bioihbjkbjnl/mcl2 huggingface dataset:
Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and
      safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50
      (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2
      diabetes mellitus.
    


Intervention name(s): biphasic insulin aspart 50; biphasic human insulin 50
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.; Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Propolis Varnish Against Oral Biofilm
Condition: Streptococcal Infections; Saliva Altered
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims to evaluate the effectiveness of a varnish containing 15% of green propolis
      on Streptococcus mutans in saliva and biofilm. Will be invited to join the study: children
      8-10 years old, free of caries, without orthodontic appliances and without having undergone
      antibiotic therapy until three weeks before the start of the study. Saliva will be collected
      before, immediately after, 24 hours and 30 days after application of the varnish. The
      collection of biofilm will be performed before, after, 24 hours and 30 days after application
      of the varnish. Data will be collected and compared between periods.
    

Detailed description: 
      Antimicrobials are substances used in dentistry as an efficient way of caries prevention.
      Substances such as chlorhexidine are the most known and most applied for this purpose and, as
      a varnish, increased its anticariogenic potential. The antimicrobial effects of natural
      substances are being studied for exhibiting antimicrobial properties similar to those of
      chlorhexidine, but less toxic in some cases. Several studies with propolis has proven its
      efficacy against several microorganisms of the oral cavity, specially Streptococcus mutans. A
      pharmaceutical formulation containing brazilian green propolis was developed based on the
      chitosan polymer that is biocompatible and biodegradable. In a previous study, we observed in
      vitro antimicrobial properties of the varnish against Streptococcus mutans. This work aims to
      study the preliminary evidence of the efficacy of the propolis dental varnish in reducing
      Streptococcus mutans in saliva and in the biofilm control through a phase II study involving
      patients with 8-10 years. After 30 days, the results will be compared and statistically
      analyzed at a level of significance of 5 % .
    

Intervention name(s): Propolis varnish
Intervention type(s): Other
Intervention description(s): Saliva and oral biofilm will be collected before and in regular times after the application of the propolis varnish. This data will be compared in order to evaluate the probable reduction of Streptococcus mutans in saliva and oral biofilm.
Intervention MeSH terms: Propolis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Streptococcus mutans; Natural products
PET Imaging of the Translocator Proteine Ligands (TSPO) With [18 F] DPA-714 Biomarker of NeuroInflammation in Cognitive Decline (NIDECO)
Condition: Memory Complaint; Mild Cognitive Impairment; Alzheimer Disease
MeSH terms: Alzheimer Disease; Neuroinflammatory Diseases; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Alzheimer's disease (AD) is the most common cause of dementia in elderly subjects. AD is
      characterized by brain lesions like extracellular deposits of ß-amyloïd proteins in senile
      plaques and intracellular neurofibrillary tangles of hyper-phosphorylated tau protein, both
      of which are associated with the loss of neurons. The development of disease biomarkers for
      AD (Tau, PhTau and βamyloid dosing in the cerebrospinal fluid, brain MRI, amyloid PET imaging
      and fluorodeoxyglucose PET imaging) to identify the pathophysiological processes underlying
      cognitive impairment biomarkers, have been incorporated into revised diagnosis guidelines.

      Post-mortem human AD and AD animal model studies have reported inflammatory processes also
      implicated in the neuropathology of AD, and upregulated levels of pro-inflammatory cytokines.

      In vivo visualization of microglial activation has become possible with the development of
      molecular imaging ligands (tracers) for use with positron emission tomography (PET). The
      translocator protein (TSPO) formerly known as the peripheral benzodiazepine receptor (PBR), a
      receptor located in the outer membrane of mitochondria, is upregulated during
      neuroinflammation. So targeting TSPO with radiolabeled ligands for PET is considered as an
      attractive biomarker for neuroinflammation.

      The main aim of this pilot study is to quantify neuroinflammation, in terms of fixation and
      distribution of [18F] DPA-714(Binding Potential BP), and to study its relationship with
      amyloid load, measured with in [18F]AV-45 (Standard Uptake Values ratio) in cognitive
      decline.
    

Detailed description: 
      Molecular imaging of microglial activation could help us document the central inflammatory
      status of study subjects and assist us in designing future research studies particularly with
      respect to which subjects to enrol into clinical trials and to evaluate the benefit of
      specific therapies in selected groups, for example, by monitoring the effects of Aß
      immunization.
    

Intervention name(s): [18F]DPA-714 PET/ [18F]AV-45 PET/neuropsychological assessment
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects
Condition: Open Wound of Lower Limb
Study type: Observational

Summary: 
      Our main aim for this study was to evaluate the long-term outcome comparisons between sural
      artery and Supramalleolar flap in the reconstruction of extensive defects of non-weight
      bearing regions of foot and ankle. The patients' information were collected through medical
      records and analyzed through SPSS
    

Detailed description: 
      In this article we intend to present our experience comparing a series of the two types of
      flaps in terms of viability, coverage of defect, cosmetic appearance, and functions of foot
      and ankle based on self-designed Tool . This Tool contains 4 parameters i.e., Activity of
      daily living, coverage of defect, cosmetic appearance of Skin post flap, and Weight bearing
      status. A score was given to each parameter and on the basis of these scores, Long term
      outcome were analyzed of each patient
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Data of all those patients was collected who underwent reconstruction of soft tissue
        defects of foot and ankle with Supramalleolar and sural artery flaps between 1996 and 2020.
        The data of these patients were collected from the Hospital inpatient management system and
        review of medical records through a structured proforma that included demographic
        variables, cause of soft tissue defects (secondary to open fractures, following debridement
        of chronic infected wounds, tumor excision and defects following release of scar
        contractures), side of defects, size and type of flap (supramalleolar or sural artery),
        complications and long-term outcome of the flap.
      
Keywords: Soft Tissue Injuries, fasciocutaneous flaps, Survival Rate
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Candidate Vaccines RTS,S/AS02D (0.5 mL Dose) and RTS,S/AS02A (0.25 mL Dose) Administered IM According to a 0, 1, 2 Month Vaccination Schedule in Children Aged 3 to 5 Years Living in a Malaria-endemic Region of Mozambique.
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK Biologicals is developing in partnership with the Malaria Vaccine Initiative at PATH a
      candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children
      living in malaria endemic areas. The vaccine would offer protection against malaria disease
      due to the parasite Plasmodium falciparum and also would provide protection against infection
      with hepatitis B virus. Studies conducted using the formulation RTS,S/AS02A (0.25 ml dose) in
      children and adults have shown to be safe. Currently all intramuscular vaccines in the EPI
      schedule are administered at a dose volume of 0.5 ml and in this context, a new variant of
      RTS,S/AS02D (0.5 ml dose) formulation has been composed which has the same active
      constituents in the same quantities as in a 0.25 ml dose of RTS,S/AS02A. In this study,
      RTS,S/AS02D (0.5 ml dose) was compared to the existing formulation, RTS,S/AS02A (0.25 ml
      dose).
    

Detailed description: 
      Children participating in this study will either receive RTS,S/AS02D (0.5 ml dose) or
      RTS,S/AS02A (0.25 ml dose) intramuscularly according to 0, 1, 2 months schedule. The children
      will be followed-up throughout the study period to record safety events. Blood samples will
      be collected at defined time points to assess the subject's immune response to the relevant
      immunological indicators.
    

Intervention name(s): RTS,S/AS02D and RTS,S/AS02A
Intervention type(s): Biological
Other intervention name(s): RTS; S/AS02D and RTS; S/AS02A
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Other
Comparison of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® Ointment 0.1% in Treating Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The aims of this study are:

        1. Compare the efficacy of Lindioil ointment and Protopic® ointment in treating atopic
           dermatitis.

        2. Compare the safety of Lindioil ointment and Protopic® ointment in treating atopic
           dermatitis.

        3. Compare the time to relapse after ceasing of treatment of Lindioil ointment and
           Protopic® ointment.

        4. Compare the change of skin microbiome before and after Lindioil ointment and Protopic®
           ointment treatment.
    

Detailed description: 
      Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by itchiness.
      Topical corticosteroids are typically used to treat AD. However, many patients have concerns
      about the safety of long-term use, and seek alternative therapies such as traditional Chinese
      medicine (TCM). In TCM, indigo naturalis has been used to treat various infectious and
      inflammatory skin diseases for hundreds of years. The investigate also found that the results
      of indigo naturalis ointment treatment in other trial were comparable to the results of
      calcineurin inhibitor (such as Tacrolimus) treatment, and would like to verify this
      assertion. The aim of this study is to compare the efficacy of Lindioil ointment with that of
      Protopic® (Tacrolimus ointment 0.1%) in treating AD.
    

Intervention name(s): Lindioil ointment; Protopic ointment 0.1%
Intervention type(s): Drug; Drug
Intervention description(s): Each gram contains 200µg of indirubin. Apply 0.5 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.; Each gram contains (w/w) 0.1% of tacrolimus. Apply 0.1 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.
Other intervention name(s): Indigo naturalis oil extract ointment; Tacrolimus ointment 0.1%
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Indigo naturalis; Tacrolimus
Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects
Condition: Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study
      to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy
      Korean Subjects
    


Intervention name(s): HM15912; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).; The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Deep Breathing Excer. With & Without PMR on Post C Section LBP, QOS & PA
Condition: Cesarean Section Complications
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      To find out the Effects of deep breathing exercises with and without Progressive Muscle
      Relaxation Technique on Post Cesarean Section low back Pain, Quality of Sleep and Physical
      Activity
    


Intervention name(s): Deep breathing excercises; Deep breathing exercises +and progressive muscle relaxation techniques; Deep breathing exercises
Intervention type(s): Other; Other; Other
Intervention description(s): Deep breathing, which is also known as diaphragmatic breathing, is a technique that is based on the notion that mind and body integration produces relaxation technique requires participants to contract the diaphragm, slowly inhaling and exhaling. Deep breathing appears to amplify blood oxygen levels, massages the inner organs located in or close to the abdomen, and possibly stimulates the vagus nerve; Begin with a deep breathing exercise. Inhale deeply through your nose, feeling your abdomen rise as you fill your body with air. Then slowly exhale out the mouth, the navel pulling in toward the spine as you expel the stale air out. Repeat 3-5 cycles; Deep breathing, which is also known as diaphragmatic breathing, is a technique that is based on the notion that mind and body integration produces relaxation technique requires participants to contract the diaphragm, slowly inhaling and exhaling. Deep breathing appears to amplify blood oxygen levels, massages the inner organs located in or close to the abdomen, and possibly stimulates the vagus nerve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cesarean section; Deep breathing excercises; Low back pain; Progressive muscle relaxation; Physical activity; Quality of sleep
Glottis Visualization in Different Lifting Methods
Condition: Intubation; Glottis Visualization
Study type: Observational

Summary: 
      Among the various types of video laryngoscopes, the McGrath MAC video laryngoscopy (VL) has
      become popular because it is lightweight and can be quickly and hygienically prepared by
      changing the blade. The aim of this study was to compare the efficacy of two different
      methods (direct and indirect) for epiglottis removal during visualization of the glottis
      using the McGrath MAC VL.
    


Intervention name(s): using McGrath Video Laryngoscope
Intervention type(s): Device
Intervention description(s): glottis visualization in indirect and direct lifting methods by using McGrath Video Laryngoscope
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA I-II, 18-65 years old patients undergoing elective surgery
      
Keywords: Endotrakeal intubation; Epiglottis; Glottis; McGrath MAC video laryngoscope
A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and compare the relative bioavailability, and
      therefore the bioequivalence of two formulations of Citalopram after a single dose
      administration under fed conditions.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg
      Tablets in Healthy Male Volunteers/Fed State

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Citalopram HBr 40 mg tablets, single dose; CelexaTM 40 mg tablets, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Purepac formulated products under fed conditions; B: Active comparator Subjects received Forest Labs formulated products under fed conditions
Other intervention name(s): Citalopram; Citalopram
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Citalopram; Healthy subjects
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, single arm study of 52 weeks duration. The study will assess the
      safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40
      kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic
      therapy.
    


Intervention name(s): Lebrikizumab
Intervention type(s): Biological
Intervention description(s): Subcutaneous injection
Other intervention name(s): LY3650150; DRM06
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eczema; Dermatitis; Dermatitis, Atopic; Skin Diseases
BCRL Prevention Pilot
Condition: Obesity; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to establish feasiblity of recruiting obese breast cancer
      survivors at the end of treatment, getting those survivors to lose weight and attend
      follow-up visits for 6 months.
    

Detailed description: 
      Breast cancer related lymphedema occurs in 20-30% of survivors. Weight loss could prevent
      onset. We seek to do a pilot study to establish feasibility of 1) recruiting survivors at
      risk for lymphedema to do a weight loss intervention, 2) achieving 10-15% weight loss over 26
      weeks in this population, and 3) attendance at follow-up visits 6 months.
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Women, aged 18-70, who are obese (BMI greater than or equal to 30), do not already have a
        diagnosis of lymphedema, who are done with surgery, chemotherapy, and radiation therapy,
        and who were diagnosed with breast cancer within the past 2 years will be invited to
        participate.
      
Keywords: obese women (BMI greater than or equal to 30), do not already have a diagnosis of lymphedema, who are done; with surgery, chemotherapy, and radiation therapy, and who were diagnosed with breast cancer within the; past 2 years will be invited to participate.
A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover
      study to evaluate the drug-drug interaction potential between plazomicin and metformin in
      healthy subjects.
    


Intervention name(s): plazomicin; metformin
Intervention type(s): Drug; Drug
Intervention description(s): single intravenous dose; single oral dose
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety, effectiveness and tolerance of low doses of oral
      naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection
      of VIVITROL.
    


Intervention name(s): NTX/BUP; NTX/PBO-B; PBO-N/PBO-B
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daily doses; Daily doses; Daily doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alkermes; Buprenorphine; Naltrexone; Vivitrol; Opioid Use; Opiates; Dependence; Abuse; Heroin; Painkillers; Substance Abuse