bioihbjkbjnl/mcl2 huggingface dataset:
Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
Condition: Hepatitis C, Chronic; HIV
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon
      (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients
      infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed
      treatment duration of 48 weeks is used.

      The aim of this study is to assess efficacy and safety of response-guided triple-therapy with
      BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration
      will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients
      will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be
      treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment
      duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of
      BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.
    


Intervention name(s): Pegylated interferon alpha-2a; Ribavirin; Boceprevir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 180mcg once weekly; subcutaneous injection; 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally; 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
Other intervention name(s): Pegasys®, Roche; Copegus®, Roche; Victrelis®, MSD
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Boceprevir; HIV/HCV-coinfection; HIV/HCV coinfection; HIV/HCV; Response-guided therapy
Applying the Use of Motivational Tools to Auditory Rehabilitation
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      The purpose of this study is to compare two different ways of helping first-time hearing-aid
      users get the most out of their hearing aids and determine if one method is better than the
      other. One method provides the patient with routine information regarding the care and use of
      hearing aids the other method uses tools to address patient-specific barriers against and
      motivators for hearing-aid use.
    


Intervention name(s): Standard-of-Care; Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): the standard of care in audiologic practice; motivational interviewing
Other intervention name(s): Motivational Interviewing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: hearing loss; hearing aids; motivational interviewing; counseling; rehabilitation
A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With Moderate to Severe Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate a drug (dasotraline) on the safety, effectiveness and how well the body
      tolerates it, in adults with moderate to severe binge eating disorder
    

Detailed description: 
      This is a randomized, double-blind, parallel-group, multicenter, outpatient study evaluating
      the efficacy and safety of 2 doses of dasotraline (4 and 6 mg/day) versus placebo over a
      12-week treatment period in adults with BED. This study is projected to randomize
      approximately 480 subjects to 3 treatment groups in a 1:1:1 ratio (4 mg/day dasotraline, 6
      mg/day dasotraline, and placebo).

      Subjects randomized to placebo will receive placebo for the duration of the treatment period.

      Subjects randomized to 4 mg/day dasotraline will receive 4 mg/day for the duration of the
      treatment period.

      Subjects randomized to 6 mg/day dasotraline will be dosed with 4 mg/day dasotraline for the
      first 2 weeks of the treatment period and will be increased to 6 mg/day at Week 2.

      If, in the judgment of the Investigator, the subject does not tolerate the assigned dose, he
      or she will be discontinued from the study.

      The study will consist of 3 periods: Screening (up to 3 weeks), 12-weeks of treatment, and a
      3-week study drug withdrawal period. Subjects who complete the 12-week double-blind treatment
      period in this study may be eligible to enroll and continue treatment for an additional 12
      months in an open-label extension study (Study SEP360-322). Subjects who do not enter the
      extension study will complete the study drug withdrawal period in this study.
    

Intervention name(s): dasotraline 4mg; dasotraline 6mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dasotraline 4mg tablet once daily; dasotraline 6mg tablet once daily; Placebo tablet once daily
Other intervention name(s): SEP225289; SEP225289
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Binge eating Disorder; dasotraline
Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT
Condition: Neurocysticercosis
MeSH terms: Neurocysticercosis; Cysticercosis; Taeniasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparing the effect of two different duration of same drug albendazole in patients with
      Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.
    

Detailed description: 
      The trial will be comparing the effectiveness of short and long duration of albendazole ie 7
      and 28 days therapy in patients with parenchymal neurocysticercosis in terms of complete
      resolution or calcification of cyst on CT head at the end of 6 months after starting
      albendazole
    

Intervention name(s): 7 days of albendazole 15 mg/kg/day; 28 days of albendazole 15 mg/kg/day
Intervention type(s): Drug; Drug
Intervention description(s): group A will receive 7 days of oral albendazole 15 mg/kg/day; group B will receive 28 days of oral albendazole 15 mg/kg/day
Other intervention name(s): Zentel; Bandy; Zentel; Bandy
Intervention MeSH terms: Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: parenchymal neurocysticercosis upto five lesions
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to evaluate the effect of erenumab compared to placebo
      on the change from baseline in monthly migraine days.
    

Detailed description: 
      This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.
      The trial consisted of four phases: screening (≤ 3 weeks of initial screening and a 4-week
      baseline phase); the double-blind treatment phase (24 weeks) in which participants received
      placebo or erenumab 70 mg or 140 mg daily; the active-treatment phase, in which participants
      underwent repeat randomization and were assigned to receive 70 mg or 140 mg of erenumab (28
      weeks); and a safety follow-up phase (12 weeks).
    

Intervention name(s): Erenumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month
Other intervention name(s): AMG 334; Aimovig™
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Headache; Prevention; Prophylaxis
Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Infection with dengue viruses is the leading cause of hospitalization and death in children
      in many tropical Asian countries, and the development of a dengue vaccine is a top health
      priority. This study will evaluate the ability of a single dose of a trivalent dengue vaccine
      to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6
      months after the trivalent dengue vaccine.
    

Detailed description: 
      There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each capable of
      causing dengue illness ranging from a mild illness to life-threatening disease. This study
      will evaluate a trivalent live attenuated dengue admixture vaccine that contains 3 different
      monovalent dengue vaccine candidates, representing 3 of the 4 dengue serotypes (DENV-1,
      DENV-3, and DENV-4). Study researchers will evaluate the safety and protective efficacy of a
      single dose of the trivalent dengue vaccine against viremia and rash induced by infection
      with an attenuated DENV-2 virus (rDEN2Δ30-7169), administered 6 months after the trivalent
      dengue vaccine.

      This study will enroll healthy adults with no history of previous flavivirus infection. At
      Day 0 (study entry), participants will be randomly assigned to receive either the trivalent
      dengue vaccine admixture or placebo. On Day 180, all participants will receive the
      rDEN2Δ30-7169 vaccine. Study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56,
      90, 150, 180, 184, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. Visits will
      include physical examinations and blood collection. All participants will record their
      temperature 3 times a day for 16 days after each vaccination.
    

Intervention name(s): Recombinant live attenuated trivalent dengue vaccine; Placebo; rDEN2Δ30-7169 vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Contains 10^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10^3.3 PFU/mL of rDEN3Δ30/31-7164 and 10^3.3 PFU/mL of rDEN4Δ30. It is administered in 0.5 mL containing 10^3.0 PFU of each component.; Live recombinant attenuated DENV-2 candidate vaccine virus; will be administered at a dose of 10^3 PFU
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Vaccine
Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.
Condition: Intrathecal Dexmedetomidine
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Highly selective α-2 agonist dexmedetomidine in increasingly used as an
      intrathecal adjuvant for caesarean section performed under subarachnoid block.

      Aim of the Study: The aim of the study is to determine whether low dose dexmedetomidine added
      to local anesthetic for spinal anesthesia will attenuate perioperative nausea and vomiting
      and shivering in lower segment caesarean section (LSCS) with minimal hemodynamic instability
      or not.

      Patients and Methods: Sixty parturients planned for elective CSs under spinal anesthesia were
      enrolled in this prospective controlled study and randomly divided into two equal groups.
      Spinal block was achieved with 10mg hyperbaric bupivacaine 0.5% plus 5µg dexmedetomidine
      (group D) (dexmedetomidine group) or 0.2 ml normal saline (group C) (control group).
      Hemodynamic parameters, incidence of nausea and vomiting and shivering were recorded.

      Keywords: Dexmedetomidine, Cesarean Section, Bupivacaine, Spinal Anesthesia, Shivering, PONV
    


Intervention name(s): Dexmedetomidine Injection [Precedex]
Intervention type(s): Drug
Intervention description(s): intrathecal injection of 5 mcg dexmedetomidine
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effect of PCV and VCV on Extravascular Lung Water
Condition: Extravascular Lung Water
Study type: Interventional

Summary: 
      Volume controlled ventilation (VCV) and pressure controlled ventilation (PCV) are the common
      ventilatory modes during OLV undergoing thoracic surgery. A controversy regarding which
      ventilation mode is better for oxygenation during OLV with PCV enhances oxygenation more than
      VCV ;given its initial high peak inspiratory flow rates and its rapidly decelerating flow
      pattern. However, this high peak inspiratory flow rate might also provoke lung injury via
      shearing and traction forces on the alveoli. Extravascular lung water describes water within
      the lungs but outside pulmonary vasculature. Lung ultrasound (LUS) assessment of EVLW by
      B-lines provides a reliable and easy alternative.
    


Intervention name(s): volume controlled ventilation; pressure controlled ventilation
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Lung ultrasound (LUS) will be performed with a 2-4 MHz phased array probe. Patients will be scanned in supine position by a recording 5 seconds videos. LUS will be assessed for the presence of B lines.
The sum of lung comets produces a score reflecting the extent of lung water accumulation. LUS will be obtained by scanning 12-rib interspaces. The sum of B-lines on each scanning site yields a score from 0 to 36; Lung ultrasound (LUS) will be performed with a 2-4 MHz phased array probe. Patients will be scanned in supine position by a recording 5 seconds videos. LUS will be assessed for the presence of B lines.
The sum of lung comets produces a score reflecting the extent of lung water accumulation. LUS will be obtained by scanning 12-rib interspaces. The sum of B-lines on each scanning site yields a score from 0 to 36
Other intervention name(s): LUS; LUS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adult patients scheduled for elective thoracic surgery with one lung ventilation will be included in the study. Patients will be randomly allocated into one of two groups:
Group V: will receive volume controlled mechanical ventilation. Group P: will receive pressure controlled mechanical ventilation.
Masking: Single (Investigator)
Primary purpose: Screening
Keywords: Extravascular lung water; one lung ventilation; volume controlled ventilation; pressure controlled ventilation
Desaturation Validation of INVSENSOR00036
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry
      measurement of somatic oxygen saturation. One investigational sensor (INVSENSOR00036) will be
      placed on the somatic site of the volunteer. The values obtained by the test sensor will be
      compared to the reference value obtained from an FDA-cleared sensor placed on the somatic
      site on the contralateral side.
    


Intervention name(s): INVSENSOR00036
Intervention type(s): Device
Intervention description(s): Noninvasive regional oximeter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Tipepidine in Children With Attention Deficit/Hyperactivity Disorder (AD/HD): a Double-blind, Placebo-controlled Trial
Condition: Attention Deficit Disorder With Hyperactivity Disease; Hyperkinesis; Attention Deficit and Disruptive Behavior Disorders
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Tipepidine (3-[di-2-thienylmethylene]-1-methylpiperidine) has been used solely as a
      nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults
      has already been established. It is reported that tipepidine inhibits G-protein-coupled
      inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by
      tipepidine is expected to modulate the level of monoamines in the brain. We put forward the
      hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD)
      symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK
      channels. The purpose of this double-blind, placebo-controlled trial is to confirm whether
      treatment with tipepidine can improve symptoms in pediatric patients with ADHD.
    

Detailed description: 
      Tipepidine (3-[di-2-thienylmethylene]-1-methylpiperidine) has been used solely as a
      nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults
      has already been established. It is reported that tipepidine inhibits G-protein-coupled
      inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by
      tipepidine is expected to modulate the level of monoamines in the brain. We put forward the
      hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD)
      symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK
      channels. The purpose of this double-blind, placebo-controlled trial is to confirm whether
      treatment with tipepidine can improve symptoms in pediatric patients with ADHD.

      See our previous open trial, An Open Study of Tipepidine Hibenzate in Patients With Attention
      Deficit Hyperactivity Disorder (ADHD) http://clinicaltrials.gov/show/NCT01835093
    

Intervention name(s): Tipepidine Hibenzate; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tipepidine, GIRK
Effects of Corn and Coconut Oils on Lipoprotein Lipids, Insulin Sensitivity and Inflammation
Condition: Healthy Men and Women
MeSH terms: Insulin Resistance; Inflammation
Study type: Interventional

Summary: 
      The objectives of this trial are to assess the effects of corn oil and coconut oil on
      low-density lipoprotein cholesterol (LDL-C) concentrations, and other aspects of the fasting
      lipoprotein lipid profile, as well as insulin sensitivity and an inflammatory marker, in men
      and women.
    

Detailed description: 
      This is a randomized, crossover, pilot study that includes two screening visits and two
      4-week test periods, separated by a 3-week washout. Subjects will consume study products
      providing 4 tablespoons oil/day of either corn oil or coconut oil replacing the same amount
      of oil in the background diet. Subjects will otherwise be encouraged to follow their habitual
      diet during both treatment periods. They will receive diet instructions on the incorporation
      of food substitutions during the test periods to maintain habitual energy intake. Subjects
      will record daily study product intake and compliance in a Daily Log. An intravenous glucose
      tolerance test (IVGTT) will be completed at baseline and the end of each treatment period for
      evaluation of insulin sensitivity. Fasting blood samples will be collected for lipid profile
      and high-sensitivity C-reactive protein (hs-CRP) measurements at all visits. Assessments of
      vital signs and body weight, review of concomitant medication/supplement use and inclusion
      and exclusion criteria for relevant changes, and evaluation of adverse effects will be
      performed throughout the study. Compliance will be assessed using the Daily Log intake
      percentages as the primary source.
    

Intervention name(s): Corn Oil; Coconut Oil
Intervention type(s): Other; Other
Intervention description(s): 4 tablespoons/day of corn oil for 4-week treatment period.; 4 tablespoons/day of coconut oil for 4-week treatment period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of VP1 Lido US for Volume Augmentation of the Cheek
Condition: Cheek Volume Augmentation
Study type: Interventional

Summary: 
      The primary objective of the study is to demonstrate non-inferiority of VP1 Lido US versus an
      approved hyaluronic acid dermal filler following deep (subdermal and/or supraperiosteal)
      injection of the cheek for volume augmentation.
    


Intervention name(s): VP1 Lido US; Restylane Lyft Lidocaine
Intervention type(s): Device; Device
Intervention description(s): Hyaluronic acid dermal filler containing lidocaine; Hyaluronic acid dermal filler containing lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a
      booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14
      months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix
      hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.
    

Detailed description: 
      The study is open and Infanrix hexa will serve as active control. Subjects will receive one
      vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before
      and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were
      primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa /
      Infanrix IPV/Hib.
    

Intervention name(s): Haemophilus influenzae type b- and meningococcal (vaccine)
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention