bioihbjkbjnl/mcl2 huggingface dataset:
To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the bioequivalence of the test product (Nicotine Prototype Mini
      lozenge 4 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini
      lozenge 4mg) in healthy smokers under fasting conditions.
    

Detailed description: 
      This study will be a single center, randomized, open label, single dose, two-way crossover in
      healthy smokers that smoke their first cigarette within 30 minutes of waking. This study will
      consist of following Visits: Visit 1 (Screening), Visit 2 (Study Period 1), followed by a
      Washout period and Visit 3 (Study Period 2). This will ensure approximately 29 evaluable
      participants per treatment arm. Each participant will be treated with a single dose of the
      two study treatments (test and reference) in a randomized sequence, under fasting conditions.
      Participants will be confined in the study facility for approximately 60 hours during each
      study session (for 36 hours pre-dosing and for 24 hours post dosing) during which
      pharmacokinetic (PK) blood samples will be obtained. Participants are to abstain from smoking
      during the confinement periods and be subject to random measurements of expired carbon
      monoxide (CO) to confirm abstinence. The CO levels must be ≤10 parts per million (ppm)
      throughout the study session. There will be at least 5-day and not more than 7-day clinical
      furlough period between treatment periods. For each treatment period, the clinical
      confinement period with restriction of smoking is at least 36 hours prior to dosing.
    

Intervention name(s): Nicotine Prototype Mini lozenge; Nicorette Mini Lozenge
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of a prototype nicotine 4mg lozenge will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.; A single dose of a 4 mg nicotine polacrilex mini lozenge (Nicorette Minis) will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lidocaine Infusion on Optic Nerve Sheath Diameter in Laparoscopic Hysterectomy in Trendelenburg Position
Condition: Lidocaine; Optic Nerve Sheath Diameter; Laparoscopic Hysterectomy; Trendelenburg
Study type: Interventional

Summary: 
      We hypothesize that intravenous lidocaine infusion may have beneficial effect to patients
      undergoing laparoscopic surgeries in Trendelenburg position by preventing ICP elevation.
    

Detailed description: 
      Lidocaine use, both intravenous (IV) and laryngotracheal (LT), has been reported to blunt the
      ICP elevations during intubation. Also, Lidocaine injected IV has been shown in models to
      induce cerebral vasoconstriction leading to a decrease in cerebral blood volume and thus ICP.
      Furthermore, IV lidocaine leads to sodium channel inhibition and thus a reduction in cerebral
      activity and metabolic demands, as well as excitotoxicity, leading to a potential ICP
      reduction effect.
    

Intervention name(s): Lidocaine; sodium chloride 0.9% solution
Intervention type(s): Drug; Drug
Intervention description(s): intravenous lidocaine 2% bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively until desufflation; intravenous sodium chloride 0.9% solution volume matched bolus and infusion.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Association of Asprosin in Periodontitis and Acute Coronary Syndrome
Condition: Cardiovascular Diseases; Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases; Cardiovascular Diseases; Acute Coronary Syndrome
Study type: Observational

Summary: 
      Asprosin, a recently discovered glucogenic adipokine, is mainly synthesized by white adipose
      tissue and released during fasting. Appetite, glucose metabolism, insulin resistance, cell
      apoptosis, etc. asprosin is associated with diseases such as diabetes, obesity, polycystic
      ovary syndrome, and cardiovascular diseases. Periodontal tissue may act as a source of
      endocrine-like inflammatory mediators (such as TNF-α, IL-6 and IL-1) that are important in
      periodontal inflammation and can affect glucose and lipid metabolism. Production of TNF-α and
      IL-6 in adipose tissues strengthens the relationship between cardiovascular diseases and
      periodontitis. Investigators postulated that asprosin may be a candidate for explaining the
      triangular relationship between cardiovascular and periodontal disease.
    

Detailed description: 
      Periodontal disease is a chronic, multifactorial, and infectious disease caused by bacteria.
      It is characterized by the formation of an inflammatory response in the supporting bone and
      connective tissue against microbial dental plaque, and the nature of the resulting
      inflammatory response determines the course of periodontal disease. Cardiovascular and
      periodontal diseases are closely related, presenting a triad association. Asprosin circulates
      in the blood at nanomolar levels and is taken to the liver, where it activatesinvestigators
      the G protein-cAMP-PKA pathway, causing rapid glucose release into the circulation.
    

Intervention name(s): Serum samples will be collected. Asprosin levels will be determined by biochemical analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Serum samples will be collected from both groups for biochemical analysis.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study was carried out on 120 patients, 50 admitted to Atatürk University Medical
        Faculty Heart Center with SD elevation myocardial infarction and 70 who applied to Atatürk
        University Faculty of Dentistry. Patients who consent to participate in the study on a
        randomized basis and comply with the inclusion criteria are divided into periodontitis and
        healthy groups after the periodontal examination. Body mass index was evaluated
A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to look at how tucatinib could affect the way other drugs work. This
      study will look at healthy volunteers and how tucatinib affects their liver enzymes. Liver
      enzymes can change how drugs work in the body. There are 5 parts to this study. Parts A and C
      are looking at how the body breaks down tucatinib when there are lower levels of certain
      liver enzymes. Part B is looking at how the body breaks down tucatinib when there are high
      levels of certain liver and stomach enzymes. Parts D and E are looking at how tucatinib could
      change the levels of some liver and stomach enzymes in the body. This will help us know more
      about how tucatinib should be given to patients.
    

Detailed description: 
      This is a fixed-sequence, drug-drug interaction study of tucatinib conducted in 5 parts in
      healthy subjects. Part A will evaluate the effect of the strong CYP3A4 inhibitor itraconazole
      on the pharmacokinetics (PK) of tucatinib. Part B will evaluate the effect of rifampin, a
      strong inducer of CYP3A4 and CYP2C8, on the PK of tucatinib. Part C will evaluate the effect
      of the strong CYP2C8 inhibitor gemfibrozil on the PK of tucatinib. Part D will evaluate the
      effects of tucatinib on the PK of substrate probes of the metabolizing enzymes CYP2C8
      (repaglinide), CYP2C9 (tolbutamide), and CYP3A4 (midazolam). Part E will evaluate the effect
      of tucatinib on the PK of a substrate probe of the transporter P-gp (digoxin). Parts A, B, C,
      D, and E of the study are independent of one another and do not need to be conducted in a
      particular order.
    

Intervention name(s): tucatinib; itraconazole; rifampin; gemfibrozil; repaglinide; tolbutamide; midazolam; digoxin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300mg dose, orally administered; 200mg dose; 600mg dose; 600mg tablets; 1mg dose; 500mg dose; 2mg dose; 0.5 mg dose
Intervention MeSH terms: Repaglinide; Tolbutamide; Itraconazole; Rifampin; Tucatinib; Digoxin; Midazolam; Gemfibrozil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation
Condition: Inflammation; Insulin Resistance
MeSH terms: Insulin Resistance; Inflammation
Study type: Interventional

Summary: 
      Red raspberries (Rubus idaeus) are a good source of health enhancing hydrolyzable and
      condensed tannins, flavonoids, anthocyanins, phenolic acids, rheosmin, potassium,
      carotenoids, vitamin C, and vitamin K1. Compared to other berries commonly consumed in the
      US, the health benefits of red raspberries to improve pre-diabetes mellitus (PDM) and type 2
      diabetes have never been explored. The clinical study proposed in this project seeks to
      investigate the protective effect of whole red raspberries against insulin resistance,
      oxidative stress, and inflammation in PDM and type 2 diabetic patients. The in vitro study
      proposed in the project will assist in identifying the molecular mechanisms by which whole
      red raspberry protect islet cells against oxidative stress, insulin resistance and loss of
      cell function.
    


Intervention name(s): Raspberries
Intervention type(s): Other
Intervention description(s): Red raspberry smoothies drink
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
B-cell Immunity to Influenza (SLVP017)- Year 5, 2013
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      In this exploratory study, investigators will be looking at immune response differences
      between age groups and between the two different vaccines given to identical twins and
      vaccine-naive young adults.
    

Detailed description: 
      This is a study of healthy children and adults who will be given standard seasonal influenza
      vaccination (IIV3). There are no exclusions for gender, ethnicity or race. Following review
      and confirmation of written informed consent, volunteers will be enrolled into the study.

      The 1-2 year-old child volunteers enrolled in Group A cannot have been previously immunized
      with an influenza vaccine. They will receive two single doses of the 2013-2014 pediatric
      formulation of seasonal trivalent inactivated influenza vaccine (IIV3), at least 28 days
      apart, given by intramuscular (IM) injection. The child volunteers will complete 4 clinic
      visits with 3 blood sample collections. Study visits will be on Day 0 (first immunization),
      Day 28-32 (second immunization), Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. The baseline
      blood sample will be drawn prior to immunization at Day 0, followed by two additional blood
      samples at Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. There will not be a blood sample
      collected at Day 28-32.

      The 18-30 year-old young adults in Group B cannot have been immunized with the 2012-2013
      seasonal influenza vaccine. Participants in Group B will receive a single dose of the
      2013-2014 IIV3 by IM injection. Young adult volunteers will complete 3 clinic visits with 3
      blood sample collections on Day 0, Day 6-8, and Day 28+4. The baseline blood sample will be
      drawn prior to immunization at Day 0.
    

Intervention name(s): Fluzone
Intervention type(s): Biological
Intervention description(s): Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Trivalent inactivated influenza vaccine; Young children; Young adults
Magnetic Resonance Imaging Combined With Venous Ultrasonography of the Legs for Pulmonary Embolism
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional

Summary: 
      Magnetic resonance imaging (MRI) represents a promising technique but can not be used as an
      alternative test to multidetector CT in patients with suspicion of pulmonary embolism (PE)
      due to its low sensitivity and high proportion of inconclusive MRI. The purpose of this study
      is to evaluate diagnostic performances of MRI combined with venous ultrasonography of the
      legs in patients with suspicion of PE.
    


Intervention name(s): MRI combined with venous ultrasonography of the legs
Intervention type(s): Procedure
Intervention description(s): In case of positive D-dimer testing or in patients with a high probability of PE, MRI and a venous ultrasonography of the legs are done.MRI protocol includes 2 sequences: 1-Unenhanced steady-state-free precession sequences (SSFP) are acquired first without ECG-gating or breath-holding in the axial plane in the multiphase cine mode, with 6 phases per location.The acquisition is repeated to cover 2-3 of the thorax, from the roof of the aorta to the diaphragm. 2- A pulmonary gradient recalled echo (GRE) sequence is performed in the axial plane.The acquisition is triggered to start when contrast enhancement occurred in the right ventricle.Two acquisitions are necessary to cover the anatomy. For each acquisition, 0.15 mL kg-1 body weight of DOTAREM Gadolinium is injected at a rate of 3 mL s-1 followed by an injection of 15 mL of normal saline at 3 mL s-1.Venous ultrasonography of the legs: the examination consists of a real-time B-mode examination of the common femoral and popliteal veins.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pulmonary embolism; magnetic resonance imaging; venous ultrasonography of the legs; diagnostic performances
Muscle Strength Assessment in Patients With Chronic Ankle Instability
Condition: Chronic Ankle Instability
Study type: Observational

Summary: 
      Patients with chronic ankle instability (CAI) show biomechanical and neuromuscular
      alterations during the performance of functional movements not only at the ankle joint level,
      but also in more proximal joints and segments. Few studies have been conducted to investigate
      the effects of chronic ankle instability on neuromuscular control at the knee joint level.
      The aim of this study is to investigate whenther abnormalities exists in maximal and
      sub-maximal isometric muscle strength expression in patients with CAI.
    


Intervention name(s): Chronic ankle instability
Intervention type(s): Other
Intervention description(s): Persistent condition of ankle instability after a first ankle sprain episode.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Orthopaedic hospital and community individuals
      
Keywords: ankle instability; muscle strength; quadriceps; hamstrings; maximal voluntary isometric contraction
Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine
Condition: Covid19; SARS-CoV Infection; Vaccine Adverse Reaction
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Randomized, Blind, Placebo-controlled Phase- I Study and Randomized, Open Phase Phase-II
      Study of QazCoVac-P - COVID-19 Subunit Vaccine in Healthy Adult Volunteers From 18 Years Old
      and Elder
    

Detailed description: 
      Purpose of the Phase-I clinical study Evaluation of the safety, acceptability and
      immunogenicity of QazCoVac-P - COVID-19 Subunit vaccine when administered twice in healthy
      volunteers aged 18-50 years.

      Purpose of the Phase-II clinical study Evaluation of the safety and immunogenicity of
      QazCoVac-P - COVID-19 Subunit vaccine with single and dual use in healthy volunteers aged 18
      and above
    

Intervention name(s): QazCoVac-P -COVID-19 Subunit Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan; The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: vaccine,; I/II phase,; safety,; immunogenicity,; QazCoVac-P
Couple-focused Intervention for Sun Protection
Condition: Skin Cancer Prevention
MeSH terms: Skin Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this pilot study is to develop and test a couple-based intervention to increase
      sun protection practices. First, the investigators will develop the intervention website, Sun
      Safe Partners online. Next, the investigators will gather feedback and preferences for
      content in a small sample of couples who do not regularly engage in sun protection practices.
      The investigators will also gather preliminary information regarding the impact of the
      couple-based intervention.
    

Detailed description: 
      Aim 1: To develop and evaluate the feasibility of a couple-based sun protection intervention.

      Aim 2: To examine the impact of the couple-based sun protection intervention on sun
      protection practices, individual attitudes, relationship perspective on sun protection, and
      couples' discussion with each other and their supportive communications about sun protection.

      Aim 3: To develop and refine a SunSafe Partners online intervention. This process includes
      refining existing intervention content drawn from the first phase of this pilot research as
      well as formative and usability studies to obtain user-generated feedback on additional
      content and the approach.

      Aim 4: To gather pilot data on participation in and evaluations of the Sun Safe partner's
      intervention from Aim 3.

      Arm 1: Web-based intervention called Sun Safe Partners Online

      Arm 2: Generic Online Sun Safety Information intervention- 4 links emailed to participants
    

Intervention name(s): Sun Safe Partners Online; Generic Online Sun Safety Information intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sun Safe Partners Online has 4 individual-focused modules and 4 couple-focused modules focusing on skin cancer prevention education and sun protection.; 4 links to sent to participants from (1) The Skin Cancer Foundation's Skin Cancer Prevention guidelines, (2) the Centers for Disease Control and Prevention's information on risk factors for skin cancer, (3) the American Academy of Dermatology's information on how to select an appropriate sunscreen, and (4) The Skin Cancer Foundation's information on sun protective clothing. Participants were emailed a link to one of the resources each week for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Skin Cancer
Endostatin in Treating Patients With Advanced Refractory Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Endostatin may stop the growth of solid tumors by stopping blood flow to the
      tumor.

      PURPOSE: Phase I trial to study the effectiveness of endostatin in treating patients who have
      advanced refractory solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and Phase II dose of endostatin in
      patients with advanced refractory solid tumors. II. Determine the qualitative and
      quantitative nature of the toxicities encountered with endostatin in this patient population.
      III. Evaluate the basic pharmacokinetics and metabolism of endostatin by measurement of
      plasma levels by EIA and mass spectrometry in this patient population. IV. Investigate the
      relationship between pharmacokinetic parameters and toxicity in this patient population. V.
      Evaluate biologic evidence of angiogenesis inhibition in patients receiving endostatin.

      OUTLINE: This is a dose escalation study. Patients receive endostatin IV over 1 hour daily
      for 28 days, followed by 1 week of rest. Patients receive subsequent courses of daily therapy
      in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive
      escalating doses of endostatin until the maximum tolerated dose (MTD) is determined. The MTD
      is defined as the dose preceding that at which 2 of 6 patients experience dose limiting
      toxicities.

      PROJECTED ACCRUAL: Approximately 30-40 patients will be accrued for this study.
    

Intervention name(s): recombinant human endostatin
Intervention type(s): Biological
Intervention MeSH terms: Endostatins
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific