bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
Condition: Chronic Hepatitis c
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to confirm the potential effects and assess the safety of a new bio-product
      Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and
      Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated
      with Interferon.
    

Detailed description: 
      Total 720 subjects are divided into two groups and treated separately according to the HCV
      genotype（genotype 2,3 and non-genotype 2,3). With 2:1 ratio between experimental group and
      positive-control group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype
      2,3 and 504 subjects for non-genotype2,3 will be enrolled. Accordingly, PEG-IFN-SA once
      weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV
      genotype 2,3 and the HCV non-genotype 2,3 .
    

Intervention name(s): PEG-IFN-SA /RBV; Pegasys /RBV
Intervention type(s): Drug; Drug
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interferon; ribavirin; sustained virological response
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5462 Following Single and Multiple Ascending Dose Administration to Healthy Volunteers
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, and pharmacokinetic (PK) of AZD5462
      following single ascending dose (SAD) and multiple ascending dose (MAD) administration in
      healthy male and female participants and healthy participants of Japanese descent.
    

Detailed description: 
      This Phase I, First in Human (FIH), randomized single-blind, placebo-controlled study will
      consist of 2 parts (Part A and Part B) with an interleaved study design.

      Part A of the study will be a sequential SAD design with 5 dose levels planned to be
      investigated across 8 cohorts, of which 3 cohorts will solely comprise of participants of
      Japanese descent. Within each cohort, 6 participants will be randomized to receive AZD5462
      and 2 participants randomized to receive placebo.

      Part B of the study will be a sequential MAD design with 4 dose levels of AZD5462 planned to
      be investigated across 5 cohorts, of which 1 cohort will comprise solely of participants of
      Japanese descent. Within each cohort 6 participants will be randomized to receive AZD5462 and
      2 participants randomized to receive placebo.

      The duration for participants randomized to Part A of the study is 5 to 6 weeks, and for Part
      B, 6 to 7 weeks.
    

Intervention name(s): AZD5462; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively.; Participants will receive Placebo matched to AZD5462.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is randomized single-blind, and placebo-controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Healthy participants of Japanese descent; First-in-Human; 2-part study
Metabolic Syndrome and Leptin Level Associated With Fructose Consumption in Spain
Condition: Healthy
MeSH terms: Metabolic Syndrome
Study type: Observational

Summary: 
      A Food Frequency Questionnaire (FFQ), will be provided to 800 adults to assess overall
      fructose intake and this will be related to a number of features related to the metabolic
      syndrome, including serum leptin, characteristic features of metabolic syndrome (body mass
      index, waist circumference, plasma lipids, blood pressure, HOMA index,fasting glucose and
      fasting insulin levels) and other as: CRP, fibrinogen, homocysteine and uric acid.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        800 Adults, age 18 to 70
      
Biospecimen description: 
      Serum and urine collections.
    
Keywords: fructose; leptin; metabolic syndrome; blood pressure; inflammation; Relationship of fructose intake to leptin levels; Relationship of fructose to metabolic syndrome; Relationship of fructose to inflammation parameters; Relationship of fructose to blood pressure
Teenage Passenger Influences on Driving Performance of Teenage Drivers
Condition: Motor Vehicle Crash Injuries
Study type: Interventional

Summary: 
      This study, conducted at the University of Massachusetts at Amherst, will examine how male
      teenage driving performance varies in the presence or absence of male teenage passengers. It
      will explore what information teen drivers and their passengers use when making decisions
      that affect their performance on the road.

      Male drivers under 18 years of age who have a Junior Operator's or Full License and have
      driven at least once in the month before enrolling in the study may be eligible to
      participate.

      In a university laboratory, participants sit in a 1995 Saturn sedan and operate the controls
      of the car just as they would those of any other car, during simulated drives in urban,
      suburban and rural areas. They are fitted with a head-mounted eye tracker that records their
      point of gaze in real time. On one drive, the subject drives alone; on another, a male
      passenger rides along. After the drives, the subject fills out some questionnaires.
    

Detailed description: 
      The purpose of this research is to examine how male teenage driving performance varies in the
      presence or absence of high versus low risk accepting male teenage passengers. Driving
      performance includes attention and risk measures including eye glance behaviors, speed
      management, following distance, closing speed and gap acceptance. To what extent does driving
      performance vary as a product of the male teen passenger risk- acceptance compared with no
      passenger present?
    

Intervention name(s): Teen Passenger Presence
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Simulated Driving; Risky Driving Behavior; Social Influences
Anesthesia for Retinopathy of Prematurity
Condition: Retinopathy
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      Premature infants experience more respiratory problems after surgical procedures. The
      investigators aimed to compare general anesthesia with sedation on the need for
      post-operative mechanical ventilation in infants undergoing retinopathy of prematurity
      surgery.
    

Detailed description: 
      60 patients who underwent laser surgery due to retinopathy of prematurity (ROP) were included
      in the study. The sedation group (Group S, n=30), received 1 mg/kg ketamine and 1 mg/kg
      propofol as a bolus for induction. The patients then received an infusion of 100-150
      mcg/kg/min propofol and 0.25mg/kg/h of ketamine for maintenance. In the general anesthesia
      group (Group G, n=30), anesthesia was induced using 8% sevoflurane by inhalation with 50%
      nitrous oxide in oxygen; endotracheal intubation was facilitated without use of a
      neuromuscular blocker agent. Anesthesia was maintained with sevoflurane (2%) and 50% nitrous
      oxide in oxygen. Our primary objective was to evaluate the need for post-operative mechanical
      ventilation.
    

Intervention name(s): Ketamine; Sevoflurane; propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation; anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen; 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol
Other intervention name(s): ketalar, 50mg/ml; sevorein; pofol
Intervention MeSH terms: Ketamine; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Prematurity, Retinopathy, propofol, ketamine, sedation
Chronotype and Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Observational

Summary: 
      Chronotype (or circadian preference) has previously been shown to be associated with sexual
      attitudes and behaviors and is an important factor affecting sexual satisfaction. The fact
      that some neurobiological variables, which are thought to have a role in ejaculation
      physiology, are also effective in the processes of sleep and the regulation of circadian
      rhythm, and evidence supporting the relationship between circadian preferences and sexual
      desire and sexual behavior; suggests that ejaculation disorders may be related to circadian
      preference. The aim of the present study was to investigate the relationship between
      intravaginal ejaculatory latency time (IELT), severity of disease and chronotype in lifelong
      PE.
    

Detailed description: 
      After being informed about the study, all patients who gave written informed consent were
      questioned and diagnosed as lifelong PE according to the definition of International Society
      of sexual medicine (ISSM) by an experienced urologist. Since erctile dysfunction (ED) may
      accompany PE, the presence of ED symptoms was evaluated by the International Index of
      Erectile Function (IIEF-5), and those with IIEF-5 score <22 were excluded from the study.
      Age- and sex-matched control cases without lifelong PE were selected randomly among cases
      attending the hospital for a checkup procedure. A total of 114 patients with PE and 103
      control subjects with similar sociodemographic characteristics were included in the study. A
      detailed medical and sexual history was taken, which included self-estimated intravaginal
      ejaculatory latency time (IELT), by an experienced sexual therapist. Moreover, Arabic Index
      of Premature Ejaculation (AIPE), Pittsburgh Sleep Quality Index (PSQI) and
      Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.
    

Intervention name(s): Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)
Intervention type(s): Diagnostic Test
Intervention description(s): Self-estimated intravaginal ejaculatory latency time IELT is defined as the time between the onset of vaginal intromission and the onset of intravaginal ejaculation. In the present research, self-estimated IELT duration was obtained as a result of interviews with the participants. Moreover, Arabic Index of Premature Ejaculation (AIPE), International Index of Erectile Function (IIEF-5), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Males who presented at the outpatient clinic of Urology with the self-reported complaint of
        lifelong premature ejaculation
Biological Standardization of Blomia Tropicalis Allergen Extract
Condition: Allergy to Mites
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the biologic activity of a Blomia tropicalis
      allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house
      reference preparation (IHRP).
    

Detailed description: 
      This is an open, unblinded and non-randomized biological assay. The study design is a slight
      modification of the recommendations proposed by the Nordic Guidelines.

      Four concentrations of Blomia tropicalis allergen extract, together with a positive and
      negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol
      saline solution, respectively, will be tested in every patient in duplicate on the volar
      surface of the forearm.
    

Intervention name(s): Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control
Intervention type(s): Biological
Intervention description(s): Four concentrations of Blomia tropicalis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Immunotherapy; Skin prick test; Standardization; Blomia tropicalis
Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Epidural anesthesia (EP) is widely used for labor analgesia. Time to onset of adequate pain
      relief of EP technique for labor analgesia may be 15 to 20 minutes.More rapid injection is
      often passible through the needle compared to catheter and could enhance the spread of
      medication within the epidural space.There is lack of research assessing the onset of labor
      analgesia with a large priming dose of local anesthetic through the epidural needle compared
      with the epidural catheter.
    

Detailed description: 
      The epidural analgesia was performed in the left lateral decubitus position at the L3-L4 or
      L2-L3 interspace using a 18 G Tuohy needle. The epidural space was accessed by the loss of
      resistance to air or saline (2ml or less) technique.

      In the epidural needle group, after identification of epidural space, a dose of 3 ml of
      0.1%ropivacaine with 0.3ug/ml sufentanil was given via the epidural needle ,3 minutes later
      labor analgesia was initiated with 15ml of 0.1 ropivacaine with 0.3ug/ml sufentanil over 30
      seconds via the epidural needle, and then the catheter was inserted 3-5cm into the epidural
      space. In the epidural catheter group, the catheter was inserted 3-5cm into the epidural
      space after identification of epidural space, a dose of 3 ml of 0.1% ropivacaine with
      0.3ug/ml sufentanil was given via the epidural catheter, 3minutes later labor analgesia was
      initiated with 15ml of 0.1%ropivacaine with 0.3ug/ml sufentanil as the same of group N.
    

Intervention name(s): epidural needle; epidural catheter
Intervention type(s): Procedure; Procedure
Intervention description(s): the loading dose for labor analgesia administrated via epidural needle before the catheter insertion; the loading dose for labor analgesia administrated via epidural catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients
Condition: Stroke; Middle Cerebral Artery Infarction
MeSH terms: Stroke; Infarction, Middle Cerebral Artery; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to determine the efficacy of brain transplants of CD34+ stem
      cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.
    

Detailed description: 
      30 patients are divided into 2 groups, one treatment group and one control group.Treatment
      group will be implanted with peripheral blood stem cell and receive convention stroke therapy
      ,and control group only receive convention stroke therapy. We expect that transplantation of
      the peripheral blood CD34+ cells has the potential of significant benefit to neurological
      recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+
      cells obtained from the peripheral blood of the chronic stroke patients was safe and
      beneficial for neurological recovery. We expect this trial can further prove the efficacy of
      this treatment method.
    

Intervention name(s): Intercerebral implantation of Autulogous Stem Cells; convention therapy
Intervention type(s): Procedure; Drug
Intervention description(s): 2-8 millions Stem cell per patients plus convention therapy; antiplatelet
Other intervention name(s): PBSC; CD34 Stem Cell
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Stem Cell; Cell Therapy; CD34 Stem cell; Peripheral blood Stem cell
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
Condition: Sexual Dysfunction; Breast Cancer Survivors
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether lactate-containing vaginal lubricant is
      effective in the treatment of young breast cancer survivors with sexual dysfunction.
    

Detailed description: 
      Study scheme

        -  study arm: apply lactate-containing lubricants at the time of sexual intercourse and
           before sleep at least 3 times per a week for 8 weeks

        -  control arm: placebo apply

      Outcome measures

        -  Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk

        -  vaginal maturation index: at 0 wk and 8 wk

        -  vaginal pH: at 0 wk and 8 wk
    

Intervention name(s): Lactate-containing vaginal lubricant; Placebo vaginal lubricant
Intervention type(s): Drug; Drug
Intervention description(s): vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week); vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
Other intervention name(s): Clino-san(commercial name in Korea); placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dyspareunia; breast cancer; sexual dysfunction; vaginal lubricant
Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility of a 10-week tai chi chuan
      intervention as a treatment for anxiety and sleep quality in young adults.
    


Intervention name(s): Anxiety Management Education; 10 week tai chi intervention; Enhanced tai chi instruction
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): written materials on management of anxiety for self-study; 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week; 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anxiety; sleep quality; tai chi chuan; young adults
Local Nasal Tolerability and Safety Study of 1146A in Healthy Adult Participants
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single-center, randomized, parallel-group, placebo-controlled study to assess
      the local nasal tolerability and safety of multiple administrations of topically
      (intranasally) administered 1146A delivered by a nasal spray applicator in healthy adult
      participants
    


Intervention name(s): Carbomer 980; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Test product containing 0.5% carbomer 980 gel; Reference product containing vehicle without 0.5% carbomer 980 gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment
      related adverse events when initiating treatment.

      The majority are local allergic reactions within the mouth and/or throat, and most of these
      reactions are mild or moderate. It is anticipated that intake of antihistamine before
      initiation of Grazax treatment would most likely reduce the discomfort associated with
      initiation of Grazax treatment. So this trial was to investigate if administration of
      antihistamine prior to initiation of Grazax treatment results in a reduction of subjects
      reporting local allergic reactions.
    

Detailed description: 
      Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment
      related adverse events when initiating treatment. The adverse events are considered
      consistent with the introduction of allergens in sensitised subjects. The majority are local
      allergic reactions within the mouth and/or throat. Most of these reactions are mild or
      moderate in intensity, have an onset almost immediately after taking a tablet, and last from
      minutes to hours after intake. Appearance of adverse events in relation to tablet intake
      tends to subside spontaneously within 1 to 7 days. Thus, initiation of treatment with Grazax
      may be associated with discomfort. It is anticipated that intake of antihistamine before
      initiation of Grazax treatment would most likely reduce the discomfort associated with
      initiation of Grazax treatment. Therefore, the rationale for this trial was to investigate if
      administration of antihistamine prior to initiation of Grazax treatment results in a
      reduction of subjects reporting local allergic reactions.
    

Intervention name(s): Grazax + Aerius; Grazax + placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment