bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Single Dose MK-3614 (MK-3614-001)(COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine if MK-3614, given as single doses, is safe and well tolerated in
      healthy males and male participants with mild to moderate hypertension.
    

Detailed description: 
      Up to three planned panels of either 8 healthy participants (Panels A and B) or 8
      participants with mild to moderate hypertension (Panel C) will be enrolled. In Panels A and
      B, 8 participants will alternately receive single rising doses of MK-3614 or placebo. All
      doses will be administered in the fasted state, except Panel A, Period 3 in which a standard
      high-fat breakfast provided approximately 30 minutes prior to dosing. Panel A will begin
      first. At least 3 days will elapse before participants in the alternate panel (Panel B) will
      receive the next higher dose. In Panel C, 8 mild to moderate hypertensive male participants
      will receive single rising doses of MK-8892 or placebo. For all panels, there will be at
      least 7 days washout between treatment periods for any given participant. Participants may
      only be enrolled in one panel of the study. All participants in periods of all panels (with
      exception of 0.25 mg fasted/fed periods) will be randomly assigned to either study drug or
      placebo, i.e., a participant could be assigned to receive study drug in one period and
      placebo in another. As per the protocol allocation plan, the same participants will receive
      0.25 mg MK-3612 in a fasted and fed state.
    

Intervention name(s): MK-3614; Comparator: Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Chronic and Acute Effects of Smoking on the Left and Right Ventricular Relaxation in Young Healthy Smokers
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Impairment of relaxation, the early phase of ventricular diastole is the first stage of heart
      diastolic dysfunction. Left ventricular diastolic function can be determined noninvasively by
      Echo- Doppler - derived mitral valve flow velocities. The addition of pulmonary venous flow
      pattern enables more accurate assessment of left ventricle diastolic function. The role of
      the right ventricle in haemodynamic function of the heart is now emphasized. The right
      ventricle diastolic function can be assess by recording the Doppler tricuspid valve flow
      pattern. Impaired LV diastolic function usually precedes systolic dysfunction and may cause
      clinical signs of congestive heart failure. Cigarette smoking is one of the major risk
      factors for cardiovascular diseases. The aim of the study was to assess left and right
      ventricular diastolic function in healthy, young and slim smokers before and after smoking
      one cigarette.

      Echocardiographic examination: before and after smoking one cigarette Echocardiographic
      evaluation of mitral valve flow, pulmonary venous flow, tricuspid valve flow and hepatic vein
      flow to assess diastolic function of ventricles.
    

Detailed description: 
      Echocardiographic examination: in left lateral position after 10 minutes rest. The first
      examination: after a 2-hour non-smoking period, the second: immediately after smoking one
      cigarette containing 0.9 mg of nicotine. The duration of the second examination: no more than
      15 minutes.

      Echocardiography equipment: Hewlett-Packard SONOS 2000 (Andover, Massachusetts) imaging
      system. The transducer's frequency: 2 MHz.

      From the apical four chamber view the visualisation of transmitral flow, pulmonary venous
      flow and transtricuspid flow. From subcostal view the visualisation of right superior hepatic
      vein and the hepatic vein flow.
    

Observational model: Defined Population
Time perspective: Other
Keywords: heart; echocardiography; diastolic function; left ventricle; right ventricle; cigarette smoking; Smoking; Heart Ventricles; Diastole; Doppler Echocardiography
Serum Endocan Levels and Gestational Diabetes
Condition: Gestational Diabetes; Endocan
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      In diabetic patients, serum endocan level has been significantly increased in patients and
      the levels on the long-term complications are correlated. Based on the Iinformation obtained
      from these studies, it can be said that there is a strong association between diabetes and
      serum endocan levels.
    

Detailed description: 
      It has been shown that endocan level of plasental tissue in gestational diabtes patients is
      significantly increased when looking at the same week compared with plasenta tissue samples
      of helathy pregnancy. From the information obtained from these studies, it can be said that
      there is a strong association between diabetes mellitus and serum endocan levels.
      investigators aimed to determine the relationship between serum endocan levels and
      gestational diabetes in the study.
    

Intervention name(s): Serum Endocan Levels
Intervention type(s): Diagnostic Test
Intervention description(s): Detection of Serum Endocan Levels and detection of possible diagnostic association with gestational diabetes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety of IW-6118 when administered as a single
      oral dose to patients undergoing third molar extraction. Efficacy will be assessed in an
      exploratory manner.
    


Intervention name(s): IW-6118; Matching Placebo; Naproxen Sodium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose; Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium; Single dose
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy subjects
5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Administered as Single Doses, With Buccal Sativex®, in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to evaluate the safety and tolerability of novel oral
      capsules containing THC and/or CBD, following a single administration to healthy volunteers.
      The secondary objective of the study was to compare the pharmacokinetic profiles of THC, THC
      metabolite 11-hydroxy-THC and/or CBD following a single administration of the investigational
      oral formulations with Sativex® Oromucosal Spray.
    

Detailed description: 
      Fifteen (15) healthy male volunteers received, following an overnight fasting and a standard
      breakfast, a single dose of either one of five administrations: PNL-THC:CBD, P-PNL-THC:CBD,
      CBD10 hard capsule, CBD100 hard capsule, Sativex® spray X 4. There was a wash-out period of
      no less than 4 days between each dosing.

      Subjects underwent screening procedures within 21 days prior to first dosing, to assess their
      eligibility to participate in the study. Eligible subjects were admitted to the Clinical
      Research Center (CRC) in the evening before each study drug administration and will remained
      in-house for 24 hours after dosing. Following an overnight fast of at least 10 hours, the
      subjects received a standard meal within 30 minutes prior to dosing. Blood samples for PK
      were drawn at the specified time points. The subjects were monitored for safety, and AEs were
      recorded throughout the study. An End-of Study (EOS)/Safety Follow-up visit took place on
      7-10 days after the last dose of study treatment.
    

Intervention name(s): PNL-THC:CBD soft gelatin capsule; Sativex; CBD hard capsule dose 1; P-PNL-THC:CBD soft gelatin capsule; CBD hard capsule dose 2
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3 soft capsules, containing a total of 10.8 mg THC and 10 mg CBD (Each capsule contains 3.6 mg THC and 3.3 mg CBD); spray X 4 actuations; 1 hard capsule containing 10 mg CBD; 2 soft capsules containing a total of 7.2 mg THC, 6.7 mg CBD and 20 mg piperine (Each capsule contains 3.6 mg THC, 3.3 mg CBD and 10 mg piperine); 1 hard capsule containing 100 mg CBD
Intervention MeSH terms: Nabiximols
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Condition: Safety Issues; Tolerance; Pharmacokinetics; Food Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double-blind and placebo-controled study to assess the safety, tolerability and
      pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy
      adult volunteers. The study is composed of 2 parts. Part 1 is to assess the safety,
      tolerability and pharmacokinetics of a single ascending doses of ZX-7101A tablet. Part 2 is
      to assess the food effect on ZX-7101A at a selected dose in a cross-over design.
    


Intervention name(s): ZX-7101A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablet; Tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: single ascending doses in part 1 and fasting/nonfasting crossover in part 2
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the
      treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
    


Intervention name(s): STSP-0601 for Injection; STSP-0601 for Injection
Intervention type(s): Drug; Drug
Intervention description(s): A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia; A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume
Condition: Aging
Study type: Interventional

Summary: 
      The purpose of this study is to compare the safety and efficacy of Neuramis® Volume
      Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with
      Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in
      the mid-facial region by inducing temporary volume restoration in mid-facial region. After
      the pivotal study, extension study will be conducted to confirm long-term safety and
      efficacy.
    

Detailed description: 
      This is a multi-centered, randomized, double-blind, split-face clinical study on
      investigational device. The subjects in this clinical trial receive application of the
      investigational device on the right and left side of the mid-facial region (Neuramis® Volume
      Lidocaine or Juvederm® Voluma® with Lidocaine). After the pivotal study, extension study will
      be conducted to confirm long-term safety and efficacy.
    

Intervention name(s): Neuramis® Volume Lidocaine; Juvederm® Voluma® with Lidocaine
Intervention type(s): Device; Device
Intervention description(s): hyaluronic acid filler; hyaluronic acid filler
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment
Condition: Liver Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine whether CVC exposures are altered in subjects with impaired hepatic function,
      compared to subjects with normal hepatic function. The results will help guide the clinical
      use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any,
      and identify the potential need for dose adjustments of CVC in this population.
    


Intervention name(s): Cenicriviroc in mild liver impaired; Cenicriviroc in moderate liver impaired
Intervention type(s): Drug; Drug
Intervention description(s): Subjects with mild hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days.; Subjects with moderate hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days.
Other intervention name(s): CVC; CVC
Intervention MeSH terms: Cenicriviroc; Liver Extracts
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Liver Insufficiency; Hepatic impairment
Evaluation of Retinal and Vascular Features in Macular Degeneration After Intravitreal Injections of Bevacizumab
Condition: Exudative Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Observational

Summary: 
      This study evaluates the retinal and vascular features in patients with macular degeneration
      under the effects of Bevacizumab intravitreal injections using optical coherence tomography
      and optical coherence tomography angiography.
    

Detailed description: 
      Bevacizumab is a vascular endothelial growth factor antagonist represent an efficacy
      treatment for exudative age-related macular degeneration acting on vascular
      hyperpermeability.

      The optical coherence tomography and optical coherence tomography angiography represent novel
      and non-invasive diagnostic techniques that allow a detailed and quantitative analysis of
      retinal and vascular features.

      The study evaluates the changes in optical coherence tomography and optical coherence
      tomography angiography parameters at baseline and after three monthly injections of
      Bevacizumab in exudative AMD.
    

Intervention name(s): Bevacizumab Injection
Intervention type(s): Drug
Intervention description(s): Three monthly intravitreal injections of bevacizumab (1.25 mg/0.05 mL)
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 50 years with diagnosis of exudative age-relative macular
        degeneration. They did not present other ophthalmological disease and did not receive
        previous treatment before Bevacizumab.
      
Keywords: optical coherence tomography angiography; optical coherence tomography angiography angiography; bevacizumab; vascular endothelial growth factor antagonists; intravitreal injection
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
Condition: Degenerative Disc Disease
MeSH terms: Spinal Diseases; Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients
      with single-level degenerative disc disease compared to other devices approved by the FDA for
      the same or similar indications.
    

Detailed description: 
      The XL TDR® eXtreme Lateral Total Disc Replacement consists of two endplates that are
      provided in a number of sizes to accommodate a variety of patient anatomies and pathologies.
      The XL TDR device is made up of a ball and socket articulation and the joint is made of
      CoCrMo alloy.

      The XL TDR is intended to be used to reconstruct the spine following the removal of part or
      all of the intervertebral disc on one level of the lumbar spine.

      The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally
      mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one
      level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc
      confirmed by patient history radiographic studies.
    

Intervention name(s): XL TDR; Lumbar fusion surgery
Intervention type(s): Device; Other
Intervention description(s): This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.; Lumbar fusion surgery
Other intervention name(s): Total disc replacement
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Single Level; Lumbar Disc Disease; DDD
Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass
Condition: Anesthetics, Intravenous; Pharmacology; Anesthetics; Cardiopulmonary Bypass
Study type: Interventional
Phase: Phase 4

Summary: 
      Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is
      performed using the Minto model. It was derived from patients undergoing general surgery.
      However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The
      investigators tested whether Minto model for target controlled infusion produces constant
      plasma remifentanil concentration during the cardiac surgery.
    


Intervention name(s): Remiva; Ultiva
Intervention type(s): Drug; Drug
Intervention description(s): Target controlled infusion of remifentanil (generic drug, Remiva™); Target controlled infusion of remifentanil (brand-named drug, Ultiva™)
Other intervention name(s): generic drug of remifentanil, Remiva™; brand-named drug of remifentanil, Ultiva™
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: remifentanil
Pharmacokinetic Study of Effect of Cardiac Output on the Uptake of Isoflurane
Condition: Anesthesia
Study type: Observational

Summary: 
      This study examines the effect of blood flow through the lungs and the body on the
      consumption and hence requirement of the anesthetic agent isoflurane.
    

Detailed description: 
      The effect of cardiac output on the uptake of isoflurane is yet to be quantified. This study
      aims to obtain a quantifiable relationship between isoflurane uptake and cardiac output. The
      study patients will be cardiac patients in whom anesthesia is induced with fentanyl ,
      propofol and maintained on isoflurane . The baseline cardiac index from the pulmonary artery
      catheter as displayed on the continuous cardiac output monitor will be used to classify the
      patients into two groups with cardiac index of 2.1 liters per minute per square meter as the
      differentiating criteria. No change in the anesthesia protocol will be done for the two
      groups.The study is designed such that all vascular catheterisations and the dose of
      isoflurane administered is as per prevailing institutional protocols and that no other
      intervention particular or unique to the study is done. As such the data that the study will
      use is also routinely acquired during the procedure but not systematically stored, which is
      what the study will do. This, we suggest, makes the study an observational study.The
      continuous cardiac output data and the inspired and expired concentration of isoflurane as
      displayed on the monitor will be recorded online. Data will be collected from the start of
      isoflurane till 30 minutes or till the surgeon starts cannulating the great vessels. The data
      so obtained will be analysed in two groups based on the baseline cardiac index using
      Statistical Package for the Social Sciences (SPSS) for difference in uptake between the
      groups.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective, open cardiac procedures under general endotracheal anesthesia
        with cardiopulmonary bypass
Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience
Condition: Abuse Potential
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a randomized, double-blind, double-dummy, placebo- and active controlled, 5
      treatment, 10 sequence, 5 period crossover single dose, Williams square design study in
      healthy adult, non drug dependent male and female participants with drug abuse experience
      with sedative drugs.
    

Detailed description: 
      The study includes Screening, a Qualification Phase consisting of a Naloxone Challenge and
      Drug Discrimination crossover study, a Treatment Phase and Follow-up. Following successful
      completion of the Qualification Phase the participants will be enrolled in the Treatment
      phase. The Treatment Phase is a randomized, double-blind, double dummy, placebo- and active
      controlled, 5 treatment, 10-sequence, 5 period crossover, single-dose, Williams square design
      study in healthy male and/or female adult, non drug-dependent recreational users. On Day 1 of
      each of the Treatment Phase 5 periods, which will be separated by a washout of at least 14
      days, participants will receive an oral dose of either NEURONTIN® 1800 mg, 1200 mg or 600 mg
      or 20 mg diazepam, or placebo. Study treatments will be administered under fasted conditions
      (overnight fast and no food until 4 hours after dosing). Water will be allowed without
      restriction until 1 hour prior to dosing and 1 hour after dosing.
    

Intervention name(s): gabapentin 600 mg; gabapentin 1200 mg; gabapentin 1800 mg; diazepam 20 mg; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): participants will receive an oral dose of gabapentin 600 mg; participants will receive an oral dose of gabapentin 1200 mg; participants will receive an oral dose of gabapentin 1800 mg; participants will receive an oral dose of 20 mg dose of diazepam; participants will receive an oral dose of placebo
Intervention MeSH terms: Diazepam; Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Neurontin; Diazepam; Abuse Liability; Gabapentin