bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Breast Augmentation on the Quality of Echocardiography Test
Condition: Breast Augmentation
Study type: Observational

Summary: 
      Breast augmentation surgery is currently the most common elective plastic surgery performed
      in the US. With regards to the surgical technique, there are 4 incisional sites available for
      breast augmentation, each with its advantages and disadvantages: Axillary, Periareolar,
      inframammary, and umbilical. The implant is inserted in either a subglandular (beneath breast
      tissue), submuscular (underneath the Pectoralis Major), or "dual-plane" (combination of both)
      manner.

      Echocardiography is the most commonly used diagnostic test in cardiology for the evaluation
      of cardiac structure and function. Its use has increased dramatically in the last decades. We
      have encountered three women with congenital heart disease who have undergone breast
      augmentation, and their echocardiographic images were significantly limited after the
      implantation. There is only one case report in the medical literature suggesting that breast
      implants interfere with echocardiographic views .

      The underlying physical property of the silicone breast implants that causes interference
      with the ultrasound beam during echocardiographic examination is not known and has not been
      studied. Similar to air in the lung but to a lesser degree, silicone breast implants appear
      to prevent penetration of ultrasound beams. The poor penetration appears to be persistent and
      unrevealing despite increase in gain or change in the ultrasound wave's frequency.

      Many women elect breast augmentation for cosmetic reasons. Women with congenital heart
      disease who have undergone cardiac surgery may have breast asymmetry or distortion and desire
      augmentation accordingly.

      Knowledge of the extent of impairment of breast implants to the echocardiographic examination
      is important for few reasons:

        1. Women with heart disease who need echocardiographic follow up and wish to undergo breast
           augmentation should be consulted as to the limitation of the echocardiographic
           examination following the procedure.

        2. Women without heart disease considering breast augmentation should be informed of
           potential echocardiographic interference, if echocardiography be needed in the future,

        3. Different surgical techniques may cause different masking effect.

        4. Different implants size and shape may cause different masking effect.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing breast augmentation
Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy
Condition: Stroke; Cerebrovascular Disorders; Central Nervous System Diseases
MeSH terms: Stroke; Nervous System Diseases; Central Nervous System Diseases; Cerebrovascular Disorders
Study type: Interventional

Summary: 
      The specific study aims will be:

        1. To develop the novel, digital, and interactive MSR system of arm and hand with
           integrated digital action observation therapy (AOT) and mirror therapy (MT).

        2. To pilot usability testing for examining the feasibility of this new MSR system from the
           users' experiences and feedback.

        3. To examine the treatment effects of digital AOT, digital MT and a control intervention
           in patients with stroke by conducting a randomized controlled trial.

        4. To identify who will be the possible good responders to digital AOT and MT based on
           their baseline motor function and mental imagery abilities.
    

Detailed description: 
      Phase I: Multi-mode stroke rehabilitation (MSR) System Development & Usability Testing

      Ten patients with stroke and 4 certified occupational therapists were recruited in this phase
      I study. During the pilot testing, each stroke patient will try to use each training mode of
      digital AOT and MT by the assistance of the therapist. At the end of the pilot testing, the
      patients and the therapists will be asked to complete the System Usability Scale and a
      self-designed questionnaire to assess the user experience and perspective about this new MSR
      system and their view of its suitability for stroke patients.

      Phase II: Validation of Clinical Treatment Efficacy

      This three-arm, single-blind, randomized controlled trial will investigate the treatment
      effects among the 3 groups of digital AOT, digital MT, and dose-matched control intervention.
      An estimated 60 patients with stroke will be recruited to participate in this phase II study.
      Each participant will receive a total of 15 training sessions (60 minutes per session) for 3
      to 4 weeks. Clinical outcome measures will be conducted at baseline, immediately after
      treatment (the fourth week), and at 1 month follow-up after treatment.
    

Intervention name(s): Digital Action Observation Therapy (Digital AOT); Digital Mirror Therapy (Digital MT); Conventional Occupational Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The participants will be asked to observe videos and then practice what the participants observed.; The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.; The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: stroke; multi-mode rehabilitation; action observation; mirror therapy; digital image technology
Bioequivalence Study for an Isotretinoin
Condition: Skin Infections (Acne)
MeSH terms: Cellulitis; Skin Diseases, Infectious
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of isotretionin (capsules) are
      bioequivalent.

      Test product was Oratane® 20 mg (Laboratorios Dermatológicos Darier) and reference product
      Roaccutan® 20 mg (Productos Roche). Two capsules administered together were the single
      dosage.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fed conditions.

      The population was composed of 36 healthy volunteers, male adults between 18-45 years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Isotretinoin 40 mg; Isotretinoin 40 mg
Intervention type(s): Drug; Drug
Intervention description(s): Roaccutan 2 capsules of 20 mg; reference drug; Oratane 2 capsules of 20 mg; test drug
Other intervention name(s): Productos Roche; Roaccutan; Laboratorios Dermatologicos Darier SA de CV; Oratane
Intervention MeSH terms: Isotretinoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; Isotretinoin; bioequivalence; Mexico
Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, sequential group
      study. The primary objective of this study is to assess the tolerability and safety of single
      doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to
      determine the systemic exposure to, and urinary elimination of, ME1100.
    


Intervention name(s): ME1100 inhalation solution; ME1100 placebo inhalation solution
Intervention type(s): Drug; Drug
Intervention description(s): ME1100 inhalation solution (arbekacin for oral inhalation at 150mg/mL), 0.6, 2.0, 3.0, 4.0, 6.0, or 9.0mL, Single Dose; Vehicle placebo
Other intervention name(s): arbekacin; ME1100
Intervention MeSH terms: Arbekacin; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Aerosol delivery through a ventilator is influenced by numerous factors from
      ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery
      through a ventilator system was studied on bench model with albuterol, yet the results were
      often overestimated. The objective of this study was to evaluate inhaled bronchodilator and
      mucolytic agents delivered through a ventilator system.
    

Detailed description: 
      Aerosolized medication is used widely to patients with respiratory illness and admitted in
      the intensive care unit, and includes bronchodilators, steroids, mucolytics, and antibiotics.
      Aerosol delivery through a ventilator is influenced by numerous factors from
      ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery
      through a ventilator system was studied on bench model with albuterol, yet the results were
      often overestimated. Only few clinical trials on aerosol delivery deposition were published
      in the last decades. In addition, inhaled bronchodilators, mucolytics, antibiotics, and
      steroids are often administered to ventilated patients in the intensive care units in Taiwan,
      but they are never studied. Therefore, the aim of this study was to evaluate inhaled
      bronchodilator and mucolytics (acetylcystine) delivered by a jet nebulizer through a
      ventilator system to intubated patients.
    

Intervention name(s): Salbutamol; Acetylcysteine
Intervention type(s): Drug; Drug
Intervention description(s): Salbutamol (albuterol ) was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.; Acetylcystine was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.
Other intervention name(s): albuterol; Mucomyst
Intervention MeSH terms: Acetylcysteine; Albuterol; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Bioequivalence and Food Effect of 250mg of Lamotrigine XR
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine
      XR in healthy male and female volunteers
    


Intervention name(s): Lamotrigine tablet; Lamotrigine caplet
Intervention type(s): Drug; Drug
Intervention description(s): Lamotrigine extended release single dose tablet will be available with dosing strengths of 200 milligrams and 50 milligrams intended to be administered orally in fasted state. It will be a round standard convex shape tablet.; Lamotrigine extended release single dose caplet will be available with dosing strength of 200 milligrams and 50 milligrams intended to be administered orally in fasted and fed state.
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; Bioequivalence; Food Effects
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
Condition: Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with
      a single injection of KRN125 or multiple daily injections of filgrastim.
    


Intervention name(s): pegfilgrastim
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pegfilgrastim; neutropenia; cancer patients; lymphoma
A Study Comparing Implant Provision by Community Health Extension Workers With Nurses and Midwives in Nigeria
Condition: Contraception
Study type: Interventional

Summary: 
      This proposed study, to be run by Marie Stopes International Organisation Nigeria (MSION)
      will investigate whether Community Health Extension Workers (CHEWs) in Nigeria can insert and
      remove contraceptive implants to the same level of safety and quality as a nurse or midwife,
      and whether this is acceptable to their clients and colleagues. The study will also document
      feasibility issues which would be relevant to any future national programmatic scale-up.
    


Intervention name(s): Training CHEWs to provide contraceptive implants
Intervention type(s): Other
Intervention description(s): Training CHEWs to provide contraceptive implants
Intervention MeSH terms: Contraceptive Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Contraceptive implant; Task sharing; Nigeria
Spectral Domain Optical Coherence Tomography Analysis for Glaucoma
Condition: GLAUCOMA 1, OPEN ANGLE, D (Disorder)
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The aim of this study is to examine whether there is a difference in macular ganglion cell
      complex thickness and retinal nerve fiber layer thickness in early-stage Primary open angle
      glaucoma and normal tension glaucoma with spectral domain OCT.
    

Detailed description: 
      Glaucoma is a progressive optic neuropathy characterized by gradual degeneration of neuronal
      tissue in which retinal ganglion cells (RGCs) are injured, leading to the loss of the visual
      field.Recent studies have separately demonstrated a reduction in the macular retinal
      thickness and in the retinal nerve fibers in both POAG and NTG.It has been demonstrated that
      in early stage NTG macular GCC thickness showed a strong correlation with thickness of the
      RNFL. However there have yet to be any reports regarding the comparison of macular thickness,
      ganglion cell complex and retinal nerve fiber layer between POAG and NTG with RS-3000
      RetinaScan at early stage.
    

Intervention name(s): RS-3000 OCT measurements
Intervention type(s): Device
Intervention description(s): Ganglion cell, retinal nerve fiber layer and retinal thickness measurements of normal subjects, primary open angle glaucoma and normal tension glaucoma patients using RS-3000 OCT RetinaScan
Other intervention name(s): GCC and RNFL in Open Angle and Normal Tension Glaucoma.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Ganglion Cell complex, Retinal Nerve Fiber Layer,Glaucoma
Clarithromycin Resistant Tailored Therapy
Condition: Peptic Ulcer; Helicobacter Pylori Infection
MeSH terms: Peptic Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin
           is one of the main causes of failure of eradication. 23S rRNA point mutation of
           Helicobacter pylori is associated clarithromycin resistance

        2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment
           regimens containing a proton pump inhibitor and combination of two antibiotics
           (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate
           Helicoabacter pylori more successfully

        3. Material & methods The investigators enroll patients diagnosed with peptic ulcer,
           endoscopically. Helicobacter pylori is documented with Urea breath test or silver
           staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S
           rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation,
           the investigators consider as resistance to clarithromycin and choose the treatment
           regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no
           mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin,
           clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare
           eradication rate with conventional treatment,proton pump inhibitor, amoxicillin,
           clarithromycin.
    


Intervention name(s): 23S rRNA point mutation test of Helicobacter pylori; UBT test & Gastroenterology with biopsy c silver stain
Intervention type(s): Procedure; Procedure
Intervention description(s): mutation test group>> Helicobacter pylori polymerase chain reaction kit by dual-priming oligonucleotide-based multiplex polymerase chain reaction system before eradication of Helicobacter pylori at mutation test groupConventional Conventional AOC group, Conventional AOM group >> no intervention; UBT test & Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group >> intervention
Other intervention name(s): Seeplex ClaR-Helicobacter pylori polymerase chain reaction kit of Seegene Incorporated, Seoul, Korea
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peptic ulcer; Helicobacter pylori; Clarithromycin; 23S rRNA; Resistance
Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will evaluate whether the sequential administration of
      Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the
      Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival
      advantage in patients with locally advanced or metastatic NSCLC.
    

Detailed description: 
      An unanswered question in first line treatment of non small cell lung cancer (NSCLC) is
      whether the administration of more than 2 active drugs provides greater efficacy than a
      two-drug combination. Docetaxel/gemcitabine combination is a well tolerated regimen, which
      has comparable efficacy to docetaxel/cisplatin or vinorelbine/cisplatin. In a recent phase II
      study in first line treatment of advanced or metastatic NSCLC, the sequential administration
      of vinorelbine/cisplatin followed by docetaxel/gemcitabine produced a response rate of 45.8%
      and a 1-year survival rate of 51%. The addition of bevacizumab to a platinum-based regimen
      provided a survival benefit in patients with advanced or metastatic NSCLC.
    

Intervention name(s): Vinorelbine; Cisplatin; Bevacizumab; Docetaxel; Gemcitabine; Bevacizumab; Docetaxel; Cisplatin; Bevacizumab
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles; Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles; Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles; Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles; Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles; Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles; Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles; Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles; Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
Other intervention name(s): Navelbine; CDDP; Avastin; Taxotere; Gemzar; Avastin; Taxotere; CDDP; Avastin
Intervention MeSH terms: Bevacizumab; Cisplatin; Gemcitabine; Docetaxel; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non Small Cell Lung Cancer; Cisplatin; VInorelbine; Docetaxel; Gemcitabine; Bevacizumab
Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine
Condition: Eastern Equine Encephalitis
MeSH terms: Encephalomyelitis, Equine; Encephalomyelitis, Eastern Equine; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine the safety and immunogenicity of Eastern Equine
      Encephalitis (EEE) Vaccine.
    

Detailed description: 
      This was an open-label, vaccine study of Eastern Equine Encephalitis Vaccine, Inactivated
      Dried, EEE, TSI-GSD 104 in healthy, adult subjects. No concurrent control group was used. The
      controls used in this study to assess immunogenicity were historical PRNT80 values obtained
      in past studies of the EEE vaccine. Rates of adverse events (AEs) were tabulated by
      relationship to product administration and severity.

      The primary objectives are to assess the safety of Eastern Equine Encephalitis Vaccine,
      Inactivated, Dried EEE, TSI GSD 104, and to assess immunogenicity of Eastern Equine
      Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104.
    

Intervention name(s): Inactivated, Dried, TSI-GSD 104, EEE
Intervention type(s): Biological
Intervention description(s): Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
Other intervention name(s): EEE A-14568
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: EEE
Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the efficacy and safety of acarbose and metformin loose-dose combination as
      compared to metformin monotherapy in the treatment of subjects with T2DM that is inadequately
      controlled by metformin alone
    


Intervention name(s): Acarbose; Metformin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Uptitrated in the treatment phase from 50 mg per day for 1 week, followed by 100 mg per day for another week, and 150 mg per day for the rest 14 weeks, oral, with the first mouthful of main meal; 500 mg 3 times daily, oral, with the first mouthful of main meal; Acarbose matching placebo, oral
Intervention MeSH terms: Metformin; Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment