bioihbjkbjnl/mcl2 huggingface dataset:
Single-Dose Clinical Pharmacology Study in Asthmatic Adolescent and Adult Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical pharmacology want to investigate the systemic availability of BDP/B17MP (active
      metabolite of BDP) and formoterol after single oral inhalation of CHF 1535 100/6 pMDI with
      and without spacer device (AeroChamber Plus™) and in comparison to a free combination of BDP
      pMDI plus formoterol pMDI licensed products; this will be additionally compared to the
      systemic exposure in adults without the spacer device.
    

Detailed description: 
      The proposed clinical pharmacology study is aimed to investigate the systemic availability of
      BDP/B17MP (active metabolite of BDP) and formoterol after single oral inhalation of CHF 1535
      100/6 pMDI (to reach a total dose of BDP 400 µg and formoterol 24 µg) with and without spacer
      device (AeroChamber Plus™) and in comparison to a free combination of BDP pMDI plus
      formoterol pMDI licensed products (to reach the same total dose of BDP and formoterol) in
      adolescent asthmatic patients. The systemic exposure to BDP/B17MP and formoterol after
      inhalation of CHF 1535 pMDI in adolescents will be additionally compared to the systemic
      exposure in adults without the spacer device.

      The chosen doses correspond to the maximum daily dose of the two components administered as
      fixed combination.
    

Intervention name(s): Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1; CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2).; BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF); CHF 1535 100/6 pMDI (Foster®) (CTR)
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Free combination of BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) in adolescents (REF); CHF 1535 100/6 pMDI (Foster®) in adults (CTR)
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adolescents; adults
A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults
Condition: Healthy Volunteer; Becker Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      EDG-5506 is an investigational product intended to protect and improve function of dystrophic
      muscle fibers. This Phase 1 study of EDG-5506 will assess the safety, tolerability, and
      pharmacokinetics (PK) and of EDG-5506 in adult healthy volunteers and in adults with Becker
      muscular dystrophy (BMD).
    

Detailed description: 
      Enrolled participants in this study will receive a single oral dose or multiple oral doses of
      EDG-5506 or a placebo. Blood and urine samples will be collected to measure how EDG-5506 is
      processed by the body and how the body responds when exposed to EDG-5506. Participants in the
      single ascending dose part of the study will remain in the clinic for 7 days with a 42-day
      follow-up period. Participants in the multiple ascending dose part of the study will remain
      in the clinic for 16 days with a 13-day follow-up period. Safety, tolerability, and
      pharmacokinetics of EDG-5506 will be assessed in healthy volunteers prior to enrolling
      participants with Becker muscular dystrophy.
    

Intervention name(s): EDG-5506; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EDG-5506 is administered orally as a single dose or once daily; Placebo is administered orally as a single dose or once daily
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Becker Muscular Dystrophy
Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
Condition: Postsurgical Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated
      for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of
      the study, where CA-008 was compared to placebo. Patients had serial assessments of safety,
      PK, and drug effect.
    

Detailed description: 
      Not provided
    

Intervention name(s): CA-008; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Local administration during surgery; Local administration during surgery
Other intervention name(s): vocacapsaicin
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part A: dose ascending, placebo-controlled Part B: randomized, double-blind, placebo-controlled, parallel design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pseudodrynaria Coronana (Wall) Ching
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The Study to evaluate the clinical effect of "Gusuibu" lasts for 3 years. It aims to evaluate
      its effect on bone density of postmenopausal osteoporosis. Besides, its effects on the liver,
      kidney and the hematological influence will be evaluated, too.
    

Detailed description: 
      Research of the this traditional chinese medicine clinucal, Gusuibu, curative effect is plan
      three years time. The entire studyaims to evaluated the effect of the traditional chinese
      medicine on postmenpausal osteoporosis as well as the possible side effects on the
      experimental animal and the human body. All subjects were postmenopausal woman with
      established osteoporosis.
    

Intervention name(s): GUSUIBU
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Study of High Dosage CIFN Plus RBV for HCV Genotype 1 Infected Patients Who Are Nonresponders to Prior Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of combination
      therapy of daily interferon alfacon-1 (Infergen, CIFN) at high dosage (24 mcg) with ribavirin
      (based on body weight) for 48 weeks in HCV genotype 1 infected subjects, who are
      non-responders to previous pegylated interferon alfa plus ribavirin therapy.

      This is an open-label, multicenter study. All subjects will receive Infergen 24 mcg
      administered by injection daily plus ribavirin 800-1400 mg (based on body weight)
      administered by mouth daily for 48 weeks

      * If any 5 of the first 10 subjects can not tolerate the 24 mcg daily dosage of Infergen by
      week 4, as determined by the principal investigator, then the dosage of Infergen will be
      changed to 15 mcg administered by injection daily plus ribavirin 800-1400 mg (based on body
      weight) administered by mouth daily for 48 weeks
    


Intervention name(s): Interferon Alfacon-1 and Ribavirin
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon alfacon-1
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Nonresponder; Genotype 1; Interferon Alfacon-1; Consensus Interferon; CIFN; Infergen; Ribavirin
Endometrial Injury and IVF-ET Outcome
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Implantation of the human embryo is the limiting factor in the success of
      invitro-fertilization and embryo transfer(IVF-ET).We wanted to find out whether creating a
      local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in
      the subsequent cycle.We believe that the injury created causes release of substances which
      help in implantation.
    

Detailed description: 
      Study Design and Subjects: This is a randomized control study designed to evaluate the effect
      of local injury to the endometrium in non-transfer cycle in patients with previous failed
      IVF.

      Patients will be randomly allotted to control and intervention group The patients in the
      intervention group Pipelle endometrial sampling 7-10th day and 24-26th day in the cycle prior
      to IVF transfer cycle.

      Outcome Measures: Clinical pregnancy rate,implantation rate and ongoing pregnancy rate.

      SAMPLE SIZE: 100 PATIENTS (50 in each group).
    

Intervention name(s): PIPELLE ENDOMETRIAL SAMPLING
Intervention type(s): Procedure
Intervention description(s): Pipelle endometrial sampling will be done twice between 7th to 10th day and 24th to 26th d in the cycle prior to IVF.
Other intervention name(s): Endometrial sampling
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: invitro-fertilization ,embryo transfer,endometrial injury
Mirena Extension Trial
Condition: Contraception
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is performed to assess if Mirena is effective and safe as a birth control method
      beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted
      for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.
    


Intervention name(s): Levonorgestrel IUS (Mirena, BAY86-5028)
Intervention type(s): Drug
Intervention description(s): Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Birth Control; Heavy menstrual bleeding
Post-Operative Pain Management With NSAIDS
Condition: Urogynecologic Surgery
Study type: Observational

Summary: 
      Specific Aim 1: To identify differences in pain perception and satisfaction with pain control
      in women undergoing urogynecologic surgery receiving nonsteroidal anti-inflammatory (NSAIDS)
      postoperatively by oral ibuprofen, intravenous ibuprofen, or intravenous ketorolac. Specific
      Aim 2: To compare the differences in narcotic usage and medication side effects.
    

Detailed description: 
      All patient will be informed that they may receive either ibuprofen or ketorolac and that the
      medication may be given (IV) or per os (PO). Patients were also informed that their pain may
      improve or worsen during the study, and that they could request additional pain medication
      (as a rescue medication) at any time.

      After surgery, all patients will be placed initially on a patient controlled analgesia (PCA)
      of hydromorphone with standardized settings of allowing the patient to dispense 0.2 mg of
      medication every 6 minutes (lockout rate) and an hourly maximum of 2.0 mg/hour. A one-time
      nursing bolus of 0.4 mg will also be ordered. The PCA will be discontinued on the morning
      after surgery no later than 12:00 noon. The patient will then be started on PO pain
      medication, either hydrocodone/acetaminophen or oxycodone/acetaminophen.

      Immediately after surgery, patients will then be assigned to one of three treatment arms with
      a computer-generated randomization schedule that is to be based on their order of enrollment.
      Patients were informed they could withdraw at any point. Three visual analog scores (VAS)
      will be obtained from the patient before noon on the first day after surgery. One scale to
      assess pain at rest, one scale to assess pain with ambulation, and one scale to assess
      satisfaction with pain control.

      The medications will each be given every 8 hours in order to keep all medications on a
      similar doing regimen. This will allow the patients to receive a total of three doses of
      medication over 24 hours, regardless of which arm of the study they are randomized to.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited and consented through an IRB-approved process. Women and
        minorities are included in the research protocol. We will not exclude potential subjects
        from participating in this or any study solely on the basis of ethnic origin or
        socioeconomic status. There are no children involved in this study.
Pathogenesis and Genetics of Environmental Asthma Ozone Study
Condition: Asthma; Inflammation
MeSH terms: Asthma; Inflammation
Study type: Observational

Summary: 
      The goals of the research are designed to accomplish genetic association studies of candidate
      genes in healthy normal individuals exposed to 0.2 ppm for 2.25 hours with intermittent
      exercise in order to search for associations between defined genotypes/haplotypes and 3
      specific in vivo respiratory endpoints: a) change in FEV1 immediately after ozone exposure;
      b) change nonspecific bronchial reactivity as reflected in the change in methacholine PC20
      FEV1 24 hours after ozone exposure ; and c) change in lung epithelial integrity as reflected
      in the Clearance Halftime of technetium 24 hours after ozone exposure. These studies have
      been carried forward to take place in 4 phases:

      i) healthy individuals have been exposed to O3 using our standard exposure protocol; and we
      will increase the numbers of individuals available for study.

      ii) perform genetic association studies for the endpoints of spirometry (FEV1, FVC,
      FEV1/FVC), PC20 FEV1 for methacholine, and epithelial integrity (Clearance Halftime) for 3
      candidate O3 response genes taken from literature searches and/or previously characterized to
      demonstrate associations. These physiologic endpoints have been examined in terms of both a
      continuum of response, and discrete "responder" and "non-responder" endpoints.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy adults, 18-35 y of age, both genders.
      
Biospecimen description: 
      plasma, and ebc collected.
    
Keywords: ozone; inflammatory airway disease; polymorphisms
Pharmacokinetics of Telmisartan Alone and in Combination With Amlodipine in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in
      combination with repeated doses of 10 mg amlodipine
    


Intervention name(s): Telmisartan; Amlodipine
Intervention type(s): Drug; Drug
Other intervention name(s): Micardis®; Norvasc®
Intervention MeSH terms: Amlodipine; Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally
      administered ALS-008176 in healthy volunteers.
    


Intervention name(s): ALS-008176; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RSV
An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage
Condition: Liver Dysfunction; Healthy Volunteers
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate BMS-986165 in participants with different levels
      of liver function.
    


Intervention name(s): BMS-986165
Intervention type(s): Drug
Intervention description(s): Oral administration
Intervention MeSH terms: Deucravacitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability Study of Cinnamon in Healthy Subjects
Condition: Healthy Males
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A partial double-blind, randomized, placebo-controlled, 4-treatment crossover study design
      will be used to evaluate bioavailability of various forms of cinnamon and to determine the
      effects of 3 and 6 g of cinnamon added to instant oatmeal on blood glucose levels in 8
      healthy subjects. In the extended dose response study, three subjects will continue the study
      and be offered 5 day consecutive feedings of 9 g cinnamon extract and on Day 6, and blood
      samples would be collected over 6 hours after a single morning dose. Urinary samples would be
      collected upon to 48 hours.
    

Detailed description: 
      Objective:

      The objective of this trial is to evaluate the bioavailability of selected procyanidin
      derived metabolites from various forms of cinnamon.

      Study Products:

      Core Study

        -  Control: Oatmeal (~70 g) without cinnamon

        -  Active A: Oatmeal (~70 g) with 3 g ground cinnamon

        -  Active B: Oatmeal (~70 g) with 3 g cinnamon extract

        -  Active C: Oatmeal (~70 g) with 6 g cinnamon extract

      Extension Study

      •9 g cinnamon extract in capsule form (unblinded) The 9 g/d cinnamon extract will be consumed
      by subjects on days 22 through 26. At visit 6 (day 27), subjects will return to the clinic
      for the test day. The cinnamon extract capsule (9 g) will be consumed with an oatmeal (70 g)
      breakfast.

      Subjects:

      Subjects will be healthy men 18 - 40 years of age (inclusive), each with a body mass index
      (BMI) 25.00-29.99 kg/m2.

      Outcome Variables:

      Primary Outcome Variable The primary outcome variables will be the area under the curve (AUC)
      from 0 to 360 min for plasma procyanidin-derived metabolites, where t=0 min is the start of
      study product consumption.

      Secondary Outcome Variables

      Secondary outcome variables will include the assessment of:

        -  The maximum concentration (Cmax) and time to reach peak concentration (Tmax) for plasma
           procyanidin-derived metabolites, as well as the net incremental AUC values to account
           for possible non-zero pre-load values.

        -  The effect of a single dose of cinnamon on the metabolic profile using an untargeted
           metabolomics analysis on both plasma and urine specimens.

        -  The effect of a single dose of cinnamon on plasma glucose and insulin.
    

Intervention name(s): cinnamon; Oatmeal
Intervention type(s): Other; Other
Intervention description(s): Intervention will be both ground cinnamon and cinnamon extract.; Oatmeal control, around 70g; without cinnamon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Cinnamon; Bioavailability; Glucose; Proanthocyanidins
Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV
Condition: Japanese Encephalitis; Varicella
MeSH terms: Chickenpox; Herpes Zoster; Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to investigate the memory immune response and the yearly persistence
      of the immunity against Japanese Encephalitis (JE) after vaccination with Japanese
      Encephalitis Chimeric Virus Vaccine (JE-CV) in participants previously vaccinated with JE-CV
      vaccine.

      Objectives:

        -  To describe JE immune status before and after JE-CV vaccination in subjects previously
           vaccinated with JE-CV vaccine

        -  To describe the immune status before and after JE-CV vaccination in JE-naïve control
           subjects.

        -  To describe the safety (in terms of solicited and unsolicited adverse events) of a
           single dose of JE-CV vaccine up to 6 months after the last vaccination.

        -  To describe all related serious adverse events (SAEs) and related deaths from 6 months
           to 5 years after vaccination in JE-CV-primed subjects.
    

Detailed description: 
      Study participants who are previously immunized with JE-CV vaccine will receive a booster
      dose of the JE-CV vaccine and will be followed up for 5 years for immunogenicity.

      The control (JE-CV naïve) participants will receive either one dose of JE-CV vaccine or one
      dose of varicella vaccine.

      All participants will be monitored for safety for 6 month post-vaccination.
    

Intervention name(s): JE-CV Vaccine; Varicella Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL (single dose), Subcutaneous; 0.5 mL (single dose), Subcutaneous
Other intervention name(s): IMOJEV; OKAVAX®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was an open, controlled, multicenter, Phase III trial. Participants in Group 1 were previously vaccinated at 12 to 18 months of age with a single dose of JE-CV vaccine and were to receive a booster dose of JE-CV vaccine on Day 0. This group was not randomized. JE vaccine naïve control children were randomized to receive one single dose of JE-CV on Day 0 (Group 2) or a varicella vaccination on Day 0 (Group 3).
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Japanese Encephalitis; Japanese encephalitis chimeric virus vaccine; Varicella; Varicella vaccine
Irbesartan in Type 2 Diabetes
Condition: Type 2 Diabetes; Microalbuminuria; Hypertension
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this multicenter, doubleblind, randomized study was to investigate the
      renoprotective effect of irbesartan treatment in patients with type 2 diabetes and
      microalbuminuria (a precursor of diabetic kidney disease). 590 patients were randomized to a
      median 24 months of treatment with 300 mg irbesartan once daily, 150 mg irbesartan once daily
      or placebo. Time to development of overt nephropathy, defined by persistent proteinuria, was
      the primary outcome measure.
    


Intervention name(s): Irbesartan treatment
Intervention type(s): Drug
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment