bioihbjkbjnl/mcl2 huggingface dataset:
Osteoclast Inhibition and Bone Formation
Condition: Bone Loss; Aging
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This protocol addresses: 1) How gene expression changes in bone cells are affected by aging?
      2) Is aging associated with decreased signaling between bone cells? 3) How does treatment
      with the osteoporosis medication denosumab affect bone cell signaling?
    

Detailed description: 
      This protocol collectively addresses the following goals: 1) What are the changes in gene
      expression in osteoblasts and osteocytes that lead to impaired bone formation with aging; 2)
      Since recent work from the investigators' group has demonstrated that osteoclasts produce a
      number of growth factors and cytokines (coupling factors) that enhance osteoblast
      proliferation and/or differentiation, is aging associated with reduced osteoclast coupling
      factor production; and 3) If osteoclasts are markedly reduced using the FDA-approved
      medication for osteoporosis, denosumab, how does that effect the quantity of coupling factors
      in the bone microenvironment and the target genes of these coupling factors in osteoblasts?
    

Intervention name(s): placebo; denosumab
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous saline injection; single subcutaneous injection of denosumab 60 mg
Other intervention name(s): saline; Prolia
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: adrenergic
A Study of LY3009104 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a 2-part, randomized, participant- and investigator-blind study in healthy males
      and females.

      Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that
      yields drug exposures slightly exceeding typical exposures anticipated from repeated
      administration of an efficacious dose to participants. The concentration of the drug in the
      blood stream will be measured and information about any side effects that may occur will also
      be collected.

      Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the
      heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral
      dose.
    


Intervention name(s): LY3009104; Placebo; moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): administered orally; Administered orally; Administered orally
Other intervention name(s): Baricitinib
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
N600X Low Saturation Accuracy Validation
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      To compare pulse oximetry saturation measurements, during normal to low saturation, to
      saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood
      samples from healthy human subjects.
    

Detailed description: 
      The study utilizes a single-site, physiology laboratory (Clinimark) to conduct this Post
      Market, non-randomized, prospective studies. The goal is to enroll a minimum of fifteen
      subjects. Subject pool goal of diversity across ethnicity, race and sex of varying skin tones
      to meet the study design requirements.

      The general purpose of Invasive Controlled Desaturation Studies is to support the SpO2
      accuracy of the post market pulse oximetry sensors and paired monitor in comparison to
      reference-standard measurements of blood SaO2 by a CO-oximeter during low saturation
      conditions. This is achieved through paired observations of SpO2 and SaO2 values over the
      specified SpO2 accuracy range of 60% to 100% SaO2 of the pulse oximeter on a group of healthy
      adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied
      to achieve a series of targeted steady-state saturation periods. Arterial blood samples are
      periodically taken from an indwelling arterial catheter for use in the comparison. Pulse rate
      accuracy will be evaluated during the same data collection period as SpO2. Pulse rate will be
      compared to reference ECG heart rate.
    

Intervention name(s): Non-Invasive Controlled Hypoxia
Intervention type(s): Device
Intervention description(s): Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation.
Other intervention name(s): Desaturation; Blood Sampling
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study Population

        The study population includes a 15 healthy non-smoking competent adults 18-50 years of age.
        With an aim of diversity across ethnicity, race and sex of varying skin tones.
      
Keywords: Oxygen Saturation; Invasive Controlled Desaturation; Pulse Oximetry; Desaturation of Blood
A Clinical Study to Assess the Effect of Change of Bile Acid on the PD and Safety of Metformin and Microbiome Profiles
Condition: Human Microbiome
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is intended to evaluate the effect of change of bile acid pool with
      cholestyramine on the pharmacodynamics and safety of metformin and intestinal microbiome
      profiles in healthy volunteers
    


Intervention name(s): Cholestyramine Resin
Intervention type(s): Drug
Intervention description(s): Change bile acid pool by cholestyramine treatment
Intervention MeSH terms: Cholestyramine Resin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to prove whether general anesthesia combined with epidural
      anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general
      anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the
      prognosis.
    


Intervention name(s): epidural anesthesia; general anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients received general anesthesia for surgery
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anesthesia; T-helper; MDSCs; Colorectal cancer; Fast track
The Immediate Effects of Intermittent Theta Burst Stimulation on Intracortical Excitability of the Primary Motor Cortex in Patients With Chronic Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study is to investigate the immediate effects of intermittent theta burst stimulation
      (iTBS) on intracortical excitatory and inhibitory circuits, neural connectivity, and network
      properties in patients with chronic stroke, using transcranial magnetic stimulation and
      electroencephalogram (TMS-EEG) and TMS-electromyography (EMG) and approaches.
    

Detailed description: 
      The neurophysiological effect of intermittent theta burst stimulation (iTBS) has been
      examined with TMS-electromyography (EMG)-based outcomes in healthy people; however, its
      effects in intracortical excitability and inhibition are largely unknown in patients with
      stroke. Concurrent transcranial magnetic stimulation and electroencephalogram (TMS-EEG)
      recording can be used to investigate both intracortical excitatory and inhibitory circuits of
      the primary motor cortex (M1) and the property of brain networks.

      This study is to investigate the immediate effects of iTBS on intracortical excitatory and
      inhibitory circuits, neural connectivity, and network properties in patients with chronic
      stroke, using TMS-EEG and TMS-EMG approaches.

      In this randomized, sham-controlled, crossover study, 21 patients with chronic stroke receive
      two separate stimulation conditions: a single-session iTBS or sham stimulation applied to the
      ipsilesional M1, in two separate visits, with a washout period of five to seven days between
      the two visits after crossover. A battery of TMS-EMG and TMS-EEG measurements are taken
      before and immediately after stimulation during the visit.
    

Intervention name(s): Intermittent theta burst stimulation (iTBS); Sham intermittent theta burst stimulation (iTBS)
Intervention type(s): Device; Device
Intervention description(s): A single-session standard 600-pulse intermittent theta burst stimulation (iTBS) is applied to the ipsilesional primary motor cortex.; The sham stimulation is the same as that of iTBS, but the coil is placed five centimeters away from the scalp. Electrical field simulation shows that the setups for sham stimulation would not induce any valid cortical activation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: stroke; theta burst stimulation; transcranial magnetic stimulation-evoked potentials; intracortical inhibition; cortical excitability
Benznidazole Absorption, Metabolism and Excretion Study
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I ADME study will be conducted to evaluate the pharmacokinetics of benznidazole.
    

Detailed description: 
      This will be a single-site, open-label, non-randomized, single oral dose absorption,
      metabolism and excretion study in healthy male subjects. Potential subjects will be screened
      to assess their eligibility to enter the study within 28 days prior to dosing on Day 1.
      Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1. Subjects will be
      confined to the CRU until at least Day 11 (240 hours postdose), and will be discharged from
      the CRU on Day 11 if all the following discharge criteria are met: >90% mass balance
      recovery; OR plasma/blood radioactivity levels below the limit of quantitation for 2
      consecutive collections; and <1% of the total radioactive dose recovered in combined excreta
      (urine and faeces) in 2 consecutive 24-hour periods. If these criteria are not met by Day 11,
      subjects will remain in the CRU until all discharge criteria are met up to a maximum of Day
      15 to continue 24-hour blood, urine and faeces collections for the analysis of total
      radioactivity, unless otherwise agreed upon by the Sponsor and Investigator. If the discharge
      criteria are not met by Day 15, subjects may be asked to collect 24-hour excreta samples on
      up to 2 further occasions on a nonresidential basis to allow extrapolation of urinary and
      faecal excretion. If needed, the 2 additional 24-hour nonresidential collections will occur
      on Day 21 (±1 day) and Day 28 (±1 day). If on the second occasion the subject has still not
      met the desired criterion, then the subject will be discharged from the study, per
      Investigator and Sponsor decision. Pharmacokinetic samples and radioanalytical samples will
      be obtained through at least 240 hours postdose, and possibly up to 4 weeks postdose
      (radioanalytical samples only), in case of not meeting discharge criteria. Samples for
      metabolite profiling/identification will be obtained through 240 hours postdose.
    

Intervention name(s): [14C]-Benznidazole
Intervention type(s): Drug
Intervention description(s): A single dose level of 100 mg; 200 μCi (7.4 MBq)
Other intervention name(s): BNZ
Intervention MeSH terms: Benzonidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Diabetes Smoking Cessation Incentives Study
Condition: Smoking Cessation; Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility of contingency management on
      improving smoking cessation among individuals with type 2 diabetes.
    

Detailed description: 
      Type 2 diabetes (T2DM) and cigarette smoking are major causes of morbidity and mortality in
      US, and research indicates there is a complex relationship between these two risk factors.
      Smoking cessation is recommended as a standard treatment of diabetes by the American Diabetes
      Association; however, patients with T2DM and their providers are often inundated with other
      challenging lifestyle changes and disease management. Due to the complex relationship between
      diabetes and smoking and the large number of competing lifestyle changes recommended at
      diagnosis, smokers with T2DM may benefit from a contingency management (CM) program that
      incentivizes cessation. Providing patients tangible rewards to reinforce positive behaviors
      such as smoking abstinence has been proven effective in substance abuse programs, smoking
      cessation among pregnant women unwilling or unable to quit, and other population subgroups.
      In this CRUK2 study the investigators aim to test and further explore the potential
      effectiveness of financial incentives contingent upon proof of quitting smoking. The
      investigators will gather diabetes-related contextual factors associated with participation
      in the program and smoking cessation.
    

Intervention name(s): Contingency Management; Usual Care smoking cessation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Escalating financial incentives contingent upon biochemical evidence of abstinence; Usual care smoking cessation support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: financial incentives; contingency management
E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
Condition: Non-small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determined the maximum tolerated dose (MTD), safety and
      tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered
      continually twice daily in combination with carboplatin and paclitaxel to patients with
      advanced or metastatic non-small cell lung cancer.
    


Intervention name(s): E7080; E7080; Paclitaxel; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1).; Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel (200 mg/m2) will be administered intravenously (IV), followed by IV carboplatin (AUC 6.0 min/mg/mL).; Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.; Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.
Intervention MeSH terms: Paclitaxel; Carboplatin; Lenvatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Lung Cancer
Study of AT-527 in Healthy and HCV-Infected Subjects
Condition: Chronic Hepatitis C; Hepatitis C; Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics
      (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In
      addition, the study will assess the antiviral activity of AT-527 in subjects infected with
      HCV.
    


Intervention name(s): AT-527; Placebo Comparator
Intervention type(s): Drug; Other
Intervention description(s): Ascending doses of AT-527 administered orally.; Matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HCV; Hepatitis C Virus; RNA Viruses; Flavivirus; Liver Diseases; Hepatitis, Viral, Human; Flaviviridae Infections
Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease
Condition: Staphylococcal Skin Infections; Streptococcal Infections
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Streptococcal Infections; Staphylococcal Skin Infections; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in
      the body, how they are distributed within the body and how they are removed from the body
      over time) of ceftobiprole after a single 250-mg intravenous (IV) infusion (given directly
      into the vein) for 2 hours, before and after dialysis to patients with end-stage renal
      disease (ESRD) requiring hemodialysis or healthy volunteers.
    

Detailed description: 
      The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in
      the body, how they are distributed within the body and how they are removed from the body
      over time) of ceftobiprole after a single 250-mg intravenous (IV) infusion (given directly
      into the vein) for 2 hours, before and after dialysis to patients with end-stage renal
      disease (ESRD) requiring hemodialysis or healthy volunteers. This is a Phase 1, open label
      study (all patients involved know the identity of the drug). Healthy volunteers will be given
      a single 2-hour infusion of 250 mg ceftobiprole; patients with ESRD on hemodialysis will be
      given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately
      after dialysis. Plasma and urine samples will be assayed for ceftobiprole. Samples will be
      collected over a 48 hour period of time. Safety evaluations will include monitoring of
      adverse events, clinical laboratory tests (hematology and serum chemistry in all
      patients/volunteers, and urinalysis in healthy volunteers subjects), pregnancy testing, vital
      signs, physical examination, and recording of concomitant medications. Healthy volunteers
      will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with ESRD on
      hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before
      dialysis or immediately after dialysis.
    

Intervention name(s): Ceftobiprole
Intervention type(s): Drug
Intervention description(s): Ceftobiprole 250mg single dose over 2 hours.
Intervention MeSH terms: Ceftobiprole; Ceftobiprole medocaril
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal Dialysis, Ceftobiprole; Skin and soft tissue Infections; Staphylococcal Skin Infections; Streptococcal Infection
Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)
Condition: Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to test the hypothesis that the accelerated infusion of infliximab is not
      inferior to the conventional 2 hour infusion with respect to the frequency of infusion
      reaction.
    

Detailed description: 
      The standard protocol of infliximab administration is the infusion for 2 hours. However, due
      to the discomfort of patients and limitation of medical resources, the accelerated infusion
      is more desirable if accelerated infusion does not increase the frequency of infusion
      reaction. Recent observational studies showed that the accelerated infusion of infliximab for
      1 hour or 30 minutes did not increase the frequency of infusion reaction if patients had not
      shown infusion reactions during previous 4 infusions for 2 hours. However, there are no
      randomized trials comparing the safety of accelerated infusion protocol and standard infusion
      protocol yet.
    

Intervention name(s): Standard 2 hours-infusion; Accelerated 1 hour-infusion; Accelerated 30 minutes-infusion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups.
After randomization to 2 hours-infusion group, patients get 5 mg/kg infliximab infusion for 2 hours. Total infusion number after randomization is 7.; Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups.
After randomization to 1 hour-infusion group, patients get 5 mg/kg infliximab infusion for 1 hour. Total infusion number after randomization is 7.; Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups.
After randomization to 30 minutes-infusion group, patients get 5 mg/kg infliximab infusion for 1 hour. If any infusion reactions do not develop during 2 infusions for 1 hour, patients get further 5 mg/kg infliximab infusion for 30 minutes. The total number of 30 minutes-infusion is 5.
Other intervention name(s): Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA); Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA); Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Crohn's disease; Ulcerative colitis; Infliximab; Infusion reaction