bioihbjkbjnl/mcl2 huggingface dataset:
Music-listening During Deep Brain Stimulation to Relieve Anxiety
Condition: Movement Disorders; Deep Brain Stimulation
MeSH terms: Movement Disorders
Study type: Interventional

Summary: 
      This study aims to demonstrate that music listening in patients undergoing awake deep brain
      stimulation reduces subjective and objective measures of anxiety. Furthermore, the
      investigators aim to demonstrate that music may alter neuronal firing patterns based on the
      type of music played and the location in the brain.
    

Detailed description: 
      While conscious neurosurgical interventions are generally well-tolerated, they often cause
      some measure of pain and anxiety. Patients have been reported to suffer from recurring
      distressing recollections of, or dreams about, the surgery and other post-operative,
      Post-Traumatic Stress Disorder-like sequelae. High anxiety during surgery correlates with
      post-operative psychological disturbances. Notably, listening to music reduces anxiety in
      patients undergoing awake surgical procedures. Nonetheless, DBS is typically performed
      without music because ambient noise typically interferes with interpretation of neuronal
      recordings. Recording objective and subjective measures of stress during DBS provides a
      unique opportunity to determine the effect of music on intra-operative patient anxiety levels
      in patients listening to music compared to non-music listening control patients. The
      investigators hypothesize that playing music will improve intra-operative anxiety as measured
      by objective and subjective measures of stress, including blood pressure, heart rate,
      cortisol levels and anxiety questionnaires. Additionally, previous data in the investigator's
      lab has demonstrated that the subthalamic nucleus (STN) responds to melodic music by
      decreasing the average frequency of neuronal firing. The investigator's pilot study also
      suggests that STN and thalamic neurons respond differently to melodic music; the neurons in
      the STN increase synchrony of firing, while neurons in the thalamus decrease synchrony of
      firing over the course of the music clip. The investigators, therefore, aim to characterize
      the neuronal firing pattern changes in patients undergoing awake DBS procedures in greater
      detail, drawing from a larger sample size.
    

Intervention name(s): Music-listening
Intervention type(s): Other
Intervention description(s): Patients listen to music on headphones
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization into two groups: music-listening vs headphones-only
Masking: Single (Participant)
Primary purpose: Treatment
Pain Related Variables
Condition: Chronic Neck Pain; Musculoskeletal Pain; Pain Modulation; Cortical Plasticity; Conditioned Pain Modulation; Temporal Summation
MeSH terms: Musculoskeletal Pain; Neck Pain
Study type: Interventional

Summary: 
      Chronic neck pain is a common problem among the general population. Patients with chronic
      neck pain used health care services twice as much as the population on average, mainly due to
      intense pain intensity. It is well-known that pain intensity depends on the association of
      pain processing in several levels of central pain processing.

      Identifying the association between conditioned pain modulation, temporal summation, and
      somatosensory representation, all represent separate central pain processing, will provide an
      opportunity to develop treatment strategies.
    


Intervention name(s): pain related variables assessment
Intervention type(s): Other
Intervention description(s): Pressure pain threshold, conditioned pain modulation, temporal summation, and two-point discrimination will be evaluated on the upper trapezius muscle. Average pain intensity will be asked.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Brief Intervention for Medication Overuse Headache
Condition: Medication-overuse Headache; Chronic Headache
MeSH terms: Headache Disorders; Headache Disorders, Secondary; Headache
Study type: Interventional

Summary: 
      The investigators will perform a cluster randomised controlled study of Brief intervention
      (BI) for medication-overuse headache (MOH) versus business as usual. GPs will be trained to
      perform a structured brief intervention after identifying patients with probable MOH using
      the severity of dependence scale. The control arm will include patients of GPs who have not
      been trained in BI. Patients will be recruited by prior short postal screening of patients
      listed on the GPs patient lists.

      The hypothesis is that BI will lead to improvement of medication-overuse and chronic headache
      as compared to no BI.

      Main outcomes are:

        -  number of medication days per month

        -  number of headache days per month

        -  headache index
    

Detailed description: 
      123 cases in all included (75 in intervention/placebo control arms and 48 in non-intervention
      Control arms) 19 did not meet predefined inclusion criteria for the different arms (5 and 8
      in intervention arm and placebo arm respectively, 4 and 2 in chronic headache Control and
      population Control respectively)

      1 case was lost to follow up in each of the 4 Groups prior to first assessment. Thus 60 cases
      remained in intervention/placebo Control arms (24 in intervention and 36 in placebo Control)
      and 40 in non intervention Control arms (15 chronic headache Controls, 25 population
      Controls).
    

Intervention name(s): Brief intervention; Business as usual; Screening and outcome evaluation only; Screening and outcome evaluation only
Intervention type(s): Behavioral; Other; Other; Other
Intervention description(s): Structured behavioural Brief intervention given by trained GPs; GPs to treat patient as they have until now based on best established practice; No additional intervention; No additional intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A proof of concept (POC) study will be conducted in 44 volunteers that have been fully
      vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and
      immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a
      newly developed intradermal injection device VAX-ID, compared to intramuscular and
      intradermal (Mantoux technique) injection.
    


Intervention name(s): VAX-ID; 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD); 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
Intervention type(s): Device; Drug; Drug
Intervention description(s): 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection; 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD); 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
Other intervention name(s): INTRADERMAL; INTRAMUSCULAR; MANTOUX_INTRADERMAL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immunogenicity; safety; proof of concept
Evaluation of the Efficacy of Prolotherapy Treatment in Patients With Plantar Fasciitis: a Randomized Double-blind Study
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      Plantar fasciitis is the most common cause of heel pain and it is diagnosed by clinically.

      Resting, stretching exercises, weight loss, nonsteroidal anti-inflammatory drugs and physical
      therapy methods are used in the treatment. Steroid injection can be applied in patients who
      do not respond to these treatments. But steroid injection is not a pathology-based treatment,
      and also can cause serious side effects, such as fat pad atrophy and plantar fascia rupture.
      At this stage, in patients who do not respond to conservative treatments, new methods such as
      dextrose prolotherapy and platelet rich plasma may be used instead of steroid injection. In
      the literature, there is insufficient study showing effect of prolotherapy in patients with
      plantar fasciitis. Because these studies enrolled small number of patients and lacked
      controlled design. The investigators design a randomized, double-blind, controlled trial to
      assess the effect after prolotherapy injection in patients with plantar fasciitis.

      The participants evaluated with clinically and sonographically. The aim of this study is to
      compare the pain, function and thickness of proximal plantar fascia in prolotherapy or
      control group.
    

Detailed description: 
      After obtaining written informed consent, patients of clinically and sonographically
      diagnosed with plantar fasciitis were randomized into intervention and control group.
      Participants in intervention group received two-session prolotherapy injection and control
      group received two-session 9cc salin + 1 cc 2% lidocaine injection in 3 weeks interval.
      Stretching and range of motion exercises were prescribed after treatment.

      The primary outcome is visual analog scale (VAS) and secondary outcomes include Foot Function
      Index , ultrasonographic measurement of proximal plantar fascia. The evaluation was performed
      pretreatment as well as on the 1st and 3th month the treatment.
    

Intervention name(s): 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine.; 9 cc salin + 1cc 2% lidocaine.
Intervention type(s): Other; Other
Intervention description(s): Plantar fascia will be injected to the places where it adheres to the bone.; Plantar fascia will be injected to the places where it adheres to the bone.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
Condition: Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to obtain serum for proficiency testing to confirm assay
      validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
    

Detailed description: 
      This single-arm trial serves to obtain serum for proficiency testing to confirm assay
      validity is maintained. Exploratory aspects of this trial include evaluating additional
      assays used for the assessment of immune responses to HIL-214 in peripheral-blood samples.
      Given the large volume of blood required, the pediatric dose will be tested in healthy
      adults. The main scientific rationale for the trial is to identify immune assays that can
      assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to
      norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).
    

Intervention name(s): HIL-214
Intervention type(s): Biological
Intervention description(s): HIL-214
Intervention model: Single Group Assignment
Intervention model description: Single-arm, Open-label Trial
Masking: None (Open Label)
Primary purpose: Prevention
Compatibility of Qnox Values With Hemodynamic Changes in Tracheal Intubation Procedures
Condition: Qnox Values as a Predictor of Pain Response
Study type: Observational

Summary: 
      The study aimed to analyze the compatibility of Qnox values with hemodynamic changes as a
      predictor of pain response in tracheal intubation procedures
    

Detailed description: 
      Fifty-four patients were given informed consent before enrolling the study. Non-invasive
      blood pressure monitor, electrocardiogram, pulse oxymetry, and Conox probe were set on the
      subjects in the operation room. Baseline hemodynamic is noted. General anesthesia induction
      was done by fentanyl 2.5 mcg/kg and propofol 2 mg/kg. Endotracheal tube intubation was
      facilitated with rocuronium 0.8 mg/kg as muscle relaxant. qNox values right before intubation
      and after intubation is noted, as well as hemodynamic changes in one minute after intubation
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        adult patients undergo general anesthesia procedure with tracheal intubation
      
Keywords: qNox Values, Hemodynamic changes, Predictor of pain
Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
Condition: Diphtheria; Tetanus; Haemophilus Infection; Pertussis; Polio
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate in a controlled manner the effect of Prevnar® on the
      immune responses of Pentacel™

      Primary Objective - Stage I:

      To compare the immune responses elicited by an infant series of Pentacel™ when given at
      different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).

      Primary Objective - Stage II:

      To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different
      times from or concurrently with Prevnar®.
    

Detailed description: 
      This is a 2-staged study. Stage I of this study is designed to compare the immune responses
      elicited by an infant series (3 doses) of Pentacel™ when given at different times from or
      concurrently with Prevnar®.

      Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™
      (all antigens) when given at different times from or concurrently with Prevnar®.
    

Intervention name(s): Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®; Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Pentacel™; Prevnar®; Pentacel™; Prevnar®
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pertussis; Whooping cough; Diphtheria; Tetanus; Haemophilus influenzae; Poliovirus Types 1, 2, and 3.
Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and
      effective and whether it can increase the therapeutic window of L-dopa in patients whose
      control of their Parkinson's Disease symptoms is limited by the development of dyskinesia
      induced by use of L-dopa.
    


Intervention name(s): AFQ056 with L-dopa; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hard gelatin capsule to be taken bid for six weeks; hard gelatin capsule to be taken bid for six weeks
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Dyskinesia; Drug-induced; Levodopa; L-dopa
A Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability of Single Intravenous Doses of CF-301 in Healthy Subjects
Condition: Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)
MeSH terms: Bacteremia; Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Placebo-Controlled, Dose-Escalating Study to Examine the Safety and Tolerability
      of Single Intravenous Doses of CF-301 in Healthy Subjects.
    


Intervention name(s): CF-301; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose escalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes
Condition: Type 1 Diabetes; Continuous Glucose Monitoring; Children; Glucose Variability
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to determine whether continuous glucose monitoring will improve
      glucose variability as measured by the coefficient of variation of glucose levels in very
      young children with T1D. The study adopts an open-label, multi-centre, multinational,
      prospective registry-based population cohort design contrasting CGM use to SMBG alone in
      young children with type 1 diabetes over 12 months.

      The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in
      glycaemic variability, measured as the coefficient of variation of glucose levels, during the
      12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time
      below range 70 mg/dl and time above range 180 mg/dl.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pre-school children below age of 7 years with type 1 diabetes (for at least 6 months) and
        treated with insulin pump fo at least 3 months.
Caloric Compensation in Infants
Condition: Self Regulation; Eating Behavior; Infant Behavior
Study type: Observational

Summary: 
      The aim of this study is, first, to describe the evolution of the caloric compensation
      ability in infants from 3 to 15 months old and, secondly, to assess the links between changes
      in the caloric compensation ability and the individual characteristics (adiposity, age,
      gender, infant's eating behavior) and maternal feeding practices.

      Three series of measurements of caloric compensation abitlity were conducted: at 3-4 months
      old, at 10.5 months old and at 14.5 months old in the laboratory.

      In this study, a preload paradigm usually employed in children and adults to measure the
      caloric compensation ability was adapted to infants below 15 months old. The maternal eating
      behavior and their feeding practices were measured by questionnaires. The infants' height and
      weight were measured at the laboratory by trained experimenters.
    


Intervention name(s): Caloric compensation
Intervention type(s): Behavioral
Intervention description(s): The investigators have adapted an established within-subject preload paradigm to assess infant's short term caloric compensation. At each studied age, the measure of caloric compensation required two visits at the laboratory on two non-consecutive days. On the first visit, the infants received a fixed amount of a food preload either low or high in energy density. The order of the two preloads was counterbalanced. After a delay (ranging from several hours in the 3-4 months old infants to 25 min in 10.5- and 14.5-month-old infants), the infants were served an ad libitum meal. Weight intakes (g) were assessed by weighing each bottle/bowl before and after consumption.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Recruitment was conducted using leaflets distributed in health professionals' consulting
        rooms, an internal database (Chemosens Platform's PanelSens, CNIL n°1148039) and with the
        help of a recruitment agency.
      
Keywords: Caloric compensation
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Observational

Summary: 
      This protocol posting deals with objectives and outcome measures of the primary phase at one
      month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use
      of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves
      male or female infants from the age of 6 weeks at the time of the first vaccination. The
      vaccination course must be completed by the age of 24 weeks.
    

Detailed description: 
      The protocol posting has been amended to reflect the two new vaccine presentations that have
      been launched in Korea. The current PMS will thus collect safety information from subjects
      who have received either Rotarix or Rotarix liquid formulation (oral suspension or prefilled
      syringe) in the course of their routine clinical practice according to the prescribing
      information in Korea.
    

Intervention name(s): Rotarix or Rotarix liquid formulation
Intervention type(s): Biological
Intervention description(s): GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine (oral suspension or prefilled syringe).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants aged at least 6 weeks will be administered two doses of Rotarix or Rotarix liquid
        formulation (oral suspension or prefilled syringe) orally as per the prescribing
        information in Korea.
      
Keywords: Gastroenteritis
Quality of Life and Visual Acuity of Visglyc Eye Drops on Dry Eye Patients
Condition: Dry Eye Syndromes; Cataract
MeSH terms: Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      Clinical trial with medical devices, post-authorization, parallel, single-blind, randomized,
      comparative, prospective to study how afects the quality of life the use of ocular eye drops
      on patients with dry eye symptomatology and age-related loss of visual acuity.

      Secondary purposes: efects on the dry eye symptomatology, efect on visual acuity and
      treatment adherence.
    


Intervention name(s): Vis Glyc Neo; Physiological saline solution
Intervention type(s): Device; Device
Intervention description(s): 1 drop in each eye, three times a day.; 1 drop in each eye, three times a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dry eye; Cataract; Visual acuity; Quality of life; Eye drops; Dry eye symptomatology; N-acetylcarnosine; Vaccinium myrtillus; Chondroitin sulfate; Chondroitin sulphate; N-Acetylcharnosine
ZAP, US. Zomig for Appropriate for Primary Care
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine how useful and effective the use of ZOMIG-ZMT™
      (zolmitriptan) 5.0 mg and ZOMIG® Nasal Spray (zolmitriptan) 5.0 mg is for patients, in
      treating migraine over a period of 6 months
    


Intervention name(s): Zolmitriptan
Intervention type(s): Drug
Intervention description(s): 5mg Nasal Spray
Other intervention name(s): Zomig
Intervention MeSH terms: Zolmitriptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zolmitriptan; ZOMIG; migraine; headache response; headache; headache pain; MIDAS; HCPC