bioihbjkbjnl/mcl2 huggingface dataset:
PET Scan and CT Scan in Evaluating Response in Patients Undergoing Radiofrequency Ablation for Lung Metastases
Condition: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor
      cells. Diagnostic procedures, such as PET scan and CT scan, may help doctors measure the
      patient's response to treatment.

      PURPOSE: This clinical trial is studying PET scan and CT scan to see how well they work in
      evaluating response to treatment in patients undergoing radiofrequency ablation for lung
      metastases.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the accuracy of positron emission tomography (PET) and CT scan in measuring
           response at 3 months after radiofrequency ablation (RFA) in patients with lung
           metastases.

      Secondary

        -  Determine the agreement between observers analyzing PET/CT scan results.

        -  Determine the outcome of these patients.

        -  Determine the false-positive rate and false-negative rate of PET/CT scan at 1 and 3
           months in these patients.

        -  Determine the optimal time for obtaining a negative PET scan.

        -  Determine the sensitivity, specificity, positive predictive value, and negative
           predictive value of PET/CT scan at 1 and 3 months.

        -  Determine the morbidity associated with RFA.

        -  Determine the disease-free survival after RFA and the factors predicting recurrent
           disease in these patients.

      OUTLINE: This is a multicenter study.

      Patients undergo positron emission tomography (PET) and CT scan at baseline. Patients then
      undergo radiofrequency ablation (RFA) for lung metastases. PET/CT scan is repeated at 1 week,
      1 month, and 3 months after RFA.

      After completion of RFA, patients are followed by clinical examination and conventional
      scanning at 6, 9, and 12 months.

      PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
    

Intervention name(s): computed tomography; positron emission tomography; radiofrequency ablation
Intervention type(s): Procedure; Procedure; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: unspecified adult solid tumor, protocol specific; lung metastases
Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures
Condition: Neurobehavioral Manifestations
MeSH terms: Neurobehavioral Manifestations; Cognitive Dysfunction
Study type: Observational

Summary: 
      Up to 50% of patients undergoing surgical aortic valve operation suffer from some level of
      post-operative cognitive dysfunction (POCD). Frontal lobes of the brain, where executive
      functions are located, are highly susceptible to trauma caused by possible blood malperfusion
      to these areas of the brain during surgery. Conventional and established neuropsychological
      test methods are poor in distinguishing these kinds of trauma, as they are isolated,
      structured tests that do not require multitasking and processing of multiple stimuli at the
      same time.

      The phase 1 goal of this study is to employ an experimental Executive reaction time (RT) test
      to see if this method could improve objective detection of subtle brain dysfunction assumed
      to underlie persistent cognitive, somatic, and affective complaints reported by patients who
      have undergone electic aortic valve replacement (AVR) surgery. Phase 2 of the study will
      concentrate on patients undergoing transcatheter aortic valve implantation (TAVI).
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Elective aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI)
        patients at Tampere University Hospital Heart Center
      
Keywords: POCD; Executive Reaction Time Test; Aortic valve surgery; Cognitive functions; Transcatheter Aortic Valve Implantation
Blood Glucose Monitoring System Clinical Study
Condition: Diabetes
Study type: Observational

Summary: 
      Verify the following with blood glucose monitoring system:

        -  precision and accuracy versus YSI reference

        -  user evaluation

        -  labeling comprehension
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People who have been diagnosed with diabetes and are testing their blood glucose level at
        least once per day.
Vortioxetine (Lu AA21004) 10 and 20 mg for Treatment of Major Depressive Disorder With Sexual Dysfunction
Condition: Treatment Outcome
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily
      (QD), compared with escitalopram on sexual functioning.
    

Detailed description: 
      The drug being tested in this study is called Lu AA21004. Lu AA21004 is being tested to treat
      people who have major depressive disorder (MDD). This study will look at sexual function in
      people who take Lu AA21004.

      The study will enroll approximately 440 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the two treatment groups-which will remain
      undisclosed to the patient and study doctor during the study (unless there is an urgent
      medical need):

        -  Lu AA21004 10 to 20 mg

        -  Escitalopram 10 to 20 mg - This is a comparator drug that is also used to treat MDD.

      All participants will be asked to take one tablet at the same time each day throughout the
      study. All participants will be asked to answer questionnaires at each study visit.

      This multi-centre trial will be conducted in the United States and Canada. The overall time
      to participate in this study is 14 weeks. Participants will make 7 visits to the clinic, and
      will be contacted by telephone 21 days after last dose of study drug for a follow-up
      assessment.
    

Intervention name(s): Vortioxetine; Escitalopram; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vortioxetine tablets; Escitalopram tablets; Vortioxetine Placebo-matching capsules
Other intervention name(s): Lu AA21004; Lexapro
Intervention MeSH terms: Vortioxetine; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sexual Dysfunction, Physiological; Depressive Disorder, Major; Depression; Antidepressive Agents; Drug Therapy
Is Bronchoscopy Necessary in the Preoperative Workup of GGO Lung Cancer?(ECTOP-1005)
Condition: Pulmonary Nodule, Solitary
MeSH terms: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
Study type: Interventional

Summary: 
      This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1005). It aims to
      evaluate the role of flexible bronchoscopy in the pre-operative workup of ground glass
      opacity featured lung cancer. All enrolled patients receive the flexible bronchoscopy
      examination before surgery. Investigators observe the intra-bronchial findings of
      bronchoscopy and the impact of these findings on established surgical plan.
    

Detailed description: 
      The appropriateness of routine use of bronchoscopy in the operative workup of a solitary
      pulmonary nodule（SPN） is debatable. Options expressed in the literature vary from routine
      preoperative bronchoscopy having no role in obtaining tissue diagnosis in small SPNs to it
      begin very useful in determining underlying etiology and surgical strategy. The American
      College of Chest Physicians（ACCP）guidelines recommend bronchoscopy only if air-bronchogram is
      present or if operator has expertise with newer guided techniques. Previous study showed that
      bronchoscopy is not indicated in SPNs that present with ground-glass opacity on CT. The
      purpose of this analysis is to define that role by examining in GGO patients
      （1）intra-bronchial findings （2）impact of these findings on established surgical plan.
    

Intervention name(s): Flexible Bronchoscopy
Intervention type(s): Device
Intervention description(s): Flexible Bronchoscopy
Intervention model: Single Group Assignment
Intervention model description: We hypothesized incidence rate that bronchoscopic findings would have changed the rate of established surgical plans as less than 2.0% (P0), then preoperative bronchoscopy examination would have limited impact on the surgical plan for GGO featured lung cancer; If bronchoscopic findings would have changed the rate of established surgical plans as more than 4.0% (P1), then bronchoscopy examination would be regarded as one routine preoperative work-up. Null hypothesis: H0: P≤P0; Alternative hypothesis: HA: P ≥ P1. α = 0.05, 1-β = 0.9. Using Simon's two-stage approach, the first phase enrolled 612 patients. If ≥18 patients supported the alternative hypothesis, they entered the second phase, otherwise the trial was terminated; the second phase enrolled 451 patients. If the patient number who eventually changes the surgical plan is ≤27, the null hypothesis is accepted, that preoperative bronchoscopy examination would be unnecessary for GGO featured lung cancer.
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children
Condition: Asthma; Bronchial Hyperresponsiveness
MeSH terms: Bronchial Hyperreactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Respiratory diseases including Asthma are high prevalent among preschool children. Specific
      treatment, nowadays, include steroid inhalers and anti leukotrienes. It is known that the
      amount of the drug reaching small airways and lungs is bigger how much smaller the particles
      liberated by inhalers. Beclometasone is being used for treating asthma for 30 years. Lately
      emerged a new presentation of beclometasone, which liberates particles as small as 2.1 µg,
      that is supposed to reach the small airways at higher concentrations and be more suitable to
      patients who don't cooperate properly to the procedure of inhalation.

      The investigators' group has reported successfully the possibility to perform Pulmonary
      Challenge tests (adenosine, methacholine and exercise) in tender age. Other studies reported
      relation between asthma control and reduction in airway hyperreactivity. The purpose of this
      study is to evaluate the efficacy of Beclometasone dipropionate - Qvar to reduce airways
      hyperreactivity in preschool children, as demonstrated by adenosine challenge test.
    

Detailed description: 
      26 - 30 patients, between 3 -6 years old, mild asthmatics, with positive adenosine challenge
      test, will received in a randomized, double blind, cross over assignment Beclometasone
      dipropionate (100µg twice a day) or placebo, through an inhaler (autohaler) device, attached
      to a spacer device, during four consecutive weeks. Adenosine Challenge test will be performed
      another time at the end of this four weeks period. After 2 weeks with no medication (wash out
      period) the patients will receive the second intervention (beclometasone dipropionate or
      placebo) in a cross over manner and will be submitted to the last adenosine challenge test.

      Clinical evaluation, resting spirometry and subjective evaluation through an analogical
      symptoms scale will be recorded in each visit.
    

Intervention name(s): Beclomethasone dipropionate HFA; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test; inhalation twice a day for one month, preceded and followed by adenosine challenge test
Other intervention name(s): Qvar
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: asthma; preschool children; bronchial hyperresponsiveness; beclometasone dipropionate - HFA; Qvar; Adenosine Challenge test
A Valsartan 80 Mg-Referenced, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg
      during 24 hours in Patients with Mild to Moderate Essential Hypertension
    


Intervention name(s): Fimasartan; Valsartan
Intervention type(s): Drug; Drug
Intervention description(s): Fimasartan 30 mg; Valsartan 80 mg
Other intervention name(s): Kanarb; Diovan
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fimasartan; 24 hours ABP monitoring(ABPM); antihypertension
FINGER Robot Therapy Study
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of training hand movement using
      FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users
      to play computer games using those movements.
    

Detailed description: 
      Robotic devices can be used to retrain movement after stroke. However, it is unclear how best
      to assist in movement. Providing physical assistance may improve the flow of proprioceptive
      information to the nervous system, which may help a person relearn to move a limb. On the
      other hand, assisting movement with a robot may cause a person to "slack", not trying as hard
      during therapy. This study will test the effect of different levels of assistance on recovery
      of finger function during robot-assisted therapy after stroke.
    

Intervention name(s): FINGER I; FINGER II
Intervention type(s): Device; Device
Intervention description(s): FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I; FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke
Brilinta DaYu Study
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the
      incidence of major cardiovascular events of ticagrelor in Chinese patients with acute
      coronary syndrome
    


Intervention name(s): Ticagrelor
Intervention type(s): Drug
Intervention description(s): 90mg/tablet, 1 tablet bid
Intervention MeSH terms: Ticagrelor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of
      coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or
      an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of
      non-childbearing potential. Subjects will be randomized to receive multiple oral doses of
      vismodegib, alone or in combination with multiple oral doses of either rabeprazole,
      itraconazole or fluconazole. Anticipated time on study treatment is up to 11 days.
    


Intervention name(s): fluconazole; itraconazole; rabeprazole; vismodegib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Multiple oral doses; Multiple oral doses; Multiple oral doses; Multiple oral doses
Intervention MeSH terms: Itraconazole; Fluconazole; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
The Treatment of Glabellar Frown Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to show that two FDA-approved botulinum toxin drugs called
      Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between
      the eyebrows (glabellar frown lines).
    

Detailed description: 
      This is a prospective, multicenter, randomized, double-blind, parallel group clinical study
      to investigate the equivalence of incobotulinumtoxinA (Xeomin®) to onabotulinumtoxinA
      (Botox®) in the treatment of glabellar frown lines.
    

Intervention name(s): IncobotulinumtoxinA; OnabotulinumtoxinA
Intervention type(s): Drug; Drug
Intervention description(s): 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection; 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
Other intervention name(s): Xeomin®; NT201; Botulinum toxin type A [150 kDa], free from complexing proteins; Botox®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glabellar Frown Lines; Frown Lines; Facial Wrinkles
Residual Replication of HIV-1 in the Gut Associated Lymphoid Tissue (GALT) of Patients on Highly Active Antiretroviral Therapy (HAART): the ANRS EP 44 Study
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens.
      Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing
      low-level virus replication. This project aims to characterize the residual replication of
      HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid
      tissue.
    

Detailed description: 
      Highly active antiretroviral therapy (HAART) successfully controls HIV-1 replication in most
      individuals, resulting in substantial immune restoration and decreased morbidity and
      mortality. However HIV-1 cannot be eradicated from infected individuals by current regimens.
      Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing
      low-level virus replication, despite maximum virus suppression on HAART. This project aims to
      characterize the residual replication of HIV-1 in subjects on HAART, particularly in the
      gut-associated lymphoid tissue (GALT). A group of 20 HIV-1-infected patients on effective
      HAART will undergo GI endoscopy and GALT biopsies will be taken. A sample of venous blood
      will also be collected. These samples will be use to characterize the residual viral
      populations on effective HAART in three compartments, plasma, monocytes, and GALT. HIV-1
      coreceptor usage and its evolution on HAART will be characterized in virus reservoirs. This
      project could provide further insights into the residual replication of HIV-1 in subjects
      receiving HAART.
    

Intervention name(s): GI endoscopy and GALT biopsies; A sample of venous blood will also be collected
Intervention type(s): Procedure; Biological
Intervention description(s): This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT); These samples of blood will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV infection; HAART; Viral DNA test positive-10063306; Blood HIV RNA 10049826; Treatment Experienced
S-flurbiprofen Bioavailability Trial to Compare a Newly Developed Patch vs. a Marketed Tablet
Condition: Comparative Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      Teikoku Seiyaku Co., Ltd. (Japan) is developing a new Esflurbiprofen Hydrogel Patch (EFHP), a
      transdermal product containing 165 mg of the S-enantiomer of flurbiprofen (S-flurbiprofen) as
      its active pharmaceutical ingredient.

      The present clinical trial will be conducted to characterise maximum observed systemic
      exposure of the newly developed EFHP (Test) vs. "Froben 100 mg" (Reference, containing 100 mg
      racemic flurbiprofen in a 1:1 ratio). Characterisation will be performed under steady state
      conditions in order to bridge the available safety information on the basis of the comparison
      of maximum observed systemic exposure by means of AUC0-24h,ss,P vs. AUC0-24,ss,T and
      Cmax,ss,P vs. Cmax,ss,T of S-flurbiprofen.
    

Detailed description: 
      This single centre, open-label, randomised (order of treatments), balanced, multiple dose
      trial will be performed in a 2-period, 2-sequence-crossover design.

      The Test Product (patch) will be applied once daily over 14 consecutive days, whereby each
      patch will remain applied for 24 h. Blood sampling will be performed after the 1st patch
      application over 24 h in order to characterise the single dose application and after the 14th
      patch application over 72 h in order to characterise pharmacokinetic parameters after
      multiple dosing including elimination phase. In between through values will be taken in the
      morning of specified study days to characterise steady-state built-up phase.

      The Reference product will be administered after a light meal as single oral doses of 100 mg
      flurbiprofen three times daily (i.e. every 8 h) over 4 days. Blood sampling will be performed
      after the 10th tablet administration over 72 h in order to characterise pharmacokinetic
      parameters after multiple dosing including elimination phase. In between through values will
      be taken in the morning of study days 1 to 4 to characterise steady-state built-up phase.

      The clinical trial will be performed as a cross-over investigation with intra-individual
      comparison, thus reducing variability of the pharmacokinetic parameters, which is supposed to
      be higher between subjects than within an individual subject.
    

Intervention name(s): Esflurbiprofen hydrogel patch 165 mg (EFHP); Froben 100 mg comprimidos revestidos
Intervention type(s): Drug; Drug
Intervention description(s): patch application with PK blood sampling; tablet administration with PK blood sampling
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioavailability