bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
Condition: Jaundice, Neonatal; Hyperbilirubinemia, Neonatal
MeSH terms: Jaundice, Neonatal; Hyperbilirubinemia, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Interventional

Summary: 
      Neonatal jaundice is a common and most often harmless condition. However, when unrecognized
      it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated
      to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in
      most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease
      is therefore to identify then children at risk. This results in the need for low-cost,
      reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.

      Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a
      smartphone application has been developed. This prototype will be evaluated in a clinical
      trial in two hospitals in Norway. A smartphone will be used to take picture of the skin of
      the newborn, and by using an algorithm an estimate of the bilirubin concentration is made.
      The results from these estimates will be compared to the bilirubin levels measured in
      standard blood samples, as well as the results from ordinary transcutaneous measurement
      devices.
    


Intervention name(s): bilirubin concentration estimation from smartphone pictures; bilirubin concentration measured in standard blood samples; bilirubin concentration measured by transcutaneous device
Intervention type(s): Device; Procedure; Device
Intervention description(s): pictures taken of the skin covering the breast bone
Intervention MeSH terms: Bilirubin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diagnosis; Cell Phones; Infant, Newborn
A New Protocol for the Management of Dental Erosion in Rugby Players
Condition: Dental Erosion
MeSH terms: Tooth Erosion
Study type: Interventional

Summary: 
      The aim of the present study is to provide a new domiciliary oral care treatment for enamel
      remineralization in rugby players patients using mouthguards. Patients selected for the study
      will be randomly divided and allocated in two groups according to the treatment:

        -  Group 1: scaling and root planing (SRP) + Biorepair Total Protective Repair toothpaste
           for home oral hygiene twice a day

        -  Group 2: scaling and root planing (SRP) + Biorepair Total Protective Repair toothpaste +
           Biorepair mouthwash (3 in 1) for home oral hygiene twice a day

      Patients will be given instructions for the cleaning of their mouthguards. The periodontal
      evaluation will be conducted before SRP, after 15, 30 and 90 days. The periodontal indices
      collected will be: PI, BoP, Schiff Air Index, BEWE index and dental sensitivity (VAS scale).
    

Detailed description: 
      The aim of the present study is to provide a new domiciliary oral care treatment for enamel
      remineralization in rugby players patients using mouthguards and to prevent further worsening
      of dental erosion. Patients selected for the study will sign the informed consent and will be
      randomly divided and allocated into two groups:

        -  Group 1: SRP + Biorepair Total Protective Repair toothpaste for home oral hygiene twice
           a day

        -  Group 2: SRP + Biorepair Total Protective Repair toothpaste + Biorepair mouthwash (3 in
           1) for home oral hygiene twice a day

      Patients will be given instructions for the cleaning of their mouthguards. The periodontal
      evaluation will be conducted before SRP, after 15, 30 and 90 days. The periodontal indices
      collected will be: PI, BoP, Schiff Air Index, BEWE index and dental sensitivity (VAS scale).
    

Intervention name(s): SRP + toothpaste + mouthwash; SRP + toothpaste
Intervention type(s): Other; Other
Intervention description(s): Use of domiciliary products twice a day; Use of domiciliary products twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: enamel remineralization
Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess reactogenicity and safety of simultaneous
      administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK
      Biologicals' DTPa-vaccine Infanrix vaccines in healthy children in Russian Federation in
      their first year of life according to National Calendar of Prophylactic Immunisation of
      Russian Federation.
    


Intervention name(s): Poliorix TM; Infanrix TM
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular administration, 3 doses; Intramuscular administration, 3 doses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: poliomyelitis; diphtheria; Primary immunization; pertussis; Children; tetanus
The Energy Balance Study
Condition: Total Energy Expenditure,Total Energy Intake
Study type: Observational

Summary: 
      The purpose of this study if to determine the specific contributions of energy intake and
      energy expenditure to changes in body weight and fat.
    

Detailed description: 
      1. Changes in body weight and fat will be positively associated with increases in total
           energy intake.

        2. Changes in body weight and fat will be positively associated with decreases in total
           energy expenditure.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 400 participants will take part in the Energy Balance Study; 200 men and 200
        women from 2 age groups: Ages 21-27 and Ages 28-35. A subsample of 200 will be randomized
        for doubly labeled water recruitment.
Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity
Condition: Music Listening
Study type: Interventional

Summary: 
      The study aim to improve the quality of EEG recordings during simultaneous fMRI acquisitions.
      The second aim is to validate the correspondence between cerebral areas activated in fMRI and
      cortical areas identified with high density EEG during the listening of emotional musical
      pieces.
    


Intervention name(s): simultaneous fMRI and EEG + peripheral measures; EEG and peripheral measures
Intervention type(s): Device; Device
Intervention description(s): Hemodynamic activity recorded with fMRI, cerebral electric activity recorded with EEG as well as peripheral physiological parameters will be recorded during music listening.; cerebral electric( with EEG) as well as peripheral physiological parameters will be recorded during music listening.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of an investigational
      anti-anxiety medication relative to placebo in patients with generalized anxiety disorder
      (GAD).
    


Intervention name(s): Gabitril
Intervention type(s): Drug
Intervention MeSH terms: Tiagabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
Condition: Pre-diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional

Summary: 
      The overall aim of this feasibility trial is to assess the effectiveness of a wearable
      technology and an e-diabetes prevention programme delivered via a smartphone application,
      including motivational messaging, in reducing weight and increasing physical activity in
      people at risk of developing type 2 diabetes.
    

Detailed description: 
      The study will examine whether a wearable technology, combined with biofeedback, motivational
      messaging and an e-diabetes prevention programme, is effective in reducing weight and
      increasing physical activity after 12 months.

      The intervention will consist of a wearable technology and a smartphone application made
      available for a 12 month period. 22 online multimedia sessions targeting diet, physical
      activity and mental resilience delivered via the smartphone application. Motivational
      messaging based on the diabetes prevention module content and biofeedback will be sent to
      participants via the application.

      The control group will receive the wearable technology and will have access to a smartphone
      application detailing their activity. Participants will be directed to the same educational
      material as is made available via the multimedia sessions, but will not receive motivational
      messages.
    

Intervention name(s): Wearable technology; Diabetes Prevention Programme educational material; Motivational messaging
Intervention type(s): Device; Behavioral; Behavioral
Intervention description(s): Buddi wearable technology will record activity levels, participants will access activity data through smartphone application; Educational material accessed through smartphone application; Messages sent via smartphone application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma
Condition: Advanced Esophageal Carcinoma
MeSH terms: Carcinoma; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line
      treatment for metastatic esophageal carcinoma.
    

Detailed description: 
      Although there are no standard second-line treatment for metastatic esophageal carcinoma,
      some studies have showed that irinotecan, fluorouracil may be effective in treating patients
      with metastatic esophageal carcinoma after failure of first-line treatment. Since irinotecan,
      fluorouracil, and leucovorin work in different ways to stop the growth of tumor. Giving more
      than one drug may be more effective. In this phase Ⅱ trial, the investigator would like to
      observe the efficacy and safety of FOLFIRI(Irinotecan/5-FU/leucovorin ) as second-line
      treatment for metastatic esophageal carcinoma.
    

Intervention name(s): FOLFIRI
Intervention type(s): Drug
Intervention description(s): Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
Other intervention name(s): Irinotecan; Leucovorin; 5-Fluorouracil
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PET/CT-directed Hyperfractionated Radiation Dose Escalation in Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional

Summary: 
      The goal of this study is to find the maximum tolerable dose of radiation that can be
      delivered with concurrent chemotherapy (carboplatin & paclitaxel) in patients with esophageal
      cancer.
    

Detailed description: 
      Concurrent chemoradiotherapy is the standard of care for esophageal cancer based on the
      results of phase III randomised trials. The current standard radiation therapy dose has
      remained 50 Gy at -2 Gy/fraction for decades.However, locoregional control remain
      problematic, with 25% of patients having persistence and 20% relapse of locoregional disease
      following the combined modality approach. New regimen is urgently needed for improving
      localregional control and survival.Investigators hypothesize that hyperfractionated radiation
      dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by
      positron emission tomography (PET) /computed tomography (CT) would improve local control and
      overall survival while reducing the acute and late normal tissue toxicity.
    

Intervention name(s): radiochemotherapy 1; radiochemotherapy 2; radiochemotherapy 3; radiochemotherapy 4; radiochemotherapy 5; radiochemotherapy 6
Intervention type(s): Radiation; Radiation; Radiation; Radiation; Radiation; Radiation
Intervention description(s): concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly; concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;; concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;; concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;; concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;; concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;
Other intervention name(s): concurrent radiochemotherapy 1; concurrent radiochemotherapy 2; concurrent chemoradiotherapy regimen 3; concurrent chemoradiotherapy regimen 4; concurrent chemoradiotherapy regimen 5; concurrent chemoradiotherapy regimen 6
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HD12 for Advanced Stages
Condition: Hodgkin´s Lymphoma
MeSH terms: Hodgkin Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in
      the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is
      necessary following effective chemotherapy.
    


Intervention name(s): Cyclophosphamide; Adriamycin; Etoposide; Procarbazine; Prednisone; Vincristine; Bleomycin; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Prednisone; Cyclophosphamide; Etoposide; Vincristine; Doxorubicin; Liposomal doxorubicin; Bleomycin; Procarbazine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin´s Lymphoma; advanced stages
Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia
Condition: Agitation; Schizophrenia
MeSH terms: Psychomotor Agitation; Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-stage adaptive Phase Ib trial design, that will identify two doses (lowest dose
      with clinical benefit and highest safe dose) in a first stage and better evaluate safety,
      tolerability and variability of effect in the second stage.
    

Detailed description: 
      This is a two-stage adaptive Phase Ib trial design. It is a randomized, double-blind,
      placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics,
      safety and tolerability of BXCL501 dosing in adult (18-65 years old) males and females with
      acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform
      disorder.

      The first stage will characterize a safe and tolerable dose range that results in a calming
      effect as measured using the PEC total score. The lowest dose with clear clinical benefit,
      and the highest safe and well-tolerated dose that demonstrates efficacy in a large proportion
      of subjects will be selected over the course of testing multiple escalating dose cohorts. The
      second stage will comprise a total of 40 subjects per dose group in a three-arm
      placebo-controlled design in order to better characterize the broader range of safety and
      tolerability as well as better estimate variability (effect size) which may be observed in
      later phase placebo-controlled trials.
    

Intervention name(s): Sublingual film containing BXCL501 (Dexmedetomidine); Placebo film
Intervention type(s): Drug; Drug
Intervention description(s): Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia; Placebo film for BXCL501
Other intervention name(s): Dexmedetomidine; Placebo
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a two-stage adaptive Phase Ib trial design. It is a randomized, double-blind, placebo-controlled, multiple ascending dose study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Phosphorus Supplementation on Body Weight
Condition: Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Phosphorus is a mineral that is naturally present in our foods and is required by our bodies
      for normal function. It has been found that phosphorus supplementation taken before meals has
      the potential to reduce meal size. However its long term effect has not been measured yet. It
      is well accepted that changes in body weight require about 3 months. Using body weight as the
      outcome, which is the ultimate outcome of weight loss approaches, would provide robust
      information on the role of phosphorus.
    

Detailed description: 
      A double-blind, randomised, placebo-controlled trial of 63 adults aged 18 to 45 years with a
      body mass index (BMI) of 25 kg/m2 or higher and normal kidney function at the American
      University of Beirut. Participants were randomly assigned to the placebo or phosphorus group
      where daily placebo or phosphorus supplements were ingested with three main meals (breakfast,
      lunch, and dinner) for a period of 12 weeks. Primary outcomes were changes in anthropometric
      measures, blood metabolites (including lipid profile, glucose, and insulin), and subjective
      appetite scores.
    

Intervention name(s): phosphorus
Intervention type(s): Dietary Supplement
Intervention description(s): phosphorus supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: phosphorus intake
Evaluation of BAV in Different Hemodynamic Entities of Severe AS
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Study type: Observational

Summary: 
      The purpose of this retrospective, observational study is to compare the profit of BAV and
      TAVI in different subtypes of serve aortic stenosis.
    

Detailed description: 
      The Balloon Aortic Valvuloplasty (BAV) is a catheter-based intervention, which can be used
      for dilatation of serve aortic stenosis. With this minimally invasive intervention an
      increase of the aortic valve area (AVA) and cardiac ejection fraction (EF), decrease of
      transvalvular gradients and ultimately a symptom relief should be achieved. The required
      effect is temporary and a definitive treatment should be aspired in suitable patients.
      Therefor Transcatheter Aortic Valve Replacement (TAVR) is available.

      Following the guidelines of the European Society of Cardiology for the management of valvular
      heart disease from 2017, the aortic stenosis can be divided into different subtypes by using
      haemodynamic parameters: High-gradient AS (HG-AS), Low-Flow-Low-Gradient AS (LFLG-AS) and
      paradoxical Low-Flow-Low-Gradient (pLFLG-AS). Patients with LFLG-AS are suspected to have a
      poorer prognosis when treated curative as well as when treated palliative medicamentous,
      because these patients show coronary and myocardial restrictions more frequently in addition
      to the valvular disease.

      The aim of the study is to compare safety and effectiveness of balloon aortic valvuloplasty
      as a bridging therapy and transcatheter aortic valve replacement as a definitive treatment in
      HG-AS, LFLG-AS and pLFLG-AS patients to verify whether the subtypes of aortic stenosis profit
      equally from these interventions.
    

Intervention name(s): BAV; BAV + TAVR; SAVR
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): BAV; BAV + TAVR; Surgical aortic valve replacement (SAVR)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in the heart failure program of the University of Duesseldorf
      
Keywords: Balloon Aortic Valvuloplasty; Severe Aortic Valve Stenosis; Surgical aortic valve replacement (SAVR)
Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C (0000-123)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the quality of the RNA and the reproducibility of
      gene expression profiling from liver tissue samples obtained by fine needle aspiration.
    


Intervention name(s): Comparator: Fine needle aspiration biopsy
Intervention type(s): Procedure
Intervention description(s): Visit 1: Screening Visit 2 (7-14 days from screening): Core needle biopsy and fine needle aspiration biopsy - liver.
Visit 3:(7 days from visit 2): Fine needle aspiration biopsy - liver. Visit 4: (14 days from Visit 3): follow-up visit
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Patients with Chronic Hepatitis C
Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection
Condition: Temporary Correction of Wrinkles
Study type: Interventional

Summary: 
      This study was purposed to evaluate the non-inferiority of HA IDF, a hyaluronic acid product,
      in terms of correction of wrinkles and safety in nasolabial fold intradermal injection,
      compared to Restylane, the control preparation.
    


Intervention name(s): HA IDF (YVOIRE classic); Restylane
Intervention type(s): Device; Device
Intervention description(s): Treatment with HA IDF; Treatment with Restylane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: IND approved from KFDA
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment