bioihbjkbjnl/mcl2 huggingface dataset:
Exercise to Restore 24h Rhythms in Metabolism
Condition: Diabetes Mellitus, Type 2; Insulin Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      This study will investigate the effect of exercise training on 24h rhythms in substrate
      metabolism in overweight subjects with impaired glucose tolerance. Subjects will perform
      exercise training for 12 weeks. Before and after the exercise period, they will be admitted
      to research facilities for 45 hours to assess 24h rhythms in substrate metabolism. In a
      single-arm longitudinal design, subjects will serve as their own control.
    

Detailed description: 
      Recent evidence shows that pre-diabetes is characterized by marked alterations in 24h
      substrate metabolism, indicating metabolic inflexibility with an inability to fully switch to
      fat oxidation during the night. Whereas exercise has been shown to promote mitochondrial
      function and insulin sensitivity, it is unknown to if exercise training is able to restore
      24h rhythmicity in overall substrate metabolism and muscle metabolism in human subjects with
      pre-diabetes.

      In this single-arm longitudinal design, subjects will serve as their own control. Subjects
      will perform high-intensity interval training for 12 weeks (3x times per week) on a cycle
      ergometer at the research facility. Pre and post exercise, subjects will stay in a metabolic
      chamber and adhere to a relatively normal life-style in order to standardize the main 24h
      measurement period. As the primary outcome, substrate metabolism will be measured with a
      ventilated hood system and by indirect calorimetry in the chambers. Muscle biopsies from the
      vastus lateralis and frequent blood samples will also be taken over the course of the 24h.
      Thereby, ex-vivo skeletal muscle mitochondrial function and muscle clock gene expression will
      serve as the main secondary outcomes.
    

Intervention name(s): High-intensity interval training
Intervention type(s): Behavioral
Intervention description(s): 3 times per week high-intensity interval training (HIIT) will be performed on a cycle ergometer for 12 weeks adding up to 36 HIIT sessions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Circadian rhythm
Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers
Condition: Obesity
Study type: Interventional

Summary: 
      Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes
      in the food industry and are also recommended to diabetic patients. Both substances are
      already in use in the food industry and are freely available. Since the 1970s, beneficial
      effects on oral health could be demonstrated as oral bacteria were influenced positively. A
      pilot study recently undertaken in the US (Flint N, 2014) has shown that diabetics profit
      from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the
      blood vessels. In this trial, investigators aim to examine whether this effect can be found
      in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.
    


Intervention name(s): E967-Xylitol; E968-Erythritol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 24g xylitol/d; 36g erythritol/d
Intervention MeSH terms: Erythritol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a Phase 0, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to assess
      the changes in ERP Biomarkers in Healthy Volunteers before and after administration of a
      sub-anesthetic dose of ketamine. Primary objectives are to quantify the effect size of
      ketamine-induced changes on MMN from a duration-deviant auditory oddball ERP test and to
      quantify the variability of ketamine-induced changes on MMN from a duration-deviant auditory
      oddball ERP test.
    

Detailed description: 
      The effects of ketamine and similar compounds on brain function have become of significant
      interest to pharma companies in the past few years. These effects are often used as a model
      for the glutamatergic hypofunction hypothesis of schizophrenia and therefore drugs targeting
      schizophrenia are being trialed to reverse or block the effects of ketamine. Esketamine has
      been recently approved as a potent treatment for depression so many pharma companies are
      trying to leverage ketamine-like modulation of the NMDA receptors as novel targets for
      depression.

      This heightened focus on NMDAr modulators has lead industry and academia to advance methods
      to measure these effects. Many studies have been performed using EEG and ERP techniques to
      measure the effect on brain function of ketamine administration but no study has been
      performed, to our knowledge, that has attempted to measure the variability and
      reproducibility of these effects. Furthermore, there is some evidence from the scientific
      literature and from unpublished results from industry-sponsored studies that ketamine may
      have a disordinal effect on various electrophysiologic measures, particularly the amplitude
      of the mismatch negativity (MMN) from an auditory oddball ERP test.

      In this study we will run various EEG/ERP tests on participants during a placebo
      administration and during two ketamine administrations separated by washout periods. This
      will allow, for the first time, the evaluation of the test-retest variability of a range
      ERP/EEG measures under ketamine administration vs placebo. This may also allow us to test the
      hypothesis that ketamine has a disordinal effect on different subjects and this disordinality
      can be predicted from a baseline (placebo) measurement.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Ketamine IV administration
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single Dose, Placebo-Controlled, 3-Arm Crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Event-related potential; Electroencephalogram; ERP; EEG; Ketamine; Mismatch Negativity; MMN; N100; P3a; P3b; P300
Effects of Erector Spinae Plane Block Method Used in Pain Management in Heart Surgery on Vascular Diameters
Condition: Coronary Artery Disease; Erector Spinae Plane Block; Bypass Extremity Graft
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Off-pump coronary artery bypass grafting (OPCABG) is a bypass method performed on the working
      heart. Pain is a frequently seen side effect experienced following this surgery. Erector
      spinae plane block is our analgesia method that the investigators routinely perform prior to
      the surgery to overcome this problem. In this method, analgesic medication is given via a
      needle in between the two superficial muscle groups (erector spinae muscles) located in
      participants back. The investigators believe this method not only provides pain relief, but
      also is beneficial (dilating) on the vessels that will be used for bypassing the clogged
      vessels during the surgery. The investigators aimed to measure some parameters in this
      routine procedure before and after performing the analgesic method with an ultrasound
      (imaging with sound waves).
    


Intervention name(s): Erector Spinae Plane Block
Intervention type(s): Procedure
Intervention description(s): One researcher will record the artery images as explained in the protocol and two researchers will measure the radius and area of those vessels separately. Researchers who are measuring the radius and area of vessels won't know whether those images belong to pre or post- ESP block. The results two researchers measure will be compared statistically and if there are no statistically significant differences, the mean value of their separate recordings will be taken into account for the statistical analysis.
Other intervention name(s): Bupivacaine
Intervention MeSH terms: Bupivacaine
Intervention model: Single Group Assignment
Intervention model description: The study is planned as prospective. Aged between 18-75, ASA III risk group and are undergoing off pump coronary artery bypass grafting surgery are selected for the study. Who are allergic to planned-medications, chronic opioid or opioid receptor agonist users, those with preoperative neuropathies, psychiatric diseases will be excluded. Electrocardiography and pulse oximetry monitorization is performed in the recovery room where a peripheric intravenous line is opened afterwards. High frequency (12-24 MHz) linear probe is used for measurements. Images will be recorded by USG from the 3., 4. and 5. intercostal spaces for the LIMA and RIMA and 3cm proximal to the wrist for the right and left radial arteries. After images are saved, the researcher will perform ESP block with USG. ESP block will be performed to right and left sides equally with 40ml %0.25 bupivacaine in total. Artery images will be recorded again by the same researcher after 45 minutes.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cardiac anesthesia; Sympathectomy; Off-pump coroner artery by-pass surgery
Study in Healthy Males to Assess Bioavailability of Single Fostamatinib With iv Micro Tracer Dose
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer
      dose.
    

Detailed description: 
      A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with
      Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers.
    

Intervention name(s): Fostamatinib; Fostamatinib
Intervention type(s): Drug; Drug
Intervention description(s): Fostamatinib 50 mg tablet; Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy male volunteers; pharmacokinetics; fostamatinib; Bioavailability; R406 plasma AUC and Cmax; R406 plasma AUC0-t; t1/2λz; tmax
Study to Assess the Taste Profile of Different ALS-008176 Oral Liquid Formulations in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate in a double-blinded fashion the taste and overall
      acceptability profile of different ALS-008176 oral liquid formulations as compared to the
      reference formulation (ALS-008176: 60 milligram per milliliters (mg/mL) oral suspension
      without sweetener/flavor) for pediatric clinical development and commercialization.
    


Intervention name(s): Formulation A (ALS-008176); Formulation B (ALS-008176); Formulation C (ALS-008176); Formulation D (ALS-008176); Formulation E (ALS-008176); Formulation F (ALS-008176); Formulation G1 (ALS-008176); Formulation G2 (ALS-008176); Formulation G3 (ALS-008176); Formulation H1 (ALS-008176); Formulation H2 (ALS-008176); Formulation H3 (ALS-008176)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Reference formulation, 60 mg/mL ALS-008176 oral suspension without sweetener/flavor.; 60 mg/mL ALS-008176 oral suspension containing 12 mg/mL sucralose.; 60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and strawberry flavor.; 60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and masking flavor and strawberry flavor.; 60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and masking flavor and cream vanille flavor.; 60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and fantasy fruit flavor.; 60 mg/mL ALS-008176 oral suspension with concentration 1 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.; 60 mg/mL ALS-008176 oral suspension with concentration 2 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.; 60 mg/mL ALS-008176 oral suspension with concentration 3 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.; 60 mg/mL ALS-008176 oral suspension with concentration 1 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.; 60 mg/mL ALS-008176 oral suspension with concentration 2 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.; 60 mg/mL ALS-008176 oral suspension with concentration 3 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Nortriptyline for Idiopathic Gastroparesis
Condition: Idiopathic Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 3

Summary: 
      The principal objective of this multicenter, randomized, placebo-controlled trial is to
      evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared
      with placebo.
    


Intervention name(s): Nortriptyline Hydrochloride; Placebo (for nortriptyline)
Intervention type(s): Drug; Drug
Intervention description(s): Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week; Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;
Other intervention name(s): Nortriptyline HCl; Pamelor
Intervention MeSH terms: Nortriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: idiopathic gastroparesis
ORAL T-6: Oral Androgens in Man-6
Condition: Contraception; Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      We propose a study to determine the single-dose pharmacokinetics of these two novel
      formulations of testosterone in normal men with experimentally induced hypogonadism.
    

Detailed description: 
      This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of
      oral testosterone (T), in normal men whose endogenous T production has been temporarily
      suppressed by the administration of the potent GnRH antagonist Acyline. We will be
      determining the relative pharmacokinetics of six different oral formulations of T in both
      rapid and slow release compared to the immediate release preparation studied previously by
      our group.
    

Intervention name(s): Acyline; Testosterone; Finasteride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300 mcg/kg; 24 hours after acyline administration on Day 2 "immediate release" Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.; 1 mg PO once daily [day -2 to day 12) 14 days total
Other intervention name(s): Oral Testosterone; Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo,; Prosteride, Gefina, Appecia, Finasterid IVAX, Finasterid Alternova,; Hyplafin, Penester, Finpros, Tectum, Prezepa
Intervention MeSH terms: Methyltestosterone; Finasteride; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Acyline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male Contraception; Hypogonadism; Testosterone
A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers
Condition: Pharmacodynamics; Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate
      safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy
      male volunteers
    

Detailed description: 
      -  To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the
           pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers.

        -  To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy
           male volunteers.
    

Intervention name(s): Tegoprazan; Revaprazan
Intervention type(s): Drug; Drug
Intervention description(s): Tegoprazan QD for 7 days; Revaprazan QD for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Iron Bioavailability From MyPyramid Menus
Condition: Nonheme Iron Absorption
Study type: Interventional

Summary: 
      This study will measure nonheme iron absorption from each of the 7 daily MyPyramid menus.
      Such measurements will confirm whether modifications are needed to meet dietary iron
      recommendations and will provide data useful for validation algorithms to calculate dietary
      iron bioavailability.
    

Detailed description: 
      Nonheme iron absorption is measured with 59Fe tracer added to a 1-day menu, with iron
      retention detected two weeks later in a whole body scintillation counter. Each subject has
      iron absorption measured from each of 7 1-d menus formulated to meet the US dietary
      guidelines (MyPyramid menus), with the order of menus randomly assigned. Each subject
      participates for 14 wk to test all 7 menus.
    

Intervention name(s): My Pyramid menu days 1, 2, 3, 4, 5, 6 or 7
Intervention type(s): Behavioral
Intervention description(s): Iron absorption measured from one of seven different menus fed for 1 day each, in randomized order for each subject, with feedings separated by 2 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: iron absorption; iron requirements; dietary guidelines; MyPyramid
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered
      subcutaneously in HIV-seropositive patients.
    

Detailed description: 
      Patients are randomized to receive P3C541b or placebo within each of two study groups.
      Enrollment in the first group will be independent of HLA type, whereas all but two of the
      patients enrolled in group 2 must have one or more HLA types A33, B8, B27, or Bw62. Treatment
      in group 2 will not begin until those in group 1 have reached day 14 without serious
      toxicity.
    

Intervention name(s): P3C541b Lipopeptide
Intervention type(s): Biological
Primary purpose: Treatment
Keywords: Vaccines, Synthetic; AIDS Vaccines
Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101
Condition: Caries,Dental
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetic (PK) study of L-arginine after exaggerated oral use of the novel dentifrice
      product COL101 after repeated daily applications in healthy adult subjects.
    


Intervention name(s): L Arginine; Sodium Fluoride
Intervention type(s): Drug; Drug
Intervention description(s): toothpaste; toothpaste
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arginine
A Study of Evacetrapib in Healthy Female Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives
      (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones
      found in the blood will be measured and compared when taken alone and when taken with
      evaceptrapib. Each woman will participate in two study periods. Information about any side
      effects that may occur will also be collected.
    


Intervention name(s): Ortho-Cyclen; Evacetrapib
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Other intervention name(s): LY2484595
Intervention MeSH terms: Moxifloxacin; Evacetrapib; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Phase 1/2a Clinical Trial to Assess the Safety of HB-adMSCs for the Treatment of Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Hope Biosciences is conducting a research study of an investigational product called Hope
      Biosciences autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as a
      possible treatment for Rheumatoid Arthritis (RA). The study purpose is to evaluate the safety
      profile of a single IV infusion of HB-adMSCs in subjects with clinical diagnosis of RA.
    

Detailed description: 
      This is a Phase 1/2a, open-label, single-dose study in subjects with active Rheumatoid
      Arthritis (RA). 12-15 patients will be enrolled for the study. The overall objective of this
      study is to evaluate the safety profile of a single IV infusion of autologous adipose-derived
      mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA. The primary
      endpoint of this study is to measure the number and frequency of adverse event(s) and/or
      severe adverse event(s) throughout the study duration. The second endpoint of this study is
      to evaluate the ability of HB-adMSCs to alter RA-related inflammation via measuring levels of
      Tumor Necrosis Factor alpha (TNF-a), Interleukin-6 (IL-6), C-Reactive Protein (CRP),
      Erythrocyte Sedimentation Rate (ESR) and Joint Count 66/68 after a single infusion of
      autologous HB-adMSCs for up to 12-month post-infusion.
    

Intervention name(s): HB-adMSCs
Intervention type(s): Biological
Intervention description(s): Hope Biosciences autologous adipose-derived mesenchymal stem cells
Intervention model: Single Group Assignment
Intervention model description: A single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arthritis; stem cells; MSCs; adipose MSCs