bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Pharmacokinetics and Pharmacodynamics of LGT209 in Healthy Volunteers With Elevated Cholesterol and in Hypercholesterolemic Patients Treated With Statins
Condition: Hypercholesterolemia; LDL Cholesterol
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of LGT209 in hypercholesterolemic patients taking common statin medications
      and in healthy volunteers.
    


Intervention name(s): LGT209 50 mg; LGT209 300 mg; Placebo; Statins (atorvastatin or simvastatin)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Active experimental drug; Active experimental drug; Placebo comparator; Stable doses of atorvastatin or simvastatin
Other intervention name(s): Atorvastatin; Simvastatin
Intervention MeSH terms: Atorvastatin; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypercholesterolemia,; LDL cholesterol lowering,; proprotein convertase subtilisin/kexin type 9 (PCSK9),; LGT209,; drug safety,; pharmacokinetics,; pharmacodynamics
Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions
Condition: Infection
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a potential generic 250 mg
      clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin
      tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.
    


Intervention name(s): Clarithromycin
Intervention type(s): Drug
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Along-term Study of OPC-262 in Patients With Type 2 Diabetes
Condition: Diabetes, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in
      patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate
      the efficacy of OPC-262
    


Intervention name(s): OPC-262
Intervention type(s): Drug
Intervention description(s): Orally administered once daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Benefits of CTO-PCI in Selected Cases With HFrEF (CTOHFrEF)
Condition: Chronic Total Occlusion Vessel
Study type: Interventional

Summary: 
      The investigators studied the effect of CTO-PCI on left ventricular function and clinical
      parameters in patients with HFrEF.
    

Detailed description: 
      Observational studies have shown that chronic total coronary occlusion percutaneous
      intervention (CTO-PCI) improves angina, left ventricular ejection fraction (LVEF), and
      survival. None of these studies aimed to assess the benefits in populations with heart
      failure with reduced ejection fraction (HFrEF). The investigators studied the effect of
      CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF.

      Using cardiac magnetic resonance (CMR), the investigators studied 29 patients with HFrEF and
      evidence of viability and/or ischemia in the territory supplied by an occluded vessel who
      were successfully treated with CTO-PCI. Non-CTO PCI was also performed in patients with
      multi-vessel disease, . Imaging parameters, clinical status, and brain natriuretic peptide
      (BNP) levels were evaluated before and six months after CTO-PCI.
    

Intervention name(s): chronic total coronary occlusion percutaneous intervention
Intervention type(s): Procedure
Intervention description(s): Percutaneous intervention of chronic total coronary occlusion with stent implantation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Coronary ChronicTotal Occlusion; Coronary Angioplasty; Reduced Ejection Fraction
Combination Facial Aesthetic Treatment in Millennials
Condition: Dermatological Non-Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      With 63% of consumers willing to consider investing in facial aesthetics and 73% of consumers
      worldwide expecting to invest in aesthetic treatments in the upcoming year, it is imperative
      to explore patient satisfaction and psychosocial impact of a multimodal aesthetic treatment
      in a millennial cohort. The investigators hypothesize that a combination approach to facial
      aesthetic treatment in a millennial cohort will result in increased patient-reported
      satisfaction in multiple areas, including perception of aging concerns and quality of life.
    

Detailed description: 
      This is a single-center, prospective, rater-blinded, pilot study to evaluate patient
      satisfaction with facial aesthetic treatment using a combination of botulinum toxin and
      dermal fillers. The three types of injectables are Botox Cosmetic (onabotulinumtoxinA),
      Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid
      gel filler). Twenty individuals who belong to the millennial generation (i.e., born between
      January 1, 1981 and December 31, 1996)1 and meet eligibility criteria will be enrolled. Study
      participants will receive all three injectables during a single procedure, with an optional
      touch-up treatment at 2 weeks. The primary endpoint is the change in satisfaction after
      facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall
      Scale. Other outcome measures include various FACE-Q Aesthetic scales, digital skin imaging
      analysis, photographs, and rater-blinded clinical assessment using the Global Aesthetic
      Improvement Scale (GAIS).
    

Intervention name(s): Botox Cosmetic Injectable Product; Juvéderm Voluma XC; Juvéderm Volbella XC
Intervention type(s): Drug; Device; Device
Intervention description(s): Acetylcholine release inhibitor and a neuromuscular blocking agent; Gel implants consisting of cross-linked hyaluronic acid; Gel implants consisting of cross-linked hyaluronic acid
Other intervention name(s): onabotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Intervention model description: This is a single-center, prospective, rater-blinded, pilot study to evaluate patient satisfaction with facial aesthetic treatment using a combination of botulinum toxin and dermal fillers. The three types of injectables are Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler). Twenty individuals who belong to the millennial generation and meet eligibility criteria will be enrolled. Study participants will receive all three injectables during a single procedure. The primary endpoint is the change in satisfaction after facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale.
Masking: None (Open Label)
Primary purpose: Treatment
Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
Condition: Therapeutic Equivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the current trial is to evaluate the bioavailability of a single oral dose of
      naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently
      marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or
      DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.
    


Intervention name(s): BAY98-7111; Naproxen Sodium (Aleve, BAYH6689); Diphenhydramine HCl; BAY98-7111
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions; 2 x Naproxen Sodium 220 mg under fasting conditions; 2 x Diphenhydramine HCl 25 mg under fasting conditions; 2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions
Intervention MeSH terms: Diphenhydramine; Promethazine; Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
Condition: Gastrointestinal Diseases; Feeding Intolerance
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to determine the safe use and tolerance of a peptide-based
      formula in children with gastrointestinal dysfunction and/or feeding intolerance.
    


Intervention name(s): Peptide based enteral formula
Intervention type(s): Other
Intervention description(s): Sole source nutrition as per HCP
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Training in the Fasted State, Glucose Metabolism and Energy Balance
Condition: Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      In healthy individuals, the body responds to glucose (sugar) ingestion by reducing the amount
      released from the liver. At the same time, skeletal muscles increase the rate at which they
      remove the glucose from the bloodstream, via the actions of the hormone insulin. This ensures
      that blood glucose levels remain in a controlled range. However, in developed countries,
      diseases such as metabolic syndrome and type 2 diabetes are becoming prevalent, due to
      dietary modifications and a reduction in physical activity. As one of the prominent barriers
      to regular physical activity is a lack of time, finding ways to maximize the health benefits
      of exercise is a priority for researchers.

      The investigators want to understand potential differences in the effects of six weeks of
      aerobic training, with the exercise performed either after breakfast or after a prolonged
      fast. Specifically, this research aims to investigate whether there is a difference in the
      change in processes implicated in glucose regulation and secondly, in subsequent eating and
      physical activity behaviors. By investigating these changes this work will explore how
      exercise and nutrition can be optimized to benefit health and weight loss.
    


Intervention name(s): Exercise; Breakfast; Maintain habitual habits
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Moderate intensity exercise; Breakfast consumption; Normal physical activity and dietary behaviors maintained
Intervention MeSH terms: Benzocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise; Fasted; Glucose; Energy Balance
Immunoblot, Chemiluminescence and ImmunoCap Allergen Specific IgE Evaluation of in Allergic Rhinitis Patients
Condition: Diagnoses Disease
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      In the present study the investigators assay house dust mites (HDMs) IgE in sera of allergic
      rhinitis patients (AR) using immunoblotting, chemiluminescence, and ImmunoCAP assays to
      compare between the accuracy of both immunoblotting and chemiluminescence assays, and
      ImmunoCAP as gold standard.
    

Detailed description: 
      All allergic rhinitits patients who were monosensitized to mixed HDMs, identified by SPT,
      will be subjected to complete history taking and assessment of the inclusion and exclusion
      criteria, performance of skin prick test and measurement of total serum IgE, measurement of
      specific IgE by Chemiluminescence Immunoassa, immunoblot assay and ImmunoCAP™ Phadiatop™. The
      patients will be followed-up for 6 months.
    

Intervention name(s): Sensitization to House dust mites
Intervention type(s): Diagnostic Test
Intervention description(s): The SPT is performed at the time of diagnosis and after six-months follow-up period. Serum specific IgE is measured by immunoblotting, chemiluminescence, and ImmunoCAP assays
Other intervention name(s): Allergen skin prick testing (SPT); Measurement of serum specific IgE
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Compare PK and Safety of CKD-381 and D026 in Healthy Male Subjects
Condition: GERD
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects
    

Detailed description: 
      A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare
      pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects
    

Intervention name(s): CKD-381(formulation I); CKD-381(formulation II); D026(Nexium 40mg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet administered before the breakfast during 7 days; 1 tablet administered before the breakfast during 7 days; 1 tablet administered before the breakfast during 7 days
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD-381; Nexium
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to evaluate the safety and clinical effect of daily oral treatment with
      laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod
      doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment
      (mycophenolate mofetil [MMF] and corticosteroids). Laquinimod is a novel immunomodulating
      drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for
      Multiple Sclerosis.
    


Intervention name(s): Laquinimod; Mycophenolate Mofetil; Prednisolone/Prednisone; Placebo; Methylprednisolone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Laquinimod will be administered per dose and schedule specified in the arm description.; Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.; Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.; Placebo matching to laquinimod will be administered per schedule specified in the arm description.; Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus (SLE); Lupus Nephritis; Laquinimod
Transvaginal Versus Transobturator Paravaginal Repair
Condition: Cystocele
MeSH terms: Cystocele
Study type: Interventional

Summary: 
      Clinical trial comparing the new technique for paravaginal repair versus the traditional
      technique
    

Detailed description: 
      trial comparing the transobturator paravaginal repair versus the traditional technique
    

Intervention name(s): Transobturator Paravaginal Repair; traditional transvaginal Paravaginal Repair
Intervention type(s): Procedure; Procedure
Intervention description(s): Transobturator application of sutures to the white line in cases needing paravaginal repair; traditional transvaginal application of sutures to the white line
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Isovorin in Colon Cancer
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of
      relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary
      endpoints include disease-free survival time, survival time, and safety.
    


Intervention name(s): Isovorin; UFT
Intervention type(s): Drug; Drug
Intervention MeSH terms: Leucovorin; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colon Cancer
the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs
Condition: Non-small Cell Lung Cancer(NSCLC)
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor
      cells(CTCs) play a key role in the process of distant metastasis. The investigators' study
      will elaborate the clinical significance of CTCs intervented by Traditional Chinese
      Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and
      recurrence, individual treatment and prognosis and so on, in order to provide a new direction
      for the treatment of lung cancer.
    

Detailed description: 
      Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor
      cells play a key role in the process of distant metastasis.In recent years, research results
      have shown that CTCs may become a emerging marker and new target in the treatment of lung
      cancer. The investigators' study will elaborate the clinical significance of CTCs intervented
      by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence,
      individual treatment and prognosis and so on, in order to provide a new direction for the
      treatment of lung cancer.
    

Intervention name(s): JinFuKang; Cisplatin; Pemetrexed
Intervention type(s): Drug; Drug; Drug
Intervention description(s): po.tid.30ml; According to the individual patient's condition; According to the individual patient's condition
Other intervention name(s): Jin Fukang oral liquid; Navelbine; Pemetrexeddisodium for Injection
Intervention MeSH terms: Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Circulating tumor cells(CTCs); Traditional Chinese Medicine(TCM); Myeloid-derived suppressor cells(MDSCs)
Peabody Developmental Motor Scaling In Children With Period Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      To perform the reliability and validity study of the Peabody Developmental Motor Scale
      (Peabody Developmental Motor Scales-2) in children with Duchenne Muscular Dystrophy (DMD).
    


Intervention name(s): Peabody Developmental Motor Scales-2, PDMS
Intervention type(s): Other
Intervention description(s): The Peabody Developmental Engine Scales-2, PDMS, is a standardized norm-referenced test used to determine the motor skill level of children aged 0 to 6, identify delays in engine development, and determine individual needs and challenges. The 2 scalar, which allows children to evaluate rough and thin motor skills, consists of 6 sub-tests and 249 articles. The rough motor scale contains 4 sub-tests and 151 items, including reflex, equilibrium, locomotion and object manipulation. The slim motor scale consists of 2 sub-tests and 98 items, including cognition and visual-motor integration. Using the age-appropriate normal value ranges in the test manual to determine developmental stress risk and level, the coarse motor skills, slim motor skills, and general motor development are categorized as "very low, low, below average, above average, high, very high".
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Ondokuz Mayıs University, Health Application and Research Center, Pediatric Neurology
        Outpatient Clinic and community samples
      
Keywords: Duchenne Muscular Dystrophy (DMD); Peabody Developmental Motor Scales-2
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in a Tablet Formulation With Three Different Coatings in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the
      pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the
      effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in a tablet
      formulation with three different coatings in healthy subjects.
    


Intervention name(s): insulin 338 (GIPET I)
Intervention type(s): Drug
Intervention description(s): Dose level of 8100 nmol will be orally administered as one tablet per dose.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole
Condition: Restless Legs Syndrome
MeSH terms: Restless Legs Syndrome; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effects of severe renal impairment and hemodialysis on the
      characteristics of the drug, ropinirole.
    


Intervention name(s): ropinirole dosing for up to 28 days
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: end stage renal impairment; tolerability; ropinirole; pharmacokinetics; hemodialysis
Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception
Condition: Social Perception
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study is to investigate the effects of oxytocin on social behavior and
      brain activity using EEG and the event-related potential (ERP) technique. The value of EEG is
      its high temporal specificity, enabling precision in the timing of social behavior to be
      addressed. In order to elicit social responses in the human brain, a variety of social and
      emotional visual stimuli will be presented during EEG recording, namely infant and adult
      faces and houses. Brain responses after intranasal oxytocin will then be compared with
      placebo, to examine the effect of intranasal oxytocin on central nervous system activity. We
      hypothesize that intranasal oxytocin will enhance the neural response to social stimuli
      (infant and adult faces) but not to non-social stimuli (houses).
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 24 International Units of Oxytocin in a Nasal Spray; Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.
Other intervention name(s): Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Intranasal oxytocin; Social perception; EEG/ERP