bioihbjkbjnl/mcl2 huggingface dataset:
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in HER2 Positive Breast Cancer Patients.
Condition: HER2 Positive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This
      study is a single-arm, prospective, open label clinical study for evaluating the efficacy and
      safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment
      in HER2 positive early stage or locally advanced breast cancer.
    

Detailed description: 
      Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used
      to reduce tumors to make them operable, and to increase breast-conserving rates. In recent
      years, the anti-HER2 treatment mode, which is double-blocked by a combination of
      dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant
      therapy. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2
      receptors. Based on previous clinical studies, we designed the study to explore the
      possibility of Pyrotinib in combination with Trastuzumab plus Docetaxel given as neoadjuvant
      treatment in HER2 positive early stage or locally advanced breast cancer.
    

Intervention name(s): Pyrotinib plus trastuzumab and docetaxel and carboplatin
Intervention type(s): Drug
Intervention description(s): pyrotinib: 320mg orally daily，6cycles; trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6cycles; docetaxel:after the biological window, 100mg/m2 for a total of 6 cycles carboplatin:d1 ，AUC 6 iv 3-weekly for a total of 6 cycles
Intervention MeSH terms: Carboplatin; Docetaxel; Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Health and Risk Factors for Oral Disease
Condition: Periodontal Diseases; Dental Caries; Quality of Life
MeSH terms: Dental Caries; Periodontal Diseases
Study type: Observational

Summary: 
      Oral health has improved considerably in recent decades in Sweden, as well as in other
      countries. However, despite great improvements with regard to periodontal disease and dental
      caries in recent decades, global problems still persist, and as a consequence of retaining
      natural teeth high up in age, the risk for oral disease increases.
    

Detailed description: 
      Traditionally, the number of teeth has been a measure of good oral health, and the World
      Health Organization (WHO) stipulated goals of a minimum of 20 functional teeth at the age of
      80 years have been reached in some industrialized countries. Oral Health means more than good
      teeth and is integral to general health. The relationship between oral and general health has
      been recognized. For example, periodontal disease is associated with diabetes and rheumatoid
      arthritis. The severity of periodontal disease and number of teeth have been associated with
      an increased burden of cardiovascular disease.

      There is a lack of longitudinal studies of oral Health and risk factors for oral disease.
    

Intervention name(s): EpiWux
Intervention type(s): Other
Intervention description(s): A cross-sectional and longitudinal study including a questionnaire and a clinical examination
Other intervention name(s): Oral Health
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Individuals in age Groups 35, 50, 65, 75 and 85 years
Blame Rebalance fMRI Feedback Proof-of-concept
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The investigators have shown that decoupling of brain networks when feeling guilty is the
      first potential functional neuroimaging biomarker of risk of major depression. It remains
      detectable on remission of symptoms (Green et al., 2012). Decoupling of neural networks was
      found while people felt guilty during functional magnetic resonance imaging (fMRI) relative
      to feeling indignation. Guilt-selective brain decoupling is therefore an excellent target for
      interventions to reduce the largely increased risk of recurrent episodes in people who have
      had one episode but are currently remitted. To our knowledge, however, there is no
      proof-of-concept study showing that self-blame-selective decoupling on fMRI can be detected
      and fed back to the participants after a short temporal delay in a real-time fMRI setting and
      whether coupling can be increased through neurofeedback training. This project aims at
      developing the first fMRI neurofeedback system to treat self-blame-selective neural
      decoupling and to test its feasibility in people with major depressive disorder currently
      remitted from symptoms.
    

Detailed description: 
      Specific aim 1: Demonstrate that anterior temporal lobe (ATL)-septal/subgenual cingulate
      (SCSR) coupling for guilt can be increased through one session of neurofeedback in the group
      seeing visual feedback based on increasing correlations during the guilt condition compared
      with the group seeing visual feedback based on keeping correlations at the same level during
      the guilt condition.

      Specific aim 2: Demonstrate that this increase in coupling is selective for guilt relative to
      indignation.

      Specific aim 3: Demonstrate that mood is not negatively affected by neurofeedback.

      Specific aim 4: Explore whether this short intervention decreases self-hate on the
      Interpersonal Guilt Questionnaire (Portuguese translation) and increases self-esteem on the
      Rosenberg scale (both show significant correlations with SCSR-ATL coupling across major
      depressive disorder and control groups in our Manchester study), or if these measures are not
      available, decreases negative affect on the Positive and Negative Affect Scale.
    

Intervention name(s): GUILT-INCREASE-CORRELATION; GUILT-STABILIZE-CORRELATION
Intervention type(s): Device; Device
Intervention description(s): This uses a novel software "FRIEND" created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner; This uses a novel software "FRIEND" created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Molecular and Cellular Characterization of Spongiotic Dermatitis
Condition: Atopic Dermatitis; Psoriasis; Contact Dermatitis
MeSH terms: Psoriasis; Dermatitis; Dermatitis, Contact
Study type: Observational

Summary: 
      Spongiotic dermatitis is the histopathologic diagnosis commonly issued by dermatopathologists
      that encompasses atopic dermatitis, contact dermatitis, and other forms of eczematous
      dermatitis.

      The information obtained will assist in development of diagnostic methods for differentiation
      of the types of spongiotic dermatitis. This study also has the potential to lead to the
      dissection of pathologic pathways involved in these diseases and development of novel
      therapeutic agents.
    

Detailed description: 
      Spongiotic dermatitis is the histopathologic diagnosis commonly issued by dermatopathologists
      that encompasses atopic dermatitis, contact dermatitis, and other forms of eczematous
      dermatitis. Atopic dermatitis is a chronic, relapsing inflammatory disease characterized by
      pruritic, scaly, red, eczematous skin lesions, and a personal or family history of atopy.
      Patients affected by atopic dermatitis experience significant morbidity from extreme
      pruritus, recurrent cutaneous infections, and extensive and/or disfiguring skin lesions.
      Allergic contact dermatitis typically manifests as pruritus and vesicular or eczematous
      lesions associated with direct exposure to environmental haptenic allergens.

      The specific aims of this research are:

        1. Identification of genes differentially expressed in atopic dermatitis, contact
           dermatitis, and psoriasis by microarray analyses.

        2. Confirmation of protein expression profiles in atopic and contact dermatitis, and
           psoriasis by immunohistochemical analyses.

        3. Identification of disease-specific potential diagnostic markers in plasma and PBMC.

      The information obtained will assist in development of diagnostic methods for differentiation
      of the types of spongiotic dermatitis. This study also has the potential to lead to the
      dissection of pathologic pathways involved in these diseases and development of novel
      therapeutic agents.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Males or females aged 18-55 with either contact dermatitis, psoriasis, atopic dermatitis,
        or no skin disease.
      
Keywords: Identification of genes by microarray analyses.
Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, efficacy and body distribution of
      Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid
      Arthritis. Neither the patient nor the doctor will know the treatment group.
    


Intervention name(s): Bimekizumab; Certolizumab Pegol; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Pharmaceutical form: Solution for infusion
Concentration: Vials at 80 mg/ml will be diluted with 0.9% sodium chloride to a final concentration to achieve the correct dose
Route of administration: iv infustion; Pharmaceutical form: Prefilled syringes
Concentration: 200 mg/ml
Route of administration: Subcutaneous injection; Pharmaceutical form: Solution for infusion
Concentration: 0.9% saline
Route of administration: Intravenous infusion
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring
Condition: Colonic Disease
MeSH terms: Colonic Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to develop and validate the accuracy and reliability of an
      artificial intelligence(AI) system for bowel preparation quality scoring based of Boston
      Bowel preparation Scoring(BBPS). Then evaluate whether this AI system can help endoscopists
      to improve the quality of colonoscopy in clinical practice.
    

Detailed description: 
      Bowel preparation is one of the most important factors which decide the quality of
      colonoscopy. Adequate bowel preparation is essential to guarantee a clear vision of colonic
      mucosa, complete inspection of entire colon and improves the adenoma detection rates(ADRs).
      Therefore, the quality of bowel preparation should be evaluated accurately and objectively.
      However, current bowel preparation quality scales depend on memories and subjective decision
      of endoscopists. Recently, articifial intelligence system based on deep learning algorithm
      has been used widely in medical fields. But, few studies have been reported to evaluate the
      performance of AI system based on deep learning in bowel preparation quality scoring. This
      study aims to develop and train an AI system to assess bowel preparation quality using the
      BBPS, and validate the AI system to improve the quality of colonoscopy.
    

Intervention name(s): AI
Intervention type(s): Device
Intervention description(s): After taking standard bowel preparation regimen, patients receive colonoscopy under the AI system device. During the withdrawal phase, bowel preparation quality is assessed by AI-associated scoring system. The withdrawal time is targeted at least 6min. Every detected polyp will be removed and obtained for pathological assessment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: artificial intelligence, deep learning, bowel preparation
Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fed Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence
      study.
    

Detailed description: 
      The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's
      Laboratories Ltd., India, desloratadine ODT 5 mg and Schering Corporation, U.S.A.(Clarinex® 5
      mg), desloratadine ODT 5 mg under fed conditions. The treatment phases were separated by a
      washout period of 14 days. 38 subjects were dosed and were enrolled in the study; 36 of these
      enrolled subjects completed the study.
    

Intervention name(s): Desloratadine
Intervention type(s): Drug
Intervention description(s): Desloratadine ODT 5 mg
Other intervention name(s): Clarinex ODT 5 mg
Intervention MeSH terms: Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Desloratadine; crossover
Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Short-axis and Long-axis Techniques
Condition: Total Knee Arthroplasty; Analgesia; Nerve Block
Study type: Interventional

Summary: 
      This study compares the long-axis and short-axis technique of continues adductor canal block
      for total knee replacement surgery. Half participants will receive long-axis catheterization,
      while the other half will receive short-axis catheterization.
    


Intervention name(s): ultrasound guided long axis placement of adductor canal catheter; ultrasound guided short axis placement of adductor canal catheter; Philip CX 50 Ultrasound Scanner; PAJUNK Contiplex S Catheter; Ropivocaine; rescue sulfentanil given postoperatively as PICA
Intervention type(s): Procedure; Procedure; Device; Device; Drug; Drug
Intervention description(s): The long axis of the ultrasound probe is placed parallel to the long axis of the adductor canal while scanning, and the catheter is placed along the long axis of the canal using an in-plane approach; The long axis of the ultrasound probe is placed vertical to the long axis of the adductor canal while scanning, and the catheter is placed along the short axis of the canal using an in-plane approach; The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning; 0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose.; bolus: 2mg, lock time: 10min, 1h limitation: 8mg
Intervention MeSH terms: Sufentanil; Dsuvia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: adductor canal block
Monitoring of Vital Signs During Skin-to-skin Holding by Mothers of Their Preterm Babies
Condition: Other Preterm Infants
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      This observational study aims to monitor the vital sign changes in both mother and baby that
      occur during kangaroo care in preterm infants and to investigate any potential correlations
      between maternal measurement values and those of the infant. The purpose of this
      observational study is to look for a method to track the earliest responses that could,
      theoretically, be considered as 'social responses' in hopes of providing developmental
      interventions earlier to at-risk infants.
    

Detailed description: 
      The goal of this observational study is to identify any signs of early "social response" in
      order to be able to assist infants that lack this response with early neurobehavioral
      modifications.
    

Intervention name(s): Mother-Infant Dyad
Intervention type(s): Behavioral
Intervention description(s): Skin-to-skin holding of preterm infants by their mothers
Other intervention name(s): Kangaroo Care
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants born at Mt. Sinai Hospital and admitted to the NICU. Preterm infants between 30 0/7
        weeks gestational age to 34 6/7 weeks gestation age.
      
Keywords: Preterm; Kangaroo Care; Skin-to-Skin; Vital Sign; Heart Rate; Respiratory Rate; Oxygen Saturation
Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
Condition: Thyroid Neoplasm
MeSH terms: Thyroid Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general
      anaesthesia through binding to its receptors in the brainstem. However, it has not been
      proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during
      emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the
      relationship between fentanyl doses and cough suppression during emergence from sevoflurane
      anaesthesia.
    


Intervention name(s): fentanyl citrate; saline
Intervention type(s): Drug; Drug
Intervention description(s): According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.; According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Change in Connectivity After mTBI Depending on Cognitive Reserve
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      The purpose of this study is to investigate the role of cognitive reserve in change in
      connectivity in the brain (measured with functional magnetic resonance imaging, fMRI) and how
      this is related to symptoms and symptom resolution.
    

Detailed description: 
      The population-based rate of mild traumatic brain injury (mTBI) is estimated to exceed
      600/100000 population per year in total, if including only patients seeking emergency care
      the estimated rate is approximately 100-300/100000. Many patients recover within 3 months
      after injury but a sustainable proportion suffer from persisting symptoms, for instance
      fatigue, headaches, irritability. As conventional neuroimaging techniques have failed to
      detect the subtle alterations that may be important for prognosis and long-term outcome after
      mTBI, studies using fMRI have shown some interesting results. Other variables, for instance
      demographic and cognitive variables, also need to be incorporated with imaging biomarkers
      when investigating the relationship between fMRI biomarkers with outcome after mTBI. A marker
      related to demographic status and cognition that have shown to be relevant for outcome in
      brain injury or pathology is cognitive reserve. Cognitive reserve is defined as an aspect of
      the brain's function or structure that impacts the relationship between injury/pathology and
      outcome. Higher cognitive reserve is related to better outcome in conditions ranging from
      Alzheimer, MS and mTBI.

      In this study 15 patients with mTBI and 15 patients with minor orthopedic injury underwent
      assessment, including cognitive testing, self-assessment of symptoms, testing of visual
      functions and resting-state fMRI at approximately one week after injury and 4 months after
      injury. Cognitive reserve was assessed with a lexical decision test designed to measure
      pre-morbid IQ.

      Descriptive statistics will be used to depict demographics, injury characteristics, results
      on neuropsychological tests and psychological screening instruments. Multi-subject and
      multi-session analysis based on general linear model will be performed and assessed using
      statistical tools including regression analysis and 2-way ANOVA.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants were all adults presenting at the emergency departement at Danderyd Hospital,
        (Stockholm, Sweden) during the given time frame, with minor head injury or minor orthopedic
        injury. An upper age limit of 40 years were set due to avoiding interference with
        age-related visual disturbances.
      
Keywords: rs-fMRI; Cognitive reserve; Fatigue; Visual disturbances
Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk
Condition: Low-Moderate Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      This clinical trial seeks to verify the efficacy of a red rice yeast dietary supplement in
      the decrease of cardiovascular risk, by assessing variables related with cardiovascular risk
      as levels of cholesterol, triglycerides and transaminases among other, in two groups of
      participants that will be taking either the dietary supplement or a placebo during a six
      months period.
    


Intervention name(s): Red Rice Yeast; Placebo Group
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months; Participants of this group will take one tablet of placebo per day for a period of six months
Intervention MeSH terms: Red yeast rice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment