bioihbjkbjnl/mcl2 huggingface dataset:
External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this study in humans with stable coronary artery disease (CAD) treatable by
      percutaneous coronary intervention (PCI) is to evaluate the efficacy of External
      Counterpulsation (ECP) with regard to the promotion of coronary collateral growth.
    

Detailed description: 
      Alternative strategies for the promotion of coronary collaterals (arteriogenesis) are a
      promising therapeutic alternative for at least 20% of all Patients with Coronary Artery
      Disease (CAD). Beside growth factors, physical exercise has been shown to improve coronary
      collateral function. Extracorporal Counterpulsation (ECP) mimics physical exercise in a
      standardized way. Before and after ECP treatment, a quantitative invasive assessment of
      absolute collateral flow (by calculating the CFI, i.e. Collateral Flow Index) and myocardial
      perfusion is performed (with calculation of the CPI, i.e. Collateral Perfusion Index and MPR,
      i.e. Myocardial Perfusion Reserve).

      The study setting is single-blinded, sham-controlled and proceptive .
    

Intervention name(s): ECP Therapy
Intervention type(s): Device
Intervention description(s): application of ECP Therapy to CAD Patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CAD; ECP; CFI; CPI; MPR
Nursing-Home Residents Given Bread Fortified With Vitamin D3
Condition: Vitamin D Deficiency; Low Bone Density
MeSH terms: Bone Diseases, Metabolic; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L
      lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of
      vitamin D3.

      Objective: We wanted to characterize the safety and efficacy of fortifying bread with a
      biologically meaningful amount of vitamin D3.
    

Detailed description: 
      Methods: In a single-arm design, 45 nursing-home residents consumed one bun/d that had been
      fortified with 125 mcg (5,000 IU) of vitamin D3 and 320 mg elemental calcium.
    

Intervention name(s): Bread fortified with vitamin D3 and calcium
Intervention type(s): Dietary Supplement
Intervention description(s): Bread fortified with vitamin D3 (5000 IU per bun) and calcium
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dietary fortification; Vitamin D3; Osteomalacia; bread; bone mineral density; geriatrics; cholecalciferol; calcidiol; osteoporosis; dual-energy photon absorptiometry; bread fortification
PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is:

      To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging
      in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced
      breast cancer patients.

      To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI,
      dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response
      to neoadjuvant chemotherapy of locally advanced breast cancer patients.

      To compare the performances of dynamic contrast-enhanced MRI using parametric response map
      analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early
      prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer
      patients
    

Detailed description: 
      Enrolled women with breast cancers who had received an anthracycline-taxane regimen and
      subsequent surgery were prospectively enrolled. DCE-MRI and FDG-PET scan were performed
      before and after the 1st cycle of chemotherapy. MR imaging parameters and SUV on PET scan
      within a tumor were analyzed. Clinicopathologic (age, clinical tumor stage, hormonal receptor
      status, and surgery type) and imaging parameters were compared according to the pathological
      response.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Breast cancer patients who are candidates for neoadjuvant chemotherapy, pre-treatment MRI
        and PET scan, post-treatment MRI and PET scan for evaluation of chemotherapy response
        monitoring and residual disease
      
Biospecimen description: 
      Core biopsy specimens of breast cancer
    
Keywords: Magnetic Resonance Imaging, Functional; Tomography, Positron-Emission; chemotherapy
Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Observational

Summary: 
      This is a short term study of the effects of bariatric surgery on body composition, gait
      parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly
      obese patients who are already scheduled for a bariatric surgical procedure.
    

Detailed description: 
      This is a prospective, exploratory, short term study of the effects of bariatric surgery on
      body composition, gait parameters during walking, lower extremity joint pain and quality of
      life (QOL) in morbidly obese patients. All patients who enroll have already agreed to undergo
      the bariatric procedure with their respective surgeon; the study team will simply follow
      specific outcome measures in addition to their normal clinical care at two time points after
      the surgery (week 4 and month 3).
    

Intervention name(s): Subject outcomes following bariatric surgery
Intervention type(s): Other
Intervention description(s): Subject outcomes (body composition, gait analysis, lower extremity joint pain and perceived quality of life) measured at per-op, 2, 4 weeks and 3 months.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All subjects will be patients already scheduled to undergo bariatric surgery for weight
        loss.
      
Keywords: body composition; gait; quality of life; Patients; undergoing; bariatric surgery.
Use of Public Health Surveillance Models in the French National Health System Database
Condition: Atrial Fibrillation; Anticoagulants; Pharmacoepidemiology
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Public health surveillance models, previously used for the ongoing detection of occurrence of
      rare events, could be used to reinforce existing pharmacovigilance systems. These models have
      not been previously used for Adverse Drug Reaction (ADR) detection in medico-administrative
      databases. DABISURV research project focuses on a new anticoagulant therapy, dabigatran,
      launched recently on the French market for atrial fibrillation (AF). This drug is at high
      risk for severe ADR and requires thus careful pharmacovigilance monitoring.

      Primary objective is to compare the results of ongoing surveillance models to detect
      hemorrhages or acute myocardial infarction (AMI) associated with dabigatran, with the results
      obtained from the analysis of a cohort of patients with AF under the same treatment.
    

Detailed description: 
      DABISURV study consists in an analyze of a cohort of patients with AF who have received at
      least one prescription Vitamin K Antagonists (VKA) - reference group - or of dabigatran in
      the French National Health Insurance System.

      The uptake of dabigatran is followed for detecting hemorrhagic events or AMI associated with
      this molecule among first users.

      The ability to detect quickly substantial ADR of new drugs is of critical importance to
      public health in order to facilitate timely public health response. If the public health
      surveillance models are found useful for this topic, then semi-automated procedures would be
      needed to detect ADR associated with new generation anticoagulants in medico-administrative
      databases. If the public health surveillance models are found not useful for the detection of
      ADR, the cohort study itself will provide essential data on the safety profile of dabigatran.
    

Intervention name(s): Dabigatran
Intervention type(s): Drug
Intervention MeSH terms: Dabigatran
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Cohort of adult patients diagnosed with AF or atrial flutter and who received at least one
        prescription of VKA (warfarin /acenocoumarol /fluindion) or dabigatran between 2009 and
        2014. As opposed to other countries, in France, warfarin is not the most prescribed VKA for
        AF.
      
Keywords: Atrial Fibrillation; Anticoagulants; Pharmacoepidemiology
18519 - Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number: SR15-43-Y65-158)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the feasibility of [18F]Florbetapir positron
      emission tomography (PET) for assessment of demyelination in the patients with relapsing
      remitting multiple sclerosis.
    

Detailed description: 
      The underlying goal of this study is to assess the feasibility of [18F]Florbetapir as an
      imaging tool to detect demyelination in the brain of MS research participants and compare to
      similarly aged healthy subjects.
    

Intervention name(s): [18F]Florbetapir PET imaging
Intervention type(s): Drug
Intervention description(s): [18F]Florbetapir and PET imaging
Other intervention name(s): Amyvid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Multiple Sclerosis
Bioequivalency Study of Zidovudine Under Fed Conditions
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg
      tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fed conditions using a
      single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
    


Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence
      of two formulations of biphasic insulin aspart 70 in healthy male subjects.
    


Intervention name(s): biphasic insulin aspart 70
Intervention type(s): Drug
Intervention description(s): A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Virtual Reality and Augmented Reality Training System on Elderly Oral Care Skill for Oral Hygiene and Nursing Students
Condition: Medical Education
Study type: Interventional

Summary: 
      Virtual reality (VR) has been proposed as a promising technology for education since the
      combination of immersive and interactive features enables experiential learning. The study
      aimed to evaluate the effectiveness of VR-based training on oral health care for dependency
      elderly among oral hygiene students.
    

Detailed description: 
      A randomized controlled trial was conducted. Overall, the study recruited students from third
      grade of Department of Oral Hygiene students in Kaohsiung Medical University during 2021. The
      participants were randomly assigned to virtual-reality experimental (EG; n = 11) and control
      (CG; n = 12) groups. The students in EG received a 2-hour VR training for elderly oral health
      care at 2-week (Time 2), 4-week (Time 3) and 6-week (Time 4) follow-ups. Each student
      collected the data by a self-administrated questionnaire before and immediately after each of
      the intervention. Linear regression in generalized estimating equations (GEE) compare the
      differences between both groups.
    

Intervention name(s): VR-based training
Intervention type(s): Behavioral
Intervention description(s): Students simulate the different physical and oral conditions of the elderly through virtual situations and provide suitable oral care methods. The whole training session took approximately two hours for each student; First, students were first given a short introduction to the VR system's use (10 minutes). Second, they were able to carry out oral care for the elderly while wearing VR goggles and using hand-controllers with the teaching and audio guides during the process (90 minutes), and an evaluation was taken after the intervention (20 minutes).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dependency; Elderly; Medical Education; Oral Hygiene; Virtual Reality
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 ×
      75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by a
      washout period of 7 days.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Torrent's Clopidogrel Tablets USP 75 mg
Intervention type(s): Drug
Intervention MeSH terms: Clopidogrel
Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances
Condition: Sleep Problems
MeSH terms: Dyssomnias; Parasomnias; Neurodevelopmental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      There is increasing evidence that chronic sleep disorders in children with autism spectrum
      disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with
      disturbed melatonin secretion and melatonin administration has been shown to be effective in
      these populations. For children who have difficulties swallowing a tablet, Neurim has
      developed an age-appropriate Melatonin formulation in the form of mini-tablets which have the
      same dissolution profile as the Circadin® tablets product, thus should produce the same
      melatonin concentration-time profile with the same effects. This study concerns the
      pharmacokinetic study.

      The purpose of this study is to :

        -  Establish the 24 hour baseline profile of endogenous saliva melatonin concentrations and
           urine 6-SMT excretion in children aged 2 up to and including 17 years with
           neurodevelopmental disorders with sleep disturbances.

        -  Establish the concentration-time profile of saliva melatonin concentrations and 24 hour
           6-SMT urine excretion after 2 and 10 mg Circadin® mini-tablets single dose
           administration in children aged 2 up to and including 17 years with neurodevelopmental
           disorders with sleep disturbances.

        -  Evaluate the adverse event profile after a single dose of 2 or 10 mg Circadin®
           mini-tablets in children aged 2 up to and including 17 years with neurodevelopmental
           disorders with sleep disturbances.
    


Intervention name(s): Circadin 2 mg; Circadin 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): First arm lower dose; Second arm higher dose
Other intervention name(s): non
Intervention MeSH terms: Melatonin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sleep problems, autism spectrum disorder, prolonged-release melatonin, Circadin, endogenous saliva melatonin; Smith-Magenis syndrome, Angelman syndrome, Tuberous Sclerosis
Effectiveness of Cervicothoracic Manipulative Treatment in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial.
Condition: Shoulder Pain; Manual Theapy; Exercises Therapy
MeSH terms: Shoulder Pain; Shoulder Impingement Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this protocol is to compare degree of improvement can be achieved in
      patients with shoulder pain by treatment with Manipulative Techniques for the cervicothoracic
      spine versus home exercises.
    

Detailed description: 
      Design: Randomized Clinical Trial. Objective: to determine the effects of manipulative
      techniques for the ervicothoracic spine versus home exercises on pain, disability, and range
      of movement in patients with unilateral shoulder inmingement syndrome.

      Methods and Measures: ninety-two subjects will be randomly assigned to one of two groups.

      Intervention: For 5-weeks, the groups 1 will undergo tratment comprising manipulative
      protocol techniques for the cervicothoracic spine (2/week) and the group 2 will develop a
      home exercise (2/week).

      Main Outcome Measures: Intensity of pain, disability, and range of motion data will be
      collected at baseline, and 24hr after the last therapy application. Mixed-model analyses of
      variance will be used to examine the effects of the treatment on each outcome measure.
    

Intervention name(s): Manipulative Therapy Techniques; Home Exercises
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Shoulder Pain; Shoulder Impingement Syndrome; Exercise therapy; Randomized Controlled Trial
Bioavailability of Anthocyanins of Blue Potatoes as Compared With Bilberries
Condition: Postprandial Glycemia
Study type: Interventional

Summary: 
      In this study, the postprandial glycemia and insulinemia caused by boiled potato with
      blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch,
      is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids
      and their metabolites is studied in plasma and urine.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC
Condition: Oropharynx Cancer; Oral Cancer; Hypopharynx Cancer; Larynx Cancer
MeSH terms: Mouth Neoplasms; Oropharyngeal Neoplasms; Laryngeal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be
      two possibilities for improving efficacy of radiotherapy in locally advanced head and neck
      carcinomas. In this multicentric study, we tested the hypothesis that accelerated
      radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU,
      aiming to improve both local control and on distant metastases as compared to very
      accelerated radiotherapy.
    

Detailed description: 
      Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive
      either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32
      fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy
      BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered
      at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after
      completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients
      responding (> 50%) to the initial course of RT-CT. The end points were event free survival
      and survival.
    

Intervention name(s): Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID); Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID); CDDP, 5 Fu
Intervention type(s): Procedure; Procedure; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and neck squamous cell carcinoma; Radiotherapy; Chemotherapy