bioihbjkbjnl/mcl2 huggingface dataset:
Gardasil Immunogenicity With Needle-Free Injection
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      1. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine
           in women given low doses of vaccine by the ID route with the NFI (Group III) to those
           women given standard doses by the IM route with a needle and syringe (Group I) at 1
           month, 6 months and 18 months following completion of the vaccination series.

        2. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine
           in women given standard doses of vaccine by the IM route with the NFI (Group II) to
           those women given standard doses by the IM route with a needle and syringe (Group I) at
           1 month, 6 months and 18 months following completion of the vaccination series.
    

Detailed description: 
      Primary hypotheses:

      The primary goal of this study is to compare the vaccination groups. Using GMTs to measure
      immunogenicity of the 3 different vaccination regimens, we will test for non-inferiority
      between Group I and Group II and between Group I and Group III.

      Our hypotheses are:

        1. GMTs of antibodies to all 4 HPV types (6, 11, 16 and 18) following a 3-dose series of
           vaccine in women given low doses of vaccine by the ID route with the NFI (Group III)
           will be non-inferior to GMTs in women given standard doses by the IM route with a needle
           and syringe (Group I). Non-inferiority criteria will have been satisfied when the upper
           95% confidence limit on the ratio of GMTs (GI/GIII) is less than 1.5 for all HPV types.

        2. GMTs of antibodies to all 4 HPV types (6, 11, 16 and 18) following a 3-dose series of
           vaccine in women given standard doses of vaccine by the IM route with the NFI (Group II)
           will be non-inferior to GMTs in women given standard doses by the IM route with a needle
           and syringe (Group I). Non-inferiority criteria will have been satisfied when the upper
           95% confidence limit on the ratio of GMTs (GI/GII) is less than 1.5 for all HPV types.

        3. The proportions of baseline-naïve vaccinees seroconverting to all 4 HPV types (6, 11, 16
           and 18) following a 3-dose series of vaccine in women given low doses of vaccine by the
           ID route (Group III) and standard doses of vaccine by the IM route (Group II) with the
           NFI will be non-inferior to the seroconversion rates in women given standard doses by
           the IM route with a needle and syringe (Group I). Non-inferiority criteria will have
           been satisfied when the upper 95% confidence limit on the difference in proportions is
           less than 10% for all HPV types.
    

Intervention name(s): GINI
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: HIV-uninfected
Impact of Inflammation on Reward Circuits, Motivational Deficits and Negative Symptoms in Schizophrenia
Condition: Schizophrenia
MeSH terms: Inflammation; Schizophrenia
Study type: Interventional

Summary: 
      This study will recruit persons with schizophrenia or schizoaffective disorder and will use
      an oral glucose tolerance test to test the hypothesis that insulin resistance drives
      inflammation.
    

Detailed description: 
      Schizophrenia is a severe mental illness that affects 1% of the population, but accounts for
      over $60 billion in costs to the national healthcare system. Negative symptoms of
      schizophrenia, including motivational deficits, are some of the most debilitating aspects of
      the disorder, being both difficult to treat and representing one of the most significant
      barriers to functional recovery. One pathophysiologic pathway that may contribute to these
      alterations in reward circuitry in schizophrenia is inflammation. Increased inflammation has
      been reliably linked to deficits in reward processing and decreased motivation via effects of
      inflammatory cytokines on regions of the basal ganglia, including the ventral striatum.
      Previous findings show that some patients with schizophrenia reliably exhibit elevated
      concentrations of inflammatory markers and that inflammatory cytokines may be related to
      negative symptoms including decreased motivation. Relevant to the impact of inflammation on
      insulin signaling, measures of insulin sensitivity are significantly worse in patients with
      schizophrenia, including at illness onset. Moreover, antipsychotic medications lead to
      metabolic syndrome, contributing to risk for insulin resistance and ultimately diabetes.
      Insulin resistance is believed to be caused by increased inflammation, and in turn can
      contribute to inflammation through alterations in glucose metabolism.

      This study uses an oral glucose tolerance test to test the hypothesis that insulin resistance
      drives inflammation. The researchers will recruit subjects with a range of insulin
      resistance, as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
      This will allow the researchers to investigate the contributions of metabolic dysfunction and
      inflammation on inflammatory and metabolic markers, brain reward circuitry, motivational
      deficits, and negative symptoms.
    

Intervention name(s): Oral Glucose Tolerance Test (OGTT)
Intervention type(s): Other
Intervention description(s): Participants will undergo a fasting blood draw for inflammatory and metabolic markers before a 75gm oral glucose tolerance test (OGTT) and at 1, 2 and 3 hours post-OGTT. Behavioral assessments will also be administered pre- and post-OGTT administration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inflammation; Magnetic Resonance Imaging (MRI); Negative Symptoms
Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether vitamin D3 supplementation is effective in
      the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to
      Irritable Bowel Syndrome (IBS).
    

Detailed description: 
      This randomized double blind clinical trial will be performed on 90 patients (45 in
      intervention and 45 in control group) diagnosed with IBS. The intervention group will receive
      50000 IU vitamin D3 and the control group will receive placebo contains edible paraffin once
      every 2 weeks for six months. Variables including biomarkers of inflammation and oxidative
      stress, serum levels of calcium and vitamin D, anthropometric indicators and blood pressure
      will be measured at baseline and end of the study. The investigators will use Rome III
      questionnaire for evaluating the clinical signs of the disease. The questionnaires will be
      filled out at baseline and every 2 weeks by the patients for six months.
    

Intervention name(s): Vitamin D3 (Cholecalciferol); placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.; placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; inflammation; oxidative stress; clinical signs; vitamin D3
A Drug-Drug Interaction Study of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult Volunteers
Condition: Health, Subjective
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to
      evaluate the interaction between two investigational drugs by comparing and analyzing the
      pharmacokinetic interaction and safety of CTL0901 and CTL0902 at steady state when
      administered alone or in combination with repeated oral doses in healthy adult volunteers.
    


Intervention name(s): Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CTL0901, single dose, daily, repeated oral administration for 4 days; CTL0902, single dose, daily, repeated oral administration for 7 days; CTL0901 and CTL0902, single dose, daily, repeated oral administration for 7 days
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bowen and Graston Technique in Patients of Tension Neck Syndrome
Condition: Neck Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      To compare the effects of Bowen and Graston technique in Tension neck syndrome for neck pain
      , ROM and disability in patients with Tension neck syndrome .
    

Detailed description: 
      Tension neck syndrome (TNS) is defined as a myofascial pain localized in the neck and
      shoulder regions. The symptoms include; pain, tenderness, fatigue and stiffness in the neck
      and shoulder musculature, headaches radiating from the neck, without a history of injury
      herniated cervical disk, or degenerative processes. It is characterized pain over the neck
      region and muscle tenderness elicited on palpation and or neck movement. TNS patients with
      pain have the reduced sensitivity of the neck proprioception. TN may be work- and
      individual-related and sociopsychological factors may have effect.

      Bowen Therapy, is a dynamic fascial and muscle release approach, consisting of gentle
      cross-fiber movements applied to the fascia, muscles, tendons, muscle insertions, muscle
      septa, ligaments and viscera.

      Grastοn technique is an instrument assisted soft tissue treatment method (ІASTM) derived from
      the Cyriax1 cross-friction massage. Physіοtherapist strikes stainless steel instrument in a
      longitudinal dіrectіοn and in circular patterns at the treatment site
    

Intervention name(s): Bowen Technique; Graston technique
Intervention type(s): Other; Other
Intervention description(s): They would be receiving conventional treatment as follow:
Hot pack for 10 minutes TENS for 10 minutes Cervical isometrics 10 reps with 5 sec hold Additionally The Bowen treatment will be 15 to 20 Bowen moves with 2 mins gap between each set for total of 20 mins.; They would be receiving conventional treatment as follow:
Hot pack for 10 minutes TENS for 10 minutes Cervical isometrics 10 reps with 5 sec hold Additionally The Graston treatment will be by using lubricant on the skin then a stainless steel instrument to relax the fascia and muscles. The frequency of the plastering and friction movements will be applied in 60 repetitions per minute for total of 20 mins.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: NECK PAIN; NECK DISABILITY; Instrument assisted soft tissue treatment method
Daily Disposable Comparison Study
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of the study is to compare the overall subjective preference between two Daily
      Disposable hydrogel lenses when refitted into a third hydrogel lens.
    

Detailed description: 
      This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two
      parallel groups. Participants were recruited into one of two groups - participants who
      habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.
    

Intervention name(s): filcon II 3; etafilcon A; nelfilcon A
Intervention type(s): Device; Device; Device
Intervention description(s): Participants were randomized to wear filcon II 3 test lens.; Participants were randomized to wear etafilcon A control lens.; Participants were randomized to wear nelfilcon A control lens.
Other intervention name(s): Hydrogel Daily Disposable Contact Lens; Hydrogel Daily Disposable Contact Lens; 1 Day Acuvue Moist; Hydrogel Daily Disposable Contact Lens; Dailies Aqua Comfort Plus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Long Term Follow Up Protocol for NiCord®/CordIn™ (Omidubicel) Patients
Condition: Patients Transplanted With NiCord/CordIn (Omidubicel)
Study type: Observational

Summary: 
      This is an observational study that will monitor clinical outcomes of patients who have
      received a NiCord®/CordIn™ (omidubicel) transplant as part of a GC clinical interventional
      study and meet the eligibility criteria for this Long Term Follow Up study.
    


Intervention name(s): NiCord®/CordIn™ (omidubicel)
Intervention type(s): Genetic
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        NiCord® (ages 12-65)/CordIn™ (ages 2-25) (omidubicel) transplanted patients
Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients
Condition: Kidney Transplantation
Study type: Observational

Summary: 
      This is an observational study designed to collect follow-up clinical date on subjects who
      were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued
      treatment prematurely or did not elect to enroll in long-term extension studies.
    

Detailed description: 
      Subjects are identified based on whether they received tofacitinib in 2 completed Phase 2
      studies who either discontinued treatment prematurely or who did not elect to enroll in
      long-term extension studies. Subjects are pre-identified
    

Intervention name(s): Tofacitinib; Tofacitinib
Intervention type(s): Drug; Drug
Intervention description(s): Subjects who previously took 15 mg BID or 30 mg BID; Subjects who previously took 15 mg BID for 3 months then 10 mg BID, or 15 mg BID for 6 months then 10 mg BID
Intervention MeSH terms: Tofacitinib
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects who received treatment with tofacitinib in 2 completed Phase 2 studies who either
        discontinued treatment prematurely or who did not elect to enroll in long-term extension
        studies.
      
Keywords: Observational; clinical follow-up data
Food Effect of VS-6766 in Healthy Adult Subjects
Condition: Food Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy
      Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766
    

Detailed description: 
      This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.

      On Day 1 of each period, subjects will receive a single oral dose of VS-6766 administered in
      a 2-way crossover fashion either under fasting conditions or following a standardized
      high-fat/high-calorie meal. PK sampling for VS-6766 will be collected predose and postdose.
      There will be a washout period between doses.
    

Intervention name(s): VS-6766
Intervention type(s): Drug
Intervention description(s): Dual RAF/MEK inhibitor
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.
Masking: None (Open Label)
Primary purpose: Treatment
Single-dose, Dose-escalation Study of Safety, PK, and Preliminary Efficacy of XOMA 052 in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary
      efficacy of XOMA 052 in subjects with active Type 2 Diabetes Mellitus (T2D).

      IV administration of XOMA 052 is likely to improve glycemic control in subjects with T2D by
      blocking certain receptors.
    


Intervention name(s): XOMA 052; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects in six successive dose groups will receive a single IV infusion (mg/kg) of study drug on Day 0. The total time of the infusion will be 1 hour ± 15 minutes.; Subjects in six successive dose groups will receive a single IV infusion (mg/kg) of study drug on Day 0. The total time of the infusion will be 1 hour ± 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Type 2; Mellitus
Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.
Condition: Immobilization
Study type: Interventional

Summary: 
      It is essential that anaesthetists successfully perform orotracheal intubation in scenarios
      in which intubation is potentially more difficult, such as where the neck is immobilized.

      The Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to
      provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.

      These devices may be especially effective in situations where intubation of the trachea is
      potentially difficult.

      The efficacy of these devices in comparison to the traditional Macintosh laryngoscope in
      situations where the cervical spine is immobilized is not known.

      The investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC
      to that of the Macintosh laryngoscope, the gold standard device, in patients in which the
      cervical spine has been immobilized by means of a Manual in-line stabilization of the spine.

      Hypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time
      to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh
      laryngoscope in simulated difficult laryngoscopy.
    


Intervention name(s): intubate with the macintosh laryngoscope; intubate with the C-MAC laryngoscope; intubate with the Airtraq device
Intervention type(s): Device; Device; Device
Intervention description(s): intubate with the macintosh laryngoscope; intubate with the C-MAC laryngoscope; intubate with the Airtraq device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: airway; airway device; cervical spine immobilisation
Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy of fractions-based herbal
      combinations of clearing heat and promoting blood circulation treating acute ischemic stroke
      and the potential mechanism of it.
    

Detailed description: 
      The interaction between fire-heat and blood stasis is a significant mechanism underlying
      pathogenesis and progress in acute ischemic stroke according to TCM theory.Clinical
      therapeutic effects are achieved with wide application of Ixeris of sonchifolia Hance
      components (KDZ injection) representing method of clearing heat and Panax notoginseng
      saponins components (Xueshuantong injection) representing method of promoting blood
      circulation.
    

Intervention name(s): Ixeris of sonchifolia Hance; Panax notoginseng saponins; Ixeris of sonchifolia Hance combined with Panax notoginseng saponins
Intervention type(s): Drug; Drug; Drug
Intervention description(s): KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.; Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.; KDZ40ml+0.9%N.S.250ml,ivdrip;0.9%N.S.50ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip.qd of each 14-day cycle.Number of cycles:one.
Other intervention name(s): KDZ injection; Xueshuantong injection
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fire-heat syndrome; blood stasis syndrome; method of clearing heat; method of promoting blood circulation; medicinal fractions-based herbal combinations
Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 Parkinsonism
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Parkinsonian Disorders; Nerve Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this protocol is to access the utility of 18F-DTBZ PET imaging as an
      in vivo biomarker to monitor neurodegeneration of both PD mouse models and PD patients.
      Secondary, the investigators will analyze progression rate of genetic-proving PARK8 and PARK6
      patients who have homogeneous phenotype and genotype by 18F-DTBZ PET imaging.
    

Detailed description: 
      Total of 60 patients, 20 LRRK2 G2385R, 20 PARK6, and 20 idiopathic PD, will be recruited.
      Subjects will be evaluated sequentially with 18F-DTBZ during a 36 month period. 18F-DTBZ PET
      scans will be performed twice, at baseline, and 24 (21~27) months following the start of
      their participation in the study. Subjects will receive a single i.v. administration of
      approximately 10 mCi 18F-DTBZ immediately prior to imaging. Whitney test will be used to
      compare the mean standard uptake value ratio (SUVR) values between groups. The decline rate
      of VMAT2 density will be calculated by comparing the SUVRs of age-matched healthy subjects
      from our previous studies. Each evaluable subject involved in this study must fulfill all the
      inclusion and exclusion criteria according the subject grouping, each subject will have 3
      visits in each scan (total 6 visits in this study), as one screening visit, one imaging
      visit, and one safety evaluation visit.

      Safety measurement will be evaluated by medical history, vital signs, physical examinations,
      laboratory examinations and collecting of adverse events.
    

Intervention name(s): 18F-DTBZ
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ (10 nmole FP-(+)-DTBZ) immediately prior to each scan.
The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic