bioihbjkbjnl/mcl2 huggingface dataset:
Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
Condition: Poliomyelitis; Polio
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive
      Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.

      Primary Objective:

        -  To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one
           month following the vaccination dose with SP059 as 2nd booster

      Secondary Objectives:

        -  To investigate seroprotection rates (percentage of subjects presenting poliovirus
           neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points,
           Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of
           individual titer ratio (GMTR).

        -  To investigate the safety after dosing of SP059 as 2nd booster.
    

Detailed description: 
      Participants will receive one dose of SP059 (at Visit 1) as a booster vaccination at an age
      from 4 to 6 years. They will be assessed for immunogenicity at baseline (pre-vaccination) and
      at 4-6 weeks post- vaccination.

      Safety data including serious adverse events (SAEs) after vaccination will be collected
      during the study period.
    

Intervention name(s): IMOVAX POLIO®: Inactive Poliovirus Vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Subcutaneous
Other intervention name(s): SP059; IMOVAX POLIO®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Poliomyelitis; Poliovirus; Polio; IMOVAX POLIO®; Inactivated polio vaccine
Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder
Condition: Parkinson Disease; REM Sleep Behavior Disorder
MeSH terms: Parkinson Disease; REM Sleep Behavior Disorder; Mental Disorders
Study type: Interventional

Summary: 
      This is a prospective cohort study to evaluate degenerative changes in the brain by
      performing functional imaging analysis in patients with RBD and its correlations with
      clinical symptoms and dopaminergic degeneration. This study also evaluates cognitive changes
      with functional imaging measures and olfactory and other premotor symptoms of Lewy body
      disease. This study also collects gene extracts and sera to develop a biomarker for early
      detection of neurodegeneration.
    

Detailed description: 
      This study will include 3 groups in relation with RBD: idiopathic RBD (iRBD), PD- RBD, normal
      controls without RBD. In all groups, neurological examinations, olfactory testings, nonmotor
      symptoms evaluations, neuropsychological evaluations (detailed outcomes are in the outcome
      section) will be performed at baseline evaluation after enrollment. Image data will be
      obtained on following modalities: brain magnetic resonance imaging (MRI),
      18F-N-ω-fluoropropyl- 2β-carbomethoxy- 3β-(4-iodophenyl) nortropane ([18F]FP-CIT) positron
      emission tomography (PET), and 18F-fludeoxyglucose([18F]FDG) PET.

      To assess progression toward Lewy body disorders, patients in iRBD group will be evaluated at
      2, and 4 years of follow-up visit. Clinical, neuropsychological tests, brain MRI, and two PET
      scans will be administered. After 4 years, patients who are willing to participate will be
      additionally followed-up yearly as a routine clinical visit with clinical and neurological
      examinations until obvious signs of Lewy body diseases will develop.

      In PD-RBD group, patients will be evaluated at 3-year follow-up period amongst days of
      routine clinic visits with administering clinical and neuropsychological tests.
    

Intervention name(s): testing, evaluation, sampling
Intervention type(s): Other
Intervention description(s): neuroimaging biomarkers using positron emission tomography and magnetic resonance imaging, and evaluation of neurological & neurocognitive status by using a predefined neuropsychological assessment battery.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Lewy body disease; REM Sleep Behavior Disorder; Parkinson disease; Imaging; Bio-markers; Prospective cohort
Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss
Condition: Osteoarthritis; Obesity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Weight Loss
Study type: Observational

Summary: 
      This is a substudy to a randomised trial investigating the effect of liraglutide on body
      weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In
      the parent trial, patients will be subjected to an 8-week diet intervention phase including a
      low-calorie diet and dietetic counseling, after which. Patients will be randomised to receive
      either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on
      re-introducing regular foods and a focus on continued motivation to engage in a healthy
      lifestyle.

      This substudy aims to investigate any changes in MRI associated with the initial 8-week
      weight loss intervention, and the value of CT scans in predicting the effect of weight loss.
    


Intervention name(s): Intensive dietary intervention
Intervention type(s): Dietary Supplement
Intervention description(s): Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals
        with knee osteoarthritis
      
Keywords: Liraglutide; Liraglutide 3 mg; Osteoarthritis; Obesity; Magnetic resonance imaging; Computed tomography; Dynamic contrast enhanced MRI
A Randomized Placebo Controlled Trial on the Efficacy of Sustained Natural Apophyseal Glide (SNAG) in Low Back Pain Patients
Condition: Low Back Pain; Manual Therapy; Sustained Natural Apophyseal Glide (SNAG)
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Objectives:

      Determine the efficacy of the SNAG technique (Mulligan) applied to a subgroup of people with
      non-specific low back pain (LBP) on two new kinematic-algorythms, on pain, functional
      disability and kinesiophobia.

      Design:

      A randomized double blinded placebo controlled trial with double arms in accordance with the
      CONSORT statement.

      Subjects:

      Patients with non-specific low back pain will be recruting from Saint-Luc hospital, only a
      subgroup of them will be included according to specific inclusion criteria tailored for
      indication of application of SNAG's therapy (Mulligan technique applied on the lumbar spine).

      Method:

      Subjects will be randomized in 2 groups; real-SNAG and sham-SNAG groups. All patients will be
      treated during a single session, and real/sham SNAG will be applied from a sitting position
      with the belt, and in a flexion direction. Two kinematic-algorythms (ROM and Speed) from a
      validated kinematic spine model will be used and recorded with an opto-electronic device
      (BTS-Elite). Pain at rest and during flexion, as well as functional disability and
      kinesiophobia will be recorded by self-reported measures. These outcomes will be blindly
      evaluated before and after treatment to compare both groups with " Two-Way-ANOVA " statistic
      with for factors; time and groups.
    


Intervention name(s): SNAG; Sham
Intervention type(s): Device; Device
Intervention description(s): sustained natural apophyseal glide: SNAG / Mulligan technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; manual therapy; Mulligan; sustained natural apophyseal glide (SNAG); Kinematic spine model
Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa
Condition: Postpartum Haemorrage Sever Bleeding After Delivery
MeSH terms: Placenta Previa; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluate role of tranexamic acid in reducing blood loss among pregnant women
      undergoing cesarean section because of placenta previa .Half of participants will receive
      tranexamia acid drug While the other half will receive placebo.
    

Detailed description: 
      Tranexamic Acid used in the field of obstetrics to decrease blood loss during and after
      cesarean section .

      Tranexamic Acid is an antifibrinolytic agent which cause reversible and competitive blockade
      of the lysine binding sites in plasminogen molecules . It is a synthetic analog of amino acid
      lysine and its action is to reduce blood loss
    

Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): tranexamic acid or placebo are given before cesarean section in patient with placenta previa
Other intervention name(s): cyclo kapron
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: obstetric bleeding placenta previa
Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess pharmacokinetics (PK) of indacaterol and
      glycopyrronium, and methodology and practical arrangements for future studies.
    


Intervention name(s): Indacaterol maleate and glycopyrronium bromide; Indacaterol maleate and glycopyrronium bromide; Indacaterol maleate and glycopyrronium bromide; Ultibro Breezhaler with oral charcoal
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Batch A Ultibro Breezhaler 85/43 μg 2 capsules; Batch A Ultibro Breezhaler 85/43 μg 1 capsule; Batch B Ultibro Breezhaler 85/43 μg 2 capsules; Activated charcoal suspension, granules 50 g / bottle
Intervention MeSH terms: Glycopyrrolate; Bromides; Maleic acid; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a 2-part crossover study where the study subjects participate either in part 1 (18 subjects) or in part 2 (16 subjects). The parts can run in sequence or in parallel. The study subjects in part 1 receive single doses of Ultibro Breezhaler on 3 periods and the study subjects in part 2 receive single doses of Ultibro Breezhaler on 2 periods.
Masking: None (Open Label)
Primary purpose: Basic Science
Response to Diaphragmatic Pacing in Subjects With Pompe Disease
Condition: Pompe Disease
MeSH terms: Glycogen Storage Disease Type II
Study type: Observational

Summary: 
      The purpose of this study is to determine the effect of diaphragm pacing on respiratory
      function in subjects with Pompe disease by evaluating the duration and pattern of spontaneous
      respiratory function versus paced ventilation respiratory function in patients with Pompe
      disease who have received the NeuDx Diaphragm pacer (DPS).
    

Detailed description: 
      Subjects with Pompe disease who are scheduled to receive a NeuRx Diaphragm pacer (DPS) will
      be invited to participate in this study. The following tests will be performed during
      participation in the study:

        1. Forced expiratory tests

        2. Maximal Inspiratory Pressure (MIP)

        3. Resting Breathing Pattern

        4. Phrenic Nerve Function Evaluation with EMG

        5. Severe Respiratory Insufficiency Questionnaire

        6. Magnetic stimulation

        7. Diaphragm conditioning consisting of:

             1. The external stimulator settings

             2. The duration of diaphragm stimulation

             3. Off-ventilator spontaneous breathing (SB)
    

Intervention name(s): Diaphragm conditioning via phrenic nerve stimulation
Intervention type(s): Other
Intervention description(s): Diaphragm pacing will be prescribed by the patient's clinical team.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with Pompe disease who are eligible for NeuRx DPS implantation
      
Keywords: Pompe disease; mechanical ventilation; diaphragm pacing
Comparison of Artificial Intelligent Clinic and Normal Clinic
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      In this study, the investigators provide participants≤14 years old the artificial intelligent
      clinic or normal clinic in the purpose of seeking out a better way to make a definite
      diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled
      study aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing
      congenital cataract.
    

Detailed description: 
      Children ≤14 years old from ophthalmic clinic without treatment were enrolled to a
      prospective, randomized controlled study. Patients were assigned to two groups: participants
      in group A went to the artificial intelligent clinic and get the initial diagnosis, while in
      Group B, the participants went to the normal clinic. Investigators provide the final definite
      diagnosis from experts for two groups. Investigators compared the accuracy of the diagnosis,
      time consuming and the satisfaction level between two groups, aiming at comparison of
      artificial intelligent clinic and normal clinic for diagnosing congenital cataract.
    

Intervention name(s): artificial intelligent clinic; normal clinic; experts diagnose
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.; Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.; After making the initial diagnosis, participants went to get the final definite diagnosis from experts with more than 10 years of clinical experience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: congenital cataract; artificial intelligent clinic
Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      Major Depressive Disorder (MDD) is the leading cause of disability worldwide. Depression and
      anxiety disorders are among the most prevalent of all mental disorders, with an estimated
      annual prevalence of 9.7% and 18.1% respectively.

      It has been known for the last 100 years that depression and anxiety both likely affect vocal
      acoustic properties. In 1921, Emil Kraepelin, characterized depressed patient's voices as
      having a lower pitch, lower volume, lower rate of speech, more monotony of prosody as well as
      more hesitations, stuttering, and whispering.

      Mechanistically, it is possible that the neural circuitry involved in the pathophysiology of
      mood and anxiety disorders impinge upon the neural circuit involved in speech production,
      affecting qualities that include rate, prosody, speech latency and other paralinguistic
      features. Thus, acoustic features of speech may be one of the more readily accessible
      biomarkers for these conditions.

      Given this understanding, the investigators sought to develop a passive vocal biomarker
      instrument for depression and anxiety screening that could markedly expand access as well as
      standardize the quality of screening in primary care settings.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study will enroll 225 men and women over the age of 18. 150 depressed participants
        will be recruited via an email from their treating psychiatrists. The researchers are
        collaborating with 2 psychiatric practices to recruit patients from.

        75 non-depressed participants will be recruited from the general population via Craigslist
        ads. Participants will go through a clinical evaluation with a mental health professional
        to rule out current episode of depression.
      
Keywords: Voice biomarkers; Speech analysis
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC)
      OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects
      with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or
      treated with a stable dose of metformin.
    

Detailed description: 
      This clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly
      OPK-88003 in subjects with T2DM. The trial consists of a screening/baseline (up to 2 weeks
      prior to first dose), treatment period consisting of a dose escalation (8 weeks) and a target
      dose (22 weeks), and a follow-up period (4 weeks). Subjects will be randomly assigned to
      volume-matched OPK-88003 or placebo administered QW.
    

Intervention name(s): OPK-88003; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): OPK-88003 subcutaneous injection; Placebo subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- Compatibility
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of irritation potential (primary
      dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the
      product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).
    


Intervention name(s): Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Intervention type(s): Drug
Intervention description(s): Lactic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Acamprosate vs. Placebo in Bipolar Alcoholics
Condition: Alcohol Dependence; Bipolar Disorder
MeSH terms: Alcoholism; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of
      acamprosate in individuals with alcohol dependence and bipolar disorder who are also
      receiving mood stabilizing medication. The study will assess the safety and efficacy of
      acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use
      and mood symptoms relative to placebo.

      The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and
      alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement
      in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary
      hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with
      acamprosate will have greater mood stability as compared to those treated with mood
      stabilizers alone.
    


Intervention name(s): Acamprosate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 666 mg po TID; 2 tabs po TID
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acamprosate; Alcoholism; Bipolar disorder; Comorbidity; Craving; Depression; GABA; Glutamate; Mania; Pharmacotherapy; Withdrawal
An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia
Condition: Mixed Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      The primary objective of this study is to compare the effect of simvastatin plus Omacor to
      simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects
      with mixed dyslipidemia.
    

Detailed description: 
      This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 4
      (Week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria
      will be randomized to one of two double-blind treatment sequences, simvastatin/Omacor first
      or simvastatin/placebo first. Each treatment period consists of 6 weeks. After randomization,
      subjects will self-administer the study drugs once a day in the evening.
    

Intervention name(s): Omacor (omega-3-acid ethyl esters)plus simvastatin; simvastatin plus placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omacor(omega-3-acid ethyl esters) - 4/g day (4 one gram capsules) simvastatin - 20 mg/day (1 tablet/20 mg); simvastatin 20mg/day (1 tablet 20 mg)plus 4 capsules matching placebo
Other intervention name(s): Lovaza
Intervention MeSH terms: Simvastatin
Observational model: Cohort
Time perspective: Prospective
Biospecimen description: 
      serum and plasma
    
Keywords: cholesterol; dyslipidemia; omega 3
Syphilis Video Tool to Promote Knowledge and Testing in the ED
Condition: Syphilis
MeSH terms: Syphilis
Study type: Interventional

Summary: 
      The objective of this study is to determine whether the "Syphilis and Men" educational video
      can be a useful tool to increase syphilis knowledge and testing among English and
      Spanish-speaking urgent care and emergency department patients, regardless of various
      self-reported characteristics that increase their risk for syphilis infection.
    

Detailed description: 
      A randomized four-group intervention-control Solomon design was implemented with Group 1
      participants receiving a pre-test survey, the educational video intervention, and a post-test
      survey; Group 2 the pre-test and post-test surveys; Group 3 the video intervention and a
      post-test survey; and Group 4 the post-test survey. This design was selected to assess the
      effect of the video in increasing syphilis knowledge while controlling for the influence of
      the pre-test instrument in potentially sensitizing participants to key facts. A
      computer-generated randomization list was created and used to assign patients to groups.
    

Intervention name(s): 'educational video'
Intervention type(s): Other
Intervention description(s): 'educational video'
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: syphilis; educational video; knowledge; black; Hispanic