bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Relative Oral Bioavailability of JNJ-63623872 Administered as Oral Concept Formulations Compared to the Current Tablet Formulation
Condition: Influenza A Virus
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of JNJ-63623872
      following administration of a single dose as three different concept formulations with that
      following administration of the current formulation, under both fed and fasted conditions, in
      healthy adult participants.
    

Detailed description: 
      This is a Phase 1, open-label, 2-panel, randomized, crossover study in healthy adult
      participants to assess the relative bioavailability JNJ-63623872. The study population will
      consist of 48 healthy adult participants, equally divided over 2 panels: 24 participants in
      Panel 1 and 24 participants in Panel 2. participants will be randomized within each panel.
      Participants will not be randomized between panels. Panels 1 and 2 will be performed
      sequentially. Participants having participated in one panel cannot also participate in the
      other panel. In Panel 1, during 4 subsequent treatment sessions (Periods I, II, III and IV),
      each participant will receive 4 treatments (Treatments A, B, C, and D), randomized according
      to a classical 4 sequence, 4 period Williams design. In Panel 2, during 3 subsequent
      treatment sessions (Periods I, II and III), each participant will receive 3 treatments
      (Treatments E, F, and G) randomized according to a classical 6 sequence, 3 period Williams
      design. Primarily, pharmacokinetic parameters will be evaluated. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): JNJ-63623872 300 milligram (mg); JNJ-63623872 600 mg; JNJ-63623872 600 mg; JNJ-63623872 600 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.; Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.; Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.; Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Influenza A virus; JNJ-63623872; Healthy
Activator and Type II Diabetics
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study (15-subject prospective case series) is to examine the effects of
      the Activator Methods technique on decreasing A1c levels in patients with type II Diabetes
      Mellitus (aka adult-onset diabetes).
    


Intervention name(s): Chiropractic Adjustment
Intervention type(s): Other
Intervention description(s): Chiropractic adjustments will be administered using Activator Methods Basic protocol
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be eligible to participate in the study if they are between the ages of 30-60
        and are clinically diagnosed with Type II diabetes by their primary care providers or
        endocrinologists (diagnosis usually based on FPG > 126 mg/dL on two occasions).
        Participants must have been diagnosed for at least one year and currently be under medical
        supervision for the disease. They must also have an A1c measurement above 7%, which
        indicates less than optimal management of the disease.
      
Keywords: diabetes
A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars
Condition: Scar Prevention; Scar Reduction
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine the safety of AZX100 Drug Product and to determine
      whether it was effective in preventing or reducing re-growth of surgically removed keloid
      scars.
    


Intervention name(s): AZX100 Drug Product; AZX100 Drug Product; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects were administered AZX100 3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.; Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.; Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: AZX100; Patient and Observer Scar Assessment Scale; POSAS; Visual Analog Scale; VAS; Keloid; Scarring; Scar reduction; Scar prevention
Norwegian Adenomyosis Study I
Condition: Adenomyosis
MeSH terms: Adenomyosis
Study type: Observational

Summary: 
      Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of
      the uterus. It affects about 15-20% of the female population.

      The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation
      (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been
      correlated with adenomyosis.

      Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as
      local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune
      and mechanical factors are also hypothesized.

      Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic
      measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin
      releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation
      have been tried, but studies are few in number, retrospective, and have small sample sizes.

      Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of
      adenomyosis remains still unclear, there are not many satisfying treatment options and
      diagnostics include mostly magnetic resonance imaging (MRI) and histology.

      The investigators designed a series of 3 studies with a broad approach in understanding
      adenomyosis. This is part 1.

      NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic
      of adenomyosis
    

Detailed description: 
      Diagnosis of Adenomyosis with 3D and 2D transvaginal ultrasound. Prospective study of a
      consecutive series of 101 patients that are scheduled for hysterectomy and suffer from
      bleeding disorders, chronic pelvic pain, dysmenorrhea or dyspareunia. All patients will
      undergo transvaginal 2D- ultrasound, 3D-ultrasound and power doppler (PD)-ultrasound (TVU),
      magnetic resonance imaging of the pelvic organs (MRI) and hysterectomy.

      We will investigate the specificity and sensitivity of 3D and 2D transvaginal ultrasound in
      the diagnosis of adenomyosis and compare data with MRI and histopathology, which is the gold
      standard by today. In addition, we will collect anamnestic information that might point to
      risk factors or connections to prior obstetrical complications and medicine use. In our study
      the pathologist will not be blinded to our ultrasound findings, and we want to investigate if
      this will raise the sensitivity of histology findings of adenomyosis.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women referred to our clinic and volunteering to participate and that are registrated in
        Norway with a norwegian social security number.
      
Keywords: Adenomyosis; Dysmenorrhea; Chronic pelvic pain; Infertility; Sensitivity histology; womens health; junction zone
ADIponectin and Asymmetric Dimethylarginine (ADMA) Level in Type-2 Diabetes Patients After 12 Weeks of Treatment With GlimepiRide And Metformin Fixed Dose Combination
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To evaluate the change in plasma levels of adiponectin and Asymmetric Dimethylarginine (ADMA)
      in type 2 diabetes patients after 12 weeks of treatment with Amaryl-M

      Secondary Objectives:

        1. To assess the role of Amaryl-M in the change of plasma levels of adiponectin and ADMA in
           type 2 diabetes patients after 8 weeks of therapy

        2. To evaluate the brachial-ankle pulse wave velocity (baPWV) change after 8 and 12 weeks
           of therapy with Amaryl-M

        3. To evaluate the efficacy of Amaryl-M in the improvement of patients glycemic level
           (Fasting blood glucose (FBG) and glycosylated hemoglobin (HbA1c))

        4. To evaluate the change of Tumor Necrosis Factor - Alfa (TNF-Alfa) after 12 weeks of
           therapy with Amaryl-M

        5. To evaluate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) change
           after 12 weeks of therapy with Amaryl-M

        6. To evaluate the HOMA-β change after 12 weeks of therapy with Amaryl-M

        7. To evaluate the relationship between adiponectin and ADMA level with FBG or HbA1c level
    

Detailed description: 
      The clinical trial will consist of 2 weeks of selection followed by a 12 weeks (3 months) of
      treatment period.
    

Intervention name(s): GLIMEPIRIDE + METFORMIN
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day
Other intervention name(s): Amaryl-M
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Infections Related Central Venous Catheters
Condition: SIRS
MeSH terms: Infections
Study type: Observational

Summary: 
      The purpose of this study is to clarify the relationship between SIRS (Systemic inflammatory
      response syndrome) and the infection associated with the use of central venous catheters at
      Critical Care center in National Defense Medical College, Japan.
    

Detailed description: 
      The doctor would remove the inserted catheter from the patient, if the patient shows SIRS. At
      the same time, the tip of used catheter and blood from the patient are checked whether the
      pathogenic bacteria exists or not by general bacterial protocol and blood culture test on a
      routine application. Unfortunately, these tests not always clarified their cause of SIRS.
      Therefore we conduct this investigation to establish the useful protocol for pathogenic
      bacteria. We check the pathogenic bacteria not only tip but through the whole catheter in
      Central Venous Catheter using general bacterial protocol and SEM observation. Additionally,
      we compared that sputum, urine, skin and blood from the patient for bacteria check.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Critical Care staff
      
Biospecimen description: 
      We will use the DNA from the only clinical isolated bacteria.
    
Keywords: Central venous catheter; nosocomial infection
To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Clarithromycin 250 mg tablets under fasting
      conditions.
    


Intervention name(s): Clarithromycin 250 mg Tablets (Geneva, USA); Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic
A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to
      receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting
      dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a
      satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose.
      The anticipated time on study treatment is 3-12 months, and the target sample size is <100
      individuals.
    


Intervention name(s): gantenerumab
Intervention type(s): Drug
Intervention description(s): Administered iv at escalating doses (7 cohorts)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Lactobacillus Casei DG (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: a Pilot Study
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of the study is to collect data for the assessment of the Lactobacillus casei DG
      (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota
      composition in patients with Irritable Bowel Syndrome.
    

Detailed description: 
      The aim of the study is to collect data for the assessment of the Lactobacillus casei DG
      (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota
      composition in patients with Irritable Bowel Syndrome. The investigators suppose that, due to
      the immunomodulatory action of probiotics, overall abdominal pain/discomfort and symptoms
      will improve, fecal Immunoglobulin A levels will change, pro-inflammatory cytokine levels
      will decrease and the production of regulatory cytokines as Interleukin 10 will improve
      following consumption of Lactobacillus casei DG (Enterolactis plus®).
    

Intervention name(s): Lactobacillus casei DG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): the patients will receive 1 capsule of Lactobacillus casei DG (Enterolactis plus®) twice daily for 4 weeks; the patients will receive 1 capsule of product without bacteria (Enterolactis placebo) twice daily for 4 weeks
Other intervention name(s): Enterolactis plus®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Lactobacillus casei dg; microbiota
A Double Blind Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Frovatriptan in the Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is:

        1. To compare the efficacy of a single dose of Frovatriptan 2.5 mg with that of placebo in
           acute treatment of up to one migraine attract

        2. To assess recurrence rate between two group

        3. To assess the safety and tolerability
    


Intervention name(s): Frovatriptan
Intervention type(s): Drug
Intervention description(s): 2.5mg, qd
Intervention MeSH terms: Frovatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Pharmacokinetics and Pharmacodynamics Study of Treatment With CHF 5074 in Healthy Young Male Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single oral doses of
      CHF 5074 in young healthy male volunteers.
    

Detailed description: 
      The primary endpoint of the study is to determine the maximum tolerated dose (MTD) of CHF5074
      after single oral administration to young healthy male volunteers.

      The secondary objective of this study is to evaluate the pharmacokinetics of CHF5074 after
      single oral administration to young healthy male volunteers. The secondary endpoint of this
      study is to verify if CHF5074 plasma levels (Cmax and AUC0-t) increase proportionally with
      the dose (dose-linearity).

      The exploratory objective of this study is to evaluate the pharmacodynamics of CHF5074 after
      single oral administration to young healthy male volunteers. The respective exploratory
      endpoint is to assess the relationship between individual maximum CHF5074 plasma
      concentrations and corresponding A-beta42 plasma concentrations corrected for baseline
      A-beta42 levels.
    

Intervention name(s): CHF 5074; placebo; CHF 5074; CHF 5074; CHF 5074; CHF 5074; CHF 5074
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1x, oral capsule, single dose; placebo, oral capsule, single dose; 2x, oral capsule, single dose; 4x, oral capsule, single dose; 8x, oral capsule, single dose; 16x, oral capsule, single dose; 24x, oral capsule, single dose
Intervention MeSH terms: 1-(3',4'-dichloro-2-fluoro(1,1'-biphenyl)-4-yl)cyclopropanecarboxylic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Exparel Use in Adductor Canal Block After Total Knee Arthroplasty
Condition: Arthritis Knee; Pain, Postoperative; Opioid Use
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Exparel has been shown to have better pain control compared to previously used infiltration
      agents, including bupivacaine, while having a minor side effect profile. The purpose of this
      study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal
      Blocks for peri-operative pain control following a total knee arthroplasty (TKA) procedure.
    

Detailed description: 
      The effectiveness of an Exparel Block (Bupivacaine Liposomal Injectable Suspension) for
      post-operative pain control has been well studied with encouraging results. At the
      investigators' institution, Exparel has been approved as a safe and effective option for use
      in shoulder surgeries and have had encouraging results in adductor canal use for pain control
      in patients undergoing TKA. Exparel has been shown to have better pain control compared to
      previously used infiltration agents, including bupivacaine, while having a minor side effect
      profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal
      bupivacaine) in Adductor Canal Blocks (ACB) for peri-operative pain control following a total
      knee arthroplasty (TKA) procedure. Specifically, the investigators look to see if Exparel ACB
      reduces opioid requirement use post-operatively, reduces pain scores post-operatively,
      provides earlier mobilization, and decreases length of hospital stay.
    

Intervention name(s): Exparel; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine; Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Exparel; adductor; knee; arthroplasty; opioid
A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches Using the ChAd63 and MVA Vectors Encoding the Antigens ME-TRAP, CS and AMA1
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label, multi-centre phase I/IIa sporozoite-challenge trial to assess the
      safety, immunogenicity and efficacy of two combination ChAd63-MVA heterologous prime-boost
      vaccination regimens. All volunteers recruited will be healthy, malaria naïve adults aged
      between 18 and 45 years.

      To determine the efficacy of each of two combinations of heterologous prime-boost
      immunisation strategies:

        1. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS

        2. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS and ChAd63-MVA AMA1

      The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and
      Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in
      Southampton, UK. The malaria challenge will take place at the insectary at Imperial College
      (Infection and Immunity Section) in London, UK.
    


Intervention name(s): ChAd63 CS/ME-TRAP; MVA CS/ME-TRAP; ChAd63 CS/ME-TRAP/AMA1; MVA CS/ME-TRAP/AMA1; Controlled Human Malaria Infection Administered by Mosquito Bite
Intervention type(s): Biological; Biological; Biological; Biological; Other
Intervention description(s): Mixture of ChAd63 CS 5 x 1010 vp and ChAd63 ME-TRAP 5 x 1010 vp. Intramuscular needle injection.; Mixture of MVA CS 2 x 108 pfu and MVA ME-TRAP 2 x 108 pfu. Intramuscular needle injection.; Mixture of ChAd63 CS 5 x 1010 vp, ChAd63 ME-TRAP 5 x 1010 vp, and ChAd63 AMA1 5 x 1010 vp. Intramuscular needle injection.; Mixture of MVA CS 1.33 x 108 pfu, MVA ME-TRAP 1.33 x 108 pfu, and MVA AMA1 1.33 x 108 pfu. Intramuscular needle injection.; Approximately three weeks post MVA dosing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Malaria; Vaccine; Plasmodium; Falciparum