bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TAK-831 when administered as single or multiple oral doses in healthy
      adult Asian participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-831. This study will assess the safety,
      tolerability, pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-831 when administered
      as single or multiple oral doses in healthy adult Asian participants (Japanese and Chinese
      participants).

      The study will enroll approximately 40 participants and include up to 5 cohorts of healthy
      adult Japanese or Chinese participants as following (8 participants per a cohort). Cohorts 3,
      4 and 5 are optional and will be decided to run based on the data of Cohorts 1 and 2. Dose
      level for these cohorts will be defined based on the result of Cohort 1 or Cohort 2.

        -  Japanese Cohort 1-A; TAK-831 100 mg single dose + TAK-831 300 mg single dose

        -  Japanese Cohort 1-B; TAK-831 100 mg single dose + Placebo single dose

        -  Japanese Cohort 1-C; Placebo single dose + TAK-831 300 mg single dose

        -  Japanese Cohort 2; TAK-831 300 mg or TAK-831 matching placebo, single dose + TAK-831 300
           mg or TAK-831 matching placebo, multiple dose *

        -  Chinese Cohort 3; TAK-831 600 mg or TAK-831 matching placebo, single dose + TAK-831 600
           mg or TAK-831 matching placebo, multiple dose

        -  Japanese Cohort 4; TAK-831 600 mg or TAK-831 matching placebo, single dose + TAK-831 600
           mg or TAK-831 matching placebo, multiple dose

        -  Japanese Cohort 5; TAK-831 50 mg or TAK-831 matching placebo, single dose + TAK-831 50
           mg or TAK-831 matching placebo, multiple dose *The dose in Cohort 2 will be adjusted
           based on the safety and tolerability as well as PK and PD in Cohort 1.

      Above all treatment, randomization information will remain undisclosed to the participant and
      study doctor during the study (unless there is an urgent medical need) and TAK-831 will be
      administered orally.

      This single center trial will be conducted in Japan. The overall time to participate in
      Cohort 1 of this study is approximately 12 days and 19 days in Cohorts 2 to 5. 11 days (for
      Cohort 1) or 12 days (for Cohorts 2 to 5) after last dose of study drug, participants will be
      contacted by telephone for a follow-up assessment unless abnormal, clinically significant
      findings are observed upon discharge.
    

Intervention name(s): TAK-831; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-831 Tablets.; TAK-831 Matching Placebo Tablets.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The primary objective of this multicenter, prospective, randomized study is to assess the
      diagnostic yield of Colon Capsule Endoscopy (CCE) versus Computed Tomographic Colonography
      (CTC) in a screening population.
    

Detailed description: 
      This is a multicenter, prospective, randomized study to evaluate the efficacy of CCE versus
      CTC in the identification of colonic polyps in a screening population.

      Subjects will be enrolled at up to 20 clinical sites in the United States. Subjects who meet
      the eligibility criteria will be screened by the gastroenterology site for study
      participation at a baseline visit which will also include a blood test for renal function
      (eGFR), and will be evaluated on the randomized procedure day (CCE versus CTC) and again on
      the day of both the blinded and unblinded OC procedures. Telephone follow-ups will be
      conducted 5 - 9 days after the CCE/CTC procedure and 5 - 9 days after the unblinded OC
      procedure to assess subject well-being and capture any Adverse Events (AEs), regardless of
      relationship to the CCE, CTC, or Optical colonoscopy (OC) procedures.

      All CCE RAPID® videos and CTC images will be evaluated by local and central readers. All
      study analyses will be based on central reader results for both CCE and CTC. Two sets of
      central readers will be utilized, one set for reading of the CCE RAPID® videos and one set
      for reading the CTC studies. Both groups of readers will be experts in the reading process
      for their respective procedures. Readers will provide a report of their findings to the
      sponsor within 2 weeks of capsule ingestion or CTC procedure in order to allow subjects to
      return within 5 weeks capsule ingestion or CTC procedure to undergo confirmatory OC. The
      first OC procedure will be performed with the clinician blinded to the CCE or CTC results.
      Immediately following this blinded procedure, the clinician will review the CCE or CTC
      results report provided by the sponsor from the central readers, and a second unblinded OC
      procedure will be performed if there are discrepancies between the CCE/CTC findings and OC.

      Colonoscopy must not be performed by the same person who conducts the local CCE reading, or
      anyone who has reviewed CCE/CTC results for that subject.

      Bowel preparation regimens for all three procedure types will be standardized across sites.
    

Intervention name(s): COLON Capsule endoscopy; Computed Tomographic Colonography
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Polyps; Capsule endoscopy; CT Colonography; Colonoscopy; Average risk patients for colorectal cancer screening
Evaluation of N1539 Following Major Surgery
Condition: Pain, Post-operative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of N1539 in a
      variety of post-surgical conditions.
    


Intervention name(s): N1539; Intravenous Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Intravenous meloxicam
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Analgesia; N1539; Phase 3
Efficacy and Safety of Botulinum Toxin Type A Haemagglutinin Complex Next Generation (BTX-A-HAC NG) in Glabellar Lines
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the protocol is to demonstrate the safety and the efficacy of a single
      injection of a new formulation of Clostridium Botulinum toxin type A haemagglutinin complex
      (BTX A HAC NG) to improve the appearance of moderate to severe glabellar lines (the lines
      between the eyebrows) and to assess the long term efficacy and safety of BTX-A-HAC NG after
      repeated injections.
    

Detailed description: 
      This is a multicentre study conducted in two periods. Subjects will first be enrolled to
      enter the double blind (DB) period Cycle 1. Subjects who are eligible for retreatment will
      then be offered to enter open label (OL) Cycles 2 to 5 as DB roll-over subjects. Once
      recruitment of the DB period is complete, the study will enrol additional BTX-naïve subjects
      (hereafter referred to as OL de novo subjects) into the OL period Cycle 1. All OL de novo
      subjects who are eligible for retreatment will also be offered to enter OL Cycles 2 to 5. A
      total of 580 subjects (180 subjects randomised in the DB period and an additional 400 de novo
      subjects in the OL period) are planned to complete the study.
    

Intervention name(s): Botulinum toxin type A; Placebo
Intervention type(s): Biological; Drug
Other intervention name(s): BTX-A-HAC NG
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Reference Values for Compound Muscle Action Potential Amplitude Obtained by Direct Muscle Stimulation
Condition: Critical Illness Polyneuromyopathy
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Direct muscle stimulation (DMS) method is one of the electrodiagnostic methods used in the
      diagnosis of critical illness myopathy (CIM) and critical illness neuropathy (CIN). The ratio
      of amplitude of compound muscle action potential (CMAP) obtained by nerve stimulation (nCMAP)
      to amplitude of CMAP obtained by DMS (dmCMAP) can be used to differentiate these two
      diseases. Although not certain, if the ratio is < 0.5, the diagnosis is thought to be
      consistent with CIN. The ratio > 0.5 is considered to be a finding supporting CIM. The
      investigators aimed to find the reference values of the ratio from healthy individuals. A
      monopolar needle electrode was used for DMS. The dmCMAP and nCMAP were recorded with a
      concentric needle. The ratio was calculated by using amplitudes of dmCMAP and nCMAP obtained
      from deltoid and tibialis anterior muscles.
    

Detailed description: 
      Age, gender, height, weight, body mass index and neurological examination findings of the
      participants were recorded. Healthy participants were not included if they had;
      polyneuropathy or a disease such as diabetes mellitus that causes polyneuropathy, complaints
      such as weakness or paresthesia, a neurodegenerative disease, abnormal neurological
      examination, myopathy or hereditary polyneuropathy in family history. In addition, healthy
      participants were excluded if the conventional nerve conduction study and needle
      electromyography (EMG) findings were abnormal. Median, ulnar, posterior tibial, peroneal,
      superficial peroneal, sural nerve conduction studies were performed to all participants.
      Needle EMG and direct muscle stimulation were applied to the deltoid and tibialis anterior
      muscles of the healthy participants.
    

Intervention name(s): needle electromyography
Intervention type(s): Diagnostic Test
Intervention description(s): Direct muscle stimulation was performed to deltoid and tibialis anterior muscles with a monopolar needle electrode. Recording was made with a concentric needle electrode.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Critical illness myopathy; Critical illness neuropathy; direct muscle stimulation
Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women
Condition: Obesity
MeSH terms: Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study plans to find out whether Celebrex may be potentially useful to decrease
      inflammation in fat tissues and thereby lower the production of substances such as estrogens
      that may increase the risk of developing breast cancer and lead to a poor outcome of the
      disease.
    

Detailed description: 
      This study seeks to examine how effective the celebrex may be in reducing inflammation,
      crown-like structures in fat tissue, the enzyme aromatase, PGE-M in the urine and estrogen in
      blood and urine. Volunteer subjects will be expected to stay in the hospital for about 2
      weeks taking Celebrex for approximately 10 days while eating a diet similar to what they
      consumed before coming into the hospital for the study.
    

Intervention name(s): Celebrex
Intervention type(s): Drug
Intervention description(s): 200 mg PO BID
Other intervention name(s): Celecoxib
Intervention MeSH terms: Celecoxib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity; Post-menopausal
Study of Chiglitazar Compare With Sitagliptin in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with
      Sitagliptin.
    

Detailed description: 
      The efficacy and safety will be compared between Chiglitazar and Sitagliptin after treatment
      of 24 weeks.
    

Intervention name(s): Chiglitazar; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Take orally; Take orally
Other intervention name(s): CS038; Sit
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chiglitazar; Sitagliptin; diabetes; type 2 diabetes
The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
Condition: Juvenile Dermatomyositis
MeSH terms: Dermatomyositis; Myositis
Study type: Interventional

Summary: 
      This project will bring together a multidisciplinary team of pediatric rheumatologists,
      neurologists, metabolic geneticists and exercise physiologists to determine the effect of
      creatine (CR) supplementation on muscle function and muscle metabolism in children with
      Dermatomyositis (DM). The investigators propose using well-established exercise testing
      techniques as well as new, powerful exercise imaging protocols in order to better delineate
      the effects of CR on muscle pathophysiology in a non-invasive way. Evidence from this study
      will provide information regarding the effect of creatine supplementation on muscle function
      in DM. Improvements in muscle function and fatigue through CR use may also contribute to an
      improvement in quality of life and have significant clinical implications for the treatment
      of children with DM.
    


Intervention name(s): Creapure; Glucose Tablet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients will be prescribed a creapure supplement by weight, to be taken 3x/day for the duration of the trial. They will be randomized to an active product start time using a multiple baseline design.; Patients will be prescribed the placebo supplement by weight, to be taken 3x/day for the duration of the trial. They will be randomized to an active product start time using a multiple baseline design.
Other intervention name(s): ultrapure creatine monohydrate; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential
Condition: Fibroid
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to asess the safety and tolerability of ascending single
      oral doses of PRA-027 in healthy women of nonchildbearing potential. The secondary purpose is
      to provide the initial pharmacokinetic (PK) and pharmacodynamic (PD) profile of PRA-027 in
      healthy women of nonchildbearing potential, and to evaluate the effect of a high-fat meal on
      the PK and PD of PRA-027 administered to healthy women of nonchildbearing potential.
    


Intervention name(s): PRA-027
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Uterine leiomyomata (Fibroids)
The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial
      enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the
      endothelial dysfunction induced by a single cigarette.
    


Intervention name(s): Bendavia; Sterile saline (0.9%); Cigarette smoking
Intervention type(s): Drug; Drug; Other
Intervention description(s): Bendavia for infusion Intravenous infusion (0.25mg/kg/hr) for 4 hours; Sterile saline for infusion (0.9%) Intravenous infusion for 4 hours; One unfiltered cigarette will be smoked at approximately 30 minutes post-study-drug administration start.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
NIRS in Neonatal Cardiac Surgery
Condition: Hypoplastic Left Heart; Surgery
MeSH terms: Hypoplastic Left Heart Syndrome
Study type: Observational

Summary: 
      Due to the small size of infants and the use of bypass machines, physicians have difficulty
      assessing whether the infant's brain and body is getting enough oxygen during heart surgery.
      This study compares continuous monitoring via the NIRS (Near Infrared Spectroscopy) to the
      traditional methods of determining oxygen saturation.
    

Detailed description: 
      One of the limiting factors in treating infants undergoing cardiac surgery is the difficulty
      in assessing systemic perfusion with accuracy. At Children's Healthcare of Atlanta,
      Near-infrared Spectroscopy (NIRS) is available, but has never been studied. In patients
      undergoing first stage palliation (Norwood) for hypoplastic left heart, routine management
      will be utilized in addition to the NIRS monitor. The following will be documented pre- and
      post-bypass, then every 4 hours for 24 hours after admission to the Cardiac Intensive Care
      Unit:NIRS readings, Lactic acid levels,mixed venous saturations,hemoglobin, hematocrit,
      arterial blood gases, heart rate, blood pressure, central venous pressure, left atrium
      pressure,core temperature, toe temperature, pulse oximeter reading, urine output, ventilator
      settings, inotropic levels. All the data will be entered into a database and analyzed.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates with Hypoplastic Left Heart Syndrome undergoing stage 1 palliation with the
        Norwood procedure.
      
Keywords: pediatric; cardiac surgery
Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure
Condition: Sedation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic
      properties. Despite off-label administration, dexmedetomidine has found a niche in critically
      ill mechanically ventilated neonates and infants because of its minimal effects on
      respiratory function at sedative doses, facilitating early extubation and fast-track
      postoperative care.
    

Detailed description: 
      Critically ill children require sedation for comfort and to facilitate mechanical ventilation
      and interventions. The ideal sedative agent for use in critically ill children has to be
      effective and short-acting, of rapid onset of action, lacks active metabolites, does not
      accumulate in patients with renal or hepatic dysfunction, has minimal to no cardiovascular or
      respiratory adverse effects, and has few drug interactions.

      Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic
      properties. Despite off-label administration, dexmedetomidine has found a niche in critically
      ill mechanically ventilated neonates and infants because of its minimal effects on
      respiratory function at sedative doses, facilitating early extubation and fast-track
      postoperative care.

      The only FDA approved indication of dexmedetomidine is sedation of intubated mechanically
      ventilated adults for less than 24h. However, the literature is full of many research studies
      that investigated the use off-lable use of dexmedetomidine for sedation more than 24h in both
      adult and pediatric population and proved its safety and effectiveness.

      The aim of this study will be to investigate the safety and efficacy of dexmedetomidine in
      two different doses in sedation for critically ill mechanically ventilated infants with
      respiratory failure for 72h duration.
    

Intervention name(s): Dexmedetomidine 0.35µg/kg /h; Dexmedetomidine 0.5µg/kg /h
Intervention type(s): Drug; Drug
Intervention description(s): the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale; the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale
Other intervention name(s): Precedex; Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK2838232 is a novel HIV-1 maturation inhibitor (MI) that is being developed for the
      treatment of HIV-1 infection in combination with other antiretroviral therapy (ART). This
      study will be a 10-day monotherapy, open-label, adaptive, dose ranging, repeat-dose study.
      This study will be conducted in two Parts (Part A and Part B) consisting single daily doses
      of GSK2838232 and Cobicistat from Day 1 to Day 10. This proof of concept open-label study
      will be aimed to characterize the acute antiviral activity, pharmacokinetics (PK), the
      relationship between PK and antiviral activity, and safety of GSK2838232/cobi administered
      across a range of doses over 10 days in HIV-1 infected patients. A cohort of 10 subjects will
      be studied in Part I followed by interim (go/no-go) analysis of Part A data. On completion of
      an interim analysis of part A data, further cohorts of 8 subjects will then be studied in
      Part B in a parallel design in two or more cohorts (depending upon the data obtained in Part
      A). Approximately 34 HIV-1 infected treatment-naive subjects will be enrolled during the
      study. Subjects in both parts will have a screening visit within 30 days prior to first dose
      and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation
      will be approximately 6 Weeks.
    


Intervention name(s): GSK2838232; Cobicistat
Intervention type(s): Drug; Drug
Intervention description(s): GSK2838232 capsules will be supplied as swedish orange, unmarked capsule (50 mg), and white, unmarked capsules (10 mg) in high-density polyethylene bottles.; Cobicistat tablets 150 mg will be supplied as an orange, round, biconvex, film-coated tablet in bulk containers for individualized dosing.
Intervention MeSH terms: Cobicistat; GSK-2838232
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment