bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Aerobic Exercise Training for Migraine Prevention.
Condition: Headache Disorders, Primary
MeSH terms: Migraine Disorders; Headache Disorders; Headache Disorders, Primary; Headache
Study type: Interventional

Summary: 
      This study has been designed in order to know the effect of 12 weeks of aerobic exercise
      training for migraine prevention. We hypothesized that the exercise training could reduce the
      number of days with migraine and the number of attacks per month in the treated group.
    

Detailed description: 
      The study will cover 20 weeks. The first 8 weeks has been designed as "baseline" period, to
      assess the migraine status and classification, colect blood exam, perform a cardiopulmonary
      exercise test to determine the maximal oxygen uptake, and fill psychometric questionnaires.
      The remaining 12 weeks will be the "intervention" period, where participants after
      randomization will be allocated to perform an aerobic exercise training (on treadmill)
      performed on a 3 times per week-based program of 40-min duration each session, or will wait
      for the equal period to repeat all the assessments, then begin the same exercise protocol.
    

Intervention name(s): Exercise Training
Intervention type(s): Other
Intervention description(s): 12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Migraine, aerobic exercise, prevention
Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
Condition: Opioid Dependence, on Agonist Therapy
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to assess safety, efficacy, and treatment retention following
      extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX)
      sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary
      efficacy and safety studies of OX219.
    

Detailed description: 
      This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to
      assess safety, efficacy, and treatment retention during maintenance treatment.

      Eligible patients had completed 1 of 2 primary efficacy and safety studies of the
      higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006
      [NCT01908842] or OX219-007 [NCT01848054]). The total duration of study treatment was 24
      weeks.
    

Intervention name(s): Higher bioavailability BNX sublingual tablets
Intervention type(s): Drug
Intervention description(s): Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks
Other intervention name(s): OX219; Zubsolv; Buprenorphine/naloxone sublingual tablets
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid, Dependence, agonist, Buprenorphine, Naloxone
Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This single centre, comparative design study will be used to investigate the efficacy of an
      experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity
      (DH) after short term use compared with a standard fluoride dentifrice
    

Detailed description: 
      This will be a single centre, three day, randomised, examiner blind, two treatment arm,
      parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected
      test teeth), controlled study, in participants with at least two sensitive teeth that meet
      all the criteria at the screening and baseline (pre-treatment) visits. Dentinal
      hypersensitivity will be assessed at baseline (pre-treatment), post-treatment and after 3
      days twice daily brushing
    

Intervention name(s): stannous fluoride; sodium monofluorophosphate
Intervention type(s): Other; Other
Intervention description(s): 0.454% weight by weight (w/w) stannous fluoride containing 1100ppm fluoride; 0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
Condition: Biliary Colic
MeSH terms: Colic
Study type: Interventional

Summary: 
      The aim of this study is to assess the analgesic efficacy of intravenous ibuprofen given in
      the Emergency Department for the treatment of biliary colic. We hypothesize that intravenous
      ibuprofen will provide a clinically significant drop in self-reported patient pain level as
      measured by the visual analog scale.
    

Detailed description: 
      It is estimated over 20 million people aged 20-74 have gallbladder disease, with biliary
      colic being a common and painful symptom in these patients. Likely due to the relatively
      recent approval of intravenous ibuprofen use for fever and pain in adults, no assessment of
      its analgesic efficacy for biliary colic currently exists in the literature.

      Utilizing a visual analog scale (VAS) for patient self-assessment of pain, this study will
      address this lack of evidence and identify intravenous ibuprofen's value as a novel analgesic
      in the treatment of biliary colic. Patients will be given a VAS at the time of study therapy
      administration, at 15-minute intervals during the first hour post-administration, and
      30-minute intervals in the second hour. Though NSAID's have been extensively studied in the
      management of this phenomenon, this study aims to help optimize pain treatment of patients
      presenting to the Emergency Department with biliary colic, and potentially pave the way for
      future analgesic treatment comparison studies.
    

Intervention name(s): IV Ibuprofen; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic; Saline will be administered to the placebo group
Other intervention name(s): Caldolor; NeoProfen
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Biliary Colic; Abdominal pain; Intravenous Ibuprofen
An Imaging Study to Investigate the Distribution of GW842166X in the Brain.
Condition: Pain, Inflammatory
Study type: Interventional
Phase: Phase 1

Summary: 
      GW842166X is being developed for the treatment and management of inflammatory pain. GW842166X
      is a CB2 receptor agonist and the mechanism is not fully understood, although it is thought
      that for the anti-inflammatory action the drug is required to cross inot the brain from the
      blood. This study aims to look at if the drug crosses into the brain once given orally using
      an imaging technique called positron emission tomography.
    


Intervention name(s): GW842166X; [carbonyl-^11C]GW842166
Intervention type(s): Drug; Drug
Intervention description(s): GW842166X will available with dose strength of 100 mg capsules. Four 100mg GW842166X capsules will be used for the 400 mg oral dose of GW842166X.; [carbonyl-^11C]GW842166 will b available as Intravenous solution.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brain,; inflammation,; CB2,; PET; analgesia,
Immune Cells in Patients With Granulomatous Mastitis
Condition: Granulomatous Mastitis
MeSH terms: Mastitis; Granulomatous Mastitis
Study type: Observational

Summary: 
      Granulomatous mastitis is a rare, chronic, benign inflammatory disease of the breast that
      plays a role in many varying etiologies, including infectious and non-infectious causes.
      Etiological reasons were examined in various studies, but neither etiology nor definite
      criteria for diagnosis were found. Our aim in this study is to examine the role of
      immunophenotyping in differentiating the etiology of granulomatous mastitis and using it as a
      prognostic marker.
    

Detailed description: 
      Granulomatous mastitis is a rare, chronic, benign inflammatory disease of the breast that
      plays a role in many varying aetiology, including infectious and non-infectious causes. This
      disease can clinically and radiographically mimic breast cancer, which can pose a diagnostic
      challenge as well as concern during evaluation. A nonspecific inflammatory response,
      'granuloma' is defined as necrosis or infiltration of other inflammatory leukocytes, with or
      without mononuclear phagocyte collection. It is thought to be caused by infectious agents or
      foreign substances that activate the immune system, leading to granuloma formation. Some of
      the known inflammatory etiologies of granulomatous mastitis are autoimmune diseases such as
      tuberculosis (most commonly caused by Mycobacterium tuberculosis), sarcoidosis, fungal
      infection and granulomatosis with polyangiitis and giant cell arteritis. These diseases
      cannot be distinguished clinically, pathologically, and radiographically from idiopathic
      granulomatous mastitis.In this study, we aimed to investigate lymphocyte subtypes in patients
      with granulomatous mastitis and to evaluate the differences in cell populations and its
      usability as a predictive marker in diagnosis.
    

Intervention name(s): Flow cytometric immunophenotyping
Intervention type(s): Diagnostic Test
Intervention description(s): To evaluate T cell subsets and monocyte
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In case group patients with granulomatous mastitis will be included to the study. During
        diagnasis if the patient is diagnosed with tuberculosis, she will be excluded from the
        study.

        Also healty volunteers who don't have breast lesions are control group.
      
Keywords: Mastitis; immunophenotyping; Flow-cytometry
Smoking and Peptidoglycan Recognition Protein-1 and Initial Periodontal Therapy
Condition: Smoking, Cigarette
MeSH terms: Chronic Periodontitis
Study type: Interventional

Summary: 
      A total of 40 patients with CP (20 smokers (S+CP) and 20 nonsmokers (S-CP)) and 40
      periodontally healthy subjects (20 smokers (S+PH) and 20 nonsmokers (S-PH)), comprising 80
      subjects, were included in this study. Baseline GCF samples were obtained from all subjects
      and clinical periodontal measurements, including probing depth (PD), clinical attachment
      level (CAL), plaque index (PI), and gingival index (GI), were recorded. In patients who had
      received initial periodontal therapy, GCF samples were obtained and all clinical periodontal
      measurements were recorded again during the 6th-8th weeks. GCF PGRP-1 levels were analyzed by
      enzyme-linked immunosorbent assay.
    

Detailed description: 
      Peptidoglycan recognition proteins (PGRPs) are one of the antimicrobial peptides that play a
      role in innate immunity and act against the bacterial cell wall. Smoking is the most
      important environmental risk factor for periodontitis. This study determined the effect of
      smoking on PGRP-1 levels in gingival crevicular fluid (GCF) in smokers and nonsmokers with
      chronic periodontitis (CP) following initial periodontal therapy.
    

Intervention name(s): Initial periodontal therapy
Intervention type(s): Other
Intervention description(s): Scaling and root planing and polishing with specific curettes were performed to patients with CP and oral hygiene education was provided to each patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic periodontitis; gingival crevicular fluid; initial periodontal therapy; peptidoglycan recognition proteins; smoking
A Study of LY3039478 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to investigate the safety of the study drug known as
      LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part
      A has three periods. Either LY3039478 or placebo will be given once by mouth in each period.
      Part B has two periods. Participants will receive both formulations of LY3039478, by mouth,
      over the course of the study. Both parts of the study will also explore how much LY3039478
      gets into the bloodstream and how long it takes the body to get rid of it. Information about
      any side effects will also be collected. Participants may only enroll in one part. The study
      will last at least 33 days, not including screening. Screening must be performed up to 30
      days before enrollment.

      Part B was added by protocol amendment approved in April, 2016.
    


Intervention name(s): Placebo; LY3039478 original formulation; LY3039478 new formulation
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      This study will evaluate the clinical performance and safety of a self administered abortive
      treatment for migraine headache using combined occipital and supraorbital transcutaneous
      nerve stimulator (Neurolief device, Relievion™).
    


Intervention name(s): Relievion device- Treatment stimulation; Relievion Device- Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): 1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation; 1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation
Other intervention name(s): Neurolief device; Sham Neurolief device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged
      15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study
      MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the
      antibody response will be evaluated in a subset of these participants who will receive a
      booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who
      have not been previously vaccinated with a meningococcal vaccine or had documented meningitis
      disease who will also receive a dose of Menactra® vaccine.
    


Intervention name(s): Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Menactra®; Menactra®; Menactra®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal infection; Neisseria meningitidis; Menactra®; Menomune®
Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants
Condition: Vaping; Nicotine Absorption
Study type: Interventional

Summary: 
      This is a single-center, open-label, concentration-ranging study to evaluate the nicotine PK
      profile and PD effects in healthy adult experienced users of closed tank/cartridge
      e-cigarettes using four different variants of P4M3 (nicotine concentration of 1.7%, 1.7% with
      1.1% lactic acid [LA], 3% with 1.1% LA, and 4% with 2% LA) or their own e-cigarettes.
    

Detailed description: 
      The goal of the study is to evaluate the nicotine concentration profiles and derived PK
      parameters, subjective effects, behavioral parameters, including puffing topography
      parameters of P4M3 with four different variants of P4M3, in experienced e-cigarette users
      after a single-use experience with fixed puffing regime and after ad libitum use of P4M3.

      Four variants of P4M3 will be evaluated together with subjects' own e-cigarettes to evaluate
      the relationship between the e-liquid composition (nicotine concentrations and presence of
      lactic acid) and the amount of nicotine absorbed, the speed of absorption, and the puffing
      topography.
    

Intervention name(s): E-cigarette; P4M3-1.7%; P4M3-1.7%LA; P4M3-3%LA; P4M3-4%LA
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Subject's own e-cigarette; P4M3 e-liquid concentration of 1.7% nicotine without lactic acid; P4M3 e-liquid concentration of 1.7% nicotine with lactic acid; P4M3 e-liquid concentration of 3% nicotine with lactic acid; P4M3 e-liquid concentration of 4% nicotine with lactic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Nicotine-containing product; Alternative to cigarettes
Diet and Exercise for Elevated Risk (DEER)
Condition: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia; Postmenopause
MeSH terms: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effect in men and postmenopausal women with elevated LDL-cholesterol and low
      HDL-cholesterol of an exercise regimen with or without the National Cholesterol Education
      Program (NCEP) Step Two diet compared to usual care control group on HDL- and
      LDL-cholesterol.
    

Detailed description: 
      BACKGROUND:

      The NCEP is a major public education program providing advice to physicians and the public on
      management and prevention of coronary heart disease. However, data supporting the advice are
      derived primarily from middle-aged men, with less data available for women and older
      individuals. Furthermore, there have been recent reports that when low saturated fat diets
      such as the NCEP Step One and NCEP Step Two diets, are followed, HDL-cholesterol is lowered
      as well as LDL-cholesterol.

      DESIGN NARRATIVE:

      Randomized, controlled, factorial design powered for men and women separately. One hundred
      eighty postmenopausal women, 45 through 64 years of age, and 197 men, 30 through 64 years of
      age, who had low high-density lipoprotein (HDL) cholesterol levels (< or =59 mg per deciliter
      in women and < or =44 mg per deciliter in men) and moderately elevated levels of low-density
      lipoprotein (LDL) cholesterol (>125 mg per deciliter but <210 mg per deciliter in women and
      >125 mg per deciliter but <190 mg per deciliter in men) were enrolled. The subjects were
      randomly assigned to aerobic exercise, the NCEP Step 2 diet, or diet plus exercise, or to a
      control group, which received no intervention. The four interventions were delivered for one
      year: usual care (written dietary materials only with delayed intervention optional),
      exercise only (supervised, progressive aerobic exercise program at least three times per
      week), diet only (group and individual dietary instruction on the NCEP Step One/Step Two diet
      delivered by registered dietitians), and diet plus exercise. At baseline and at the end of
      one year, measurements were made of blood lipids and lipoproteins, plasma glucose and
      insulin, glucose tolerance, blood pressure, body composition through hydrostatic weighing and
      waist and hip circumterences, aerobic fitness (VO2 max), and five unannounced 24-hr. recalls.
      The primary outcomes measured was HDL-cholesterol, major secondary endpoints included LDL-C,
      LDL-C/HDL-C ratio, and triglycerides.
    

Intervention name(s): diet, fat-restricted; exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Primary purpose: Prevention
Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant Obsessive-compulsive Symptoms in Patients With Schizophrenia
Condition: Schizophrenia; Obsessive-Compulsive Symptoms
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms
      in patients with schizophrenia.
    


Intervention name(s): Active rTMS; SHAM rTMS
Intervention type(s): Device; Device
Intervention description(s): rTMS over supplementary motor area, 1hz, no pauses, 20 minutes/sessions, 5 sessions/week, 4 weeks. Total 20 sessions.; Sham rTMS, without brain stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment