bioihbjkbjnl/mcl2 huggingface dataset:
A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects
Condition: Coronavirus Disease 2019 (COVID-19)
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human (FIH), Phase 1, single-center, randomized, double-blind,
      placebo-controlled, single ascending dose study to evaluate the safety, tolerability, PK and
      immunogenicity of AK119, a humanized monoclonal antibody targeting the CD73. The study will
      consist of 4 cohorts of healthy subjects. Eight subjects will be enrolled per cohort,
      randomized in a 3:1 ratio to receive a single dose of either the active drug AK119 (N=6) or
      matching placebo (N=2). Approximately 32 subjects (24 receiving active drug and 8 receiving
      placebo) will participate in this study.
    


Intervention name(s): AK119; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of AK119 is administered via intravenous infusion to healthy subjects; Single dose of placebo is administered via intravenous infusion to healthy subjects
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Anti-CD73; immunotherapy
Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will study the impact of a strong CYP3A4 inhibitor (itraconazole) on the
      pharmacokinetics of bardoxolone methyl (RTA 402) in healthy adult subjects.

      This is an open-label, fixed-sequence crossover pharmacokinetic (PK) study in healthy
      volunteers.

      Subjects will complete a screening visit within 28 days of Study Day 1. Subjects must qualify
      for the study based on inclusion/exclusion criteria. For Period 1, all qualified subjects
      shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1. For Period 2,
      following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be
      administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone
      methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration).

      Bardoxolone methyl doses will be administered under fasted conditions. Itraconazole will be
      administered under fed conditions on Study Days 15-17, and Study Days 19-27.

      On study Day 18, itraconazole will be administered under fasted conditions. Subjects will be
      confined beginning on Study Day -1 through the last blood sample collection on Study Day 9
      during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 28 during
      Period 2.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Bardoxolone methyl capsules 10 mg; Itraconazole capsules 100 mg
Intervention type(s): Drug; Drug
Intervention description(s): One 10 mg capsule of bardoxolone methyl administered on Study Day 1 (Period 1) of the trial and one 10 mg capsule of bardoxolone methyl administered on Study Day 18 (Period 2) of the trial; Two 100 mg capsules of itraconazole administered once daily during Study Days 15 - 27 (Period 2) of the trial
Other intervention name(s): RTA 402; Sporanox
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Intervention model description: All participants are placed into a one group to receive two interventions: one intervention during Period 1 and a second intervention during Period 2.
For Period 1, all qualified subjects shall receive a single oral dose of bardoxolone methyl (10 mg) on Day 1.
For Period 2, following a washout of 14 days, itraconazole (SPORANOX®) capsules (100 mg) will be administered as a 200-mg single daily dose on Study Days 15 through 27, with bardoxolone methyl (10 mg) administered on Day 18 (1 hour after itraconazole administration)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RTA 402; Bardoxolone methyl; Itraconazole; Sporanox; CYP3A4
Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients
Condition: Gout; Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, Multicenter, Randomized, Double-blind, Placebo controlled, Multiple Dose
      study to evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001
      in Gout Patients with Hyperuricemia.
    

Detailed description: 
      This multiple dose study will include up to 4 cohorts. Each cohort will be comprised of 15
      patients who will be dosed with SAP-001 or placebo once daily (QD) for 28 days. Dose
      escalation from Cohort 1 to Cohort 2 will occur after preliminary data are partially
      unblinded and safety data along with PK and PD parameters are analyzed and reviewed.
      Enrollment in Cohort 3 will begin after the last subject is randomized into Cohort 2.

      Prior to starting enrollment into Cohort 4, a complete safety assessment of Cohorts 1, 2 and
      3 will be performed to select the dose to be used in Cohort 4.
    

Intervention name(s): SAP-001
Intervention type(s): Drug
Intervention description(s): SAP-001 or placebo treatment in a 4:1 randomization ratio
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
Condition: Postsurgical Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this proof of concept study are to evaluate the safety and preventive
      analgesic efficacy of a single preoperative intrathecal administration of AYX1 Injection in
      patients undergoing unilateral total knee arthroplasty.
    


Intervention name(s): Placebo Injection; AYX1 Injection 110 mg; AYX1 Injection 330 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug); 3mL solution for intrathecal injection with 110 mg of AYX1; 3mL solution for intrathecal injection with 330 mg of AYX1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Postsurgical pain; Total knee arthroplasty; Total knee replacement
Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
Condition: Fever
MeSH terms: Fever
Study type: Interventional

Summary: 
      Anticholinergic drugs have traditionally been used for their antisialagogue properties. But
      use of anticholinergic drugs can interfere with thermoregulation via inhibition of the
      parasympathetically mediated sweat secretion. Sweating inhibition can reduce heat
      elimination, and children's thermoregulation depend more on sweating than adults and they can
      become hyperthermic when given these agents.

      The investigators evaluated the fever-causing effects of adjunctive anticholinergics in
      children under general anesthesia using ketamine.
    


Intervention name(s): Glycopyrrolate
Intervention type(s): Drug
Intervention description(s): Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group
Intervention MeSH terms: Glycopyrrolate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Child; outpatient; premedication
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the weight loss effect of lorcaserin during and at the
      end of 1 year of treatment in overweight and obese patients.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of
      lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and
      female volunteers aged 18 to 65 years inclusive.
    

Intervention name(s): Lorcaserin 10 mg once daily (QD); Lorcaserin 10 mg twice a day (BID); Matching Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.; Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.; Matching placebo tablet each morning and evening for a duration of 52 weeks.
Other intervention name(s): APD356; APD356
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Weight loss; lorcaserin; APD356; BLOSSOM; Hypertension; Dyslipidemia; Sleep apnea; glucose tolerance; cardiovascular disease; Arena
Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin
Condition: Gonorrhea
MeSH terms: Gonorrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, parallel, open-label, randomized, cross-over, single-center study with
      zoliflodacin administered as granules for oral suspension with or without food.

      It is planned to enroll 2 cohorts (Cohorts 1 and 2) of 24 subjects each (48 subjects in
      total), with the target of achieving data in 20 evaluable subjects per cohort. Single doses
      of zoliflodacin will be assessed within each cohort in a two period cross-over design.

      Each subject will receive one of the following regimens per period, depending on cohort, in a
      sequence according to the randomization schedule (per cohort, subjects will be randomized
      immediately before dosing in Period 1), separated by a minimum 4 day washout between each
      period. The actual length of washout period may change pending emerging PK data.

      Cohort 1:

        -  Regimen A: 3 g zoliflodacin oral suspension; oral administration after an overnight fast

        -  Regimen B: 3 g zoliflodacin oral suspension; oral administration with a standardized
           high calorie, high-fat breakfast

      Cohort 2

        -  Regimen C: 4 g zoliflodacin oral suspension; oral administration after an overnight fast

        -  Regimen D: 4 g zoliflodacin oral suspension; oral administration with a standardized
           high calorie, high-fat breakfast
    


Intervention name(s): Zoliflodacin; high calorie, high fat breakfast
Intervention type(s): Drug; Other
Intervention description(s): oral suspension; oral administration; fasted/fed conditions
Intervention MeSH terms: Zoliflodacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: It is planned to enroll 2 cohorts of 24 subjects each. Single doses of zoliflodacin (3 g and 4 g) will be assessed within each cohort in a two period cross-over design.
Cohort 1
Regimen A: 3 g zoliflodacin oral suspension; oral administration after an overnight fast
Regimen B: 3 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast
Cohort 2
Regimen C: 4 g zoliflodacin oral suspension; oral administration after an overnight fast
Regimen D: 4 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast
There will be a minimum washout of 4 days between each period.
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Effect of RO4917838 on the QTcF Interval in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This multiple-center, multiple-dose, randomized, double-blind, double-dummy,
      placebo-controlled, positive-controlled, parallel group study will investigate the effect of
      RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to
      one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm C:
      placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and moxifloxacin
      on Day 11. The anticipated time on study treatment is 11 days.
    


Intervention name(s): Moxifloxacin; Moxifloxacin; RO4917838; RO4917838; RO4917838 placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose on Day 1; Single oral dose on Day 11; Multiple daily low doses of RO4917838 for 10 days; Multiple daily oral high doses of RO4917838 for 10 days; Oral daily doses of placebo to RO4917838 for 10 days
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib
      Hydrochloride Cream in patients with mild to moderate psoriasis.
    

Detailed description: 
      Icotinib Hydrochloride is a small-molecule epidermal growth factor receptor (EGFR) tyrosine
      kinase inhibitor, which has been approved for the treatment of advanced nonsmall- cell lung
      cancer (NSCLC) in China in its oral form. As EGFR is implicated in the pathogenesis of
      psoriasis, icotinib hydrochloride is being developed as a cream for the treatment of mild to
      moderate psoriasis. This is a single-center, randomized, doubleblind, placebo-controlled
      study of 0.5%, 1.0%, 2.0%, 4.0% icotinib hydrochloride cream by topical administration.
      Icotinib hydrochloride cream will be applied to subjects with mild to moderate psoriasis.
      Approximately 40 subjects will be enrolled.
    

Intervention name(s): 0.5% Icotinib hydrochloride cream; 1.0% Icotinib hydrochloride cream; 2.0% Icotinib hydrochloride cream; 4.0% Icotinib hydrochloride cream; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Topical administration for twice daily; Topical administration for twice daily; Topical administration for twice daily; Topical administration for twice daily; Topical administration for twice daily
Other intervention name(s): no other name; no other name; no other name; no other name; Blank cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: EGFR inhibitor; topical agent; psoriasis; phase 1
A Study to Examine the Effects of Cosmeceutical Therapy in Subjects Undergoing Full Facial Rejuvenation
Condition: Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers
MeSH terms: Facies
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the efficacy of Sensi Peel®, Rejuvenating
      Serum, and the C&E Strength Max skin care products in subjects who undergo full facial
      rejuvenation, with a botulinum neurotoxin A and/or hyaluronic acid filler, in improving the
      appearance of the skin, patient satisfaction with aesthetic appearance, and the projected
      first impressions.

      The secondary objective of this study is to examine patient satisfaction with the continuous
      use of Sensi Peel®, Rejuvenating Serum, and the C&E Strength Max products.
    


Intervention name(s): Basic Skin Care; Active Skin Care
Intervention type(s): Other; Other
Intervention description(s): Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®); Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)
Other intervention name(s): Group A; Group B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Longterm Effects of Expectations on Mood
Condition: Healthy Participants
Study type: Interventional

Summary: 
      The study tries to identify whether positive expectations, induced with a placebo
      nasal-spray, have short- and longterm effects on participant's mood.
    

Detailed description: 
      Healthy volunteers are informed that a new application method for a well-known antidepressant
      would be tested. They will randomly be assigned to the experimental group (taking the
      antidepressant which is in fact an active placebo) or the control group (not taking a
      placebo). Then participants watch a well established film sequence to induce sadness. Sadness
      is assessed before and after receiving the nasal spray and watching the film sequence. In the
      seven consecutive days the participant's mood is assessed each day, only the experimental
      group is taking the placebo each day. Afterwards participants will watch another sad film
      sequence and sadness will be assessed before and afterwards.
    

Intervention name(s): Placebo
Intervention type(s): Other
Intervention description(s): Placebo nasal spray
Film Sequence
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Arterial Stiffness in Type I Diabetes Mellitus
Condition: Arterial Stiffness in Youth With Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of
      65 children with Type I diabetes mellitus. This prospective, crossover study will help
      determine if there is an acute increase in arterial stiffness in children with Type I
      diabetes mellitus who do not give extra insulin to cover a meal. This will give more support
      to show why it is so critical to bolus every time they eat and to bolus on time to decrease
      cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving
      insulin before a meal compared to not giving insulin before a meal will be associated with
      lower arterial stiffness in children with type I diabetes.
    

Detailed description: 
      The subject will fast overnight (nothing to eat or drink for at least 8 hours). The subject
      will be asked to drink a mixed meal replacement drink (Boost) and will be randomized (like
      flipping a coin) to bolus insulin for the "meal" or to not bolus insulin using their standard
      insulin dose. Glucose will be monitored with a finger prick before they drink the meal
      replacement, 1 hour later and finally 2 hours after drinking the meal replacement.

      Stiffness of the blood vessel of the wrist will be determined using radial tonometry. Radial
      tonometry is safe and does not hurt. A pen like probe is placed on the blood vessel of the
      wrist. When the machine reads a good wave form the computer will calculate the stiffness of
      the blood vessel. This test will be done along with the glucose checks; before drinking the
      meal replacement drink, and 1 and 2 hours after drinking the meal replacement drink.

      During the next study visit, the subject will repeat the exact same study described above.
      However, this time they will receive the other insulin assignment they were assigned during
      the first study (either bolus or no bolus).
    

Intervention name(s): Pre-meal bolus; No meal bolus
Intervention type(s): Drug; Drug
Intervention description(s): Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost; Long Acting insulin as scheduled per usual routine (given once daily)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        University of Florida diabetes clinic and the Florida Camp for Children and Youth with
        Diabetes. Subjects had type 1 diabetes for at least one year, were using a basal-bolus
        insulin regimen, and were not taking oral hypoglycemic agents or antihypertensive drugs.
      
Keywords: type I diabetes; healthy; children; adolescents; young adults
Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions
Condition: Prophylaxis of Organ Rejection
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg
      Capsules under fed conditions.
    


Intervention name(s): mycophenolate mofetil
Intervention type(s): Drug
Intervention description(s): mycophenolate mofetil 250 mg capsule
Other intervention name(s): CellCept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Oxcarbazepine Suspension 600 mg under fed conditions
    


Intervention name(s): Oxcarbazepine
Intervention type(s): Drug
Other intervention name(s): Trileptal
Intervention MeSH terms: Oxcarbazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Cold Exposure on Energy Expenditure
Condition: Cold Exposure
Study type: Interventional

Summary: 
      Cold-induced thermogenesis, or the increase in energy expenditure upon cold exposure,
      indicates metabolic stress, as such, cold-induced thermogenesis may signal an appropriate
      stimulus to improve metabolic health. Cold acclimation may alter cold-induced thermogenesis
      due to changes in (non)shivering thermogenesis and blood flow. The main aim of this research
      is to compare the energy expenditure responses, during a standardised cold stress (~ 9°C air
      temperature, maximum 1 hour), of Siberian adults with Western European adults. The subjects
      will be individually matched for age, sex, body mass and height. It was hypothesised that
      cold-induced thermogenesis will be reduced in the Siberian population.
    


Intervention name(s): Cold exposure
Intervention type(s): Other
Intervention description(s): Cold air exposure (~ 9°C, maximum 1 hour duration)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cold exposure; Energy expenditure