bioihbjkbjnl/mcl2 huggingface dataset:
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK
      Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster
      dose or as a two dose catch-up vaccination in the second year of life to the Nigerian
      subjects previously enrolled in the primary vaccination study NCT00678301.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00678301).
    


Intervention name(s): Pneumococcal vaccine GSK1024850A; InfanrixTM
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 1 or 2 doses; Intramuscular injection, 1dose
Other intervention name(s): DTPa
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal disease; Pneumococcal vaccine; Catch-up vaccination; Immunogenicity; Booster vaccination; Safety
Relation Between Vasovagal Tendency and Smoking Among University Students
Condition: Vasovagal Syncope; Smoke Inhalation
MeSH terms: Syncope; Syncope, Vasovagal; Smoke Inhalation Injury
Study type: Observational

Summary: 
      Almost everyone is aware these days is aware about the risk of smoking. Still many people
      start this habit specially in early life and during college year. We aim to investigate in
      this study if there is a drive to smoke in people with vasovagal tendency to improve their
      symptoms, even if not aware of this. Vasovoagal symptoms are common and include dizziness,
      smoking, sweating, abdominal pain, fatigue and syncope. Some studies have shown correlation
      between smoking and a positive tilt table test which is indicative of vasovagal tendency. By
      collecting the information regarding smoking habit and vasovagal symptoms analysis can be
      done to see if there is correlation between these two factors
    

Detailed description: 
      Methods

      A questionnaire will be conducted among university students to investigate the tendency
      toward vasovagal symptoms and also smoking habits. Statistical correlation will be
      subsequently conducted to see if there is correlation between those two problems (vasovagal
      symptoms and smoking)

      Study criteria inclusion

      Benefit to the patient:

      There is no direct benefit for participation in the study. The information obtained may help
      in the future to find factors that increase smoking and being aware of these factors may help
      in controlling the habit of smoking.
    

Intervention name(s): Comparison between two groups
Intervention type(s): Behavioral
Intervention description(s): Comparison will be made between smokers and non smokers regarding vasovagal tendency
Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Students at the university or college
A Switch-Over Study of the Safety and Efficacy of ISU302 in Patients With Type 1 Gaucher Disease
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with
      Type 1 Gaucher disease previously treated with Imiglucerase.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient diagnosed with type-1 Gaucher disease
      
Keywords: Type I Gaucher; ISU302; Imiglucerase
A Trial of HR19042 Capsule in Healthy Chinese Subjects
Condition: Primary IgA Nephropathy
MeSH terms: Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the safety and pharmacokinetics of HR19042 capsule
      after single administration in healthy Chinese subjects. To explore the pharmacokinetic
      characteristics and safety of HR19042 capsule in healthy Chinese subjects.
    


Intervention name(s): HR19042 capsule
Intervention type(s): Drug
Intervention description(s): phase 1 :8mg; phase 2:12mg; phase 3:16mg
Intervention model: Single Group Assignment
Intervention model description: Single center, open, three-period, sequential design
Masking: None (Open Label)
Primary purpose: Other
Dengue 3 Human Infection Model (DENV-3)
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to
      develop an appropriate challenge model. This study will examine the safety and effectiveness
      of the Dengue 3 Live Virus Human Challenge (DENV-3-LVHC) product and assess the ability of
      this virus strain to elicit an uncomplicated dengue-like illness.
    

Detailed description: 
      Healthy subjects between 18 and 45 years old will be inoculated with Dengue 3 Live Virus
      Human Challenge (DENV-3-LVHC) in a dose ranging study. Subjects will be closely monitored for
      the first 28 days with continued follow up through 6 months. Clinical and laboratory
      parameters, viremia and antibody levels will be assessed. The goal is to determine the dose
      that produces uncomplicated dengue-like illness.
    

Intervention name(s): Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)
Intervention type(s): Biological
Intervention description(s): Dengue subtype 3 Challenge Virus (DENV-3) strain CH53489 administered as a single injection.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Nine subjects will be assigned to the low dose group. Twenty-one days post inoculation, data will be reviewed for safety and if performance parameters are met. If safety profile is acceptable but performance parameters have not been met, dose escalation to the medium dose will proceed in nine additional subjects. Twenty-one days post middle dose inoculation, data will be reviewed as above and a determination will be made to proceed to the high dose.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dengue; Flavivirus Infections; Virus Diseases
Prospective Study on Polypectomy Complications: SPoC.
Condition: Endoscopic Polypectomy
Study type: Observational

Summary: 
      Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due
      to its capability to detect and remove precancerous lesions. However, polypectomy is
      associated with complications, such as bleeding and perforation, with an estimated overall
      incidence of about 10%, with polyp size and right-sided location considered as major risk
      factors. Aim of present study was to prospectively evaluate the early and delayed (30-days
      follow-up) complications of polypectomy in a multicenter regional Italian real practice
      setting
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population undergoing endoscopic polypectomy
Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      STA-5326 is an experimental drug that has been shown to block the release of interleukin-12
      from peripheral blood mononuclear cells. Given this activity on the immune system, STA-5326
      mesylate is a potential treatment for various autoimmune diseases, such as Crohn's disease,
      that are mediated by the inappropriate expression of Th1 cytokines.

      This study is evaluating the use of STA-5326 mesylate in patients with moderate to severe,
      active Crohn's disease. Study visits include a screening visit, 9 treatment period visits
      over 6 months and a follow-up visit that will occur 30 days following the end of treatment.
      Study drug treatment will continue for up to 6 months.
    


Intervention name(s): STA-5326 mesylate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Crohn's disease; Gastroenterology
Evaluation of the Treatment of Recurrent Corneal Erosions by Anterior Stromal Puncture With Nd: YAG Laser
Condition: Recurrent Corneal Erosion; Trauma
MeSH terms: Recurrence
Study type: Observational

Summary: 
      To evaluate the clinical outcomes in patients with recurrent corneal erosions who received
      anterior stromal puncture by use of neodymium:yttrium-aluminum-garnet (Nd:YAG) laser.
    

Detailed description: 
      Participants: From 2000 to 2005, thirty-three eyes in 33 patients with unilaterally recurrent
      corneal erosions who showed poor response to conservative managements and were treated with
      Nd:YAG laser were studied.

      Intervention: Anterior corneal stromal puncture with Nd:YAG laser was performed in the
      loosened epithelium or epithelial defect area. The causes and frequency of corneal erosions
      and the spot numbers and total energy of the Nd:YAG laser were recorded. Slit-lamp
      biomicroscopic examination, refraction, corneal topography, and times of laser were reviewed.
      A questionnaire regarding the preoperative and postoperative difference in the intensity of
      pain and frequency of corneal erosion was provided.

      Main Outcome Measures: Rate of recurrence and pain assessment by numerical rating scale.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        to evaluate the clinical outcomes after anterior stromal puncture with Nd:YAG laser in a
        consecutive series of 33 eyes in 33 patients with unilaterally recurrent corneal erosion.
      
Keywords: Nd: YAG laser; recurrent corneal erosions; trauma; anterior stromal puncture
FreeStyle Libre Glucose Monitoring System in Pediatric Populations
Condition: Diabetes Mellitus
Study type: Observational

Summary: 
      This study is a non-randomized, single-arm, multi-center study that is designed to evaluate
      the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in
      pediatric populations.
    

Detailed description: 
      Up to 85 subjects will be enrolled at up to four (4) clinical research sites in the United
      States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be
      given to the subject. All Readers will be masked during the study (i.e. subjects will not be
      able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be
      asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary
      Reader. Interstitial glucose readings from each Sensor will be obtained with the
      corresponding Readers immediately following each BG test. Subjects will be instructed to
      report any problems with the device. Subjects will make four (4) to five (5) scheduled visits
      to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the
      subjects weight, subjects will have up to two (2) in-clinic visits during which intravenous
      blood draws and YSI reference testing will occur.
    

Intervention name(s): FreeStyle Libre Flash Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects aged 6-17 years, with type 1 or type 2 diabetes who currently perform capillary
        blood glucose (BG) testing at least four (4) times a day.
A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler
      versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm,
      in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second,
      FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.
    


Intervention name(s): CHF1535 NEXThaler; CHF1535 pMDI; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rescue treatment; Rescue treatment; Rescue treatment
Other intervention name(s): Foster NEXThaler; Foster
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
iADAPT to Support Strategy Training After Stroke
Condition: Stroke; Adherence, Patient; Strategy Training
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Adherence to rehabilitation interventions is associated with functional outcomes (e.g.
      independence in daily activities, return of motor function) after stroke. Low adherence to
      rehabilitation home programs is common after stroke. Interventions delivered via mobile
      health applications demonstrated positive effects on adherence to health behaviors (e.g.
      medication routines, smoking cessation). The investigators developed the iADAPT mobile
      application to support adherence to Strategy Training. Strategy Training is an iterative
      rehabilitation intervention the promotes goal setting, planning, and self-monitoring after
      stroke. This study examines the effects of the iADAPT mobile health application relative to a
      workbook on adherence to Strategy Training after stroke.
    


Intervention name(s): Strategy Training
Intervention type(s): Behavioral
Intervention description(s): Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Disability; Mobile Health Technology
Tel Aviv Sourasky MC Home Monitoring Clinic Registry
Condition: Home Monitoring With ICD Patient
Study type: Observational

Summary: 
      The purpose of the registry is to assess workload of a Home Monitoring based follow up for
      Biotronik implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy
      defibrillators (CRTD) patients.
    

Detailed description: 
      EP unit device clinic is a very busy clinic. Every 6 month the patients arrive for device
      follow up where the device parameters, patient condition and arrhythmic events are being
      reviewed, and reprogramming of the device (if needed) is done. Average net time of patient's
      stay in the clinic is between 30-45 minutes.

      Patients implanted with the Lumax device family allows for a better automated follow up
      procedure via remote management (Home Monitoring).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ICD or CRTD implanted patient
Safety and Efficacy of IQP-AK-102 in Reducing Appetite
Condition: Weight Loss; Appetite Modulation (Focus of Study)
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several
      studies demonstrating their efficacy, we are conducting this study to look into the efficacy
      and safety of this novel combination of three fibres, in appetite regulation, aiming to
      reduce the appetite.
    


Intervention name(s): IQP-AK-102; Placebo
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.
Condition: T2DM
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 open label study is being conducted to characterize the pharmacokinetic (PK) and
      safety profiles of Chiglitazar with Empagliflozin，Atorvastatin and Valsartan in healthy
      subjects.
    


Intervention name(s): Chiglitazar; Empagliflozin; Atorvastatin; Valsartan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Chiglitazar 48mg; Empagliflozin 10mg; Atorvastatin 20mg; Valsartan 160mg
Intervention MeSH terms: Empagliflozin; Valsartan; Atorvastatin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets
      10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.
    

Detailed description: 
      An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose
      Bioequivalence Study of Zolpidem Tartrate Tablets containing Zolpidem Tartrate 10 mg ( Test
      Formulation, Torrent Pharmaceutical Ltd., India) Versus Ambien® Tablets 10 mg containing
      Zolpidem Tartrate 10 mg (Reference , Sanofi-Synthelabo Inc) in Healthy Human Volunteers Under
      Fed Condition.
    

Intervention name(s): Zolpidem Tartrate Tablets 10 mg; 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between the Analgesic Effectiveness of Virtual Reality and Topical Anesthesia: A Clinical Study
Condition: Pain
Study type: Interventional

Summary: 
      A split-mouth, controlled trial aimed to clinically compare and evaluate the effectiveness of
      virtual reality versus topical anesthesia gel prior to administration of dental anesthesia
      injection in reducing the perceived pain and anxiety level in adult patients and to find out
      their preferred procedure.

      Heart rate before and after the end of the procedure will be identified, pain intensity of
      the injection will be identified using a scale, and finally patients' preference will be
      identified using a questionnaire.
    

Detailed description: 
      Steps of the Experiment

      Step I: before the administration of the local anesthesia injection, heart rate will be
      measured for the patients using an FDA Approved pulse oximeter (Santa Medical SM-165 Finger
      Pulse Oximeter). Findings will be recorded.

      Step II: at the first appointment, patients will be randomly allocated to receive the
      injection of the local anesthesia either with topical anesthetic gel or with virtual reality
      in one side of the jaw.

      Step III: immediately after dental anesthesia injection procedure, the patient will be asked
      to rate the level of perceived pain, using Wong-Baker faces pain rating scale (WBFPS).

      Step IV: after the administration of the local anesthesia injection, heart rate will be
      measured for the patients an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse
      Oximeter). Findings will be recorded.

      Step V: in the next appointment, the other technique (virtual reality or topical anesthetic
      gel) will be used on the contralateral side for the same patients.

      So each patient will receive local anesthesia injection twice, one with topical anesthetic
      gel and one else with VR in the contralateral side.

      Step VI: after completion of both procedures, each patient will be asked to state his/her
      preference for the delivery system of future injections to be recorded.
    

Intervention name(s): Dental injection and topical gel application; Dental injection and virtual reality device
Intervention type(s): Drug; Device
Intervention description(s): Topical anesthesia gel will be applied followed by dental injection with 1.8 ml Xylocaine 20mg/ml (DENSPLY Pharmaceutical); adrenaline: 1 : 100.000, delivered in cartridges using a 27 -gauge short needle (0.4 x 25 mm,C-K jet) and sterile non-aspirating syringe.; Dental injection will be made while the participants are wearing virtual reality device.
Other intervention name(s): No other name; No other name
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain perception; virtual reality
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy and Safety of Imsidolimab (ANB019) in Subjects with Hidradenitis Suppurativa
    

Detailed description: 
      This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to
      evaluate the efficacy and safety of imsidolimab in adult subjects with hidradenitis
      suppurativa (HS). This study also will characterize the pharmacokinetic (PK) profile of
      imsidolimab and explore the immune response to imsidolimab in subjects with HS.
    

Intervention name(s): Imsidolimab; Placebo Solution
Intervention type(s): Biological; Biological
Intervention description(s): Humanized Monoclonal Antibody; Placebo
Other intervention name(s): ANB019
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IL-36 receptor; Interleukin 36; Imsidolimab
Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole
      monotherapy in the improvement of early-episode schizophrenia through the assessment of
      social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as
      episodes occurring ≤ 5 years after the onset of the first episode.
    


Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): Treatment (16 weeks) Up to 4 mg/day, once daily dose, tablets, orally
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; Mental Disorders; Psychotic Disorders; social avoidance; emotional withdrawal; passive/apathetic; social withdrawal; antipsychotic