bioihbjkbjnl/mcl2 huggingface dataset:
Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis
Condition: Chorioamnionitis
MeSH terms: Chorioamnionitis
Study type: Observational

Summary: 
      Retrospective Chart Review to determine the selective use of antibiotics in neonates born to
      mothers with suspected chorioamnionitis
    

Detailed description: 
      To determine the incidence and types of adverse outcomes in infants born to mothers with
      signs of chorioamnionitis when these infants are asymptomatic and are not treated with
      antibiotics empirically.
    

Intervention name(s): Retrospective Chart Review
Intervention type(s): Other
Intervention description(s): Retrospective Chart Review
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients born at Women's Hospital/Cone Health in Greensboro, NC, from July, 2012 (when EMR
        was implemented), to present.
PK and Safety Study of HCP1102, HGP0813 and HGP1408
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, open label, single dose, two-way crossover clinical trial to
      investigate the pharmacokinetics and safety/tolerability of HCP1102 in comparison to HGP0813
      and HGP1408 administered in healthy male volunteers.
    


Intervention name(s): montelukast and levocetirizine FDC; Singulair + xyzal
Intervention type(s): Drug; Drug
Intervention description(s): HCP1102; HGP0813 + HGP1408
Intervention MeSH terms: Montelukast; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Hypothesis:

      Sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a
      period of 18 months has anti-inflammatory and neuroprotective properties in patients with
      relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical
      examination (EDSS and MSFC).
    

Detailed description: 
      This multicentric, national study investigates the efficacy and safety of EGCG in patients
      with relapsing-remitting multiple sclerosis.
    

Intervention name(s): epigallocatechin-gallate (Sunphenon); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg twice daily, after 3 months 400 mg twice daily; 2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; inflammation; neurodegeneration; neuroprotection
Psychopharmacotherapy in Multiple Substances Abuse
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12
      weeks after adjusted methadone dose. During the study, the investigators will evaluate
      treatment response and adverse effect from multiple dimensions to elucidate the therapeutic
      effect of add-on memantine on addictive behaviors. It will also explore the possible
      advantage of this treatment on social re-adaptation and psychopathogenesis of opioid
      dependence.
    

Detailed description: 
      Opioid dependence is currently a severe problem for public health and social security.
      Methadone maintenance therapy may decrease the criminal rate and increase the quality of life
      for individuals with opioid dependence, but the high drop-out rate and long-term requirement
      to use of methadone are major problems in methadone maintenance therapy for opioid
      dependence. Methadone is after all another long acting opioid which may cause dependence.
      Therefore, current effort of methadone maintenance therapy is limited.

      Memantine used to be recognized as a noncompetitive N-methyl-D-aspartate receptor antagonist.
      It was found with neuroprotective effects in several neurodegenerative diseases in recent few
      years. Memantine could inhibit brain inflammatory response through its action on reuroglial
      cells and provide neurotrophic effect. Previous studies also found memantine with inhibitory
      effects addictive behaviors in several substances. All of the above demonstrated that the
      combination of memantine and methadone in treating substance dependence prossess unique
      advantages, which may be superior to the original treatment. The main purpose of this study
      is to explore the neuroprotective effect of memantine on inhibition of brain inflammatory
      response through its action on reuroglial cells. Besides, we will evaluate the therapeutic
      effect of the combination of memantine and methadone in the subjects with opioid combine
      amphetamine dependence/abuse. It will also investigate multiple pathogenesis of addictive
      behaviors from the perspective of treatment response.
    

Intervention name(s): Memantine
Intervention type(s): Drug
Intervention description(s): Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, we will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hamstring Stretch Effect (STRETCH-HAMS)
Condition: Postural; Defect
Study type: Interventional

Summary: 
      Randomized clinical trial to evaluate the elongation of the hamstrings after making different
      types of stretching. One group receives a stretch of global postural reeducation (RPG),
      another group receives a mobilization of sciatic nerve, and a third group received a placebo
      treatment. The evaluation of these treatments are done previously, immediately after and 20
      min later. The test used to evaluate elongation are the Sit and Reach and active knee
      extension (AKE test).
    

Detailed description: 
      Randomized clinical trial to evaluate the elongation of the hamstrings after making different
      types of stretching and mobilizations used in physiotherapy. This study is realized with
      university students to be long time studying in sitting position, and each subject is
      randomly assigned to one of three different groups. One group receives 10 minutes of global
      postural reeducation stretching (RPG), another group receives 10 minutes of bilateral
      mobilization of sciatic nerve, and a third group received a placebo treatment. The evaluation
      of these treatments are done previously, immediately after and 20 min later. The test used to
      evaluate elongation are the Sit and Reach and active knee extension (AKE test). The order of
      measurement of each test is also randomized in each subject. The intervention is always
      applied to the same physical therapist, and measurements were always performed by another
      physiotherapist blinded.
    

Intervention name(s): Active stretching; Dynamic Stretching; Control
Intervention type(s): Other; Other; Other
Intervention description(s): 10 minutes of active stretching of the posterior muscle chain with RPG techniques; 10 minutes of dynamic stretching of the sciatic nerve and the posterior muscle chain with manual techniques of mobilization the nerves; 10 minutes with the patient lying on a machine off of magnetotherapy
Other intervention name(s): Postural Global Reeducation; Mobilization of sciatic nerve; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: manual therapy; muscle chains; Dynamic stretching; Active stretching
Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of
      single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment
      compared to matched healthy subjects with normal liver function.
    


Intervention name(s): Alisporivir
Intervention type(s): Drug
Intervention description(s): Capsules supplied as open labeled bulk medication in 10-unit blister packages
Other intervention name(s): DEB025
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: hepatic impairment; mild and moderate hepatic impairment; Alisporivir
BONAMI (BOne Marrow in Acute Myocardial Infarction)
Condition: Acute and Severe Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can
      be used to improve cardiac function in patients after acute myocardial infarction. In this
      randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow
      cells could improve myocardial viability at 3 and 12 months' follow-up.
    

Detailed description: 
      After successful percutaneous coronary intervention (PCI) for acute myocardial infarction,
      100 patients are randomly assigned to either a control group (n=50) who receives an optimal
      medical treatment, or a bone-marrow-cell group (n=50) who receives an optimal medical
      treatment and intracoronary transfer of autologous bone-marrow cells 7•10 days after PCI.
    

Intervention name(s): Intracoronary injection of autologous bone marrow mononuclear cells
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cell therapy; bone marrow mononuclear cells; myocardial infarction
Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)
Condition: Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of study is

        -  Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2

        -  Part B : To evaluate the proof of concept (POC) of GX-E2
    

Detailed description: 
      The secondary objective of study is to evaluate:

        -  change of red blood cell indices in anemic patients with chronic kidney disease
           receiving hemodialysis/peritoneal dialysis when administering GX-E2
           intravenously/subcutaneously

        -  change of reticulocyte indices in anemic patients with chronic kidney disease receiving
           hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously

        -  safety of GX-E2 when administering intravenously/subcutaneously

        -  incidence of blood transfusion in anemic patients with chronic kidney disease receiving
           hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously

        -  Immunogenicity in anemic patients with chronic kidney disease receiving
           hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
    

Intervention name(s): GX-E2; GX-E2; GX-E2; NESP; MIRCERA
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg; Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg; Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg; Each Group of Hemodialysis (n=30) will be administered NESP 30ug; Each Group of Peritoneal dialysis (n=24) will be administered MIRCERA 0.6ug/kg
Other intervention name(s): GC1113; GC1113; GC1113; Aranesp; Darbepoetin alfa; Methoxy Polyethylene glycol-epoetin beta
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Phase 2
Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients
Condition: Hypertension; Type 2 Diabetes Mellitus
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effects of nebivolol on glycemic control compared with
      metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus
    


Intervention name(s): Nebivolol; Metoprolol ER; HCTZ
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration; Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration; HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Other intervention name(s): Bystolic (TM); Hydrochlorothorazide
Intervention MeSH terms: Metoprolol; Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nebivolol; Bystolic ™; Hypertension; Diabetes
A Study to Assess Cerebrospinal Fluid INflammatory Markers After Addition of Maraviroc to MONotherapy Darunavir/Ritonavir - The CINAMMON Study
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate the possible benefits of giving the anti-HIV drug
      maraviroc to people who are taking darunavir/ritonavir alone for their HIV treatment. Many
      people successfully take only darunavir/ritonavir treatment for their HIV. However, there are
      some concerns that this treatment may not reach some areas of the body, such as the brain and
      spinal cord (central nervous system or CNS), as effectively as it does the bloodstream.

      There is already a large clinical study looking at any differences between 'conventional' HIV
      treatment with 3 drugs and single drug treatment with a protease inhibitor, also called PI
      monotherapy, such as darunavir/ritonavir. This includes differences in the effects on the
      CNS. However, this study will only be finished in 2013.

      The investigators know that maraviroc can reach the CNS very effectively. The investigators
      in this study will investigate the effect of adding maraviroc to darunavir/ritonavir
      monotherapy by looking at levels of inflammation within the fluid that surrounds the CNS,
      called cerebrospinal fluid or CSF.

      Maraviroc is a licensed drug for the treatment of HIV treatment.. It showed good results in 2
      clinical studies when it was taken by people whose HIV virus had developed resistance to
      previous HIV treatments.

      This study will also investigate safety as well as monitor effectiveness when patients take
      maraviroc is taken on top of normal treatment of darunavir/ritonavir monotherapy.

      Maraviroc has been shown to be present in the fluid that surrounds the brain in people taking
      Maraviroc. It is not known if whether the presence of Maraviroc has any impact on brain
      function. Therefore this study will also investigate brain (neurocognitive) functioning with
      a computer test and some written tests.
    


Intervention name(s): maraviroc
Intervention type(s): Drug
Intervention MeSH terms: Maraviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treadmill Exercise Prescriptions to Improve Fitness Versus Ambulatory Function After Stroke.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      Individuals disabled by stroke are at risk of losing cardiovascular fitness and muscle due to
      disease. This worsens disability and can increase the risk of having another stroke or a
      heart attack. We would like to find out if and how different types of regular exercise
      (intense walking, long walking) can increase fitness, balance and improve walking function
      and activities of daily living in individuals who have suffered a stroke.
    

Detailed description: 
      This randomized study compares effects of duration vs. velocity-based TM training regimens on
      fitness and ambulatory function in chronic stroke patients. Phase 1 - patients are screened
      (Mini Mental Status, CESD for depression, alcohol intake survey) and undergo routine medical
      and CV evaluations and blood labs in VA RRDC Assessment Clinic to establish medical
      eligibility. Standard neurological evaluations (NIH Stroke Scale, Modified Asworth Spasticity
      Scale, range of motion and manual motor testing) and review of imaging records assess
      neurological eligibility, deficit profiles and stroke subtypes. Physician supervised
      treadmill tolerance test and peak effort constant velocity exercise stress test with vital
      signs monitoring determine treadmill safety, functional eligibility to participate (must walk
      3 minutes at 0.2 MPH with handrail support), and cardiopulmonary safety in response to
      strenuous exertion. Eligible candidates undergo baseline testing (phase 2) including measures
      of fitness (VO2 peak, gait economy), ambulatory function and BOLD fMRI of knee movement.
      Phase 3 - 6 months TM training with either velocity or duration based progression, followed
      by Phase 4 -repeat of fitness and ambulatory function tests after 3 months, and Phase 5 -
      repeat of all baseline tests after 6 months training
    

Intervention name(s): Exercise
Intervention type(s): Procedure
Intervention description(s): Treadmill Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aerobic exercise; Balance, postural; Cardiovascular deconditioning; Gait; MRI, functional; Physical therapy techniques; Self Efficacy; Treadmill test
Tafenoquine/Chloroquine DDI Study
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      DDI study of Tafenoquine and Chloroquine
    

Detailed description: 
      Safety, Tolerability, and Pharmacokinetic Study of Concomitant Chloroquine and Tafenoquine in
      Healthy Volunteers
    

Intervention name(s): Chloroquine, Tafenoquine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Chloroquine and Tafenoquine; Placebo
Other intervention name(s): Tafenoquine; Chloroquine; Placeob
Intervention MeSH terms: Chloroquine; Chloroquine diphosphate; Tafenoquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Drug-Drug Interaction
Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two
      different drugs in the treatment of patients diagnosed with moderate to severe back pain.
    

Detailed description: 
      -  double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to
           treat trial.

        -  Experiment duration: 04 days.

        -  03 visits (days 0, 2 and 4).

        -  Efficacy will be evaluated for back pain relief based on visual analog scale.

        -  Adverse events evaluation.
    

Intervention name(s): Ketorolac Tromethamine; Naproxen
Intervention type(s): Drug; Drug
Intervention description(s): Every 8 hours for 4 days.; Every 8 hours for 4 days.
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial of the Safety and Immunogenicity of a Tetravalent Dengue Virus Vaccine Admixture TV005 in the Elderly Aged 50-70 Years in Taiwan
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II, randomized, double-blind, placebo-controlled study of the safety and immunogenicity
      of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 in the
      elderly in Taiwan
    

Detailed description: 
      In Taiwan, people who aged 50 to 70 years accounted for over 40% among those who infected by
      dengue virus every year. Therefore, to understanding the immunogenicity and safety of TV005
      vaccine among people aged 50 to 70 years is important for whether TV005 can be introduced
      into Taiwan as a major intervention to control dengue. This trial is a phase II,
      double-blind, multicenter, and placebo-controlled one. The investigators plan to enroll 252
      subjects whose age are 50 to 70 years at four study sites. One single-dose TV005 vaccine or
      placebo will be given subcutaneously. After vaccination, detailed data of the subjective
      symptoms, physical examination, laboratory examination, and titer of neutralization antibody
      from all subjects will be recorded. After completion of the present trial, the investigators
      can clarify the immunogenicity and safety of TV005 among people aged 50 to 70 years.
    

Intervention name(s): Tetravalent live attenuated dengue vaccine admixture TV005; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): The admixtures of the candidate vaccines each contain 4 live attenuated dengue viruses, each of a different serotype.; PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: tetravalent dengue vaccine; Phase II clinical trial