bioihbjkbjnl/mcl2 huggingface dataset:
Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With T2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the impact of a comprehensive diabetes education and
      management program based on frequent communication with patients using teleconsultation, text
      messaging, and phone calls on diabetes related outcomes in Latino patients with type 2
      diabetes. The investigators hypothesize that the decline in hemoglobin A1c value between the
      baseline and the six-month visit will be at least 0.5 percent greater in the intervention
      group than in the control group.
    

Detailed description: 
      In this study participants will be followed for a period of 9 months. The control group will
      receive usual care during this period of time. While, the intervention group will be part of
      a diabetes education and management program lasting 6 months via a smartphone participants
      will receive. The 6 month intervention will be followed by a 3 month observation period.
    

Intervention name(s): Virtual Diabetes Self-Care and Education Program; Fitbit; Smartphone
Intervention type(s): Behavioral; Device; Device
Intervention description(s): Participants will be able to have frequent contact in order to share physical activity and glucose data with the diabetes educator using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the diabetes educator.; Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application.; All virtual visits were performed via provided smartphone. In addition, participants will receive a Glooko MeterSync Blue cable which is able to connect to most glucose meters in order to download glucose data to the Glooko Population Management tool on their smartphones
Other intervention name(s): physical activity tracker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Telehealth; Hispanics; Latinos; Self-Care; Mobile Health; mHealth
A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral
      activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve,
      HIV-1-infected participants.
    


Intervention name(s): Doravirine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Doravirine tablets, orally, once daily for 7 days at a dose of 25 mg in Panel A and 200 mg in Panel B; dose in Panel C to be determined (≤200 mg).; Placebo tablets once daily for 7 days.
Other intervention name(s): MK-1439
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to
      compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed
      combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan)
      administered once in the evening (20:00) in newly-diagnosed patients with exfoliation
      syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated
      and IOP greater than 29 mm Hg.
    


Intervention name(s): Bimatoprost/Timolol, 24-hour intraocular pressure monitoring; Latanoprost, 24-hour intraocular pressure monitoring
Intervention type(s): Drug; Drug
Intervention description(s): Administered once in the evening; assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
Other intervention name(s): Ganfort; Xalatan; Ganfort; Xalatan
Intervention MeSH terms: Timolol; Bimatoprost; Latanoprost; Cloprostenol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      This study aim to compare the efficacy of intraoperative dexmedetomidine infusion versus
      Nitroglycerin infusion in cancer patients with accidental uncontrolled intraoperative
      elevation of blood pressure.
    

Detailed description: 
      Nitroglycerine is a direct vessel wall vasodilator with more venodilator effect than arterial
      dilator effect. It is used as an anti-anginal and antihypertensive drug. On the other hand,
      dexmedetomidine is a highly selective alpha 2 adrenergic agonist with sympatholytic effect.
      This study aim to compare the efficacy of intraoperative dexmedetomidine infusion versus
      Nitroglycerin infusion in cancer patients with accidental uncontrolled intraoperative
      elevation of blood pressure.
    

Intervention name(s): Nitroglycerin; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): data will be retrieved from intraoperative medical records for the period from May 2020 to May 2021 for patients meeting the eligibility criteria who developed uncontrolled elevation of their blood pressure and received nitroglycerine infusion; All patients who develop uncontrolled elevation of their blood pressure and meeting the eligibility criteria from July 2021 to July 2022 will receive dexmedetomidine bolus of 1mic/kg over 20 minutes and then continuous infusion of 0.2-0.7 mic/kg/hour adjusted according to each patient hemodynamic response.
Intervention MeSH terms: Nitroglycerin; Dexmedetomidine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cancer patients with controlled hypertension and undergoing surgical procedures under
        general anesthesia
Autogenous Ramus Bone Block Harvesting With Piezosurgery
Condition: Alveolar Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional

Summary: 
      The aim of this randomized prospective clinical trial was to evaluate the outcome of bone
      block harvesting from the retromolar region using the Conventional and Piezosurgery Method.

      The study was planned on 19 patients (13F,6M) on 31 donor sites. In patients with bilateral
      bone harvesting, the donor site and the surgical method to be used were determined by the
      randomization protocol, while in patients with bone harvesting from a single site, the donor
      site was determined by considering parameters such as proximity to the operation site and
      distance to the inferior alveolar nerve. Clinical parameters such as operation time, pain,
      swelling, trismus, nerve damage were evaluated.
    


Intervention name(s): Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation; Bone harvesting from ramus area with conventional burs for autogenous bone augmentation
Intervention type(s): Device; Device
Intervention description(s): In this invervention, the piezo-surgical device settings were set to irrigation: '4', function: 'cortical', light: 'auto'. After the full-thickness flap was lifted with the periosteal elevator, superior and vertical osteotomies were performed with the OT-12 piezo-surgical tip. Lower horizontal osteotomies were performed using OT8-L or OT-8-R piezo tips according to the studied quadrant, combining the vertical osteotomy.; In control group, After the full-thickness flap is lifted with the periosteal elevator, using a thin #9 fissure burand the surgical handpiece S-11 Straight tip , the physiodispenser settings are according to the manufacturer's recommendations. The osteotomy was performed after it was adjusted to 40,000 rpm as appropriate. Bone incisions were completed with a round bur to combine the lower horizontal osteotomies and 2 vertical osteotomies. The osteotomies were completed with the help of a thin flat drill, and the block graft was carefully separated from the donor site.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the effect of PF-06882961, administered at 2
      steady-state dose levels, on the PK of single doses of atorvastatin (20 mg) or midazolam (5
      mg), administered separately, in healthy adult male and female participants (Part A), or an
      OC in healthy PM female participants (Part B).
    


Intervention name(s): PF-06882961; Atorvastatin; Midazolam; Levonorgestrel & Ethinyl Estradiol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets; Tablets; Syrup; Tablet
Intervention MeSH terms: Midazolam; Atorvastatin; Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of Reliability of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions.
Condition: Proximal Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the Clinical performance of the near-infrared imaging
      system VistaCam iX Proxi in comparison with digital radiographic findings and ICDAS-II in
      detection of approximal carious lesions.
    


Intervention name(s): Vistacam; Bitewing radiograph
Intervention type(s): Device; Radiation
Intervention description(s): device for early proximal caries detection; radiograph for proximal caries detection
Intervention model: Single Group Assignment
Intervention model description: screening of the Patients who join the Conservative Dentistry Department clinic will be done until the target population is achieved. The Patients' teeth will be subjected to visual examination and diagnosis using dental charts. once the patient is eligible to be included in this study, they will be contacted by the research investigator who will explain the study and identify the patient interests .If the patient show interest ,further clarification and discussing wil be held .
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of CTrach, Intubating Laryngeal Mask Airway (ILMA) and I-gel for Tracheal Intubation
Condition: Intubation
Study type: Interventional

Summary: 
      Various supraglottic airways may be used as a dedicated airway for insertion of intubating
      fibrescope and tracheal intubation in the patients with difficult to manage airways
      (Difficult Airway Society Guidelines).

      The investigators aim to compare three different types of supraglottic device as a conduit
      for tracheal intubation - CTrach optical laryngeal mask, Intubating laryngeal mask airway and
      I-gel supraglottic airway. Null hypothesis for this study is that all three devices will
      perform without statistical difference in the means of success rate and time needed for their
      insertion and tracheal intubation.
    

Detailed description: 
      Supraglottic airway devices such as I-LMa, Igel and LMA Ctrach are designed to create a
      "dedicated" airway which safely allows both spontaneous and controlled ventilation. The use
      of supraglottic airways can allow planned fibreoptic intubations in expected difficult cases
      and can provide an emergency airway in cases of unexpected difficult airway.

      The ILMA (Intavent Orthofix Ltd.,Wokingham, UK) has been designed for either blind or
      fibrescope-guided tracheal intubation, in patients with expected and unexpected difficult
      airway. Since its development in 1997, it has been used for both blind and fibrescope-guided
      tracheal intubations in the patients with difficult airway. The ILMA is currently a 'gold
      standard' in supraglottic airways used for tracheal intubation.

      The I-gel (Intersurgical Ltd., Wokingham, UK) is a newer dedicated airway device, which with
      its wide bore allows direct passage of a tracheal tube.

      The CTrach (The Laryngeal Mask Company,Singapore) is a newer device for airway management. It
      has special optical fibres built-in inside its bowl and a liquid crystal display which allows
      views of the larynx while the endotracheal tube is being placed.

      With reference to these supraglottic airway devices, only a small number of case reports
      detail tracheal intubation through an I-gel in patients with difficult airways. There have
      been manikin studies comparing ILMA and CTrach, and some descriptive studies on the use of
      CTrach in patients with predicted difficult airways- but no studies comparing the performance
      of these devices in clinical practice.
    

Intervention name(s): Tracheal intubation
Intervention type(s): Procedure
Intervention description(s): Insertion of a plastic tube under direct vision (built-in camera, intubating fibrescope) into trachea.
Other intervention name(s): intubation; insertion of tracheal tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: difficult airway; fibreoptic intubation; supraglottic airways; laryngeal mask airway
Thorough QT Assessment of Cedazuridine in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the effect of therapeutic and supratherapeutic oral doses
      of cedazuridine on cardiac repolarization, as detected by QTc in healthy subjects, in
      accordance with regulatory guidelines. Moxifloxacin will be used to validate the study. Study
      duration per participant is approximately 20 days.
    


Intervention name(s): Cedazuridine; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet for oral administration; Capsule for oral administration; Tablet for oral administration
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study Comparing Pharmacokinetics of Different Formulations of Evobrutinib in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and
      safety and tolerability of evobrutinib after oral administration of immediate release (IR)
      and modified release (MR) formulations in healthy participants.
    


Intervention name(s): Ref (TF2); Evobrutinib MR-T1; Evobrutinib MR-T2; Evobrutinib MR-T3; Evobrutinib MR-T4; Evobrutinib MUPS-C1; Evobrutinib MUPS-C2; Evobrutinib MUPS-C3; Evobrutinib MUPS-C4; Evobrutinib MR-T adapated
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive 2 single oral doses of Ref (TF2) on Day 1 in treatment period 1, 2, or 3 of Part A, B, C and D.; Participants will receive single oral dose of MR-T1 on Day 1 in treatment period 1, 2, and 3 of Part A.; Participants will receive single oral dose of MR-T2 on Day 1 in treatment period 1, 2, and 3 of Part A.; Participants will receive single oral dose of MR-T3 on Day 1 in treatment period 1, 2, and 3 of Part A.; Participants will receive single oral dose of MR-T4 on Day 1 in treatment period 1, 2, and 3 of Part A.; Participants will receive single oral dose of MUPS-C1 on Day 1 in treatment period 1, 2, and 3 of Part B.; Participants will receive single oral dose of MUPS-C2 on Day 1 in treatment period 1, 2, and 3 of Part B.; Participants will receive single oral dose of MUPS-C3 on Day 1 in treatment period 1, 2, and 3 of Part C.; Participants will receive single oral dose of MUPS-C4 on Day 1 in treatment period 1, 2, and 3 of Part C.; Participants will receive single oral dose of MR-T adapted on Day 1 in treatment period 1, 2, and 3 of Part D.
Other intervention name(s): M2951; M2951; M2951; M2951; M2951; M2951; M2951; M2951; M2951; M2951
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part A, B and C, periods 1 to 3 will be an incomplete cross-over; Part A, B and C, periods 4 and 5 are sequential. Part D, periods 1 and 2 will be 2-sequence cross-over design with 2 treatment sequences; Part D, period 3 is optional.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bruton's tyrosine kinase; delayed release; multiparticulate
Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
Condition: Acne
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear
      Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
    

Detailed description: 
      Not required
    

Intervention name(s): Tretinoin microsphere 0.1%; Brand Retin-A Micro tretinoin microsphere gel 0.1%; placebo microsphere gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment of acne vulgaris; Treatment of acne vulgaris; treatment of acne vulgaris
Other intervention name(s): Retin-A Micro
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose
Condition: Meningococcal Infection
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to assess the longevity of immune response in adolescents for approximately 48
      months after receipt of a primary series of bivalent rLP2086 vaccination, which is then
      followed by a booster dose and an assessment of immune response for 12 or 26 months post
      booster vaccination.
    

Detailed description: 
      This study is to assess the longevity of immune responses in adolescents (aged 10 to <19
      years at the time of entry into a primary study) following receipt of a vaccination regimen
      of 2 or 3 doses of bivalent rLP2086 in a primary study. A booster dose of bivalent rLP2086 at
      approximately 48 months was given following the final dose of the 2- or 3-dose primary
      bivalent rLP2086 vaccination series. The study was therefore divided into Stage 1 (4-year
      persistence of immune responses following receipt of a primary vaccination series) and the
      booster stage (follow-up through 12 months for all boosted or 26 months for a subset of the
      boosted).

      Subjects participating only in Stage 1 will attend up to 6 study visits for collection of a
      20-mL blood sample at each visit. Subjects participating in both Stage 1 and booster stage
      will attend up to 9-10 study visits with 1 visit for booster dose vaccination and 8-9 visits
      for collection of a 20-mL blood sample at each visit.
    

Intervention name(s): blood sampling; bivalent rLP2086
Intervention type(s): Procedure; Drug
Intervention description(s): Blood sample collection at different time points; A booster dose of bivalent rLP2086 at approximately 48 months following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series will be given at Visit 7.
Masking: None (Open Label)
Primary purpose: Other
BRown Fat Activity Measurement With Infrared imaginG tHermography andThermogenesis - the BRIGHT Study
Condition: Energy Expenditure; Obesity; Adipose Tissue, Brown
Study type: Interventional

Summary: 
      The whole body calorimeter is sensitive enough to reliably measure cold-induced thermogenesis
      as a surrogate marker of brown adipose tissue (BAT) activation.

      The infrared (IR) energy flux from activated BAT can be accurately imaged and quantified
      using an IR imaging device, and that this IR energy output may be correlated to the increased
      energy expenditure quantified by the whole body calorimeter.
    

Detailed description: 
      The recent rediscovery of functional brown adipose tissue (BAT) in healthy adults has opened
      up the exciting possibility of manipulating BAT for obesity management, and it is imperative
      to develop BAT imaging modalities that are non-invasive and safe for repeated use. Given that
      heat is a specific end-product of uncoupling protein-1 (UCP-1)-mediated BAT, this study
      examines whether surface body temperature assessed using infrared (IR) thermography can be a
      non-invasive measure to accurately and precisely predict brown adipose tissue (BAT)
      activation upon cold stimulation, which involves verifying an semi-automated method for
      characterizing thermal images. In addition, this study also aims to validate the use of a
      whole-body calorimeter to pick up changes in energy expenditure upon cold-induced
      thermogenesis. Lean, healthy male volunteers will be recruited. Thermal imaging of
      cervical-supraclavicular BAT will be done using an IR camera to assess changes in BAT
      activation. Blood samples will also be drawn at regular intervals to track changes in serum
      metabolites upon BAT activation. All in all, this study hopes to provide more supporting
      evidence that IR thermography is a viable imaging modality that is non-invasive, safe and
      reproducible of studying BAT activity.
    

Intervention name(s): Cold air; Cold water
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD
    


Intervention name(s): tiotropium bromide
Intervention type(s): Drug
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study
Condition: Mitral Valve Regurgitation
MeSH terms: Mitral Valve Insufficiency
Study type: Interventional

Summary: 
      Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty
      Ring.
    

Detailed description: 
      Establish the technical feasibility and safety of implantation of the investigation device,
      adjustment of the investigational device post-implantation, and the ability of the
      investigational device to reduce mitral valve regurgitation.
    

Intervention name(s): Adjustable Annuloplasty Ring
Intervention type(s): Device
Intervention description(s): The investigational device is intended for use in the treatment of mitral valve regurgitation.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment