bioihbjkbjnl/mcl2 huggingface dataset:
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
Condition: Autistic Disorder; Autism; Asperger's Disorder; Asperger Syndrome; Autism Spectrum Disorders; Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Developmental Disabilities; Child Development Disorders, Pervasive; Asperger Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and
      efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's
      Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
    

Detailed description: 
      This clinical study was a 12-week, multicenter, double-blind, placebo-controlled, randomized
      withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or Pervasive
      Developmental Disorder Not Otherwise Specified (PDD-NOS). Patients who completed at least 12
      weeks of study drug exposure and met protocol specified responder criterion in lead in Study
      MEM-MD-91 (NCT01592786) at two consecutive visits separated by at least two weeks were
      eligible to transition to this study. The responder criterion was defined as having at least
      a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total
      raw score relative to the Visit 1 total raw score in Study MEM-MD-91.

      Weight based dose limits were selected in this study to ensure that exposure in terms of area
      under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a
      10-fold lower exposure than observed at the NOAEL(No observed adverse effect level) of 15
      mg/kg/day in juvenile rats.

      The weight-based dose limits in this study were as follows:

        -  Group A: ≥ 60 kg; maximum 15 mg/day

        -  Group B: 40-59 kg; maximum 9 mg/day

        -  Group C: 20-39 kg; maximum 6 mg/day

        -  Group D: < 20 kg; maximum 3 mg/day
    

Intervention name(s): Memantine Hydrochloride (HCl); Memantine Hydrochloride (HCl); Placebo capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Extended Release Dose ranging from 3-15mg/day; administered orally; Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally.; Once daily, oral administration.
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asperger's; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS); Memantine; Pediatric Disorder; Randomized Controlled Trial
The Effect of Welchol on Glucose Metabolism in Type 2 Diabetics
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this study was to determine the metabolic mechanism for a certain type
      medication's ability to lower blood sugar after a meal in Type 2 Diabetics, in order to
      develop a better understanding of it's potential role in the treatment of obesity.
    

Detailed description: 
      Welchol (colesevelam hydrochloride) is a bile acid sequestrant (BAS) recently approved by the
      FDA for glucose lowering in patients with type 2 diabetes mellitus. Four randomized,
      controlled clinical studies in subjects with type 2 diabetes have demonstrated significant
      treatment difference in HbA1c (-0.5%). Study durations ranged from 12-26 weeks of therapy. In
      diabetes clinical studies, a therapeutic response to colesevelam hydrochloride, as reflected
      by reduction in A1c was initially noted following 4-6 weeks of treatment and reached maximal
      or near-maximal effect after 12-18 weeks of treatment. Reductions in both fasting plasma
      glucose and postprandial concentrations have been demonstrated. Simple measures of insulin
      secretion and action have suggested that this is due to improved insulin action rather than
      improved insulin secretion. The mechanism by which bile acids interact with the key pathways
      regulating glucose concentrations is largely unknown. The investigators propose a randomized,
      double-blind, placebo controlled trial with a parallel-group design where subjects are
      randomized to receive colesevelam or matching placebo for a 12 week treatment period. A
      labeled mixed meal before and after treatment will be used to measure intestinal transit,
      postprandial and fasting glucose fluxes, insulin secretion and action as well as
      enteroendocrine secretion.
    

Intervention name(s): Colesevelam; Placebo; Diet; Metformin
Intervention type(s): Drug; Other; Behavioral; Drug
Intervention description(s): Colesevelam hydrochloride; three 625mg tablets taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period.; Three placebo tablets matching the active drug colesevelam in appearance, taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period.; Subjects were instructed to follow a weight maintenance diet (~55% carbohydrate, 30% fat and 15% protein) for the 12 week study period.; Subjects continued to take their pre-study therapeutic doses of metformin (Metformin 500mg tablets taken by mouth twice daily for a total daily dose of 1000 to 2000 mg) through the 12 week study period.
Other intervention name(s): Welchol; Glucophage; Glucophage XR; Glumetza; Fortamet
Intervention MeSH terms: Metformin; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Incretins; colesevelam; hepatobiliary circulation
S(+)-Ibuprofen Effects on Asprin Treated Volunteers
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet
      inhibition under steady state acetylsalicylic acid conditions.
    


Intervention name(s): S(+)-ibuprofen
Intervention type(s): Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Folate-Rich Foods Improve Folate Status
Condition: Folic Acid Deficiency
MeSH terms: Folic Acid Deficiency
Study type: Interventional

Summary: 
      This study evaluates the effects of folate-rich foods regarding improvement of folate status
      compared with folic acid supplement. A randomized, parallel intervention trial with two
      active groups (folate-rich foods or folic acid supplement) and one control group (apple juice
      - 0 µg/d folate) was executed over 12 weeks.
    

Detailed description: 
      Sixty-two women in reproductive age, apparently healthy, non-smokers, not consuming special
      diets (vegetarian), not pregnant, not planning conception or not lactating.

      A randomized, controlled, parallel intervention trial with two active groups and one blinded
      control group was carried out for 12 weeks (March to June, 2013). The active food group (n =
      21) consumed folate-rich foods (germinated canned faba beans, cookies, orange juice,
      providing additional 250 μg/d folate); the active folic acid supplement group consumed a
      supplement (n = 19, providing 500 μg/d folic acid); and the control group (n = 22) received
      apple juice containing no folate or folic acid) in addition to the freely chosen diet.

      Fasted venous blood samples were collected at baseline, two months and three months for
      quantification of folate in plasma and erythrocytes and of homocysteine in plasma.
    

Intervention name(s): Natural food folate; Folic acid; Apple juice
Intervention type(s): Other; Other; Other
Intervention description(s): Consumed folate-rich foods (providing additional 250 μg/d folate).; Received a folic acid supplement (providing additional 500 μg/d folic acid).; Received apple juice containing no folate or folic acid.
Other intervention name(s): Food folate
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Folate; folic acid; intervention trial; folate status; women in childbearing age; food folate
Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment
      of non-specific low-back pain of lumbosacral localization in ambulatory care.
    

Detailed description: 
      We enrolled patients between 40 and 65 years of age who had low back pain for at least 12
      weeks with a pain intensity >3 on a 0-10 point visual analogue scale (VAS). Major exclusion
      criteria were presence of fibromyalgia, degenerative spondylolisthesis, and alcohol and/or
      drug abuse. All patients were treated with ARTRA (combination of glucosamine hydrochloride
      500 mg and chondroitin sulfate 500 mg in tab; Unipharm Inc.) at a dose of 1 tab bid for the
      first month and then 1 tab daily for the next two months. The primary endpoint was pain
      intensity (at rest and movement) as measured on a 0-10 point VAS. Secondary endpoints
      included Oswestry Disability Index, patient global assessment of efficacy (0-5 scale) and
      NSAID consumption.
    

Intervention name(s): ARTRA
Intervention type(s): Dietary Supplement
Intervention description(s): ARTRA (glucosamine and chondroitin sulfate)
Other intervention name(s): Glucosamine; Chondroitin sulfate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic low back pain in ambulatory care
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV
Condition: HIV Infections; H1N1 Influenza
MeSH terms: Infections; Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety and effectiveness (immune response) to a
      licensed H1N12009 influenza vaccine in HIV-infected adults. The study will enroll 150 adults
      (ages 20-59 years). Participants will be randomized into 2 groups and will receive either one
      dose or two doses of a licensed H1N1 vaccine. Study procedures include: medical history,
      blood samples and completing a memory aid. Participants will be involved in study related
      procedures for approximately 6 days.
    

Detailed description: 
      During the first wave of the H1N12009 pandemic in Canada, adults with immune deficiency were
      more likely to die with severe infections than were other Canadians. Of 76 deaths attributed
      to date to this new virus, 37% occurred in persons with immune system compromise. Adults with
      human immunodeficiency virus (HIV) infection constitute a significant proportion of the
      at-risk population with over 56,000 affected individuals. Most such individuals retain some
      capacity to respond to influenza vaccination. The dosing regimen for the pandemic vaccine
      will be based on limited studies in the general population, leaving open the question of
      whether HIV-infected persons can respond satisfactorily to the recommended dosing.
      Availability of an adjuvanted formulation of the pandemic vaccine may improve responsiveness
      but two doses may be required for the best possible response. Thus it would be optimal to
      evaluate the safety and immunogenicity of the pandemic vaccine among the earliest
      HIV-infected persons to receive it, to inform the subsequent vaccination of others.

      The objectives of this study are three-fold:

        1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience
           sample of adults with HIV infection.

        2. To compare immune responses of subjects randomized to receive either one or two doses of
           adjuvanted vaccine to identify the optimal regimen.

        3. To complete this evaluation soon after the pandemic vaccine becomes available so as to
           inform the subsequent use of the vaccine in HIV-infected persons.
    

Intervention name(s): Arepanrix; Arepanrix
Intervention type(s): Biological; Biological
Intervention description(s): Group A receives one dose of Arepanrix; Group B receives 2 doses of Arepanrix 3 weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; vaccine,; H1N1; influenza; H1N1 Influenza vaccine; Arepanrix; Pandemic; H1N1 2009 Influenza; HIV preventive vaccine
How Astigmatism Influences Corneal Biomechanics and Intraocular Pressure
Condition: Corneal Astigmatism; Intraocular Pressure; Cataract Senile
MeSH terms: Cataract; Astigmatism
Study type: Observational

Summary: 
      The aim of the study was to identify whether preoperative corneal astigmatism can influence
      corneal biomechanics and the assessment of intraocular pressure (IOP) following
      micro-incision phacoemulsification.
    


Intervention name(s): non-contact measurement of intraocular pressure
Intervention type(s): Diagnostic Test
Intervention description(s): Non-contact measurement of corneal biomechanical properties and intraocular pressure with an Ocular Response Analyzer. Parameters measured: corneal hysteresis (CH), corneal resistance factor (CRF), Goldman-correlated IOP (IOPg), corneal compensated IOP (IOPcc) and waveform score (WS).
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        39 patients diagnosed with cataracts were enrolled in the study
      
Keywords: Corneal astigmatism; Cataract surgery; Corneal hysteresis; Corneal resistance factor; Intraocular pressure
Comparison Between Nurse-Administered Propofol Sedation and Diazemuls / Pethidine in Outpatient Colonoscopy
Condition: Colonoscopy
Study type: Interventional

Summary: 
      Colonoscopy is a common endoscopic procedure as an investigation of colorectal pathology.
      Different modalities of pain control have been described in the past. Propofol is a perfect
      drug for endoscopic procedure since it has the characteristic of fast onset, short half-life
      and early recovery. Its unfamiliarity and its potential cardiovascular and respiratory side
      effect make it unpopular to endoscopists. Recent reports showed propofol is safe in bolus
      titration by nurse in Caucasian in all endoscopic procedures. Our previous pilot study showed
      nurse administered propofol sedation (NAPS) is effective and safe and highly acceptable by
      Chinese patients. Here we conduct a randomized controlled study to compare the effectiveness
      of NAPS versus traditional sedation.
    


Intervention name(s): diazemuls, pethidine; Propofol and Alfentanil
Intervention type(s): Drug; Drug
Intervention description(s): 5mg Diazemuls and 25mg Pethidine one min. before procedure followed by bolus doses of 2.5mg Diazemuls / 12.5mg Pethidine at the discretion of endoscopists Maximal dose of 0.2mg/kg Diazemuls and 1mg/kg Pethidine; Loading dose of 40-60mg or 0.8mg/kg Propofol one min. before procedure Propofol 200mg + Alfentanil 0.5mg, 1.5ml per bolus (bolus dose of 14.3mg Propofol + 35ug Alfentanil) via PCA pump No maximal dose Zero lockout time
Intervention MeSH terms: Meperidine; Diazepam; Alfentanil; Propofol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Propofol; colonoscopy; sedation; pain; compare NAPS versus diazemuls in outpatient colonoscopy
Neuroimmune Response to Lipopolysaccharide
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, healthy adult volunteers will undergo two positron emission tomography (PET)
      scans using the radiotracer [11C]PBR28 which binds to the 18kDa translocator protein (TSPO).
      Approximately 3 hours prior to the second [11C]PBR28 PET scan, lipopolysaccharide (LPS;
      endotoxin) will be administered to evoke a robust neuroimmune response. Subjects will also
      undergo behavioral and cognitive testing. Vital signs, subjective response, and peripheral
      cytokine levels will be assayed periodically throughout the experimental session.

      Specific aims: Quantify the magnitude of neuroimmune response after a classical immune
      stimulus.

      Secondary aims: Quantify changes in cognitive function after a classical immune stimulus.

      Hypothesis: Individuals will exhibit a robust whole-brain neuroimmune response and impaired
      cognitive function after LPS.
    


Intervention name(s): Lipopolysaccharide
Intervention type(s): Biological
Intervention description(s): Endotoxin E Coli
Other intervention name(s): LPS
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All subjects will complete one 120-minute [11C]PBR28 PET scan before and one scan 3-hours after lipopolysaccharide (LPS; 1.0ng/kg; IV) administration. A subset of subjects will complete a follow-up [11C]PBR28 PET scan 24+ hours after LPS.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PET TSPO Imaging; Microglia Activation/Proliferation; Lipopolysaccharide
Extracorporeal Shock Wave Therapy Versus Manual Lymphatic Drainageon Cellulite Post Liposuction
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      To determine whether extracorporeal shock wave therapy (ESWT) or manual lymphatic drainage
      (MLD) is more effective for decreasing post-liposuction cellulite.

      Thirty females with grade 3 cellulite were randomly distributed into two equal groups: group
      A (ESWT group) (n=15) and group B (MLD group) (n=15). The cellulite grade was assessed by
      using the cellulite grading scale, and the thickness of subcutaneous fat was assessed by the
      skinfold caliper. The assessment was carried out before starting the treatment and after 4
      weeks. All participants received treatment 2 times/ week for 4 weeks.
    


Intervention name(s): Extracorporeal shock wave
Intervention type(s): Other
Intervention description(s): The participant was placed into supine lying position then the head of the shock wave was applied on the anterior or posterior aspect of the thigh which was scanned with 2000 shots for both horizontal direction and vertical direction. The period of each session was 15 minutes, 2 times/week for 4 weeks
Other intervention name(s): Manual lymphatic drainage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A 12 Week, Phase II Trial to Evaluate the Efficacy and Safety of WIN-34B in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase
      II clinical trial and aimed at osteoarthritis of the knee.

      Patients who signed informed consent voluntarily and eligible for this study are assigned
      randomly to one of 3 groups after 2 week-Washout period.

        1. st group (experimental) : WIN-34B 450mg BID

        2. nd group (experimental) : WIN-34B 900mg BID

        3. rd group (Comparator) : Placebo BID

      Patients will take WIN-34B or Placebo BID for 12 weeks. Based on baseline, after 4
      weeks(Visit 3) and 12 weeks(Visit 5), Researchers check patients' physical examination,
      questionnaire, laboratory experiment.

      After 8 weeks(Visit 4), researchers check adverse effects and current medication status via
      telephone interview.

      After 12 weeks(Visit 5) patients stop taking drugs and after 16 weeks(Visit 6) researchers
      check patients' physical examination, questionnaire, adverse effects and current medication
      status.
    


Intervention name(s): WIN-34B; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; WIN-34B
Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy
Condition: Hepatitis B, Chronic; Tumor
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Neoplasms; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effectiveness and safety of tenofovir for different treatment duration in
      preventing HBV relapse in patients with malignancies after receiving chemotherapy and
      off-treatment of chemotherapy.
    

Detailed description: 
      This study aims to evaluate the effectiveness and safety of tenofovir in preventing HBV
      relapse in HBV carriers with malignant tumor following chemotherapy. Approximately 100
      patients who are planned to receive chemotherapy for malignant tumor will be invited to
      participate in this trail. A 1 or less 1-week tenofovir prophylaxis treatment should be
      administered by all subjects prior to the chemotherapy and eligible subjects will be randomly
      assigned to extend 24-week prophylaxis group A or 48-week prophylaxis group B in a 1:1 ratio
      at the end of the chemotherapy. The subjects could be stopped or withdrawn from this study
      earlier if HBV relapses or need to receive another course of chemotherapy respectively. The
      relapse episode will be followed until 24 weeks after the end of prophylaxis therapy. Data
      collection will take place at screening, every cyclic visit of chemotherapy, at the end of
      chemotherapy, and the following prophylaxis period, then every 4 weeks during the follow-up
      period. Patients in both groups will be treated with tenofovir or other antiviral agent
      according to investigator judgement when HBV relapse after discontinuation of tenofovir
      therapy.
    

Intervention name(s): TDF
Intervention type(s): Other
Intervention description(s): To compare extend TDF 24 wks versus 48 wks prophylaxis efficacy in chemotherapy CHB patients
Other intervention name(s): viread
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Tenofovir 300mg QD. Two arm: 6 month and 12 month.
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Chronic hepatitis B; HBV; Chemotherapy; Reactivation; Prophylaxis
HORIZON-PFT: Pivotal Fracture Trial
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per
      year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures
      are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine
      the benefits of zoledronic acid in fracture reduction at both the hip and spine.
    


Intervention name(s): Zoledronic Acid
Intervention type(s): Drug
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bisphosphonate,BMD,Height loss, Hip protectors,HRT,; Osteoporosis