bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of
      linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of
      African American origin.
    


Intervention name(s): linagliptin QD (once daily) for 7 days
Intervention type(s): Drug
Intervention description(s): dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration
Intervention MeSH terms: Linagliptin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of BKR-013 on Average Daily Glucose Levels
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of BKR-013 on average daily glucose (ADG)
      levels in type 2 diabetes (T2D) subjects during 28 days of either placebo or active test
      product administration. Subjects will serve as their own controls in this crossover design,
      and ADG will be compared while a subject is on active test product versus while they received
      placebo test product.
    

Detailed description: 
      The study consists of a screening period followed by a 28-day treatment period, a 3 to 5 week
      washout period, and a second treatment period. All subjects receive both active test product
      and placebo, but the order in which they receive them (Part 1 or Part 2 of the study) is
      randomized in this single crossover study. Fourteen subjects will be randomized to ensure
      that 10 subjects complete both Part 1 and Part 2 of the study.

      There are a total of 7 study visits including screening. In Part 1, Visits 2, 3 and 4 occur 2
      weeks apart; in Part 2, Visits 5, 6 and 7 also occur 2 weeks apart. Visits 4 and 7 are
      overnight visits during which time hunger and satiety will be assessed and a Mixed Meal
      Tolerance Test (MMTT) will be performed after an overnight fast. The MMTT requires use of an
      indwelling IV catheter so that 11 blood draws can be more comfortably obtained over a period
      of 4 hours.

      Subjects will be required to wear a glucose monitoring sensor during Part 1 and Part 2 of the
      study in order to obtain ADG levels.

      Routine chemistry and hematology tests are done at 4 timepoints during the study. An ECG and
      physical exam is performed at screening.

      A rapid HbA1c will only be tested at screening; if the value is between 6.5% and 10.5%, all
      other screening procedures will be performed; if the HbA1c value is not within the qualifying
      range, the subject will be considered a screen failure and no other screening procedures will
      be performed.

      Subjects are required to keep a daily diary to document dosing (twice daily), medication
      changes and any adverse events.

      Safety tests include chemistry/hematology, vital signs and adverse events.

      Subjects with type 2 diabetes must be under the care of a healthcare professional to take
      part in this study. The test product BKR-013 is not designed to treat diabetes; it is being
      evaluated as a non-prescription medical food for nutritional use in managing glucose levels.
    

Intervention name(s): BKR-013 or Placebo
Intervention type(s): Other
Intervention description(s): Encapsulated L-glutamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect
Condition: Dental Caries; Periodontal Diseases
MeSH terms: Dental Caries; Periodontal Diseases
Study type: Interventional

Summary: 
      a double-blind cross-over in vivo study was performed to measure the salivary concentration
      of Xylitol released from the two chewing gums containing different amount of the polyol. The
      study had a cross-over design: the first half of the sample used the chewing-gum with Xylitol
      as the only sweeteners (64.5% of chewing-gum weight) and the other half use the chewing-gum
      with Xylitol among the sweeteners (22% of chewing-gum weight), after a 7-days wash-out
      period, the two sub-groups inverted the chewing gums. Subjects were instructed to consume the
      products as they normally would be consumed.
    

Detailed description: 
      x
    

Intervention name(s): 100% Xylitol Gum; 22% Xylitol Gum
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects were instructed to consume the gums as they normally would be consumed.; Subjects were instructed to consume the gums as they normally would be consumed.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: a double-blind cross-over in vivo study was performed to measure the salivary concentration of Xylitol released from the two chewing gums containing different amount of the polyol. The study had a cross-over design: the first half of the sample used the chewing-gum with Xylitol as the only sweeteners (64.5% of chewing-gum weight) and the other half use the chewing-gum with Xylitol among the sweeteners (22% of chewing-gum weight), after a 7-days wash-out period, the two sub-groups inverted the chewing gums. Subjects were instructed to consume the products as they normally would be consumed.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Xylitol; Saliva; Bacteria; Dental Plaque; Antimicrobial effect; Chewing gum
Value of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia for Knee Arthroscopic Meniscectomy
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative analgesia is provided by local anesthesia combined with intrathecal narcotics.
      In addition, for the first 24 hours, this combination has a parenteral opioid sparing effect.
      However, despite its benefits, this method has been associated to an increased incidence of
      urine retention, nausea, and vomiting, as well as pruritus. A new localized analgesic
      approach called as IPACK (infiltration between the knee capsule and the popliteal artery) has
      been employed in practice.
    

Detailed description: 
      The goal of this study was to compare fentanyl based spinal anesthesia to IPACK Block-based
      spinal anesthesia during knee arthroscopy.

      Patients and Methods: The study enrolled sixty patients with ASA (I-II) ranging in age from
      25 to 60 years old after receiving ethical committee permission and written informed consent
      from patients. They were divided into two groups: group F (30 patients) received spinal
      anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) and group I (30
      patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block
      using plain bupivacaine 0.5% (15ml). Results: In the first 4 hours postoperatively, there
      were no variations in VAS scores between the two groups; however, following 4 hours and over
      the next 12 hours, Group I, VAS scores were lower. The amount of morphine used overall was
      lower in Group I, which took longer than Group F to reach initial rescue analgesia. The level
      of patient satisfaction 48 hours after surgery was higher in group I than in group F.
    

Intervention name(s): spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)
Intervention type(s): Procedure
Intervention description(s): group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml).
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: IPACK Block, spinal anesthesia, Knee arthroscopy.
A Study to Evaluate the Drug Interaction of ASP015K and Tacrolimus
Condition: Healthy; Pharmacokinetics of ASP015K and Tacrolimus
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to characterize the effect of multiple doses of ASP015K on the
      pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.
    

Detailed description: 
      This is a 2-part study. Part 1 is a 2-sequence, drug interaction study to determine the
      effect of two different ASP015K doses on the pharmacokinetics of oral tacrolimus. Part 2 is a
      1-sequence drug interaction study to determine the effect of the higher dose ASP015K on the
      pharmacokinetics of IV tacrolimus.
    

Intervention name(s): Tacrolimus; ASP015K
Intervention type(s): Drug; Drug
Intervention description(s): Oral and Intravenous; Oral
Other intervention name(s): FK506; Prograf
Intervention MeSH terms: Tacrolimus; Peficitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP015K; tacrolimus; healthy volunteers
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
Condition: Disc Degenerative Disease; Spondylolisthesis; Spinal Fracture; Spinal Deformity; Spinal Stenosis; Spinal Tumor
MeSH terms: Spinal Cord Neoplasms; Spinal Neoplasms; Spinal Stenosis; Spondylolisthesis; Intervertebral Disc Degeneration; Spinal Fractures
Study type: Interventional

Summary: 
      The primary objective of this study is to demonstrate that the efficacy and safety of Spine
      fusion system manufactured in China is no inferior than imported product.
    

Detailed description: 
      This study is a prospective, multicenter, randomized, comparative, non-inferiority study
      comparing the change of Japanese Orthopaedic Association Score from baseline at postoperative
      24 weeks for patients implanted with local made Spine Fusion System versus imported products.
    

Intervention name(s): Johnson&Johnson Medical Suzhou made Spine Fusion System; Imported EXPEDIUM screws and OPAL cage
Intervention type(s): Device; Device
Intervention description(s): interventional device is Spine Fusion System that is manufactured by Johnson & Johnson Medical Suzhou Ltd.; Comparator in this study is active comparator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone
Condition: Cholecystitis
MeSH terms: Cholecystitis
Study type: Interventional

Summary: 
      A semi-rigid cervical collar is recommended for immobilization of the cervical spine in
      patients with cervical spine injury. It has been suggested that a reduction in mouth opening
      is the major contributing factor to the deterioration in the glottic view obtained.
      Fiberoptic intubation is among the most versatile techniques for managing both the
      anticipated and the unanticipated difficult airway. Recently, combination of fiberoptic
      bronchoscope with videolaryngoscope has been suggested to permit visual control of the
      passage of the tube over the fibrescope into the laryngeal inlet. The aim of this study is to
      compare the intubation time and ease of intubation between fiberoptic bronchoscope alone and
      bronchoscope with pentax airwayscope.
    


Intervention name(s): fiberoptic bronchoscope; pentax-airway scope; semi-rigid collar
Intervention type(s): Device; Device; Procedure
Intervention description(s): Tracheal intubation using fiberoptic bronchoscope; Tracheal intubation using pentax-AWS; semi-rigid collar immobilization of the cervical spine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)
Condition: Healthy
Study type: Interventional

Summary: 
      This research is being done to better understand the pulmonary consequences of completing an
      ultra marathon at altitude and a sea level city.
    

Detailed description: 
      Subjects will be asked to undertake three (3) sets of assessments at prescribed time
      intervals: Baseline (at 72-24h prior to each event), immediately post (within 2h of race
      completion) and during recovery (within 24-48h of race completion). Each assessment will
      consist of 1)lung function tests; 2) a saliva and blood sample; 3) a lung and cardiac
      ultrasound. Subjects will be recruited from a range of age groups and fitness levels, before
      being divided into a sham or therapy group. Groups will use Pulsed Electromagnetic Field
      (PEMF) therapy or related sham before the event and during recovery.
    

Intervention name(s): Pulsed Electromagnetic Field therapy (PEMF); Pulsed Electromagnetic Field Sham therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): PEMF Therapy based on Biological Electromagnetic (BEM) microbial wave technology provides micro-magnetic emissions to the center of the palm (Laogong acupoint). While participating in the study, the subjects will undertake 2 sessions of therapy every day (1 session in the morning and evening). Each session will last for 16-min (8-min for left and 8-min for right hand).; PEMF therapy will be administered however it will not produce micro-magnetic emissions. The therapy will be used on the center of the palm (Laogong acupoint) of each hand. While participating in the study, the subjects will undertake 2 sessions of therapy every day (1 session in the morning and evening). Each session will last for 16-min (8-min for left and 8-min for right hand).
Other intervention name(s): Bioboosti; Bioboosti Sham
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Ultramarathons; Electromagnetic field therapy; Endurance; Exercise; Environmental conditions
Effects of Ovarian Reserve on Sexual Satisfaction
Condition: Sex Behavior; Ovarian Failure
Study type: Interventional

Summary: 
      This is a survey study. The primary aim of the study is to investigate the relationship
      between the ovarian reserve and sexual satisfaction. All the patients who underwent ovarian
      reserve assessment for any reason will fill a questionnaire about sexual satisfaction. And
      the survey results will be compared with patients' ovarian reserve.
    


Intervention name(s): Survey
Intervention type(s): Behavioral
Intervention description(s): Patients will fill a questionary with 8 questions.
Intervention model: Single Group Assignment
Intervention model description: Survey Study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ovarian Reserve; Sexual Satisfaction
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children
Condition: Prevention of Meningococcal Infection
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C
      Conjugate Vaccine in healthy children
    

Detailed description: 
      The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when
      administered in different schedules at different years of life: 2 doses in the first year of
      life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of
      life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the
      second year of life, or only 1 dose in the second year of life.
    

Intervention name(s): Meningococcal C conjugate vaccine
Intervention type(s): Biological
Intervention description(s): Meningococcal conjugate vaccine, active comparator.
Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Meningococcal Meningitis; meningococcal vaccines; conjugate; immunology; infant; antibody persistence
Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage
Condition: Abscess
MeSH terms: Abscess
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized clinical trial aims to compare the analgesic efficacy of intranasal fentanyl
      to placebo as analgesic adjunct to conventional local anesthesia for the treatment of pain of
      the overall procedure in adult patients undergoing lidocaine infiltration and subsequent
      abscess incision and drainage in the Emergency Department (ED).
    


Intervention name(s): Intranasal fentanyl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fentanyl Citrate; Sterile Water Up to 5Cc
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Treatments for Depression: Drug Versus Psychotherapy
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®),
      venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which
      is more effective in treating major depression.
    

Detailed description: 
      MDD is one of the most prevalent psychiatric disorders. Different forms of psychotherapy for
      depression have been found effective. This study compares a form of dynamic psychotherapy
      called supportive-expressive psychotherapy to medication and to placebo.

      Participants are evaluated on 2 occasions, 1 week apart, before they are randomly assigned to
      receive either supportive-expressive psychotherapy, sertraline (Zoloft) (followed by
      venlafaxine [Effexor] if patients do not respond to sertraline), or placebo. The active phase
      of treatment lasts 4 months. The frequency of patients' visits depends on the assigned
      treatment.

      Patients who are randomized to receive medication or placebo are initially seen on a weekly
      basis, then less often, depending on the rate of symptomatic improvement. Patients who are
      randomized to psychotherapy are seen twice a week for the first 4 weeks, then once a week for
      the remaining 12 weeks. Outcome is monitored at week 2,4,6,7,8, 12, 15 and 16. At the end of
      the first 16 weeks of treatment, patients are thoroughly evaluated. Those who have responded
      to treatment are assigned to a continuation phase and are seen once a month for another 16
      weeks. At the end of the 16-week continuation phase, patients are again evaluated and all
      treatments are stopped. Follow-up continues every 3 months for up to 2 years to ensure that
      the patients' depression remains under control.
    

Intervention name(s): Supportive Expressive Therapy; Sertraline; Pill Placebo; Venlafaxine
Intervention type(s): Behavioral; Drug; Drug; Drug
Intervention description(s): The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.; Participants will receive sertraline.; Participants will receive a pill placebo.; Participants will receive venlafaxine.
Other intervention name(s): Zoloft; Effexor
Intervention MeSH terms: Sertraline; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder
NEXUS™ Aortic Arch Stent Graft System First In Man Study
Condition: Thoracic Aortic Arch Disease; Thoracic Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
Study type: Interventional

Summary: 
      A multicenter, prospective, open-label, non-randomized, interventional clinical study,
      sponsored by Endospan Ltd. Patients will be followed-up for five years.
    

Detailed description: 
      The purpose of the study is to evaluate the safety and performance of the Nexus™ Aortic Arch
      Stent Graft System for the endovascular treatment of thoracic aortic pathologies requiring
      landing in the Aortic Arch (zone 0, zone 1, zone 2).

      The Nexus™ Aortic Arch Stent Graft System is indicated for the endovascular treatment of
      thoracic aortic pathologies involving the aortic arch (such as aneurisms and dissections).
      The Nexus™ is intended to exclude the lesion from the blood circulation in patients diagnosed
      with thoracic aortic pathology and who have appropriate anatomy to accommodate the Nexus™
      system in an endovascular procedure.

      The primary objectives of the study are to evaluate the safety and performance of the Nexus™
      Aortic Arch Aneurysm Stent Graft System.
    

Intervention name(s): Stent Graft Placement (Nexus)
Intervention type(s): Device
Intervention description(s): The Nexus stent graft is introduced through a groin to the diseased location at the Aortic Arch. Depending on the patients anatomy and other medical considerations the physician may decide that blood flow to the sub-clavian artery and possibly also to the left carotid artery is required to be maintained via "surgical bypass grafting", either immediately, or a few days, before the implantation. In addition to the incision for introducing the investigational stent graft, two smaller access sites are required, one at the groin on the opposite side and on into the Right Arm to the Brachial Artery.
This endovascular procedure will likely require full anesthesia. The entire procedure is assisted by an angiography imaging system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TAA
Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human
      Laboratory Model of Stress-precipitated Smoking Behavior.
    

Detailed description: 
      The study will be performed in subjects who are heavy cigarette smokers currently not seeking
      treatment for tobacco use disorder.

      The study is a crossover design study (within-subject analysis), which allows for subjects to
      be their own control.

      Each period of the crossover consists of a 7-day out-patient treatment period followed by a
      single out-patient testing day on Day 8. Subjects will participate in a laboratory session
      following the McKee Stress-Smoking Lapse Test. Upon completion, subjects will undergo a 7 day
      washout period followed by the second period of the crossover design and a 7-day follow-up
      visit.
    

Intervention name(s): CERC-501; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CERC-501; Placebo
Intervention MeSH terms: Aticaprant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment