bioihbjkbjnl/mcl2 huggingface dataset:
A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The need exists for alternatives to 99mTc based perfusion radiotracers for cardiac patient
      management. An alternative radiotracer, I123-CMICE-013, has been developed at the Canadian
      Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute.
      Initial testing results in rats and pigs suggest that in addition to being a
      cyclotron-produced alternative to 99mTc tracers, I-123-CMICE-013 may be a superior tracer for
      measuring myocardial perfusion.This Phase 1 study will study the safety and tolerability,
      biodistribution, pharmacokinetics and radiation dosimetry, and distribution and localization
      of I123-CMICE-013in healthy adult volunteers.
    

Detailed description: 
      Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is an
      established, cost effective tool for the risk stratification and management of patients
      suspected or known to have coronary artery disease (CAD)Myocardial perfusion imaging is
      significantly affected by interruptions in the supply of 99mMo, the parent isotope of 99mTc
      used for the majority of MPI. An alternative radiotracer, I123-CMICE-013,developed at the
      Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart
      Institute, has completed pre-clinical trial testing and is ready for Phase 1 human trials.

      This Phase I study will be a single centre, open label study. Subjects will receive 2 doses
      of study drug. One rest dose and one stress dose will be administered on separate days, one
      week apart. Subjects will undergo a standard clinical exercise stress protocol for the stress
      dose. Gamma camera imaging following each administration will be done over 2 days.

      Biodistribution, pharmacokinetics, dosimetry and safety variables will be analyzed.
    

Intervention name(s): 123I-CMICE-013
Intervention type(s): Drug
Intervention description(s): 2 intravenous doses of drug will be given one week apart. Doses will be equivalent to 1 rest dose and 1 stress dose. Serial nuclear imaging will follow dose injections.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: myocardial perfusion imaging; single photon emission tomography; Coronary artery disease; gamma camera imaging; Phase 1 clinical trial; cyclotron
Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to compare and evaluate the pharmacokinetic characteristics of
      febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in
      healthy adults; and to evaluate safety and tolerance following a single-dose administration.
    


Intervention name(s): Feburic®; TMX-67
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg*1 tablet; 40 mg*2 tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: crossover; pharmacokinetic; hyperuricemia; gout
Sars-CoV-2/COVID-19 Ivermectin Navarra-ISGlobal Trial
Condition: Covid-19; Coronavirus Infection; SARS-CoV-2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates
      the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in
      SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial
      is currently planned at a single center in Navarra.
    

Detailed description: 
      SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates
      the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in
      SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial
      is currently planned at a single center in Navarra.

      Participants will be randomized to receive a single dose of 400 mcg/kg ivermectin or a
      placebo. The randomization code will be generated by the trial statistician using blocks that
      ensure balance between the groups.

      The allocation will be made by the investigator after obtaining informed consent, and
      confirmation of fulfillment of all inclusion and none of the exclusion criteria. The
      investigational product will be administered by a researcher not involved in patient care or
      participant follow up.

      Participants will remain in the trial for a period of 28 days.

      In the interests of public health and containing transmission of infection, trial visits will
      be conducted in the participant's home by a clinical trial team comprising nursing and
      medical members.

      Subsequent visits will be to assess clinical and laboratory parameters.

      A final study visit will be made for participants who withdraw prematurely from the study or
      are withdrawn by the investigator.
    

Intervention name(s): Ivermectin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of STROMECTOL® tablets at 400mcg/kg; Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.
Other intervention name(s): Stromectol
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ivermectin
Modulation of Remifentanil-induced Postinfusion Hyperalgesia
Condition: Hyperalgesia, Secondary
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 4

Summary: 
      In addition to alleviate pain there is growing evidence that µ-opioids enhance pain. This
      problem is known as opioid induced hyperalgesia(OIH).The NMDA receptor is involved in opioid
      induced hyperalgesia it may be possible to block OIH by cyclooxygenase inhibitors. This has
      been demonstrated with parecoxib, a COX-II inhibitor, in a experimental pain model.Both COX-1
      and COX-2 are expressed in the spinal cord. It would be of interest to investigate whether a
      COX-1 preferring inhibitor like ketorolac also can reduce opioid induced hyperalgesic in this
      experimental pain model.
    

Detailed description: 
      Remifentanil is an fast acting opioid which has become very popular to use during surgery.

      There are studies, both experimental 1-3 and clinical 4;5, which indicate that remifentanil
      after end of infusion trigger enhanced pain experience and enhanced opioid consumption
      postoperatively.

      Therefore it is important to look at possibilities to block this enhanced pain experience
      (opioid induced hyperalgesia - OIH). Ketamin has demonstrated to block this effect 5;6
      through the NMDA receptor. Unfortunately ketamin has some seriously side-effects like
      hallucinations, and is therefore not suitable in ordenary clinical use.

      Recently, it has been demonstrated that parecoxib (a COX-2 inhibitor) can prevent
      remifentanil-induced postinfusion hyperalgesia in a study on healthy volunteers.7 COX-2
      inhibitors have some disadvantages because of the longterm adverse effects like cardiac
      arrest. Therefore it would be of interest to look at a COX-1 preferring NSAID, like
      ketorolac, to see if also non-selective NSAIDs can partly block remifentanil-induced
      postinfusion hyperalgesia.

      To investigate this and to provoke pain and secondary hyperalgesia we use an intradermal
      electrical pain model which is well established.1;7-9 Detailed description of this model look
      at reference 7. H0 : Parecoxib prevents remifentanil postinfusion secondary hyperalgesi.
      Ketorolac does not prevent remifentanil postinfusion secondary hyperalgesi HA : Parecoxib and
      ketorolac prevent remifentanil postinfusion secondary hyperalgesi.
    

Intervention name(s): Placebo; Remifentanil; Ketorolac and remifentanil; Parecoxib and remifentanil
Intervention type(s): Other; Drug; Drug; Drug
Intervention description(s): Placebo IV before placebo infusion; placebo IV and remifentanil infusion; Ketorolac IV and remifentanil infusion; Parecoxib IV and remifentanil infusion
Other intervention name(s): Ultiva; Toradol; Dynastat
Intervention MeSH terms: Ketorolac; Parecoxib; Remifentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: hyperalgesia; remifentanil; ketorolac; parecoxib; COX-1 inhibitor; COX-2 inhibitor
Epidural Labor Analgesia and Infant Neurobehavior
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Infant neurobehavior alteration is predictor of later intelligence development. Many factors
      would influence or are associated with infant neurobehavior, of which exist or appear during
      perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective
      method in relieving labor pain. Although previous studies showed that opioid used in epidural
      analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation
      associated manner, whether epidural analgesia itself would produce unpredictable effect on
      newborn neurobehavior is still unknown. Hereby the investigators designed this trial to
      investigate the hypothesis that epidural analgesia for labor pain control itself would not
      produce negative effect on infant neurobehavior.
    


Intervention name(s): Ropivacaine and sufentanil; Ropivacaine and sufentanil; Ropivacaine and sufentanil; Ropivacaine and sufentanil; Ropivacaine and sufentanil; Ropivacaine and sufentanil
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ropivacaine 0.125% plus sufentanil 0.3 microgram; Ropivacaine 0.125% plus sufentanil 0.4 microgram; Ropivacaine 0.125% plus sufentanil 0.5 microgram; Ropivacaine 0.0625% plus sufentanil 0.4 microgram; Ropivacaine 0.1875% plus sufentanil 0.4 microgram; Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other intervention name(s): Naropin; Sufenil; Naropin; Sufenil; Naropin; Sufenil; Naropin; Sufenil; Naropin; Sufenil; Naropin; Sufenil
Intervention MeSH terms: Sufentanil; Dsuvia; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neurobehavior; Epidural analgesia; Local anesthetic; Opioid
Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a global Phase III, randomized, double-blinded, placebo-controlled study for subjects
      with evidence of early AD. The protocol is designed to determine whether ALZT-OP1 combination
      treatment (ALZT-OP1a + ALZT-OP1b) will slow down, arrests, or reverse cognitive and
      functional decline, in subjects with evidence of early stage Alzheimer's disease (AD).
    

Detailed description: 
      This Phase III study is designed as a randomized, double-blinded, placebo-controlled study
      for subjects with evidence of early AD. The study will evaluate safety and tolerability,
      efficacy as measured by CDR-SB, and will determine if the combination therapy ALZT-OP1 will
      slow down, arrests, or reverse cognitive and functional decline in an early stage AD
      population.

      Subjects will be randomly assigned to one of four treatment arms: Group I will consist of
      ALZT-OP1a (cromolyn) for inhalation, plus an oral placebo tablet; OR the Group II arm, which
      will consist of ALZT-OP1 combination therapy ALZT-OP1a (cromolyn) for inhalation, plus
      ALZT-OP1b (ibuprofen) tablet for oral administration; OR to the Group III arm, which will
      consist of inhaled placebo, plus ALZT-OP1b (ibuprofen) tablet for oral administration; OR to
      the Group IV placebo arm, which will consist of inhaled placebo plus an oral placebo tablet.

      A minimum of 400 evaluable subjects will be randomized to receive one of four possible
      treatment assignments containing various combinations of active study drug or placebo.

      To account for subject dropouts (estimated rate of 30%), it is anticipated that up to 600 (or
      150 subjects per treatment arm) may be recruited and randomized, to achieve a minimum of 100
      evaluable subjects per treatment arm.
    

Intervention name(s): ALZT-OP1a; ALZT-OP1b; Placebo ALZT-OP1a; Placebo ALZT-OP1b
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): 1) Mast cell stabilizer, 2) Neuroinflammatory microglial modulator, 3) A-beta oligomerization inhibitor, and 4) anti-inflammatory; Anti-inflammatory; Non-active capsules; Non-active tablets
Other intervention name(s): Cromolyn; Ibuprofen
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early stage AD; MCI; aMCI; prodromal; Memory loss; Memory problems; Aging; Early Alzheimer's Disease; Early AD
Magnetic Resonance Spectroscopy (MRS) Validation Study in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD)
Condition: Liver Diseases
MeSH terms: Liver Diseases; Fatty Liver
Study type: Observational

Summary: 
      The purpose of this study is to see how effective the investigators' optimized magnetic
      resonance spectroscopy (MRS) sequence in quantifying hepatic triglyceride content (HTGC) to
      enhance MRS as a diagnostic tool in non-alcohol fatty liver disease (NAFLD).
    

Detailed description: 
      One way to gauge MRS as an effective diagnostic tool is by looking at the reproducibility of
      the liver fat measurements on subjects by calculating the coefficient of variation (CV). This
      study assesses the modified MRS sequence, using both breath holds and free breathing. The
      HTGC levels are measured twice in the same individuals on two independent events separated by
      10 minutes. Subjects are then given a high fat, high carbohydrate meal of Pizza Hut pizza,
      Pepsi, and Oreo cookies. Two hours after eating the meal, the subjects return to the scanner
      and repeat all MRS scans.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        St. Louis community
      
Keywords: Obese; MRS; hepatic triglyceride content; MR spectroscopy
Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether GLYX-13 reduces depression score in
      patients with treatment-resistant depression.
    


Intervention name(s): GLYX-13
Intervention type(s): Drug
Intervention description(s): single IV dose
Other intervention name(s): ThrProProThr
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; NMDA antagonist; treatment resistant
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers
Condition: Pain; Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of PF-04427429 in healthy women.
    


Intervention name(s): PF-04427429; Normal saline
Intervention type(s): Biological; Other
Intervention description(s): Intravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg.; Intravenous, normal saline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 1; PF-04427429
Case-control Study on Individual Risk Factors of CTS
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Observational

Summary: 
      This study is conducted to observe the characteristics of the risk factors of CTS in Chinese
      population.
    

Detailed description: 
      Carpal tunnel syndrome (CTS), or median neuropathy at the wrist, is a medical condition in
      which the median nerve is compressed at the wrist, leading to paresthesia, numbness and
      muscle weakness in the hand. It's the most common neuro-compressive disease. With the
      development of the modern life, the morbidity of CTS is also raised. As a common disease, the
      study on etiology is very important in Carpal Tunnel Syndrome, which can improve the life
      quality of patients with carpal tunnel syndrome. The risk factors include individual factors
      such as age, gender, diabetes, Hypothyroidism, obesity, complication of systematic diseases,
      tobacco, injury and occupational factors.

      As most of the research were based on the population in western country and the life style
      and the ethnicity between Chinese people and western country people is quite different, there
      may be some similarities and differences in epidemiology. There is seldom similar research in
      China so that this study was conducted to observe the characteristics of these risk factors
      in Chinese population.
    

Intervention name(s): the disease
Intervention type(s): Other
Intervention description(s): Observation the patients and non-patients
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The present case-control study was based on the single medical center in Shanghai, China,
        in which more than 5000 CTS patients per year are treated. The hospital involved in the
        study is a university teaching hospital. Cases were recruited from the surgical wards and
        appropriate outpatient clinics, while the controls were recruited from the outpatient
        clinics.
      
Keywords: Carpal Tunnel Syndrome; etiology; risk factor
Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
Condition: Knee Injuries
MeSH terms: Knee Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic
      surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma
      initiates an acute inflammatory response, including swelling and pain, that leads to
      restricted joint motion and loss of function. OMS103HP was designed to deliver targeted
      therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit
      inflammation and pain before they can begin.

      The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving
      knee function following ACL reconstruction. Secondary benefits being evaluated include
      reduced postoperative pain, improvement in knee range of motion and earlier return to work.
    


Intervention name(s): OMS103HP; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.; Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anterior cruciate ligament reconstruction; ACL reconstruction
Topical Formulations of Liposomal Local Anesthetics
Condition: Administration, Topical Drug; Administration, Topical; Anesthetic Drugs
Study type: Interventional
Phase: Phase 1

Summary: 
      This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated
      ropivacaine formulations.
    

Detailed description: 
      This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1
      and 2% ropivacaine gel formulations.
    

Intervention name(s): Ropivacaine; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.; 100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 20% benzocaine gel were applied once during 30 minutes.
Other intervention name(s): Topical anesthesia in the palatal mucosa; Topical anesthesia in the buccal mucosa.
Intervention MeSH terms: Anesthetics; Ropivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: topical anesthetic; liposomal ropivacaine; dentistry