bioihbjkbjnl/mcl2 huggingface dataset:
Dysport® Adult Lower Limb Spasticity Study
Condition: Leg Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to assess the efficacy of Dysport® compared to placebo
      in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or
      traumatic brain injury.
    


Intervention name(s): Botulinum toxin type A; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): I.M. injection on day 1 (single treatment cycle); I.M. injection on day 1 (single treatment cycle)
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long-Duration Stimulant Treatment Study of ADHD in Young Children
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in
      4-to-5-year olds.
    

Detailed description: 
      This is a single site, open-label, four-week feasibility study of long-duration beaded
      methylphenidate (B-MPH), also known as Ritalin LA™. B-MPH is a FDA-approved medication for
      children 6 years and older with attention-deficit/hyperactivity disorder (ADHD), but there
      are no studies of its use in preschoolers. This study will evaluate the safety and
      effectiveness of B-MPH for ADHD treatment in 4-to-5-year old children.

      Total study duration is approximately 5 weeks. It includes a screening evaluation and 4 weeks
      of B-MPH treatment with doses ranging from 10 to 30 mg (based on the individual tolerability
      and efficacy). The study doctor will conduct parent-training sessions during the treatment
      visits.
    

Intervention name(s): B-MPH
Intervention type(s): Drug
Intervention description(s): Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days
Other intervention name(s): Ritalin LA
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Attention-deficit/hyperactivity disorder (ADHD)
14 vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with HCV genotype 2 or 3 infection who have a rapid virological response to
      treatment are randomised to either 14 or 24 weeks HCV treatment. Our hypothesis is that there
      is no important difference in effect between the two treatment effect.
    

Detailed description: 
      Patients with HCV genotype 2 or 3 infection are currently recommended 6 months treatment with
      pegylated interferon alfa (2a or 2b) and ribavirin.Approximately 80% obtain sustained
      virological response (HCV RNA undetectable 6 months after treatment) to this approach.
      However, the treatment is associated with many and sometimes serious side effects. In
      addition, the treatment is costly also in econimical terms. Increasing the treatment duration
      beyond 6 months does not increase the response rate. Shorter treatment has only been assessed
      in small trials, but the results have been encouraging.

      In this randomised, open label,multicenter phase 3 trial with acitive controls patients are
      treated with pegylated interferon alfa 2a (PegIntron (R), Schering Plough NJ)(1,5 mcg/kg)and
      ribavirin (Rebetol (R), Schering Plough, NJ) (800-1400mg based on weight)for 4 weeks. Those
      who are HCV RNA negative at week 4 (<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic)
      are defined as rapid virological responders and randomised to either an additional 10 or 20
      weeks combination treatment. Patients who are HCV RNA positive are all treated for 20 more
      weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24
      weeks after end of treatment.

      Our hypothesis is that there is no important difference in the effect in the two groups.

      This is a non-inferiority trial. The smallest difference considered to be clinically
      important is 10%. Thus to state "non-inferiority" the 95% confidence interval of the observed
      difference between the groups shall not overlap 10%. Both intention to treat and and per
      protocol analyses will be published. Conclusion will be conservative and based on the
      analysis who detect the biggest difference.
    

Intervention name(s): Pegylated Interferon alfa 2b and ribavirin
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interferon; Pegylated interferon; Pegylated interferon alfa 2b; Hepatitis C; Genotype 2; Genotype 3; Rapid virological response; Short treatment; 14 weeks treatment; health related quality of life; sick leave; Injecting drug use
A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the
      blood stream and how long it takes the body to get rid of it, when given via autoinjector
      compared to mirikizumab (reference) solution given via autoinjector. The information about
      any adverse effects experienced will be collected and the tolerability of mirikizumab will
      also be evaluated.

      Screening is required within 35 days prior to enrolment. For each participant, the total
      duration of the clinical trial will be about 17 weeks including screening.
    


Intervention name(s): Mirikizumab
Intervention type(s): Drug
Intervention description(s): Administered SC.
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema
Condition: Lipedema
MeSH terms: Lipedema
Study type: Interventional

Summary: 
      This study is designed to gain preliminary information via a uniform protocol regarding the
      clinical effects of Vasculera in patients with lipedema and the possible role of the
      glycocalyx as a physiological target for Vasculera activity. It is anticipated that the
      results of this case study will inform the development of a formal randomized, double-blind,
      placebo controlled trial.
    

Detailed description: 
      The goal of this type of clinical trial is to compare the measurement of participants legs
      before treatment and after using the treatment for approximately 3 months in clinic patients
      20 to 70 years old with lipedema. The main questions it aims to answer are: does the leg
      circumference decrease and does the participants' overall wellbeing improve? Participants
      will:

        -  Have physical examinations and measurements at baseline and 3 month visit

        -  Complete wellbeing self-assessments at baseline and 3 month visit

        -  Have blood drawn for chemical markers at baseline and 3 month visit

        -  Complete four visits total
    

Intervention name(s): Diosmiplex
Intervention type(s): Dietary Supplement
Intervention description(s): diosmin glycoside in combination with alkaline granules known as alka4-complex
Other intervention name(s): Vasculera
Intervention model: Single Group Assignment
Intervention model description: three (3) month open-label case study
Masking: None (Open Label)
Primary purpose: Treatment
Ulthera® System for Treating Axillary Hyperhidrosis
Condition: Primary Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      Up to 20 enrolled subjects will be treated. Subjects will receive two Ulthera® treatments on
      the axillas provided 30 days apart. Follow-up visits will occur at 7, 30, 90 and 180 days
      following the last treatment.

      Protocol amendment: The study was expanded to enroll an additional 20 subjects into Group A.
    

Detailed description: 
      This study is a prospective, single-center, randomized clinical trial. Up to 20 subjects who
      are naïve to Ultherapy for treatment of hyperhidrosis will be enrolled and treated at a 2.0mm
      depth at two different treatment densities (Group A and Group B).

      Group A will include up to 10 treated subjects. Subjects receiving treatment in a 3 x 4 grid,
      12 treatment squares, 60 lines of treatment per square, at one treatment depth (2.0mm), at
      0.30 J of energy.

      Group B will include up to 10 treated subjects. Subjects receiving treatment in a 3 x 4 grid,
      12 treatment squares, 40 lines of treatment per square, at one treatment depth (2.0mm), at
      0.30 J of energy.

      Gravimetric sweat production measures and starch iodine tests will be completed at baseline,
      treatment visit #2, and at all follow-ups for all study groups. Digital images of the starch
      iodine test will be obtained. Hyperhidrosis Disease Severity Scale (HDSS) scores will be
      obtained at baseline, each treatment visit, and at all follow-ups for all study groups.
    

Intervention name(s): Ulthera System treatment
Intervention type(s): Device
Intervention description(s): Micro-focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulthera System; Ultherapy
A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, six-week, randomized, double blind, placebo-controlled, multi-center
      study in patients with schizophrenia who are experiencing an acute exacerbation of psychosis.
    

Detailed description: 
      This study consists of a 5- to 14-day screening period to include antipsychotic medication
      washout, followed by a six-week double blind treatment period. Patients completing the 6-week
      treatment period may continue double-blind treatment in an optional extension period of at
      least 6 weeks' duration. Patients randomized to placebo during the initial 6-week period will
      be randomized to BL-1020 low or high dose during the extension treatment period.
      Approximately 40 study centers in four countries will participate.
    

Intervention name(s): BL - 1020; BL - 1020; Placebo; Risperidone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg/day; BL 1020 20-30 mg/day; Capsules; Capsules
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating Anti-Tobacco Message Effectiveness Among Lesbian, Gay, Bisexual, and Transgender Young Adults
Condition: Tobacco-Related Carcinoma
Study type: Interventional

Summary: 
      This trial refines and evaluates anti-tobacco messages among lesbian, gay, bisexual, and
      transgender (LGBT) young adults at risk for the use of more than one tobacco product
      (polytobacco use). Polytobacco use is associated with nicotine dependence and tobacco use
      into adulthood, and is disproportionately high among LGBT young adults. This trial seeks to
      determine effective communication of polytobacco use risk to at-risk LGBT young adults.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Identify absolute and relative risk anti-tobacco messages that effectively communicate
      polytobacco risks to lesbian, gay, bisexual, transgender (LGBT) young adults.

      Participants view anti-tobacco messages and rate them for perceived effectiveness and
      reactance.
    

Intervention name(s): Health communications
Intervention type(s): Other
Intervention description(s): Participants are assigned to view health communications with risk and efficacy statements.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Clonidine Versus Midazolam for Premedication
Condition: Anxiety; Pain
Study type: Interventional

Summary: 
      alpha2-agonists like clonidine offer several useful effects that make these drugs an
      interesting alternative to benzodiazepines for pharmacological premedication. We therefore
      sought to determine the effect of pre-anesthetic medication with clonidine vs. midazolam in a
      randomized, double-blind, placebo controlled study. Effects of pre-anesthetic medication were
      assessed on (1) bispectral index (BIS),(2) sedation score and visual analog scales for
      anxiety and pain, (3) neuropsychologic tests to assess cognitive function and (4) circulating
      stress hormones.
    


Intervention name(s): midazolam; clonidine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time; pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time; inert tablet p.o., 60-90 min prior to estimated induction time
Other intervention name(s): Dormicum; Catapresan
Intervention MeSH terms: Clonidine; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: bispectral index; sedation; stress hormones; cognitive function
An fMRI Study of Satiation in Healthy Volunteers.
Condition: Appetite
Study type: Interventional

Summary: 
      To our knowledge no study has assessed the effects of a meal on neural responses to food cues
      and compared this with a condition simulating natural inter-meal hunger levels. This is
      important, as the existing literature often compares the effect of fasting to satiation,
      which may not reflect typical appetite processes. Thus, the purpose of this research was to
      examine the effect of a satiating lunch compared to a normal pre-meal state on blood oxygen
      level dependent (BOLD) activity in the human brain, as measured using functional magnetic
      resonance imaging (fMRI).
    

Detailed description: 
      We hypothesized that satiation would be associated with decreased brain activity across brain
      regions involved in both appetite and reward such as ventromedial prefrontal cortex,
      orbitofrontal cortex, ventral striatum, hypothalamus, insula, amygdala and hippocampus. 16
      healthy participants (8 males) were scanned on two separate test days, before and after
      eating a meal to satiation, or after not eating for 4 hours (satiated vs. pre-meal). fMRI
      BOLD signals to the sight and/or taste of the stimuli were recorded. Participants were given
      questionnaires to complete about their mood state and appetite before and after all scans.
    

Intervention name(s): Satiated / Pre-meal; MRI
Intervention type(s): Other; Device
Intervention description(s): All participants were scanned before and after not being fed (pre-meal), and before and after being given a satiating lunch (satiated).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fMRI; reward; satiation
Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to compare the efficacy of two doses of a fixed combination of
      ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in
      patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a
      treatment period (8 weeks). The study will provide further data on safety and tolerability of
      ciclesonide/formoterol fumarate.
    


Intervention name(s): Ciclesonide/Formoterol Combination
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Formoterol Fumarate; Long-acting beta2-agonists; LABA; Steroids
Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED)
Condition: Leukopenia
MeSH terms: Mycoses; Invasive Fungal Infections; Leukopenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, open label parallel controlled, multicenter study to evaluate safety and
      efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic
      patients for prevention of invasive fungal infection
    


Intervention name(s): Posaconazole; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg/mL; 200 mg (5 mL) TID
Treatment was continued with each cycle of chemotherapy until:
The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
3 chemotherapy cycles or
Total treatment duration up to 12 weeks (84 days); 50 mg/capsule (2 capsules), 150 mg/capsule (2 capsules);
400 mg QD
Treatment was continued with each cycle of chemotherapy until:
The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
3 chemotherapy cycles or
Total treatment duration up to 12 weeks (84 days)
Other intervention name(s): Noxafil; SCH 056592
Intervention MeSH terms: Fluconazole; Posaconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: high-risk leukopenic patients
Effects of Physical Training on Bone and Muscle Quality, Muscle Strength, and Motor Coordination in Children With NF1
Condition: Neurofibromatosis Type 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Interventional

Summary: 
      A physical training program will improve quality of life, participation in physical activity,
      motor coordination, muscle strength, and bone and muscle strength in children with
      neurofibromatosis type 1.
    

Detailed description: 
      Disorders of the Ras pathway have significant phenotypic overlap and include Noonan syndrome,
      Cardiofaciocutaneous syndrome (CFC syndrome), Legius syndrome, Costello syndrome and
      neurofibromatosis type 1 (NF1). NF1 is one of the most common genetic disorders presenting in
      childhood with an incidence of 1/3000. NF1 is associated with skeletal abnormalities such as
      short stature, scoliosis, and long bone fracture with non-union. We recently reported that
      children with NF1 have abnormalities of bone and muscle architecture as evidenced by
      decreased bone mineral density, decreased bone strength, and low muscle mass, all of which
      may predispose them to fractures and scoliosis (Stevenson et al., 2005, 2007, 2009). Our
      preliminary data show that children with NF1 have poor motor coordination and muscle
      strength, potentially secondary to abnormal neuromotor learning. We hypothesize that poor
      motor coordination and decreased muscle strength contribute to the osteopenia in NF1. Our
      objective is to identify effective and non-invasive strategies to improve motor coordination,
      muscle strength, and bone and muscle architecture in children with disorders of the Ras
      pathway, in hopes of decreasing fractures and improving physical activity levels. Plyometric
      physical training consists of quick, high-intensity, weight-bearing movements, and is an
      encouraging intervention for use in these children.
    

Intervention name(s): Plyometric training program
Intervention type(s): Other
Intervention description(s): The intervention is a year long individualized plyometric exercise training program. Examples of plyometric activities include jumping, hopping, running, and throwing. The number of plyometric exercises will increase gradually to prevent over training to a total of five lower extremity exercises and five upper extremity exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neurofibromatosis type 1; NF1
Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as
      monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type
      2 Diabetes for 52 weeks administration.
    


Intervention name(s): Teneligliptin; Teneligliptin + Sulfonylurea
Intervention type(s): Drug; Drug
Intervention description(s): Teneligliptin for 52 weeks; Teneligliptin for 52 weeks in combination with sulfonylurea
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DPP-IV inhibitor