bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Influence of Nevirapine to Atazanavir in Steady State Equilibrium in HIV Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the influence of nevirapine in exposure to
      atazanavir boosted with ritonavir, in steady state equilibrium, in HIV-infected adult
      patients.
    

Detailed description: 
      In recent years, new treatment strategies have appeared aimed at reducing the risk of
      treatment-derived toxicity without compromising efficacy.

      Of the recent antiretroviral drugs, atazanavir is a protease inhibitor (PI) whose
      pharmacokinetic profile allows it to be given in a single daily take with a scant impact on
      lipid metabolism. This second characteristic makes atazanavir a good alternative for patients
      with a high vascular risk. However, one of its drawbacks is that it may present clinically
      relevant interactions with other drugs.

      Another antiretroviral agent with a scant impact on lipid metabolism is nevirapine. Different
      studies have described an improvement in lipid profile, as well as a less atherogenic
      tendency in patients treated with nevirapine. Moreover, the combination of nevirapine with PI
      drugs in the context of nucleoside-sparing strategies may permit a suitable control of viral
      replication, and an improvement in the mitochondrial toxicity derived from treatment with
      NTRI, which may possibly result in a minor incidence or in a clinical improvement of
      lipodystrophy.

      The combination of atazanavir with nevirapine may be of major interest in HIV-infected
      patients that have had a cardiovascular event (secondary prevention) or are at a high risk of
      having one (primary prevention). Similarly, this combination of drugs may be promising as a
      nucleoside-sparing strategy. However, according to preliminary data, the joint administration
      of nevirapine with atazanavir may lead to a reduction in the atazanavir plasma concentration.
      Thus, before evaluating the clinical utility of this combination of drugs, pharmacokinetic
      studies evaluating the existence of significant pharmacokinetic interactions between both are
      necessary
    

Intervention name(s): Atazanavir (Reyataz); Ritonavir (Norvir); Nevirapine (Viramune)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Atazanavir (Reyataz): capsules 150 mg (2 capsules/24h); Ritonavir (Norvir): capsules 100 mg (1 capsule/24h); Nevirapine (Viramune): tablets 200 mg (1 tablet/12h*)
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Nevirapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nevirapine; Atazanavir; Pharmacokinetics; Interactions
Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to
      placebo, are efficacious, safe and tolerable in improving glycemic control in patients with
      type 2 diabetes. Doses of 2 to 5 mg/day will be studied.
    


Intervention name(s): RO 205-2349
Intervention type(s): Drug
Other intervention name(s): Edaglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All potential participants entered the placebo run-in phase. At the end of the placebo run-in phase, eligible participants who met the final inclusion/exclusion criteria were randomized to the double-blind treatment period.
treatment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase I, 2-part (Part 1 Being a Single Dose Escalation and Part 2, a Parallel Group) Study of Toll-like Receptor (TLR4) Agonist (GSK1795091) in Healthy Subjects
Condition: Cancer; Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an ascending dose first-time-in-human study to determine the safety,
      tolerability, pharmacodynamic (PD), and pharmacokinetics (PK) profile of GSK1795091 in
      healthy subjects. The results will support the design of future clinical trials of GSK1795091
      administered to subjects with advanced malignancies in combination with immune system
      modulators.

      Part 1 will be a randomized, double-blind (sponsor-unblinded), placebo-controlled, single
      center, single dose escalation, sequential group evaluation of intravenously administered
      GSK1795091 to evaluate the safety and tolerability in healthy subjects. Part 2 will be an
      open-label, parallel group evaluation of 2 doses of GSK1795091 administered, either 1 week
      apart (Part 2, Cohort 1) or 2 weeks apart (Part 2, Cohort 2). In Part 2, on Day 1, subjects
      will receive intravenous GSK1795091 at a dose determined by results from Part 1. The total
      duration of this study is approximately 10 weeks from screening to the last study visit.
    


Intervention name(s): GSK1795091; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK1795091 will be supplied as solution for injection vial. Each 5 mL vial contains 0.001 milligram/mL (mg/mL; 1000 ng/mL) or 0.0001 mg/mL (100 ng/mL)of GSK1795091 and will be administered as IV bolus over 2-5 minutes (min) followed by a IV bolus of 10 mL normal saline.; Matching placebo will be supplied as a solution for injection vial and will be administered as IV bolus over 2-5 min followed by a IV bolus of 10 mL normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics; TLR4 agonist; cancer; tolerability; GSK1795091; pharmacodynamics; safety
Sleep Intervention for Kids and Parents: A Self-Management Pilot Study
Condition: Sleep Disturbance; Asthma
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Behavioral intervention for 6-11 year children with persistent asthma and sleep disturbance
      and a parent with sleep disturbance.
    


Intervention name(s): Sleep Intervention for Kids and Parents (SKIP)
Intervention type(s): Behavioral
Intervention description(s): Dyadic approach using self-efficacy theory to set goals, anticipate barriers, problem solve
Intervention model: Single Group Assignment
Intervention model description: Dyadic intervention for school-age children and a parent
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: School-age child
A Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Cilostazol in Subjects With Vasospastic Angina
Condition: Vasospastic Angina
MeSH terms: Angina Pectoris; Angina Pectoris, Variant
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted in accordance with the local regulation of New Drug Application.
      Overall duration of this trial will be 3 years after approval of KFDA.

      Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in
      period, 4 weeks double blind period and 1 week safety follow up period
    

Detailed description: 
      A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic
      confirmatory Study.

      The subject who has at least one episode of chest pain weekly and at least two episodes of
      chest pain during last week despite Amlodipine 5mg qd taking during 2 weeks will have
      treatment of Pletaal(Cilostazol) or Placebo for 4 weeks. Pletaal(Cilostazol) is taken 100mg
      oral tablets bid during 2 weeks after dosing of Pletaal(Cilostazol) 50mg oral tablets bid
      during 2 weeks. Placebo of Pletaal(Cilostazol) is used as the control medication.
    

Intervention name(s): Cilostazol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100mg oral tablets bid during 2 weeks after dosing of 50mg oral tablets bid during 2 weeks; 100mg oral placebo tablets bid during 2 weeks after dosing of 50mg oral placebo tablets bid during 2 weeks
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment for vasospastic angina
Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
Condition: Psychosis
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to reveal the specific effects of computer-aided cognitive
      training on course and rehabilitation in early onset schizophrenia
    

Detailed description: 
      Impairment in cognitive functions is one of the main symptoms in schizophrenia and is
      currently one of the challenges in the treatment of the disease. We examine the beneficial
      effect of computer-aided training program on course and rehabilitation of young psychotic
      patients with early onset psychosis. In addition we develop predictors for the course of
      disorder from neuroimaging data.
    

Intervention name(s): Brain Fitness Training, Posit Science SF
Intervention type(s): Behavioral
Intervention description(s): Computer aided cognitive training based on principles of neuroplasticity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Brain Oscillations; Cognitive Performance
Dye Assisted Lymphatic Sparing Subinguinal Varicocelectomy
Condition: Varicocele
MeSH terms: Varicocele
Study type: Interventional
Phase: Phase 2

Summary: 
      We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who
      received 2 ml intratunical space injection of methylene blue before spermatic vein ligation
      with 40 controls in whom no mapping technique was adopted in the period between January 2008
      and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the patients were
      assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy,
      pain or other complications with mean follow up was 15+ 7months.
    

Detailed description: 
      Methods. We prospectively compared outcomes of subinguinal varicocelectomy for 40 patients
      who received 2 ml intratunical space injection of methylene blue before spermatic vein
      ligation with 40 controls in whom no mapping technique was adopted in the period between
      January 2008 and Feb. 2010, in Mansoura university hospital ward 7.After surgery, the
      patients were assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele
      formation, atrophy, pain or other complications with mean follow up was 15+ 7months.

      Results: There were no intraoperative complications in either group. There were no adverse
      reactions, scrotal haematomas or atrophy. In group 1, no patient had a hydrocele at 3 months
      after surgery. By contrast, in group 2 (surgery alone) there were four cases of secondary
      hydrocele (10%; P=0.025)); no testicular hypertrophy was observed following lymphatic sparing
      surgery , One patient in each group had varicocele recurrence. Pregnancy was reported in 30
      patients (37.5%) during a follow up period, 17 of them (42.5%) were group(1),P >0.34.
      difference was not significantly different among the two groups
    

Intervention name(s): without dye varicocelectomy; without dye varicocelectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): 40 controls in whom no mapping technique was adopted in the period between; 40 controls in whom no mapping technique was adopted in the period between
Other intervention name(s): optical subinguinal varicocelectomy; microoptic subinguinal varicocelectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: varicocele, methylene blue, varicocelectomy, hydrocele,
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
Condition: Poliomyelitis; Tetanus; Acellular Pertussis; Diphtheria; Haemophilus Influenzae Type b
MeSH terms: Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine
      when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6
      months of age.
    


Intervention name(s): Infanrix™-IPV+Hib; Infanrix™ IPV; Hiberix™; Synflorix™; Rotarix™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular, 3 doses; Intramuscular, 3 doses; Intramuscular, 3 doses; Intramuscular, 3 doses; Oral, 2 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary vaccination; combination vaccine; South Korea
Evaluating Accommodative Responses of Soft Contact Lenses for Myopia Control
Condition: Visual Acuity
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This is a bilateral, non-dispensing, randomized, controlled, double-masked, 7x7 cross-over
      study. Each subject will be bilaterally fitted with one of the 7 test articles in each of the
      7 periods for a total of four visits. Up to two lens types will be fit at each of the four
      study visits.
    


Intervention name(s): Test Lens 1; Test Lens 2; Test Lens 3; Test Lens 4; Test Lens 5; Control Lens 1; Control Lens 2
Intervention type(s): Device; Device; Device; Device; Device; Device; Device
Intervention description(s): EMO-114; EMO-116; EMO-118; RMY-100; Biofinity multifocal D Lens; EMO-117; Proclear 1 day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Device Feasibility
A Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open-label, 2-cohort, fixed-sequence, DDI study in healthy
      adult subjects. Healthy volunteers will be administered multiple oral doses of ATI-2173 in
      combination with midazolam or clarithromycin and assessed for safety and tolerability
      including blood tests to show how the body metabolizes and eliminates the investigational
      drug as well as how the investigational drug interacts with midazolam or clarithromycin.
    


Intervention name(s): ATI-2173; Midazolam; Clarithromycin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth; Midazolam is a sensitive CYP3A index substrate; Clarithromycin is a sensitive P-gp index inhibitor to evaluate potential effect of P-gp inhibition on ATI-2173 and its metabolites(clarithromycin)
Intervention MeSH terms: Clarithromycin; Midazolam
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Trans Fatty Acids From Ruminant Sources on Risk Factors for Cardiovascular Disease
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objectives of this study are to : 1) determine if vaccenic acid (trans-11-octadecenoic, a
      naturally occurring trans fatty acid isomer from ruminant animal products) raises LDL
      cholesterol in a quantitatively comparable manner as mixed trans fatty acid isomers from
      partially hydrogenated vegetable oils at 3% of energy intake, 2) determine if cis-9, trans-11
      conjugated linoleic acid (a naturally occurring polyunsaturated fatty acid from ruminant
      animal products) raises LDL cholesterol compared to a control diet, and 3) demonstrate that
      mixed trans fatty acid isomers from partially hydrogenated vegetable oil raises LDL
      cholesterol compared to a low trans fatty acid diet.
    


Intervention name(s): PHVO; CLA; VA; base
Intervention type(s): Other; Other; Other; Other
Intervention description(s): base diet plus 3.0% energy mixed isomers of trans fatty acids from partially hydrogenated vegetable oil; base diet plus 1.0% energy added from cis-9, trans-11 conjugated linoleic acid; base diet plus 3.0% energy added from vaccenic acid; base diet containing approximately 0.1% energy of mixed trans fatty acid isomers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: trans fatty acids; ruminant; cardiovascular disease
Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain
Condition: Injection Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Propofol remains the most common drug for induction of general anaesthesia, although it
      causes considerable pain or discomfort on injection. Anesthesia providers have attempted a
      large number of remedies to prevent this pain on injection. Previously explored ideas include
      injecting propofol into larger veins, warming of the hand with hot packs, and intravenous
      pretreatment with numerous other medications. No studies to date have looked at the
      dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. The
      investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of
      propofol related pain on injection.
    


Intervention name(s): saline; dexketoprofen; tenoxicam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): before the anesthesia induction, 2mL saline iv injection; before the anesthesia induction, 50 mg (2mL) iv dexketoprofen; before the anesthesia induction, 20 mg (2mL) iv tenoxicam
Other intervention name(s): serum physiologic; Arveles; Leodex; Oksamen-L; Tilcotil
Intervention MeSH terms: Dexketoprofen trometamol; Tenoxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Safety and Pharmacokinetics Study of DWC20155 and DWC20156 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to Compare the safety and pharmacokinetics between
      co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects
    


Intervention name(s): Co-administration of DWC20155 and DWC20156; DWJ1366 Tab.
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults
Condition: Hepatitis E
MeSH terms: Hepatitis A; Hepatitis E; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly
      infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to
      15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E
      vaccine.

      This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial.
      This study will determine the safety and immunogenicity of the investigational recombinant
      hepatitis E vaccine in healthy adults between 16 and 65 years.
    


Intervention name(s): 30μg/0.5ml Hepatitis E vaccine; 30μg/0.5ml Recombinant Hepatitis E vaccine
Intervention type(s): Biological; Biological
Intervention description(s): three doses, 30μg/0.5ml per dose; 30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co.,Ltd.,three doses, 30μg/0.5ml per dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Safety; immunogenicity; Hepatitis E
Single Rising Dose Tolerability Study of BIBN 4096 BS in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to obtain information about the safety, tolerability
      and pharmacokinetics of BIBN 4096 BS after single intranasal administration of increasing
      doses in healthy male and female volunteers
    


Intervention name(s): BIBN 4096 BS- in single rising doses; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olcegepant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
National Health and Nutrition Examination Survey 24-hour Urine Collection Feasibility Study, 2013
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      A 24-hour urine pilot study was conducted as part of the 2013 NHANES to test the feasibility
      of implementing a 24-hour urine collection as part of NHANES in 2014.
    

Detailed description: 
      The 24-hour urine pilot study was conducted March - June 2013 in three NHANES locations. A
      random half-sample of non-pregnant US adults, aged 20-69 who were examined in the NHANES
      mobile examination center were selected. Participants received instructions, started and
      ended the urine collection in a urine study mobile examination center (UMEC), and answered
      questions about collection. A random half of participants who collected a complete 24-h urine
      were asked to collect a second 24-h urine. Urinary sodium, potassium, chloride, and
      creatinine excretion were analyzed.

      Participation rates in two other post-examination components, the Physical Activity Monitor
      and the Dietary Recall, were monitored to determine whether collecting a 24-hour urine had an
      effect on response rates for the two components.
    

Intervention name(s): Collect 24-hour urine specimen
Intervention type(s): Other
Intervention description(s): A random half sample of NHANES participants 20-69 examined in the mobile examination center were asked to collect a 24-hour urine specimen.
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        NHANES participants aged 20-69 years who were examined in the mobile examination center.
Electromyography and Yoga
Condition: Yoga
Study type: Interventional

Summary: 
      This study examined the muscle activity, movement patterns, and oxygen consumption during a
      series of yoga poses with slow and rapid transitions.
    


Intervention name(s): High-speed yoga; Low-speed yoga
Intervention type(s): Other; Other
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: aerobic; muscle activity; energy expenditure