bioihbjkbjnl/mcl2 huggingface dataset:
Dexmedetomidine vs. Midazolam Sedation for Endobronchial Ultrasound
Condition: Conscious Sedation During Procedure; Endobronchial Ultrasound
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The randomized controlled trial will compare efficacy and safety of dexmedetomidine to
      midazolam for sedation during endobronchial ultrasound
    

Detailed description: 
      Benzodiazepines, opioids, and propofol are currently used alone or in combination for
      achieving sedation during endobronchial ultrasound and other bronchoscopic procedures.
      However, all these agents carry a risk of respiratory depression. Dexmedetomidine, a highly
      selective adrenergic alpha-2 agonist, has sedative and analgesic properties but does not
      cause respiratory depression. This study aims to compare efficacy and safety of
      dexmedetomidine as a sedative to midazolam in patients with hilar/mediastinal lymphadenopathy
      undergoing convex-probe endobronchial ultrasonography on day care basis. Patients will be
      randomized to receive either dexmedetomidine plus fentanyl or midazolam plus fentanyl prior
      to procedure, followed by dexmedetomidine or saline infusion respectively during the
      procedure. Ramsay sedation score of two will be targeted, failing which patients in both
      groups will receive midazolam bolus on as-needed basis. Bronchoscopist will remain blinded to
      group allocation. Patients will be monitored for sedation, oxygenation and hemodynamic
      parameters throughout. Need for additional midazolam, sedative efficacy, frequency of adverse
      respiratory and hemodynamic events, and bronchoscopist and patient satisfaction with the
      procedure will be compared between the two groups.
    

Intervention name(s): Dexmedetomidine; Midazolam bolus; Saline placebo; Rescue midazolam; Fentanyl
Intervention type(s): Drug; Drug; Other; Drug; Drug
Intervention description(s): Dexmedetomidine 1µg/Kg in 100 mL saline intravenously over 10-15 minutes immediately prior to procedure, followed by Dexmedetomidine infusion at 0.6 µg/kg/hour as maintenance dose during entire procedure; Midazolam 2 mg as slow intravenous bolus immediately prior to procedure; 100 mL saline infusion over 10-15 minutes immediately prior to procedure; Rescue boluses of 0.5 mg midazolam, if needed during procedure; 1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchoscopy; Sedation; Dexmedetomidine
Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss
Condition: Age-Related Hearing Loss
MeSH terms: Hearing Loss; Deafness; Presbycusis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to demonstrate that the investigational drug AUT00063 is effective and safe
      in the treatment of age-related hearing loss.
    

Detailed description: 
      Reduced activity at certain sites in the brain (called "voltage-gated potassium channels")
      has been linked to hearing problems, like age-related loss of hearing or tinnitus (a
      'ringing' or buzzing noise in the ears).

      AUT00063 is an experimental new medicine that enhances the action of these specific channels
      and so may treat the brain component of these hearing problems.

      The main purpose of this study is to try to demonstrate an improvement in a speech-in-noise
      deficit after 4 weeks of treatment with the study drug versus the placebo (dummy drug which
      does not contain the drug). Subjects will undergo a safety follow-up after the treatment
      period.

      Safety and efficacy will be determined by looking at a number of assessments (physical
      examinations, blood sampling, hearing assessments, questionnaires, etc.).

      The amount of drug in the blood will also be measured. It is expected that around 70 people
      (at least 35 in each arm) with age-related hearing loss may take part in the study. The study
      participants will be recruited at around 13 sites in the USA.
    

Intervention name(s): AUT00063; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg, orally, once a day, for 4 weeks; orally, once a day, for 4 weeks
Other intervention name(s): Experimental; Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hearing loss; speech-in-noise
Effect of Child Delivery on Intraocular Pressure
Condition: Intraocular Pressure; Delivery, Obstetric
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effect of child delivery on the intraocular
      pressure in healthy women.
    

Detailed description: 
      Little is known about the changes in intraocular pressure (IOP) during child delivery. During
      labor there are several stages which are accompanied by many physiological changes and
      pharmacological interventions that may potentially influence the IOP. Among these are
      delivery position (lying versus sitting or kneeling), vascular changes and pharmacological
      effects (anesthetic agents, oxytocin and other drugs). The purpose of this study is to
      evaluate the effect of child delivery on the intraocular pressure (IOP) in healthy women.
      This will expend our understanding of the physiology of labor and its effect on the eye and
      it may serve as basis to determine the management of labor.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women candidate for chlid delivery
      
Keywords: Intraocular pressure; Ocular tonometry; Obstetric delivery
Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation
Condition: Hypertension; Blood Pressure; Endothelial Function
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Ginseng has been used for many years in a wide array of anecdotal medicinal properties.
      Animal and limited clinical research points to the vascular effects of Korean Red Ginseng
      (KRG). The present project aims to assess the efficacy of KRG and contribution of its
      factionated components on various indices of vascular function in healthy individuals. Our
      primary objective is to compare the acute effects of KRG and placebo on endothelial function.
      Moreover, our secondary objective is to evaluate the effect of isolated KRG factions on
      arterial stiffness, blood pressure and vasoactive markers. We hypothesize that (1)
      consumption of KRG will cause an improvement in endothelial function in healthy individuals,
      as compared to placebo; (2) consumption of KRG will cause an improvement in arterial
      stiffness and blood pressure in healthy individuals, as compared to placebo; (3) the
      ginsenoside faction of KRG is primarily responsible for the anticipated vascular effects.
    


Intervention name(s): Korean Red Ginseng; Korean Red Ginseng (Panax ginseng); Cornstarch; Korean Red Ginseng (Panax Ginseng)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea.
Dosage form: whole root in capsules (3g); Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea.
Dosage form: total ginsenoside fraction in capsules; Placebo; Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea.
Dosage form: total polysaccharide fraction (panaxans) in capsules
Other intervention name(s): Kyonggi-do Farm; C. A. Meyer; Kyonggi-do Farm; C. A. Meyer; Kyonggi-do Farm; C. A. Meyer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ginseng; Korean Red Ginseng; Ginsenoside; Flow Mediated Dilation; Endothelial Function; Hypertension
Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment
Condition: Functional Dyspepsia; Peptic Ulcer
MeSH terms: Peptic Ulcer; Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and
      without Bismuth for H.pylori treatment.
    

Detailed description: 
      The success rate of the standard triple therapy for H. pylori infection is decreasing
      recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the
      treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in
      our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple
      therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.
    

Intervention name(s): Bismuth; Lansoprazole; Levoﬂoxacin; Amoxicillin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bismuth 220mg b.i.d for 2 weeks; Lansoprazole 30 mg b.i.d.for 2 weeks; Levoﬂoxacin 0.5 q.d. for 2 weeks; Amoxicillin 1 g b.i.d. for 2 weeks
Other intervention name(s): Bismuth potassium citrate; Proton Pump Inhibitor
Intervention MeSH terms: Amoxicillin; Levofloxacin; Potassium Citrate; Lansoprazole; Dexlansoprazole; Bismuth; Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eradication; helicobacter pylori; bismuth
Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy
Condition: Abdominal Hysterectomy
Study type: Interventional

Summary: 
      The objective of the study to evaluate whether a bolus administration of intravenous
      lidocaine decreases postoperative pain and represents an opioid-minimizing strategy after
      abdominal hysterectomy compared with placebo.
    

Detailed description: 
      Total abdominal hysterectomy (TAH) is the most common gynecological operation worldwide. Some
      studies noticed about abused of opioids in postoperative care, led to a more adverse effect
      of opioids, slow recovery, prolong the length of hospitalized stay and consequently increase
      the unnecessary cost of treatment.

      Guidelines have considered using preoperative analgesics for reducing post-operative opioids
      consumption, including lidocaine infusion. With its anti-inflammatory, anti-hyperalgesia and
      analgesic properties, intravenous perioperative lidocaine infusion (IVLI) has been used for
      optimal postoperative care in different surgeries and in various procedures involving
      hysterectomy.

      Therefore, the aim of this study is to assess the efficacy of bolus administration of
      intravenous lidocaine at the time of abdominal hysterectomy to decrease postoperative pain
      and reducing morphine requirements, after TAH.
    

Intervention name(s): lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): a bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.; a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia.
Other intervention name(s): Experimental; Placebo Comparator
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be a single-center, randomized double-blind, placebo-controlled, parallel group trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: lidocaine; Postoperative Pain; hysterectomy
A GBT021601 ADME Microtracer Study in Healthy Volunteers
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label Study of GBT021601 in 8 to 10 healthy male or female participants to evaluate
      the absorption, distribution, metabolism, and excretion (ADME) of GBT021601.
    

Detailed description: 
      This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in
      healthy participants.
    

Intervention name(s): GBT021601
Intervention type(s): Drug
Intervention description(s): Single oral dose of 200 mg GBT021601, containing ~74 kBq (~2 µCi) of [14C]-GBT021601
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Test How Well Different Doses of BI 765845 Are Tolerated by Healthy People
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 765845 in healthy male subjects and female subjects of
      non-childbearing potential following intravenous administration of single rising doses.
    


Intervention name(s): BI 765845; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 765845; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Spread And Effectiveness Of Botulinum Neurotoxin A In Spastic Equinus In Cerebral Palsy
Condition: Cerebral Palsy and Botulinum Toxin
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives. To study the short-term neurophysiological and clinical outcome of botulinum
      toxin type A(BoNT-A), injected at standard doses, and assess toxin spread to neighboring
      uninjected muscles in children with cerebral palsy.

      Subjects and methods. The investigators studied 18 ambulatory children with dynamic equinus
      foot deformity (mean age 6.1 years). The gastrocnemius muscle on the affected side was
      injected with BoNT-A (Dysport, range from 8.9-19.4 U/kg). As the primary neurophysiological
      outcome measure, compound muscle action potential (CMAP) areas were assessed in the lateral
      gastrocnemius (LG) and tibialis anterior(TA) muscles on the treated and untreated side before
      BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections. Clinical scales
      were assessed and video gait was analyzed at all three time points.

      Results. In all patients, CMAP areas recorded from the LG and TA muscles on the treated side
      decreased significantly from pre-injection values at T10 (p<0.05) and T30 (p<0.002).
      Assessment at both time points after injections also showed that ankle spasticity had
      diminished (p<0.05), equinus foot excursion increased (p<0.05), and functional gait improved
      (p<0.05).

      Conclusion. Although BoNT-A injected at standard doses improves gait in children with spastic
      equinus foot the toxin spreads to uninjected leg muscles. BoNT-A treatment for cerebral palsy
      therefore needs individualizing according to the child's clinical features.
    


Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Drug
Intervention description(s): BoNT-A (Dysport, Ipsen) ,into the medial gastrocnemius (MG) and LG muscles unilaterally on the affected spastic hemiplegic side; dose mean± SE, 283.3± 24.7 U.. The mean dose/kg injected was 14.4± 0.8, range from 8.5 to 20 U/kg, diluted in 2.5 ml saline. frequency: once.
Other intervention name(s): dysport, ipsen
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BoNT-A-botulinum neurotoxin type A; CMAP-compound muscle action potential; CP-cerebral palsy; LG-lateral gastrocnemius; MG-medial gastrocnemius; TA-tibialis anterior; PROMS-passive range of movement; MAS-modified Ashworth scale; EVGS-Edinburgh visual gait scale; GMF-CS-gross motor function classification system
Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
Condition: Vaccines, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the
      13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC)
      and to compare the immune response to concomitant vaccines administered with 13vPnC and
      7vPnC.
    


Intervention name(s): 13 valent pneumococcal conjugate vaccine; 7vPnc pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.; 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Immunity Improvement Effect of Ulmus Macrocarpa Water Extract in Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, placebo-controlled, double-blind study evaluates the efficacy and
      tolerability of Ulmus macrocarpa water extract for immunity improvement in relatively healthy
      adults. 58 subjects received 500 mg of Ulmus macrocarpa water extract per day or a placebo
      for 4 weeks.
    


Intervention name(s): Ulmus macrocarpa water extract
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Ulmus macrocarpa water extract; immunity
Efficacy, Safety, and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      ADHD has been associated with persistent deficits in the efficient allocation of attention
      and supports the notion that regulation of the cholinergic system may improve these cognitive
      deficits in ADHD. It has been suggested that the effects of nicotine are most pronounced on
      tasks that demand effortful processing (Rusted and Warburton 1994). In addition, a recent
      theory proposes that the cholinergic system allocates additional attentional resources during
      tasks that are demanding (i.e. sustained attention, set shifting, etc; Sarter and Bruno
      1997). Thus it may be that in ADHD, cholinergic systems are under-responsive or
      under-developed and thus stimulation of nicotinic receptors via nicotinic agents may result
      in improved cognitive performance particularly on tests requiring effortful processing.
    

Detailed description: 
      A randomized, parallel, forced-titration design is being used to assess effects of TC-5619
      versus placebo on efficacy. A parallel group design allows the effects of TC-5619 to be
      clearly established, and the randomized nature of the design allows minimization of observer
      and subject bias. Because a forced dose up-titration design will be used, effects of
      individual doses will be preliminary, because the design confounds dose with time.

      The doses chosen (1mg, 5mg, and 25mg) reflect an appropriate range around the anticipated
      efficacious dose (3-10 mg), based upon preclinical extrapolations to the human, and upon the
      pro-cognitive effects of TC-5619 identified by CDR in the MRD study (Targacept Study
      TC-5619-238-CLP-002).

      All subjects will be tobacco non-users. It is possible that tobacco (nicotine) interferes
      with α7 NNR-mediated effects.
    

Intervention name(s): TC-5619-238; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TC-5619-238 will be provided as white, opaque gelatin capsules in strengths of 1mg, 5mg, and 25mg (as free base). Subjects will take 1mg TC-5619, 5mg TC-5619, 25mg TC-5619, or matching placebo - one capsule once daily p.o.; Placebo will be provided as white, opaque gelatin capsules in sham strengths of 1mg, 5mg, and 25mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Hyperactive Disorder
Powertoothbrushing for Treating Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      In this three-month interventional clinical trial for the treatment of gingivitis the
      investigators will assess the use of an oscillating-rotating powered toothbrush in comparison
      to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene.
    

Detailed description: 
      In this single-masked, parallel-armed, interventional clinical trial for treatment of
      gingivitis the investigators will assess the use of an oscillating-rotating powered
      toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of
      interproximal hygiene. The primary outcome variable is the change from baseline in the
      Modified Gingival Index at 2, 4 and 12-weeks from Baseline. Secondary outcome variables
      include change from baseline in bleeding on probing as well as change from baseline in the
      Turesky Modification of the Quigley-Hein Plaque index measuring overnight plaque formation.
      There will also be an assessment of single use efficacy in reduction of overnight plaque
      levels at the baseline visit t
    

Intervention name(s): Oscillating rotating power toothbrush
Intervention type(s): Device
Intervention description(s): a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene
Other intervention name(s): powertoothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 month home use parallel-arm design to assess the efficacy of powered toothbrush use in the treatment of gingivitis in a moderate sized population, n=70.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: power toothbrush, oscillating rotating