bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Inulin on Production of Phenolic Acids From Tomato Onion and Lovage Soup
Condition: Healthy Adults
Study type: Interventional

Summary: 
      This is an acute human bioavailability study in self-reported healthy participants aged 20-70
      years old. The investigators hypothesize that combination of polyphenolics from a soup rich
      in rutin and quercitin and the non-digestible carbohydrate (NDC) inulin will increase the
      production of phenolic acids by bacteria in the human colon and these will be detected in
      urine. Participants will attend for three arms in a randomized order: Tomato, onion and
      lovage soup (high polyphenol food), Inulin (NDC) or Mixture of tomato, onion and lovage soup
      and inulin.

      During each feeding study, urine, blood and stool samples will be collected at regular
      intervals for the duration of 24 hrs after consumption of test food. Participants will be
      asked to follow a low polyphenol diet for 2 days prior to the feeding study.
    

Detailed description: 
      Polyphenol rich plant foods have been associated with several health benefits but their
      bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in
      the small intestine and enter the colon where the colonic microbiota metabolise them to
      release a range of phenolic acids, which are now thought to be the main bioactive components
      related to the reduction in disease risk. Very little is known about the impact of other
      constituents of the diet on the metabolism and bacterial catabolism of these polyphenols.

      Colonic bacteria are key agents in the release of the bioactive molecules from polyphenols
      but also ferment non-digestible carbohydrates (NDC) such as inulin to short chain fatty
      acids. It is likely that there are key interactions in the colonic bacterial metabolism of
      NDC and phenolics. The investigators hypothesize that combination of polyphenolics (in
      onions, tomatoes and lovage) with inulin (NDC) will increase the urinary output of bioactive
      phenolic acids.
    

Intervention name(s): Tomato, onion & lovage soup with inulin; Tomato, onion & lovage soup; Inulin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Source of polyphenols and non digestible carbohydrate; Source of polyphenols; Source of non digestible carbohydrate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Acute human bioavailability studies with a cross-over design. Subjects will be given a soup or drink in one of three combinations
Tomato onion and lovage soup
Inulin
Mixture of tomato onion and lovage soup with inulin
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; Polyphenols; Dietary fibre; Phenolic acids
A Study of AZD8233 in Participants With Dyslipidemia.
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase 1 and 2 Study of AZD8233 in Participants with Dyslipidemia and this study consists of
      Part A , Part B and Part C. Part A is designed as a randomized, single-blind (blinding of
      participants and sites), placebo-controlled, multiple dose, phase 1 study. Part B is designed
      as a randomized, double-blind, placebo-controlled, dose-ranging, phase 2 study. Part C is
      designed as a randomized , single-blind (blinding of participants and sites),
      placebo-controlled, multiple dose, phase 1 study.
    

Detailed description: 
      Part A: This is designed as a randomized, single-blind (blinding of participants and sites),
      placebo-controlled, multiple dose, phase 1 study.

      Approximately 11 Japanese participants will be randomized in an 8:3 ratio into 1 of the 2
      single-blinded treatment arms; AZD8233 high dose or placebo. Participants will be dosed SC on
      Days 1, 8, 29, and 57.

      Part B:This is designed as a randomized, double-blind, placebo-controlled, dose-ranging,
      phase 2 study. Approximately 60 Japanese participants will be randomized in a 1:1:1 ratio
      into 1 of the 4 double-blinded treatment arms; AZD8233 low dose, AZD8233 medium dose, or
      placebo. Participants will be dosed SC on Days 1, 29, and 57.

      Part C:This is designed as a randomized, single-blind (blinding of participants and sites),
      placebo-controlled, multiple dose, phase 1 study.

      Approximately 11 Japanese participants will be randomized in an 8:3 ratio into 1 of the 2
      single-blinded treatment arms; AZD8233 medium dose or placebo. Participants will be dosed SC
      on Days 1, 29, and 57.
    

Intervention name(s): Part A:Placebo; Part A:AZD8233; Part B:Placebo; Part B:AZD8233; Part C: Placebo; Part C: AZD8233
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo solution; PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.; Placebo solution; PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.; Placebo solution; PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: AZD8233; Efficacy; PK; PD; Immunogenicity; Safety; Tolerability
Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of a high fat meal and light meal on the
      blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs
      as a fixed-dose combination in healthy subjects.
    

Detailed description: 
      IND Number: 100,932/79,599/101,943

      Primary Purpose:

      Other: Phase 1 clinical pharmacology bioavailability study to assess food effect
    

Intervention name(s): DCV 3DAA FDC
Intervention type(s): Drug
Intervention description(s): Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study in Healthy People to Compare 2 Different Formulations of BI 1015550 Taken With or Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of BI 1015550
      intended Commercial Formulation (iCF) compared with Trial Formulation 2 (TF2) and the effect
      of food on the pharmacokinetics of BI 1015550 iCF following oral administration.
    


Intervention name(s): BI 1015550 ICF; BI 1015550 TF2
Intervention type(s): Drug; Drug
Intervention description(s): BI 1015550 intended Commercial Formulation (iCF); BI 1015550 trial formulation 2 (TF2)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Subject Insights to Understand the Hand Osteoarthritis (HOA)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Osteoarthritis (OA) is a degenerative joint disease which causes joints to become painful and
      stiff. HOA is the second most common form of OA and is characterized by stiffness, joint pain
      and inflammation and tenderness in the knuckles or around the waist. This cross-sectional,
      qualitative interview study aims to explore the experience of erosive HOA as well as explore
      the content validity of the Michigan Hand Outcomes Questionnaire (MHQ) by conducting
      semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone
      interviews and real-time data capture. The conceptual model developed from this data will be
      used to support the development of GSK3196165, a human monoclonal antibody target for the
      treatment of HOA. The CE interviews (45 minutes duration) will explore the experience of
      subjects suffering with HOA and will collect information about symptoms, health related
      quality of life (HRQoL), treatment experience and the language used by subjects to describe
      them whereas the CD interviews (45 minutes duration) will assess the content validity of the
      MHQ. The real-time disease experience of subjects will be captured by the real-time data
      capture app-based activity over a period of 7 days. Approximately 30 subjects from the United
      States (US) of which 15 subjects will be erosive HOA and rest 15 will be non-erosive HOA.
    


Intervention name(s): Michigan Hand Outcomes Questionnaire; Real-time data capture app
Intervention type(s): Other; Other
Intervention description(s): The MHQ is a self-report measure that assesses the function of the hand(s) and/or wrist(s). The MHQ contains six distinct scales including overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.; Real time data capture app is a smart-phone or web-based application which will allow the subjects to provide responses about their experience of HOA in real-time via varying video, audio, photographic and text forms.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Thirty adult US-English speaking subjects with erosive HOA will be included in this study.
      
Keywords: Michigan Hand Outcomes Questionnaire; Real-time data capture; Cognitive debriefing; Hand Osteoarthritis; Concept elicitation
ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.
Condition: Non-small Cell Lung Cancer With EGFR-Activating Mutations
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the
      efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib
      in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal
      growth factor receptor EGFR-activating mutation (s). Analyses of primary objective
      (Progression Free Survival) will be done as defined in the protocol.
    

Detailed description: 
      452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib.
    

Intervention name(s): Dacomitinib (PF-00299804); Gefitinib
Intervention type(s): Drug; Drug
Intervention description(s): Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.; Gefitinib 250 mg tablets, continuous oral daily dosing.
Other intervention name(s): Dacomitinib; Iressa
Intervention MeSH terms: Gefitinib
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: first-line; locally advanced or metastatic; non-small cell lung cancer; epidermal growth factor receptor; EGFR; ARCHER; mutation; dacomitinib; PF-00299804
Perfusion Index Variability in Respiratory Distress Syndrome
Condition: Poor Peripheral Perfusion
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      Perfusion index may vary according to type of surfactant during the treatment of respiratory
      distress syndrome.
    

Detailed description: 
      Peripheral tissues of preterm infants are very sensitive for hypoperfusion, but there are
      rare data in the literature for peripheral perfusion after surfactant treatment. In this
      study the investigators aimed to compare the perfusion index (PI) variability in premature
      infants with respiratory distress (RDS) following instillation of one of two different
      natural surfactant preparations.
    

Intervention name(s): Beractant; Poractant alfa
Intervention type(s): Drug; Drug
Intervention description(s): Beractant;both initial and subsequent dosing is 100 mg/kg (4 mL/kg), which may be given every 6 hours up to four total doses; porcine lung extract, initial dosing is 200 mg/kg (2.5 mL/kg) and repeated dosing is given at 100 mg/kg (1.25 mL/kg) every 12 hours, up to maximum of two additional doses when indicated
Other intervention name(s): Beractant (Survanta); Poractant alfa (curosurf)
Intervention MeSH terms: Poractant alfa; Beractant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: natural surfactants; perfusion index
Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis
Condition: Procalcitonin; Bronchiectasis; Antibiotic Therapy
MeSH terms: Bronchiectasis
Study type: Interventional

Summary: 
      To explore effectiveness of procalcitonin-guided antibiotic therapy in acute exacerbations of
      bronchiectasis, and to explore the clinical value of procalcitonin in bronchiectasis.
    


Intervention name(s): Procalcitonin; Clinical Experience
Intervention type(s): Other; Other
Intervention description(s): The application of antimicrobial agents is determined by PCT results.; The application of antimicrobial agents is determined by clinical experience of doctors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy/Safety Study to Explore a New Revised Topical Formulation in Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The study shall explore whether treatment of atopic dermatitis is equally effective with
      respect to a marketed medical device and a new medical device.
    


Intervention name(s): Phoenix II (BAY81-2996); Phoenix I (BAY81-2996)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Phoenix; Mild atopic dermatitis; efficacy; safety
Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B
      meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11
      to 18 years.
    


Intervention name(s): serogroup B meningococcal vaccine; serogroup B meningococcal vaccine; serogroup B meningococcal vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.; 0.5mL doses in pre-filled syringes. All subjects will receive the study vaccine following a 0,2,6 vaccination schedule.; 0.5mL doses in pre-filled syringes. All subjects will receive the placebo following a 0,2,6 vaccination schedule.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Meningococcal Disease; Meningococcal Meningitis; Vaccine
Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
Condition: Symptomatic Cervical Disc Disease
MeSH terms: Spinal Diseases; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      The objective of this clinical investigation is to compare the safety and effectiveness of
      ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of
      symptomatic cervical disc disease (SCDD).
    


Intervention name(s): Total Disc Replacement; ACDF
Intervention type(s): Device; Device
Intervention description(s): Total Disc Replacement using ProDisc-C; Anterior Cervical Discectomy and Fusion
Other intervention name(s): ProDisc-C; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ProDisc; ProDisc-C; Spinal Fusion; Anterior cervical diskectomy; Cervical spine; Disc disease; Implant; Degenerative disc disease; Intervertebral disc
A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis
Condition: Myasthenia Gravis, Generalized
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to
      placebo in subjects with MG.
    

Detailed description: 
      The primary objective is to evaluate the efficacy of IGIV-C in subjects with generalized
      myasthenia gravis (MG) on standard of care treatment at study entry in terms of improvement
      in MG symptoms as measured by the mean change in Quantitative Myasthenia Gravis (QMG) score
      from Baseline (Week 0) to Week 24 as compared to placebo.

      The safety objective of this study is to evaluate the safety and tolerability of IGIV-C
      loading dose of 2 g/kg followed by 7 maintenance dosages of 1 g/kg every 3 weeks through Week
      21 in subjects with MG.
    

Intervention name(s): IGIV-C; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Meglimine Sodium Succinate for Correction of Metabolic Acidosis in Critically Ill Patients
Condition: Metabolic Acidosis
MeSH terms: Acidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      An acid-base imbalance, called metabolic acidosis (acid-base disorder lasting from several
      minutes to several days, caused by a decrease in serum bicarbonate ion (HCO3) concentration),
      is often observed in critically ill patients with various underlying diseases. Metabolic
      acidosis has a negative impact on the cardiovascular, respiratory, digestive, nervous,
      excretory, hematological, endocrine, musculoskeletal and immune systems and is associated
      with unfavourable outcomes. Reamberin® is a solution of disubstituted sodium salt of succinic
      acid, which has an alkaline reaction and succinate is capable to integrate into the Krebs
      cycle and restore energy metabolism in the cell. The aim of the present study is to evaluate
      the efficacy and safety of meglumine sodium succinate at a dose of 500 to 3000 ml in
      critically ill patients with metabolic acidosis and choose the optimal volume of its solution
      for the correction of metabolic acidosis in critically ill patients.
    


Intervention name(s): Meglumine Sodium Succinate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 ml of 1.4% solution IV at a rate of at least 4 ml and not more than 10 ml per minute; Ringer's solution, 500 ml IV at a rate of at least 4 ml and not more than 10 ml per minute
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: metabolic acidosis; critical illness; acid-base disorder
Relative Bioavailability of Telmisartan and Dipyridamole After Co-administration Compared to the Bioavailability of Telmisartan or Dipyridamole Alone in Healthy Female and Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relative bioavailability of telmisartan respectively of dipyridamole after
      concomitant administration of 80 mg telmisartan in Micardis® and 25 mg acetylsalicylic acid
      (ASA)/200 mg extended release (ER) dipyridamole (DP) in Aggrenox® (Test 1) relative to ER-DP
      in Aggrenox® alone (Reference 1), respectively relative to telmisartan in Micardis® alone
      (Reference 2).

      To investigate the relative bioavailability of dipyridamole respectively of telmisartan
      administered as 25 mg ASA/200 mg ER-DP 30 minutes after intake of 80 mg telmisartan (Test 2)
      relative to dipyridamole in Aggrenox® alone (Reference 1), respectively relative to
      telmisartan in Micardis® alone (Reference 2).
    


Intervention name(s): telmisartan; ASA/ER-DP
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Absorption and Systematic Pharmacokinetics of IDP-121 Lotion in Subjects With Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant
      metabolites after topical dermal application of IDP-121 lotion.
    

Detailed description: 
      Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant
      metabolites after topical dermal application of IDP-121 lotion in subjects with moderate to
      severe acne vulgaris under maximal use conditions.
    

Intervention name(s): IDP-121 Lotion
Intervention type(s): Drug
Intervention description(s): Lotion
Other intervention name(s): Lotion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment