bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      This open label study is designed to evaluate the ability of OrthoPulse™ to safely and
      effectively increase the rate of orthodontic tooth movement with fixed appliances.
    

Detailed description: 
      The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of
      orthodontic tooth movement during alignment with fixed appliances in the mandibular arch.

      The secondary aim of this study is to determine whether patients treated with OrthoPulse
      demonstrate root resorption beyond what is commonly expected during orthodontic treatment.

      The study also aims to collect confirmatory evidence on the safety of the device.
    

Intervention name(s): Orthodontic Treatment; OrthoPulse™
Intervention type(s): Other; Device
Intervention description(s): Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.; Participants carry out daily OrthoPulse™ treatments at home.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Photobiomodulation; Orthodontic treatment; Malocclusion; OrthoPulse™
A Study of LY2157299 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken
      at least 4 days apart. One dose will be given without food. One dose will be given with a
      high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug
      gets into the blood stream. Side effects will be documented. This study will last
      approximately 15 days not including screening. Screening is required within 30 days prior to
      the start of the study.
    


Intervention name(s): LY2157299
Intervention type(s): Drug
Intervention description(s): Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Healthy Subjects
Condition: Healthy Volunteers, Gluten
Study type: Interventional

Summary: 
      The investigators will investigate the effects of acute and sub-acute administration of
      gluten on mood, intestinal permeability, gastrointestinal symptoms and gut peptide levels in
      healthy volunteers (HV).
    


Intervention name(s): Gluten; Placebo
Intervention type(s): Other; Other
Intervention description(s): Tereos; Whey protein from Nestlé Healthy Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: single-blinded, randomised controlled, cross-over study
Masking: Single (Participant)
Primary purpose: Basic Science
Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of
      Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
    


Intervention name(s): EDP-938; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive EDP-938 once daily on Days 1 and 14; Subjects will receive fluconazole once daily on Days 5 to 18
Intervention MeSH terms: Fluconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug-drug interaction
In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus
Condition: Smoking Cessation; Smokeless Tobacco; Harm Reduction
Study type: Interventional
Phase: Phase 1

Summary: 
      In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users
      will be given repeated doses of four different types of portion snus: "General", "Catch",
      "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen
      (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific
      nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation
      of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco
      specific nitrosamines (TSNAs) respectively, will be done for each type of snus.
    

Detailed description: 
      Comparisons:

      A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

      B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per
      portion.

      C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine
      per portion.

      D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg
      nicotine per portion.

      Swedish portion snus will be administered once every hour (4 administrations/brand) and will
      be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.
    

Intervention name(s): Buccal administration of nicotine
Intervention type(s): Procedure
Intervention description(s): Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
Other intervention name(s): Smokeless Tobacco; ST; Potential reduced exposure products; PREP
Intervention MeSH terms: Lobeline; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: smokeless tobacco; Nicotine; Cadmium; lead; Tobacco Specific Nitrosamines
Population Effects of MI on Pediatric Obesity in Primary Care
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      In this cluster randomized effectiveness trial, pediatric primary care practices will be
      recruited from the American Academy of Pediatrics' national Pediatric Research in Office
      Settings (PROS) practice-based research network, as well as the client database of the
      Physician's Computer Company (PCC) - an Electronic Health Record (EHR) vendor. We will
      recruit 18 practices. 9 practices will be randomized to the Intervention arm and 9 practices
      to Usual Care. Intervention arm practices will select 1-2 pediatric clinicians, including
      pediatricians (PED) and nurse practitioners (NP), to receive in-person training in
      Motivational Interviewing (MI), behavioral therapy, billing and coding, and study procedures.
      Usual Care practices will select 1-2 pediatric clinicians to receive billing / coding and
      study protocol training only, via telephone and webinar; they will be offered in-person MI
      training at the close of the trial. Around 316 parents of overweight or obese children (BMI >
      85th percentile for age and gender) between 3 and 11 years of age at baseline that are
      patients of participating Intervention arm clinicians will be enrolled. Over 24 months, these
      parents may receive up to 4 in-person, MI-based counseling sessions with a trained pediatric
      clinician and up to 6 telephone counseling sessions with an MI-trained Registered Dietician
      (RD). There will be no study-specific contact with parents or their children in Usual Care
      practices during the trial - they will continue to receive usual care. EHR and billing data
      for all 3-11 year old children within all participating practices will be extracted by PCC to
      permit determination of the effectiveness of the intervention versus usual care on change in
      BMI z-score among 3 groups: 1) all eligible children in the Intervention arm), 2) all
      eligible children whose parent actively participates in the trial , and 3) all 3-11 year old
      children in all participating practices.
    


Intervention name(s): Intervention by Clinicians; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): PCPs deliver 4 sessions of MI in person, and RDs deliver 6 sessions of MI via telephone. PCPs and RDs will receive 2 days of MI training.; PCPs provide care as normal
Other intervention name(s): MI Intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: After two years of intervention arm study, the usual care arm will receive MI training.
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week
      study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160
      mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in
      pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo.

      Patients took 1 inhalation (with assistance from parents/guardians/caregivers, as needed)
      from each of 2 devices (BAI device followed by MDI device in that order) twice daily as per
      the double-dummy study design: 1 BAI treatment or placebo device and 1 MDI treatment or
      placebo device for a total of 2 inhalations each time.
    


Intervention name(s): Beclomethasone dipropionate BAI; Placebo BAI; albuterol/salbutamol 90 mcg; Beclomethasone dipropionate MDI; Placebo MDI
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a breath-actuated inhaler (BAI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.; Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day.; Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.; Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a metered-dose inhaler (MDI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.; Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day.
Other intervention name(s): BDP; breath-actuated inhaler; breath-actuated inhaler; bronchodilators; BDP; metered-dose inhaler; QVAR®
Intervention MeSH terms: Beclomethasone; Albuterol; Bronchodilator Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; breath-actuated inhaler; metered dose inhaler
National Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The relative effectiveness of current treatments and their different mechanisms of action
      yield to consider more and more that the multiple sclerosis (MS) therapeutic approach must
      use multiple molecules, both combined and sequential.

      In this sense, one can assume that the combination of two molecules with different but
      complementary mechanisms of action, can delay progression of the disease. Mitoxantrone has a
      powerful action, immediate and total, whereas interferon a selective action, immunomodulatory
      and delayed.
    

Detailed description: 
      This study is based on the hypothesis that there is a synergistic effect of both increasing
      the dose of interferon and also the use of mitoxantrone, allowing to further reduce the
      conversion rate MS.

      Because mitoxantrone decreases the rate of relapses 2 times more than interferon beta, a (at
      least) 2 times higher benefit on the disease activity is expected with interferon
      mitoxantrone combination than with interferon alone.
    

Intervention name(s): Interferon beta 1a; Mitoxantrone
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection of 44µg 3 times a week; 10 mg / m² monthly infusion for 6 months
Other intervention name(s): REBIF; ELSEP
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Mitoxantrone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Mineralocorticoid Receptor in the Treatment of Severe Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The proposed research aims to compare the onset of action and the efficacy of
      fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid
      antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in
      65 inpatients with severe depression. The study will also explore the utility of the
      hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be
      a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo
      during three years.
    


Intervention name(s): Spironolactone; fludrocortisone; escitalopram
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fludrocortisone; Spironolactone; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease
Condition: Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      The study aimed to prove EEN is effective for inducing early clinical remission, mucosal
      healing, promoting fistula closure and reducing the size of abscess to adult CD patients.
      They plan to include about 50 patients and observe the effect of EEN.
    


Intervention name(s): EEN
Intervention type(s): Drug
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The detailed inclusion criteria included: 1. >18 years old 2. Patients with CD was
        diagnosed clinically according to previously established international criteria [9] 3. The
        diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT
        enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation
        but not fibrosis. Intolerance or failure to steroids or IFX was judged by medical history
        4. The disease was in an active period.
A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine
Condition: Migraine; Common Migraine; Classic Migraine; Headache
MeSH terms: Migraine Disorders; Migraine with Aura; Migraine without Aura; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate
      (50 milligrams[mg], 100mg, and 200mg taken daily) compared with placebo in the prevention of
      migraine.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to
      evaluate the effectiveness and safety of three different doses of topiramate (50mg, 100mg,
      and 200mg daily) in migraine prophylaxis. The study consists of five phases: baseline
      (determination of whether patients meet the eligibility criteria and tapering of any migraine
      medication patients are already taking); initial titration and double-blind phase (8 weeks)
      which begins with 25 mg/daily increasing to the assigned (50, 100, 200 mg/day topiramate);
      followed by a maintenance period at the target dose (18 weeks); tapering transition phase (up
      to 7 weeks); and open-label extension up to 6 months (to a maximum topiramate dose of 1600
      mg/day); doses are adjusted to maximize effectiveness and minimize side effects. The primary
      study hypothesis is that one or more of the three doses of topiramate (50, 100, 200 mg/day)
      will be superior to placebo in the prophylaxis of migraine based on the change in monthly (28
      day) migraine period rate from the prospective baseline period to the double-blind phase and
      that topiramate treatment is well tolerated. During the titration period (8 weeks), doses are
      increased to target dose of daily topiramate (50 milligrams[mg], 100, or 200mg) or placebo,
      taken twice daily by mouth. Doses are continued for 18 weeks, adjusted over 7 weeks, and
      continued for up to 6 months during the Open-Label Extension.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Migraine; Common Migraine; Classic Migraine; Headache; Topiramate; Prophylaxis
Dose Finding Study In Subjects With Crow's Feet
Condition: Lateral Canthal Lines; Crow's Feet
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment
      of Crow's Feet.
    


Intervention name(s): ANT-1401; Vehicle
Intervention type(s): Biological; Biological
Intervention description(s): Active; Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: wrinkles
Pharmacokinetics and Bioequivalence of XC8 10 mg and 40 mg Tablets in Fasted Volunteers
Condition: Influenza; Respiratory Viral Infection
MeSH terms: Virus Diseases
Study type: Interventional

Summary: 
      Comparative study of the pharmacokinetics of XC8, film-coated tablets, 10 mg and XC8,
      film-coated tablets, 40 mg, when administered once in equal doses (40 mg) on an empty stomach
      in healthy volunteers.
    


Intervention name(s): XC8
Intervention type(s): Drug
Intervention description(s): A single dose of R or T drug in each of 2 periods of the study in fasted conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of the G4 System when
      worn for up to 7-days by children and adolescent subjects (6 to <18 years-old) with type 1
      diabetes mellitus.
    

Detailed description: 
      Device performance will be primarily evaluated in terms of the proportion of G4 System values
      that are within ±20% of the study meter reference value for glucose levels >80 mg/dL and ±20
      mg/dL at meter glucose levels <80 mg/dL. This proportion will be compared to the proportion
      of such points observed in the DexCom clinical study that will be used to apply for FDA
      approval of the G4 System (PTL 900360) for adults.

      Safety data of the G4 System will also be collected and safety will be characterized by the
      incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse
      Device Effects experienced by study participants.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This clinical study population will consist of a minimum of 64 and up to 80 subjects with a
        previous diagnosis of type 1 diabetes mellitus. It is desirable to achieve an equal number
        of subjects enrolled into each of the following four subgroups as defined in the FDA
        guideline for Age Ranges of Pediatric Subgroups:

          -  Female children* 6-12 years-old

          -  Female adolescents** 13-17 years-old

          -  Male children 6-12 years-old

          -  Males adolescents 13-17 years-old
      
Keywords: diabetes mellitus
Effect of Minocycline on Pain Caused by Nerve Damage
Condition: Neuropathic Pain Caused by Lumbar Radicular Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if minocycline is effective in the treatment of
      neuropathic pain. The effect of minocycline will be compared to the effect of placebo and
      amitriptyline.
    

Detailed description: 
      Neuropathic pain is pain caused by damage to the central or peripheral nervous system. To
      date, therapy consists of tricyclic antidepressants (such as amitriptyline) or
      anticonvulsants. However, results are disappointing. Minocycline, a FDA-approved second
      generation tetracycline, was efficacious in various animal models of neuropathic pain. We
      want to study the effect of minocycline in neuropathic pain in humans. The type of
      neuropathic pain we want to investigate is lumbar radicular pain since this is the most
      prevalent condition associated with neuropathic pain in humans.

      This placebo-controlled randomized double blind trial consists of 3 arms:

        1. Placebo, once daily by mouth during 14 days.

        2. Amitriptyline 25mg, once daily by mouth during 14 days.

        3. Minocycline 100mg, once daily by mouth during 14 days.

      Patients can take rescue medication if necessary: tramadol 50mg by mouths up to 3-times
      daily.

      Brain-derived neurotrophic factor is implicated in the generation and maintenance of
      neuropathic pain in different animal models of neuropathic pain. To study the role of
      brain-derived neurotrophic factor in neuropathic pain in humans, we will determine its
      concentration in serum and plasma before and after 14 days medication intake.
    

Intervention name(s): Minocycline; placebo; Amitriptyline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg once daily by mouth during 14 days; once daily by mouth during 14 days; 25mg once daily by mouth during 14 days
Intervention MeSH terms: Minocycline; Amitriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
First-in-human Single and Multiple Dose Trial of ATR-258
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial,
      conducted in 3 parts.
    


Intervention name(s): ATR-258; ATR-258; ATR-258
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single Ascending Dose; Multiple Ascending Dose; Repeat Dose
Other intervention name(s): Placebo; Placebo; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment