bioihbjkbjnl/mcl2 huggingface dataset:
Staccato Loxapine Single Dose PK
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to assess the safety, tolerability and pharmacokinetics of a
      single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy
      volunteers.
    

Detailed description: 
      Safety and pharmacokinetic data obtained from 50 subjects (between the ages of 18 to 55
      years) entered into this randomized, placebo-controlled study. To obtain 50 enrolled
      subjects, screening procedures and inclusion/exclusion criteria were evaluated for 126
      subjects during a variable screening period of up to 21 days. Once enrolled, subjects were
      randomized to either Staccato Loxapine or Staccato placebo.

      Plasma samples for pharmacokinetic analysis were collected beginning on Day 0, pre-dose and
      continuing for 24 hr post dose. Blood samples for the PK analysis of loxapine and its
      metabolites (8-OH loxapine, 7-OH loxapine and amoxapine) were obtained at time 0 (immediately
      before dosing), at 30 sec, 1, 2, 3, 5, 10, 30, 45 min, 1, 2, 4, 6, 12, 24 hr after dosing.
      Plasma concentrations of loxapine and metabolites were used to estimate the following PK
      parameters for loxapine and its metabolites: area under the plasma concentration time curve
      from time 0 extrapolated to infinity (AUCinf), AUC from time 0 to time tlast, the last
      quantifiable concentration (AUClast), maximum observed plasma concentration (Cmax), observed
      time of Cmax (tmax), terminal phase elimination rate constant (ke), apparent terminal
      elimination half life calculated from ke (T½ ), apparent total body clearance / fraction
      absorbed calculated from AUCinf and dose (CL/F) (for loxapine and the metabolites where
      permitted by measurable concentrations).

      Safety was evaluated by the incidence of adverse events, clinical laboratory testing (blood
      chemistry, hematology, and urinalysis), physical examination, vital signs, pulse oximetry,
      postural vital signs, 12-lead electrocardiogram, pulmonary function tests, continuous 12-lead
      Holter monitoring, sedation assessments, akathisia assessments.
    

Intervention name(s): inhaled Loxapine 0.625 mg; inhaled Loxapine 1.25 mg; inhaled Loxapine 2.5 mg; inhaled Loxapine 5 mg; inhaled Loxapine 10 mg; inhaled Placebo (0 mg)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single 0.625 mg (lowest) dose of inhaled loxapine; Single 1.25 mg (2nd) dose of inhaled loxapine; Single 2.5 mg (3rd) dose of inhaled loxapine; Single 5 mg (4th) dose of inhaled loxapine; Single 10 mg (5th) dose of inhaled loxapine; Single placebo dose of inhaled loxapine
Other intervention name(s): ADASUVE; ADASUVE; ADASUVE; ADASUVE; ADASUVE; PLACEBO
Intervention MeSH terms: Loxapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia, Staccato Loxapine
Vascular Effects of Attention Deficit Hyperactivity Disorder (ADHD) Medications in Youth
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      4.4 million children and adolescents in the United States have been diagnosed with attention
      deficit hyperactivity disorder (ADHD) and more than half are treated with medication. Most
      ADHD medications are stimulants, which activate the sympathetic nervous system (SNS). SNS
      activation is closely associated with vascular functional and mechanical abnormalities.
      Therefore, ADHD medications, via instigating SNS activation and altering the hemodynamic
      profile, may have untoward effects on the vasculature and increase risk of developing
      cardiovascular disease in children and adolescents who use them.

      Our overall objective in this study is to determine whether ADHD medication use is associated
      SNS activation, endothelial dysfunction, and arterial stiffness in children and adolescents.
      We will address this objective by conducting a case-control study and obtain non-invasive
      measures of SNS activation, endothelial function, and arterial stiffness in children and
      adolescents (8-17 years old) with (using stimulant medication) and without ADHD.
    

Detailed description: 
      SPECIFIC AIMS AND HYPOTHESES

      Our overall objective in this study is to determine whether ADHD medication use is associated
      SNS activation, endothelial dysfunction, and arterial stiffness in children and adolescents.

      Our hypothesis is:

      Children and adolescents taking ADHD medications will have higher SNS activation, lower
      digital reactive hyperemia, and higher pulse wave velocity and aortic augmentation index
      compared to sibling controls without ADHD.

      Study Design We will obtain non-invasive measures of SNS activation (heart rate variability),
      endothelial function (digital reactive hyperemia and brachial artery flow-mediated dilation),
      and arterial stiffness (carotid-radial pulse wave velocity; aortic augmentation index) in
      youth taking ADHD stimulant medication and in their healthy siblings without ADHD.

      Study visits will be conducted at the Clinical and Translational Science Institute (CTSI) at
      the University of Minnesota. All vascular testing will occur in the Vascular Biology
      Laboratory within the CTSI.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Eighty youth who are taking ADHD stimulant medication and eighty of their healthy siblings
        without ADHD.
      
Keywords: ADHD
Effect of Ertugliflozin on Cardiac Function in Diabetes
Condition: Type2 Diabetes; Heart Failure
MeSH terms: Heart Failure; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to investigate the beneficial role of ertugliflozin, a new SGLT2
      inhibitor, in cardiac function via measuring GLS as well as other hemodynamic factors using
      echocardiogram in patients with T2D and HF, who are not controlled with oral antidiabetic
      medications including DPP4 inhibitors.
    

Detailed description: 
      This study is a phase 3, randomized, double-blind, active-competitor, parallel-group study
      that is anticipated to enroll 120 patients. Patients taking metformin and/or DPP4 inhibitors
      as per local label for ≥12 weeks without a dose adjustment before enrollment will be eligible
      for screening. All patients will have a screening period comprised of an up to 2-week
      screening phase prior to randomization. In order to qualify for randomization, patients must
      demonstrate compliance based upon pill count (80%) and discretion of the investigators during
      the Run-in phase.

      Glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) will be masked to patients after
      randomization. To prevent partial unblinding, urinary glucose excretion (UGE) results will be
      masked to patients. Urine glucose, albumin, calcium, and creatinine will be measured
      separately on-site visits.
    

Intervention name(s): Ertugliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ertugliflozin as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes; Placebo as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes
Other intervention name(s): Steglatro
Intervention MeSH terms: Ertugliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 2 diabetes; heart failure; ertugliflozin; Global longitudinal strain (GLS)
Naloxone, Hypoglycemia and Exercise
Condition: Diabetes Mellitus, Type 1
MeSH terms: Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective of this project is to determine if the intranasal administration of
      naloxone during exercise will be a novel approach to preserve the counterregulatory response
      to hypoglycemia experienced the next day in patients with type 1 diabetes. Exercise induced
      autonomic failure contributes to the development of impaired awareness of hypoglycemia.
      Treatments that blunt the consequences of exercise induced autonomic failure, such as
      preserving the post-exercise counterregulatory response to hypoglycemia, may improve
      awareness of hypoglycemia. Naloxone, an opioid antagonist, is an extremely promising agent.
      In healthy volunteers, intravenous administration of naloxone during exercise preserved the
      counterregulatory response to hypoglycemia the following day (1). In this study,
      investigators will extend the clinical applicability by administering intranasal naloxone to
      individuals with type 1 diabetes. Specifically, the investigators will use a randomized,
      placebo controlled, crossover design to administer drug or placebo to patients with type 1
      diabetes during acute exercise and assess the counterregulatory response to hypoglycemia the
      following day. The use of intranasal naloxone is a highly innovative aspect of this proposal.
      Intranasal naloxone translates readily to clinical use and, as demonstrated by the
      investigators preliminary data, achieves similar plasma drug concentrations as after IV
      administration.
    


Intervention name(s): Naloxone then placebo; Placebo then Naloxone
Intervention type(s): Drug; Drug
Intervention description(s): naloxone intranasal 4mg, then placebo; placebo then naloxone intranasal 4mg
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Role of High Density Surface ECG in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
Condition: Arrhythmogenic Right Ventricular Cardiomyopathy
MeSH terms: Cardiomyopathies; Arrhythmogenic Right Ventricular Dysplasia
Study type: Interventional

Summary: 
      The diagnosis of Arrhythmogenic right ventricular cardiomyopathy can be difficult. The 80
      lead ECG may increase the specificity and sensitivity in diagnosing this potentially life
      threatening inherited cardiac condition. This pilot would form the basis of a much larger
      clinical trial to test the utility of this novel diagnostic tool.
    


Intervention name(s): 80 lead ECG
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this study are to evaluate the efficacy of filgotinib in the
      induction and maintenance treatment of moderately to severely active ulcerative colitis (UC)
      in participants who are biologic-naive and biologic-experienced.

      Participants who complete the study, or met protocol specified efficacy discontinuation
      criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead
      Study GS-US-418-3899: NCT02914535).
    


Intervention name(s): Filgotinib; PTM filgotinib
Intervention type(s): Drug; Drug
Intervention description(s): Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Other intervention name(s): GS-6034; GLPG0634
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005)
Condition: Pain, Postoperative; Tooth Extraction
MeSH terms: Toothache; Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to evaluate the safety and tolerability of the drug and to
      evaluate its efficacy compared to placebo and to ibuprofen in the treatment of postoperative
      dental pain in male patients.
    


Intervention name(s): MK2295
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dental Pain, Postoperative
Safety and Pharmacokinetics of Hemay005 In Healthy Male Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the
      treatment of psoriasis. This study is the first administration of Hemay005 in humans to
      establish the initial safety, tolerability, and pharmacokinetic profile following single
      doses of Hemay005. A total of approximately 44 subjects will be randomized into 6
      cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg), approximately 8 healthy subjects will be
      enrolled (6 active and 2 placebo) at each dose cohort by sentinel method(1 active and 1
      placebo,5 active and 1 placebo), with the exception of 10mg (4 active) cohort. This study
      includes an 28-day Screening Period, a 1-day Treatment Period, and an End of Study Visit
      occurring approximately 11days (±3 days) after study drug administration.
    


Intervention name(s): Hemay005; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized into 6 cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg) orally single dose; Subjects will be randomized into 5 cohorts(20mg, 40mg, 80mg, 120mg, 180mg) orally single dose
Intervention MeSH terms: Hemay005
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MicroRNAs as Biomarkers of Pain Intensity in Patients With Chronic Fatigue Syndrome (CFS)
Condition: Chronic Fatigue Syndrome (CFS)
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue; Pain
Study type: Observational

Summary: 
      MicroRNAs were shown to play an important role in regulating pain-processing in a wide range
      of experimental models and clinical pain disorders. Thus, the aim of the present study is to
      evaluate a set of Micro-RNAs as diagnostic biomarkers of pain intensity in adolescents with
      chronic fatigue syndrome (CFS) and to correlate with inflammatory markers and pain related
      comorbidities.
    

Detailed description: 
      The present study was performed to evaluate a set of Micro-RNAs as diagnostic biomarkers of
      pain intensity in adolescents with chronic fatigue syndrome (CFS) and to correlate with
      inflammatory markers and pain related comorbidities. Thus, a total of 150 adolescents aged
      (12-18 years) were invited to participate in this study. They are classified into two groups;
      adolescents with CFS (n=100) and healthy control (n=50). RT-PCR and immunoassay analysis were
      used to estimate miRNAs (miR-558, miR-146a, miR-150, miR-124, and miR-143) and
      immune-inflammatory markers (IL-6, TNF-α, COX-2) respectively.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A total of 150 adolescents aged (12-18 years) were invited to participate in this study.
        Based on CFS diagnosis, participants were classified with CFS (n=100) and healthy controls
        (n=50). adolescents who had constant or persisting fatigue lasting 3 months with the severe
        functional disability to such extent that prevents normal school attendance and also had no
        drug prescriptions (including hormone contraceptives), any medical or psychiatric disorder
        that might explain the fatigue were included in this study.
      
Biospecimen description: 
      Blood was collected from all subjects and serum samples were obtained following
      centrifugation for 1 min. at 1400 rpm, were given a coded study identification number, and
      were shipped frozen at 20° C for analysis
    
Keywords: MicroRNAs; Chronic fatigue syndrome; Pain intensity
The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Nonalcoholic Fatty Liver Disease
Condition: Fatty Liver; Fatty Liver, Nonalcoholic
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria
      multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease
      (NAFLD).
    

Detailed description: 
      In a randomized double-blind placebo-controlled clinical trial Shirazi's Thyme is compared
      with placebo. Investigators select randomly 90 patients with NAFLD by inclusion criteria.
      Investigators measure anthropometric and laboratory parameters including fasting blood sugar,
      insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90
      days later. Patients are divided into two equal groups. Intervention group in addition to
      diet and exercise recommendations receive capsules containing 700 mg of Shirazi thyme powder
      daily for 90 days. Placebo group in addition to the same recommendations for diet and
      exercise, receives placebo capsules twice daily.
    

Intervention name(s): Thyme; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Thyme capsule 350 mg twice daily; Placebo capsule 350 mg twice daily
Other intervention name(s): Shirazi's Thyme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thymus Plant; Multiflotriol [Supplementary Concept]; Zataria multiflora; Complementary Therapies; Herbal Medicine; Medicine, traditional
Study of Multiple-dose Kukoamine B Mesilate in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, tolerance and pharmacokinetics of
      Multiple-dose Kukoamine B Mesilate in healthy volunteers
    


Intervention name(s): Kukoamine B Mesilate; placebo multiple doses
Intervention type(s): Drug; Drug
Intervention description(s): Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy
A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, double-blind, placebo-controlled phase 1 clinical trial to
      evaluate the safety, tolerability and pharmacokinetic characteristics of GLH8NDE after single
      and multiple ocular administrations in healthy Korean and Caucasian volunteers
    


Intervention name(s): 5% GLH8NDE; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 5% GLH8NDE as eye drops; Placebo as eye drops
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study design:

      This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4
      groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of
      HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a
      single dose of a currently marketed PEG-interferon.
    

Detailed description: 
      Primary objective:

      to study the safety and tolerability of HM10660A, including immunogenicity, as compared to
      PEG-interferon alpha-2a

      Secondary objective:

      to study the pharmacokinetics and pharmacodynamics of HM10660A as compared to PEG-interferon
      alpha-2a
    

Intervention name(s): HM10660A; HM10660A placebo; Pegasys
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg; Single dose of HM10660A Placebo; Single dose of Pegasys 180ug
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure
Condition: Cardiorenal Syndrome
MeSH terms: Cardio-Renal Syndrome; Heart Failure
Study type: Interventional

Summary: 
      Although the traditional determinant of renal dysfunction in heart failure was suggested as
      decreased cardiac output and renal hypo perfusion, recent studies have demonstrated the
      association of persistent systemic venous congestion and kidney dysfunction. Relief of the
      congestion has demonstrated to improve renal functions in decompensated heart failure. The
      current trial was set up to investigate the changes of renal venous impedance and renal
      arteriolar resistivity indices with diuretic therapy, in patients with congestive renal
      failure. The investigators asked whether measurement of renal venous impedance index or renal
      arteriolar resistivity index can guide the practice of diuretic therapy.
    


Intervention name(s): intravenous furosemide
Intervention type(s): Drug
Intervention description(s): Decongestant therapy for decompensated heart failure which may be administrated as intravenous bolus or infusion
Other intervention name(s): Lasix
Intervention MeSH terms: Furosemide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: cardiorenal syndrome, decompensated heart failure, renal resistivity index, venous impedance index, kidney failure