bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will investigate the administration of two new tuberculosis vaccines, called
      AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these
      vaccines are given one after the other. The trial will assess the safety of both vaccines and
      also their ability to stimulate an immune response within the body. It is hoped that when
      these two vaccines are given in sequence, the combined immune response is even better than
      when each vaccine is used individually.
    


Intervention name(s): AERAS-402; MVA85A
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular needle injection 1x10^11 vp; Intradermal needle injection 1x10^8 pfu
Other intervention name(s): Ad35 TB-S; AERAS-485
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis; Phase I; MVA85A; AERAS-402
Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to choose the preferred treatment modality for multiple, small
      hepatocellular carcinomas.
    

Detailed description: 
      To compare the below things between PEIT group and TACE group

        1. Survival

             1. 5 year overall survival rate

             2. Disease free survival rate

        2. Recurrence a. recurrence rate
    

Intervention name(s): Transarterial chemoembolization; Percutaneous ethanol injection therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): lipiodol, adriamycin and/or mitomycin; 99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week
Other intervention name(s): TACE; PEIT
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCC, TACE, PEIT
The Safety and Tolerability of STSA-1002 Following Intravenous Infusion in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized,double-blind,placebo-controlled,single-ascending dose phase Ⅰa study to evaluate
      the safety,tolerability,pharmacokinetics and pharmacodynamics of STSA-1002 following
      intravenous infusion in healthy subjects
    


Intervention name(s): STSA-1002 injection; Placebo; STSA-1002 injection; Placebo; STSA-1002 injection; Placebo; STSA-1002 injection; Placebo; STSA-1002 injection; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection; Intravenous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2016-2017 Season
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective annual release study is designed to evaluate the safety of 1 new influenza
      virus vaccine strain to be included in FluMist Quadrivalent for the 2016-2017 influenza
      season
    

Detailed description: 
      This prospective, randomized, double-blind, placebo-controlled release study will enroll
      approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly
      assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by
      intranasal spray. Randomization will be stratified by site. This study will be conducted at 3
      sites in the United States of America. Each subject will receive 1 dose of investigational
      product on Day 1. The duration of study participation for each subject is the time from study
      vaccination through 180 days after study vaccination.
    

Intervention name(s): Monovalent Influenza Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): A single dose of 10^(7.0 ± 0.5) FFU strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1.; A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Trivalent; Influenza; FluMist Quadrivalent; Vaccine; Prevention; Healthy; Monovalent
Efficacy and Safety of SPD465 in Adults With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and effectiveness of SPD465 compared to
      placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also
      look at how SPD465 affects sleep and how the participants perceive their quality of life.
    


Intervention name(s): Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate
Intervention type(s): Drug
Intervention MeSH terms: Amphetamine; Dextroamphetamine; Adderall
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Gabapentin Treatment of Cannabis Dependence
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the efficacy of the medication gabapentin in treating persons
      with cannabis dependence.
    

Detailed description: 
      This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the
      efficacy of gabapentin in treating outpatients with cannabis dependence. Counseling and
      research assessments occur weekly throughout the 12-week treatment phase.
    

Intervention name(s): Placebo; Gabapentin
Intervention type(s): Drug; Drug
Intervention description(s): Placebo
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabis treatment; marijuana treatment
Blood Flow Restriction Strength Training in Professional Soccer Players
Condition: Resistance Training; Blood Pressure
Study type: Interventional

Summary: 
      The aims of this clinical study are evaluated the effects of Blood Flood Restriction training
      on the sport performance of professional and semi-professional soccer players. The
      participants are twenty male professional and semi-professional soccer players who are
      playing at RCD Mallorca. Participants will be assigned in two different groups. Both groups
      develop for six weeks a strength training programs. The first group will base their training
      in Low Load using Blood Flow Restriction (20-50% of one maximum repetition). The second group
      will base their training in High Load (60-80% of one maximum repetition). This training
      program includes three type of exercises in each training session; back squat, single
      deadlift and barbell hip thrust. Before and after this program the investigators will collect
      sociodemographic and anthropometrics data. On top of that, the investigators will evaluate
      the muscle mass, the electrical activity produced by skeletal muscles, the muscle strength
      and the sprint ability of every participant. Before to the evaluation, the soccer players
      will warm-up during 15 minutes under the control of the evaluators.
    

Detailed description: 
      PARTICIPANTS:

      Participants are soccer players of RCD Mallorca (Second Spanish Football Division) and RCD
      Mallorca B (Third Spanish Football Division).Before to start the study, every participant
      will receive an informed consent about the clinical study. This informed consent will be
      signed by them according to Declaration of Helsinki. At the same time, the data will be
      anonymized and only the main researcher of the study will have access to it, to ensure
      compliance with the Data Protection Law.

      W-UP:

      The warm-up will consist of 5 minutes running slow (treadmill), 5 minutes mobility, and 5
      minutes of running exercises. In addition, the warm-up will contain a familiarization with
      the jump test
    

Intervention name(s): Blood Flow Restriction Strength training with low load; High Load Strength Training
Intervention type(s): Other; Other
Intervention description(s): Low Load (20-50% 1RM), 4 set of 30/15/15/15 repetitions, 30 seconds resting between sets.; High Load (60-80% 1RM) 4 sets of 8 repetitions, 2 minutes resting between sets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Strenght Training; Soccer; Blood Flood Restriction; Performance; Sport Injuries
CB1 Receptors in Human Brown Adipose Tissue
Condition: Obesity
Study type: Interventional

Summary: 
      This study investigates cannabinoid CB1 receptors in human brown adipose tissue (BAT) and
      other tissues using positron emission tomography (PET) imaging. Subjects will be scanned in
      room temperature conditions and during controlled cold exposure, and the density of CB1
      receptors in BAT and other tissues will be quantified. The investigators hypothesize, that
      cannabinoid signaling is increased in cold conditions, when BAT is metabolically active.

      Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is
      important and beneficial in fighting against the epidemic of obesity and diabetes.
    

Detailed description: 
      Endocannabinoids have an important role in regulating energy balance and metabolism.
      Cannabinoid 1 receptors (CB1) are found in several tissues such as brown adipose tissue
      (BAT). Endocannabinoids and CB1 receptors participate in the control of lipid and glucose
      metabolism, and blockage of CB1 receptors has been found to improve metabolic factors linked
      to obesity and cardiovascular disease, making CB1 antagonists potential drugs against obesity
      and diabetes.

      In this study the investigators use a PET radiotracer [18F]FMPEP-d2, which binds to CB1
      receptors in vivo, to quantify the CB1 receptor density in BAT, white adipose tissue, muscle
      and the brain. This study is done once in warm conditions and once during controlled cold
      exposure. To verify whether the subject has metabolically active BAT, an additional PET scan
      with the radiotracer [18F]FDG is performed.
    

Intervention name(s): Cold exposure; [18F]FMPEP-d2; [18F]FDG
Intervention type(s): Other; Other; Other
Intervention description(s): Controlled cold exposure is performed before and during PET scan; PET radiotracer used in imaging; PET radiotracer used in imaging
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Brown adipose tissue; Cannabinoid receptor; PET imaging; Metabolism
Effectiveness of Mobile Applications During the Administration of Local Anesthesia in Pediatric Dentistry
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      To evaluate the mobile games' effect on patient acceptance of local anesthesia and decreasing
      dental pain and anxiety levels in pediatric patients.
    

Detailed description: 
      a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention
      group: mobile application (little lovely dentist) control group: Tell-Show-Do technique. in
      children aged 4-6 years who need local anesthesia for dental treatment during their first
      dental visit.

      For both groups:

      Verbal assent from participating patients and written consent from their legal guardians will
      be taken.

        1. Taking personal data, medical and dental history.

        2. Diagnosis and determination of the required treatment.

        3. Measuring preoperative anxiety using a pulse oximeter.

        4. Evaluate preoperative anxiety using RMS-pictorial scale.

        5. Using the behavior guidance technique:

           Intervention group: Allow the child to play the module simulating the required
           procedure. Control group: tell-show-do technique is used to explain the procedure to the
           child

        6. Administration of local anesthesia and evaluation of child behaviour during the
           administration of local anaesthesia using Venham's behaviour rating scale and Frankl
           behaviour rating scale .

        7. Measuring postoperative anxiety using the pulse oximeter.

        8. Evaluate postoperative anxiety using RMS-pictorial scale.

        9. Evaluate postoperative pain using the visual analog scale.

      in second visit (after 1 week)

      1) Evaluation of child behavior during the second dental visit using Venham's behavior rating
      scale and Frankl behavior rating scale. outcome:

        1. ry: Pre and postoperative anxiety using Pulse oximeter and RMS-pictorial scale.

        2. ry: Postoperative pain using Visual analog scale, evaluation of attitude during the
           administration of local anaesthesia at first and second dental visits using -Venham's
           behavior rating scale-Frankl behavior rating scale. the study will be held in 2 visits.
    

Intervention name(s): mobile application (little lovely dentist).
Intervention type(s): Behavioral
Intervention description(s): mobile application
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel-group and allocation ratio (1:1) Intervention: mobile application (little lovely dentist). Control: Tell-Show-Do technique.
Masking: None (Open Label)
Primary purpose: Health Services Research
A Comparative Analysis of Arterial Blood Flow in Unexplained Infertility, Tubal Infertility and Fertile Groups
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Factors affecting the success of the treatment of infertility can evaluate before and after
      embryo transfer in two stages. Most of the patients reach the embryo transfer stage.
      Unfortunately, the investigators are able to intervene very few of the factors that will
      affect the success of the post-transfer. All factors and treatments that affect the
      implantation is vital to identify. Basically, healthy vasculature is essential for a
      successful implantation. The investigators will try to understand relationship between
      vascular resistance and type of infertility. The investigators will examine whether the
      effect of the ovarian uterine and spiral artery resistance over infertility.
    

Detailed description: 
      In this study the investigators will examine whether the alterations of doppler indices in
      the uterine, ovarian and spiral arteries can help to explain tubal or unexplained infertility
      as a standard screening method. Patients in unexplained-tubal infertility groups were treated
      in our IVF clinic. Patients will be invited to the hospital according to the criteria of the
      study. Fertile patients will be selected according to the criteria for patients who have come
      for the annual smear control. The study hypothesis is that the resistance in ovarian, uterine
      and spiral artery doppler will be higher in cases with tubal and unexplained infertility as
      opposed to low resistance in fertile women.Ovarian, uterine and spiral artery pulsatility
      index (PI = (peak systolic velocity - end diastolic velocity) / time averaged velocity and
      resistance index ( RI= (peak systolic velocity - end diastolic velocity) / peak systolic
      velocity ) will measure with doppler ultrasonography in the mid-luteal phase ( 21th day).
      Measured values are to be compared.
    

Intervention name(s): doppler ultrasonography
Intervention type(s): Other
Intervention description(s): Ovarian, uterine and spiral artery pulsatility index and resistance index will measure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women received infertility treatment
      
Keywords: unexplained infertility; tubal infertility; pulsatility index; resistance index; fertile women
PK of Serelaxin in Severe Renal Impairment and ESRD
Condition: Renal Failure, Chronic; End-Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the pharmacokinetics, safety and tolerability,
      immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with
      severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.
    


Intervention name(s): Serelaxin
Intervention type(s): Drug
Other intervention name(s): RLX030
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal disease; renal impairment; End stage renal disease; Healthy volunteer; Pharmacokinetics
Proof of Concept Study of MTC896 Gel to Reduce Sebum Production on the Forehead of Healthy Male Volunteers
Condition: Oily Skin; Seborrhea
MeSH terms: Dermatitis, Seborrheic
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the potential of topically applied 0.75% (w/w) MTC896 Gel to reduce sebum
      production on the forehead of healthy male volunteers.
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo-controlled proof-of-concept study
      of the investigational product (0.75% (w/w) MTC896 Gel) compared to a placebo control.
      Subjects will be randomized to 1 of 2 treatment groups, 0.75% (w/w) MTC896 Gel or Placebo.
      Approximately 134 subjects will be enrolled to yield 60 completed subjects in each group. One
      group will receive once daily topical applications of 0.75% (w/w) MTC896 Gel to the forehead
      for 28 consecutive days, and the other will receive placebo under the identical regimen.
      Enrollment will be staggered to allow monitoring of safety and tolerability. A lead cohort
      will include approximately 20 subjects (10 in the MTC896 Group and 10 in the Placebo Group).
      Application on additional subjects will not be initiated until the lead cohort has completed
      the study.
    

Intervention name(s): MTC896 Gel
Intervention type(s): Drug
Intervention description(s): 0.75% w/w gel applied daily for 28 days to the forehead
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oily Skin; Sebum
Gaze Contingent Feedback for Anxiety Disorders in Children
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether giving gaze-contingent feedback is an
      effective attention modification procedure, helping in the treatment of anxiety disorders in
      children.
    

Detailed description: 
      Attention biases in threat processing have been assigned a prominent role in the etiology and
      maintenance of anxiety disorders. The purpose of this study is to determine whether giving
      gaze-contingent feedback is an effective treatment for anxiety disorders in clinically
      anxious 6-10 year-olds children. Participants will be assessed using clinical interviews and
      parent- and self-rated questionnaires before and after eight training sessions. Outcome
      measures will be anxiety symptoms and depression as measured by gold standard questionnaires
      as well as structured clinical interviews with children and their parents. Attentional threat
      bias and Attentional control will also be measured to explore potential mediators of ABMT's
      effect on anxiety.
    

Intervention name(s): Gaze-contingent feedback
Intervention type(s): Behavioral
Intervention description(s): Participants will receive gaze-contingent feedback according to their viewing patterns
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention bias modification treatment; Anxiety disorders; Attention training
Bioequivalence Study to Compare Ibuprofen/ Paracetamol Tablets (200mg Ibuprofen/ 500mg Paracetamol) Versus Nuromol® Tablets (200mg Ibuprofen/ 500mg Paracetamol)
Condition: Migraine; Headache; Backache
MeSH terms: Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence
      study to compare Ibuprofen/ Paracetamol tablets (200mg Ibuprofen/ 500mg Paracetamol) versus
      Nuromol® tablets (200mg Ibuprofen/ 500mg Paracetamol) in healthy subjects under fasting
      condition.
    


Intervention name(s): Ibuprofen/ Paracetamol tablets; Nuromol® tablets
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet of 200mg Ibuprofen/ 500mg Paracetamol; 1 tablet of 200mg Ibuprofen/ 500mg Paracetamol
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other