bioihbjkbjnl/mcl2 huggingface dataset:
Stearidonic Acid and Lipid Metabolism
Condition: Lipid Metabolism Disorders
MeSH terms: Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evidence exists that EPA (eicosapentaenoic acid or C20:5n-3) supplementation can reduce the
      risk for coronary heart disease. EPA can be synthesized from α-linolenic acid (ALA or
      C18:3n-3), but conversion is low. It has been suggested that the rate-limiting step for this
      conversion is the Δ6-desaturation of ALA into stearidonic acid (SDA or C18:4n-3). Thus,
      providing oils rich in SDA may increase the endogenous synthesis of EPA. This may
      subsequently lower serum triacylglycerol concentrations, an effect frequently observed after
      EPA supplementation, especially in people with increased triacylglycerol levels.

      The objective is to study the effects of echium oil, rich in SDA on serum triacylglycerol
      concentrations in healthy overweight and slightly obese men and women. The minor objective is
      to study the effects of echium oil on the omega-3 index, which is negatively related to
      cardiovascular risk and defined as the proportion of EPA and DHA in red blood cells.
    

Detailed description: 
      Using a randomized, double-blind, placebo controlled crossover design, subjects will receive
      in random order for six weeks with a washout period of at least 14 days, daily 10 g of echium
      oil or a high-oleic acid sunflower oil (HOSO) as control.

      Thirty-six healthy men and women, aged 18-70 yrs, with a body mass index between 25 and 35
      kg/m2 will participate. Subjects with an increased BMI are at increased risk to develop
      hypertriglyceridemia.

      During the experimental period, subjects will receive daily one sachet at lunch and one
      sachet at dinner each providing 5 g of echium oil. During the control period, subjects will
      receive daily at the same time points sachets with the same amount of HOSO.

      The main study parameter is the change in fasting serum triacylglycerol concentrations. The
      secondary endpoint is the change in the omega-3 index.
    

Intervention name(s): Echium oil (SDA-rich oil); high-oleic acid sunflower oil (HOSO) (low in SDA)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The echium oil will be provided in sachets containing 5 g of oil, and should be taken for six weeks during the experimental period twice a day, i.e. one sachet at lunch and one sachet at dinner; The HOSO will be provided in sachets containing 5 g of oil, and should be taken for six weeks during the control period twice a day, i.e. one sachet at lunch and one sachet at dinner
Other intervention name(s): Oil rich in Stearidonic acid; Oil low in Stearidonic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: n-3 polyunsaturated fatty acids; Stearidonic acid; Lipid metabolism; Serum triacylglycerol
The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the immunogenicity and safety of three different potencies of NBP608 and
      Varivax which are indicated for active immunization for the prevention of varicella. Total of
      152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are
      enrolled, and each subject is administered with single dose of vaccine which is randomly
      assigned.
    

Detailed description: 
      This is a multi-center, randomized, double blinded, active controlled, parallel-group study
      to evaluate the immunogenicity and safety of three different potencies of NBP608(low, middle,
      high potency) and Varivax which are indicated for active immunization for the prevention of
      varicella. Total of 152 subjects (38 subjects per each treatment arm) of 12 months to 12
      years of age are enrolled, and each subject is administered with single dose of vaccine which
      is randomly assigned in 1:1:1:1 ratio. Stratified randomization for age group is used to
      achieve the balance of treatment assignment within age strata.

      Total of four visits are scheduled including two visits via telephone contact. Blood sampling
      is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 1
      and Visit 3 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination
      through Visit 2*, Visit 3 and Visit 4* (*telephone contact)
    

Intervention name(s): NBP608; Varivax
Intervention type(s): Biological; Biological
Intervention description(s): Preparation of the Oka/SK strain of live, attenuated varicella virus; Preparation of the Oka/Merck strain of live, attenuated varicella virus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention of varicella; Varicella-zoster vaccine
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section
Condition: Pain, Postoperative; Postoperative Nausea and Vomiting; Cesarean Section
MeSH terms: Vomiting; Pain, Postoperative; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 %
      versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.

      The hypothesis is that systemic local infiltration will reduce pain and postoperative opioid
      consumption.
    


Intervention name(s): Ropivacaine; Ropivacaine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ropivacaine 0.5%; Ropivacaine 0.2%; Isotonic NaCl
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Observational

Summary: 
      The purpose of this observational study was to evaluate the effects of a topical
      fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media
      through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in
      the nose, and in the throat.
    

Detailed description: 
      Pediatric patients with tympanostomy tubes were enrolled into one of two groups: 1)
      Treatment, i.e., patients with signs of otic infection, to be treated with CIPRODEX; or 2)
      Healthy, i.e., patients without signs of otic infection, to receive no treatment.
      Microbiological specimens were collected from four areas (ear canal, skin, nose, throat)
      during three study visits (Day 1, Day 8, and Day 42), and the specimens collected from the
      Healthy group served as a comparison (control) group for identifying fluoroquinolone (FQ)
      resistant bacterial strains.
    

Intervention name(s): Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension
Intervention type(s): Drug
Intervention description(s): Four drops in the outer ear canal of infected ear(s) while awake 2 times per day for 7 days
Other intervention name(s): CIPRODEX®
Intervention MeSH terms: Ciprofloxacin; Dexamethasone
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants were selected from medical practices serving pediatric patients.
      
Keywords: ear tubes; ear drainage; ear infection; ear drops; tympanostomy tubes
Evaluation of the Effect of Changyou Probiotic Flavored Yogurt on Intestinal Health
Condition: Intestinal Health
Study type: Interventional

Summary: 
      This was a randomized, double-blind, single-center, placebo-controlled, three-arm study.

      The objectives of this study were to evaluate the effect of the Bright Changyou Probiotic
      Flavored Yogurt on:

      Improving gastrointestinal health; Relieving symptoms of functional constipation or
      functional diarrhea; Improving gut immunity; Adjusting microbiological flora in
      gastrointestinal tract.
    


Intervention name(s): Bright Changyou probiotic flavored yogurt; Bright Changyou lactobacillus flavored yogurt; Bright flavored yogurt
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Oral consumption of Bright Changyou probiotic flavored yogurt 100 g at a time and twice per day for 28 days. The experimental product has similar package and taste as the comparators.; Oral consumption of Bright Changyou lactobacillus flavored yogurt 100 g at a time and twice per day for 28 days.; Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
The Pharmacokinetics and Safety of IDV/r With NRTIs in HIV/TB Co-infected Patients Receiving Rifampicin
Condition: HIV Infections; Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a
      boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK
      profile associated with adequate antiretroviral potency, tolerability and efficacy.
    

Detailed description: 
      The fixed-dose combination of d4T+3TC+NVP (GPOvir) has been widely used in Thailand since
      June 2002. The prevalence of NNRTI resistance has increased since 2005. Efavirenz-based
      antiretroviral therapy (ART) is preferred in patients with TB/HIV receiving
      rifampin-containing TB regimens. However, efavirenz cannot be used in the context of NNRTI
      failure, intolerance or toxicity. The optimal ART in populations receiving rifampicin remains
      unknown. Rifabutin, which is recommended in combination with a boosted protease inhibitor
      (PI/r) is expensive and not available in Thailand and other developing countries.
      Ritonavir-boosted indinavir (IDV/r) is potent and the cheapest boosted PI available in
      Thailand. If IDV/r in combination with rifampin demonstrates suitable pharmacokinetics and is
      well tolerated, this regimen might prove useful and could be widely implemented. However,
      high rates of gastrointestinal and renal toxicity have been demonstrated in Thai patients
      receiving standard doses of IDV/r 800/100 BID. We believe that there is a strong rationale to
      study if IDV/r 600/100 BID in combination with rifampin is able to produce a satisfactory
      pharmacokinetic profile, with antiretroviral potency, tolerability and efficacy.
    

Intervention name(s): indinavir/ritonavir
Intervention type(s): Drug
Intervention description(s): IDV/r 600/100 mg BID + rifampicin OD for at least 2 weeks
Intervention MeSH terms: Ritonavir; Indinavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: indinavir/ritonavir; HIV/TB; rifampicin; PK and efficacy of IDV/RTV 600/100 mg BID with rifampicin; Treatment Naive
Efficacy and Safety of Shinbaro Capsule
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new
      herbal anti-arthritic agent, in patients with osteoarthritis of the knee.
    


Intervention name(s): Shinbaro Capsule; Celebrex
Intervention type(s): Drug; Drug
Intervention description(s): Herbal drug (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex)
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis
Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetic parameters of anifrolumab in Chinese participants with active
      systemic lupus erythematosus(SLE).
    

Detailed description: 
      This is a Phase I, open-label, single-arm, multiple-dose study to evaluate the
      pharmacokinetics (PK), pharmacodynamics(PD), safety and tolerability profile of intravenously
      administered anifrolumab in Chinese participants with active SLE despite receiving standard
      of care (SOC).
    

Intervention name(s): Anifrolumab
Intervention type(s): Biological
Intervention description(s): intravenous infusion (IV)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: systemic lupus erythematosus; SLE; pharmacokinetic; anifrolumab
Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity
Condition: Spasticity; Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Oral baclofen is used commonly to treat spasticity in children with cerebral palsy. Although
      for adults there is dosing,safety and efficacy information in the package insert, this is not
      the case for children. The purpose of this study is to determine how fast the drug is cleared
      from the body, the correct dose, and long-term safety and efficacy for children with
      spasticity.
    

Detailed description: 
      Although oral baclofen has been used for several decades for the treatment of spasticity in
      adults and in children, there is very little data regarding the pharmacokinetic (PK) or
      pharmacodynamic (PD) properties of baclofen in children. Therefore, pediatric guidelines,
      including dose ranges, dosing schedules, dose escalation strategies and anticipated side
      effects are extrapolated from adult data and require an assumption that safety and efficacy
      in children is comparable to that in adults. Furthermore, there is wide variability in dosing
      strategies among practitioners who treat children with cerebral palsy (CP) with respect to
      starting doses, maximum doses and rates of dose escalation.Establishment of safe and
      effective dosing strategies for children with CP requires an understanding of the PK and PD
      properties of baclofen in children and recognition of individual differences that may
      contribute to divergent clinical responses to baclofen among children with CP.
    

Intervention name(s): baclofen
Intervention type(s): Drug
Intervention description(s): 2.5 mg oral baclofen tablets given three times a day; dose gradually escalated as specified in the protocol
Other intervention name(s): Lioresal
Intervention MeSH terms: Baclofen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spasticity; cerebral palsy; baclofen; pharmacokinetics; pharmacodynamics; dosing; safety; efficacy
9 Minutes for Colonoscopy Withdrawal
Condition: Colon Polyps; Colorectal Adenomas
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      A withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the
      adenoma detection rate and the critical quality criterion of colonoscopy. However, several
      large observational investigations demonstrated that 9 minutes will be in favor of higher
      adenoma detection rate and lower risk of interval colorectal cancer, when compared with
      6-minute withdrawal. Meanwhile, a few studies also indicated that no significant benefit were
      observed in longer withdrawal time. Up to now, no randomized controlled trials have been
      conducted to give a definitive conclusion. Therefore, we performed a multicenter,
      prospective, randomized Controlled trial to compare adenoma detection rate of 6-minute and
      9-minute withdrawal in colonoscopy.
    


Intervention name(s): 9-minute withdrawal; 6-minute withdrawal
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw; Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of a computerized approach/avoidance
      training (AAT) procedure in a sample of individuals diagnosed with social anxiety disorder
      (SAD). The training procedure is designed to modify automatic approach responses for positive
      social stimuli. Previous research has shown that a single administration of approach-positive
      AAT influences social behavior in the laboratory. The goal of this study is to examine the
      effects of a four-session AAT procedure on measures of positive social-emotional functioning.
      The investigators hypothesize that individuals assigned to the approach-positive AAT
      condition will demonstrate larger increases in positive affect and improvements in social
      relationship functioning from pre- to post-assessment compared to those assigned to the
      control condition.
    


Intervention name(s): Approach-positive AAT; Control AAT
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis Efficacy
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Hypothesis: Intradialytic blood pressure and dialysis efficacy (in terms of urea removal)
      improve under electrical muscle stimulation or passive leg movement on a treadmill.
    


Intervention name(s): transcutaneous muscle stimulation, treadmill
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dialysis associated hypotension; Urea removal
A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease
Condition: Parkinsons Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The study objective is to explore Deep Brain Stimulation (DBS) in two specific brain regions
      (Globus Pallidum, or GPI, plus the pedunculopontine nucleus, or PPN) for on medication
      freezing of gait (FoG) in Parkinsons Disease (PD). Hopefully, information gathered from these
      two brain regions after surgery will allow for the development of a personalized DBS system
      to address FoG. The primary outcome will be a comparison of the pre-operative number of FoG
      episodes in the laboratory during the FoG battery versus those 6 months post-DBS at the
      optimized device settings.
    

Detailed description: 
      As a participant in the study you will have the following procedure performed:

      A series of questions by interview, questionnaires, and checklists will be collected. In
      addition, basic information (such as age, sex, race) and psychiatric, medical, and family
      history, physical and neurological exam that will include measuring vital signs (heart rate
      and blood pressure). There will be a "Falls Diary' to complete (an account of falling
      incidents and the details). Specific testing will be done to evaluate the gait and balance
      which will be repeated throughout the study. A psychiatric evaluation of mood and emotion
      will be performed including a detailed psychological testing, consisting of perception,
      learning, and memory. These psychological assessments will be repeated at every study visit.
      An MRI and a CT scan will be performed to make sure of the exact location of the DBS implant.
      The study will end in 24 months.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): Deep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Deep Brain Stimulation
The Depth of Endotracheal Tube Insertion
Condition: Endotracheal Intubation
Study type: Observational

Summary: 
      Virtual experiment : comparing the new method with conventional method of determining the
      depth of endotracheal intubation.
    

Detailed description: 
      Effective airway management is the primary concern of the anesthesiologist. The conventional
      method of determining the insertion length of the endotracheal tube, 21 cm for women and 23
      cm for men, shows a high incidence of endobronchial intubations in the analyzed
      population.The aim of this study is form a new and safe practice habit by passing the
      endotracheal tube with the balloon just 2 cm below the vocal cords during intubation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult patients who are scheduled for elective surgery under general anesthesia
      
Keywords: Endotracheal tube; Endobronchial intubation; Vocal cords; Bronchoscopy
Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin
      combination treatment group is non inferiority compare to pioglitazone and metformin
      combination.
    

Detailed description: 
      The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 and
      metformin combination for 24 weeks in type 2 diabetes mellitus. Furthermore, the extension
      study for additional 28weeks is designed to confirm long term safety of CKD-501 as an oral
      hypoglycemic agent.
    

Intervention name(s): CKD-501 0.5mg; Pioglitazone 15mg
Intervention type(s): Drug; Drug
Intervention description(s): CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.; Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.
Other intervention name(s): Lobeglitazone
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment