bioihbjkbjnl/mcl2 huggingface dataset:
Botox Injections for Patients With Persistent Facial Pain
Condition: Facial Pain
MeSH terms: Facies; Facial Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to investigate efficacy and safety of injecting botulinum
      toxin towards the sphenopalatine ganglion using MultiGuide in patients with persistent
      idiopathic facial pain
    


Intervention name(s): botulinum toxin type A; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide; solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide
Other intervention name(s): botox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a randomized, double-blind, cross-over, placebo-controlled pilot study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Botulinum Toxins, Type A; Injections; Sphenopalatine Ganglion Block
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
Condition: Hyperglycemia; Aortic Valve Replacement; Aortic Stenosis; Cardiac Surgery
MeSH terms: Aortic Valve Stenosis; Hyperglycemia
Study type: Interventional

Summary: 
      The overall research plan is to test the hypothesis that intraoperative treatment of
      hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial
      function and short-term outcomes compared with standard glucose management.
    

Detailed description: 
      Specific Aim #1:To determine whether intraoperative use of HNC affords cardioprotective
      benefits measured by improved echocardiographic measures of myocardial function, serum
      markers of cardiomyocyte injury, and hemodynamic indices measured immediately (at end of
      surgery) and during the short-term (initial hospitalization).
    

Intervention name(s): hyperinsulinemic normoglycemic clamp (HNC); control group
Intervention type(s): Other; Other
Intervention description(s): Prior to anesthetic induction, a baseline blood glucose value will be obtained, followed by an insulin infusion of 5 mU.Kg-1.min-1. When blood glucose is <110 mg/dL, a variable continuous infusion of glucose (dextrose 20%) supplemented with potassium (40 mEq/L) and phosphate (30 mmol/L) is administered to preserve normoglycemia (80-110 mg/dL). The glucose infusion is titrated to target glucose levels by checking blood glucose every 5 - 15 min with Accu-Check (Roche Diagnostics, Switzerland) glucose monitor. At sternal closure, insulin infusion is decreased to 1 mU/Kg/min. On admission to the ICU, insulin treatment follows the ICU protocol. The dextrose infusion is slowly weaned off over 2 - 4 hrs maintaining blood glucose > 80 mg/dL. Arterial blood glucose is measured every 30 - 60 min for 2 hrs, then, as stated in ICU protocol.; Baseline arterial blood glucose will be obtained before anesthetic induction. Repeat measurements are performed every 30-90 min. Glucose >150 on CPB will receive insulin according to intraoperative protocol. After surgery, insulin is given according to ICU protocol. Target glucose < 180 mg/dL.
Other intervention name(s): glucose; standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperglycemia; open heart surgery; bypass
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional

Summary: 
      The investigators hypothesis is that if sensitivity and specificity are found to be
      significantly higher than the current reports with Technesium-99 and ISB colorimetric dye,
      SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby
      limiting peri-operative morbidity. SLN biopsies might also improve the detection of
      metastatic disease, essentially lowering the recognized false-negative rate of standard
      lymphadenectomy analyzed by routine H&E pathologic analysis.
    

Detailed description: 
      The study objective is to compare two sentinel lymph node detection technologies
      [fluorescence imaging and Indocyanine Green (ICG) dye verses standard laparoscopic
      colorimetric analysis using Isosulfan Blue (ISB) dye] for sensitivity and specificity of
      detecting metastatic disease in pelvic lymph nodes of women with endometrial cancer
      undergoing robotic-assisted laparoscopic hysterectomy and lymphadenectomy. The following
      three specific aims would be addressed in this research proposal:

      Specific Aim 1: To determine the ability of mapping bilaterally pelvic SLN in women with
      endometrial cancer undergoing robotic-assisted laparoscopic staging comparing two different
      methods (i.e., comparing the combination of colorimetric analysis-ISB dye + fluorescence
      imaging-ICG dye vs. colorimetric analysis-ISB dye alone).

      Specific Aim 2: To estimate the negative predictive value (NPV) of pelvic SLN in endometrial
      cancer with respect to predicting nodal metastasis.

      Specific Aim 3: To evaluate the ability of sentinel lymph nodes to increase the detection of
      metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by
      comparing IHC results and standard hematoxylin and eosin (H&E) results.
    

Intervention name(s): ISB dye and standard white light imaging; ICG dye and FireFly fluorescence imaging
Intervention type(s): Device; Device
Intervention description(s): Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.; Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.
Other intervention name(s): Isosulfan Blue dye; Indocyanine green dye
Intervention MeSH terms: Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sentinel lymph nodes; da Vinci; Firefly; Sentinel lymph node mapping; Fluorescence Imaging; SLN; SLN mapping
Pharmacokinetics of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Intravaginal rings (IVRs) may offer an ideal way to deliver antiretroviral (ARV) drugs to
      prevent HIV infection. This study will evaluate the pharmacokinetics and safety of two IVRs
      containing different doses of a combination of two HIV ARV drugs, vicriviroc (VCV) (MK-4176)
      and MK-2048, in healthy, HIV-uninfected women.
    

Detailed description: 
      The development of safe and effective HIV prevention strategies remains a global health
      priority. IVRs are currently being studied as a method to deliver HIV ARV drugs in women.
      This study will evaluate the pharmacokinetics and safety of two IVRs containing different
      doses of a combination of two HIV ARV drugs, vicriviroc (VCV) (MK-4176) and MK-2048, in
      healthy, HIV-uninfected women.

      This study will enroll healthy, HIV-uninfected women, 18 to 45 years old. Participants will
      be randomly assigned to receive either the low dose MK-2048A IVR or the original dose
      MK-2048A IVR. Participants will receive their assigned IVR at the enrollment visit, and the
      IVR will be removed on Day 28. Participants will attend study visits at screening, enrollment
      (Day 0), and Days 1, 2, 3, 7, 14, 21, 28, 29, 30, 31, and 35. Study visits may include
      medical history reviews, physical examinations, blood collection, pelvic specimen collection,
      urine collection, and counseling and adherence assessments.
    

Intervention name(s): MK-2048A IVR (Low Dose); MK-2048A IVR (Original Dose)
Intervention type(s): Drug; Drug
Intervention description(s): Contains 91 mg of vicriviroc (MK-4176) and 10 mg of MK-2048.; Contains 182 mg of vicriviroc (MK-4176) and 30 mg of MK-2048.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
PIRA vs Standard Preoperative Education
Condition: Anesthesia; Anesthesia Emergence Delirium; Procedural Anxiety
MeSH terms: Emergence Delirium
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility and acceptability of enhanced
      preoperative education using a Pediatric Interactive Relational Agent (PIRA), designed for
      children ages 4 through10 years and their families, compared to the standard preoperative
      education currently provided. The study will also look at any differences in anxiety between
      the two educational groups.
    


Intervention name(s): Pediatric Interactive Relational Agent (PIRA)
Intervention type(s): Other
Intervention description(s): The PIRA is an interactive, online tool used to educate children and families about their child's upcoming surgical and anesthesia experience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: education
Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.
Condition: Pre-diabetes; Older Adults
MeSH terms: Diabetes Mellitus; Prediabetic State; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a
      long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead
      to greater weight loss than will a calorie-restricted diet alone in subjects who are older
      (50 to 60 years of age), overweight/obese, and prediabetic. These individuals have been
      selected for study because they are at greatly increased risk to develop type 2 diabetes
      (2DM) and cardiovascular disease (CVD), and it is hypothesized that the addition of
      liraglutide to a calorie-restricted diet will significantly decrease risk of these adverse
      outcomes.

      There is considerable evidence that GLP-I compounds, including liraglutide, improve glycemic
      control in patients with manifest 2DM. However, there is relatively little information as to
      the potential utility of these compounds in nondiabetic individual at greatly increased risk
      of 2DM and CVD. This research proposal is aimed at providing some of this information by
      quantifying the effects of liraglutide, a long-acting GLP-1 analogue, on weight loss, insulin
      secretion, insulin action, and multiple CVD risk factors in a very high risk group-older,
      overweight/obese, prediabetic individuals. Furthermore, by using specific methods, not
      surrogate estimates, and avoiding the confounding effects of glucotoxicity, it will be
      possible to gain new insights into the effects of GLP-1 on insulin secretion and insulin
      action.
    


Intervention name(s): liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.; Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma): Adult
Condition: BRONCHIAL ASTHMA
MeSH terms: Asthma; Chronic Disease
Study type: Interventional

Summary: 
      Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to
      inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough,
      wheezing and severe life-threatening attack and lower quality of life. In addition, it make
      large amount of socioeconomic loss as about 3.7 billion US dollars.
    


Intervention name(s): SMART ARM
Intervention type(s): Device
Intervention description(s): The smartphone application for self-management of Asthma offers symptom diary, general information for asthma, the information of asthma drugs,the guideline for inhaler and the specific action plan according to daily symptom and FEV1.
Other intervention name(s): SMART-Asthma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: ASTHMA; SMARTPHONE APPLICATION
Safety and Efficacy of GTS21 in Adults With Attention-deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will be a randomized, double-blind, placebo-controlled crossover study to assess
      the effects of GTS21 (25 mg three times a day (tid), 75 mg tid, 150 mg tid) compared to
      placebo in non-smoking adults aged 18-55 with a diagnosis of ADHD, any subtype.
    


Intervention name(s): GTS21/Placebo
Intervention type(s): Drug
Intervention MeSH terms: 3-(2,4-dimethoxybenzylidene)anabaseine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder in adults
CP4ACS - Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium
Condition: STEMI; Quality Indicators
MeSH terms: ST Elevation Myocardial Infarction
Study type: Observational

Summary: 
      RAND/UCLA modified Delphi study on quality indicators for STEMI to determine the
      appropriateness of quality indicators retrieved from literature and guideline review. We aim
      to engage 20 cardiologists and 20 nurses with relevant experience in the care for STEMI
      patients.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We aim to engage 20 cardiologists and 20 cardio nurses, all experienced in the care for
        STEMI patients
      
Keywords: Quality improvement; STEMI; Belgium
SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism?
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Research has shown that replacing sitting time with low intensity physical activity (such as
      slowly walking and standing) has beneficial effects on metabolic health, like insulin
      sensitivity, comparable to improvements after sitting all day in combination with 1h
      streneous exercise.

      The main objective of this study is to investigate the underlying mechanisms responsible for
      improved insulin sensitivity after 4 days of sitting less compared to sitting and exercise in
      healthy obese women. Our secondary objective is to investigate the effects of sitting less on
      cardio metabolic parameters.
    


Intervention name(s): Activity regime
Intervention type(s): Other
Intervention description(s): Activity regime of 4 days followed by a test day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: insulin sensitivity; sitting time
Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening
Condition: Skin Tightening; Skin Laxity; Wrinkle Reduction
MeSH terms: Cutis Laxa
Study type: Observational

Summary: 
      We study the efficacy of 1 pass of stacking pulses of long pulse 1064nm laser on the face for
      skin tightening immediately post laser and 3 months follow up.
    

Detailed description: 
      To study the efficacy on facial skin tightening and wrinkle reduction after a single pass of
      double stacking pulses of long pulse 1064nm laser on the face in skin types III-V immediately
      post procedure and at 3 months. The study is a split-face placebo-controlled single-blind
      study.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy adults with visble signs of aging
      
Keywords: 1064nm YAG laser; laxity; rhytides; asian
Clinical Evaluation of a Multidose Preservative-free Lubricating Eye Drops Contained in Novelia® Eye Dropper in Non-Contact Lens Wearing Patients
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 30-Day, multi-site, single-masked, bilateral, active- controlled, 2-Arm parallel
      group study to evaluate the safety and efficacy of an Investigational product.
    


Intervention name(s): Investigational Lubricating Eye Drop in a Novelia® bottle; Blink® Tears eye Drops
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Product; Control Product
Intervention MeSH terms: Ophthalmic Solutions; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional

Summary: 
      Sedation in the operating room, the Post Anesthesia Care Unit and the Intensive Care Unit is
      common and often necessary for patients with intracranial brain tumor. Repeated neurological
      function assessments is needed in those locations, especially in patients with tumors in or
      near eloquent regions, this is to monitor their neurologic performance to determine if there
      are alterations that require treatment. Some slowly infiltrative low-grade gliomas near
      eloquent regions do not show any detectable neurologic deficits, perhaps from reorganization,
      but with sedation by some sedatives such as benzodiazepine midazolam and anesthetic hypnotic
      propofol, the disease may seem much worse resulting in inappropriately aggressive treatment.
      This may be especially problematic in patients undergoing awake craniotomy for tumors in
      eloquent regions.

      This is a single-center perspective study. Patients will be mildly sedated to keep them
      responsive and cooperative. Motor and sensory function will be evaluated before and after
      mild sedation. Specific benzodiazepine antagonist will be used if sedated by midazolam.

      The purpose of this study is to observe if commonly used benzodiazepine midazolam exacerbates
      or unmasks motor and sensory function in patients with intracranial eloquent area gliomas.

      Hypothesis:

      mild sedation can unmasks or exacerbate motor and sensory deficits in patients with eloquent
      area glioma but not in non-neurosurgical patients/healthy volunteers. If the neurologic
      deficits induced by benzodiazepine agonist, then can be reversed by flumazenil.
    


Intervention name(s): Midazolam
Intervention type(s): Drug
Intervention description(s): specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: sedation; eloquent area glioma; neurologic function
Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to explore lung function effects of two doses of indacaterol acetate,
      75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic
      exposure to indacaterol in plasma with historical data in adults, to identify an appropriate
      dose to Phase III evaluation.
    


Intervention name(s): Indacaterol acetate 75 μg; Indacaterol acetate 150 μg
Intervention type(s): Drug; Drug
Intervention description(s): Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler; Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
Other intervention name(s): QAB149; QAB149
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: indacaterol acetate, asthma, GINA 2015, pediatrics
An Exploratory Study of Tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain
Condition: Osteoarthritis; Low Back Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find the clinical dose range of an active ingredient of
      JNS013 - Tramadol hydrochloride in chronic-pain patients who cannot attain a sufficient
      analgesic effect from non-steroidal anti-inflammatory drugs (NSAIDs).
    

Detailed description: 
      Since JNS013 is a combination of tramadol hydrochloride (TRAM) acting as a weak opioid with
      acetaminophen (APAP) inhibiting central COX-3, it is expected to have an intermediate effect
      between narcotic analgesics and NSAIDs (non-steroid anti-inflammatory drugs). This is a
      multicenter, open-label, dose response study. The purpose of this study is to find the
      clinical dose range of TRAM in patients with chronic pain due to osteoarthritis (OA) of the
      knee or low back pain (LBP) who cannot attain a sufficient analgesic effect from NSAIDs. The
      investigational product will be orally administered 4 times daily (after each meal and before
      bedtime) at a dose of 25 to 100 mg at least 4-hour intervals. Treatment will be started at an
      initial dose of 100 mg/day, and the dose is titrated by 25 mg every 7 days if the analgesic
      effect is insufficient and there is no problem with the safety. Treatment will be continued
      up to 35 days in total at a dose of 400 mg/day or a dose of which a sufficient analgesic
      effect can be obtained. The primary efficacy endpoint is the change in the intensity of pain
      from the beginning of dose-finding period (baseline) to the final assessment point (Up to Day
      36), by using VAS (Visual Analog Scale). The safety evaluations are adverse events,
      laboratory examinations, blood pressure/pulse rate and body weight. Total study period of
      this study is 49days, Screening period is 7days, Administration period is 35 days and
      Follow-up period is 7 days. The investigational product will be orally administered 4 times
      daily (after each meal and before bedtime) at a dose of 25 to 100 mg at least 4-hour
      intervals. Treatment will be started at an initial dose of 100 mg/day, and the dose is
      titrated by 25 mg every 7 days if the analgesic effect is insufficient and there is no
      problem with the safety. Treatment will be continued up to 35 days in total at a dose of 400
      mg/day or a dose of which a sufficient analgesic effect can be obtained.
    

Intervention name(s): Tramadol Hydrochloride; JNS013
Intervention type(s): Drug
Intervention MeSH terms: Tramadol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoarthritis; low back pain; oral drug; tramadol