSH terms: Darapladib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: SB-480848; methacholine challenge; asthma; inhaled steroid
Naltrexone Treatment for Alcoholic Women
Condition: Alcoholism; Eating Disorder
MeSH terms: Alcoholism; Feeding and Eating Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess naltrexone's effectiveness in treating alcoholism in women and provide
      information on its potential value in treating eating disorders common among alcoholic women.
      Alcoholic women with and without both eating disorders and depression will be randomly
      assigned to placebo or naltrexone treatment. Each group will receive behavioral therapy for
      12 weeks, with followup 6 months after treatment.
    

Detailed description: 
      Background: Despite important gender differences in drinking patterns, physiological effects
      of alcohol, and co-occurring psychiatric conditions, relatively little is known about the
      efficacy of naltrexone for the treatment of alcohol dependence in women. This study
      investigated the safety and efficacy of naltrexone in combination with Cognitive Behavioral
      Coping Skills Therapy (CBCST) in a sample of alcohol-dependent women, some with comorbid
      eating pathology.

      Methods: One hundred three women meeting DSM-IV criteria for alcohol dependence (29 with
      comorbid eating disturbances) were randomized to receive either naltrexone or placebo for 12
      weeks in addition to weekly group CBCST.
    

Intervention name(s): naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.; A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient.
Other intervention name(s): Revia; Depade
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the clinical efficacy of repeat subcutaneous
      (SC) doses of dupilumab, compared with placebo, to relieve symptoms in adult participants
      with active, moderate to severe Eosinophilic Esophagitis (EoE).

      The secondary objectives of the study are:

        -  To assess the safety, tolerability, and immunogenicity of SC doses of dupilumab in adult
           participants with active, moderate to severe EoE

        -  To assess the effect of dupilumab on esophageal eosinophilic infiltration

        -  To evaluate the pharmacokinetics (PK) of dupilumab in adult participants with EoE
    


Intervention name(s): Dupilumab; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): DUPIXENT®; REGN668(SAR231893)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to to assess the effect of multiple oral doses of ZD4054
      (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male
      subjects.
    


Intervention name(s): midazolam; ZD4054
Intervention type(s): Drug; Drug
Intervention description(s): ZD4054 10 mg od
Other intervention name(s): Dormicum®; Zibotentan
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ZD4054; Healthy Volunteers
TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.
Condition: HIV; AIDS; Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics (how the drug is absorbed
      into the bloodstream, distributed in the body and eliminated from the body) after a single
      dose and after repeated administration of TMC278 administered once daily for 11 days in
      subjects with mild or moderate hepatic impairment (impaired liver function), compared with
      healthy control subjects. Furthermore the short-term safety and tolerability (how well the
      body tolerates the drug) of TMC278 will be assessed.
    

Detailed description: 
      Human immunodeficiency virus (HIV)-infected patients are routinely being treated with
      combinations of 3 or 4 drugs (highly active antiretroviral therapy [HAART]), to reduce the
      risk of viral resistance development. Development of new potent antiretroviral (ARV) drugs is
      urgently needed to prolong suppression of viral replication in subjects infected with HIV.
      This is a Phase I, open-label, parallel, controlled, sequential study to investigate the
      single-dose and steady-state pharmacokinetics, and short-term safety and tolerability of
      TMC278 in subjects with mild or moderate hepatic impairment compared to subjects with normal
      hepatic function. The trial aims to provide guidance on administration and dose
      recommendations of TMC278 in subjects with mildly or moderately impaired hepatic function.
      The study population will consist of a total of 32 male and female subjects between 18 and 65
      years. Panel A will consist of 8 subjects with mild hepatic impairment and 8 healthy subjects
      matched for sex, age (± 5 yrs), and BMI (± 15%). Panel B will consist of 8 subjects with
      moderate hepatic impairment and 8 healthy subjects matched for sex, age (± 5 yrs), and BMI (±
      15%). Treatment in Panel A and Panel B will be conducted sequentially. Subjects in Panel A
      will receive a TMC278 25 mg tablet once daily for a total of 11 days. Recruitment for
      subjects for Panel B will start after evaluation of the safety, tolerability and
      pharmacokinetic data from subjects in Panel A. The anticipated dose of TMC278 to be
      administered to subjects in Panel B is the same dose as for Panel A (25 mg once daily for 11
      days), but this dose might be adjusted depending on the results of Panel A.
    

Intervention name(s): TMC278
Intervention type(s): Drug
Intervention MeSH terms: Rilpivirine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: TMC278-TiDP6-C130; TMC278-C130; healthy volunteer; hepatic impairment; HIV Infections