bioihbjkbjnl/mcl2 huggingface dataset:
AZD2624 Multiple Ascending Dose Study in Japan
Condition: Healthy; Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      This multiple ascending dose study will evaluate safety and tolerability after repeated
      ascending doses of AZD2624
    


Intervention name(s): AZD2624; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension, 3 doses
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; Tolerability; Phase I
Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)
Condition: Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids
      for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe
      steatoblepharon (excess eyelid fat).
    


Intervention name(s): XOPH5 Ointment; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: steatoblepharon; blepharoptosis; dermatochalasis; blepharoplasty; periorbital; orbital; eyelid; eyebags; eye bags
Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the
      treatment of acute severe pain in the emergency department. The investigators primary
      hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in
      Emergency Department patients aged 21-64 years. The primary outcome is the proportion of
      patients in each arm who choose to forgo additional pain medication at 60 minutes.
    


Intervention name(s): H2O; 1+1
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg IV hydromorphone; 1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Other intervention name(s): Dilaudid; Dilaudid
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: acute; pain; emergency department; hydromorphone
A Pilot Trial of Homeopathic Treatment for Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents
      during childhood, and is characterized by developmentally inappropriate levels of inattention
      and/or hyperactive-impulsive behavior. It is proposed that classical homeopathic treatment
      can reduce the symptoms of ADHD without serious side effects. This is an open label pilot
      feasibility study (36 participants). Participants, age 6-16, will consult with a homeopathic
      practitioner who will select treatments based on classical homeopathy principles. All
      participants will be assessed on a 4-weekly basis for a total of 36 weeks. The purpose of the
      study is to assess feasibility of recruitment and patient retention, to obtain pilot data on
      which to base a sample size calculation for future study, and to identify major safety
      concerns. The study will use single homeopathic medicines approved for over-the-counter use
      in Canada. The primary outcome measure will be the validated Conners 3rd Edition - Parent.
    


Intervention name(s): Homeopathic Remedies
Intervention type(s): Other
Intervention description(s): Homeopathic remedies prepared according to the standards as set out by Health Canada
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder; ADHD; ADD; Homeopathy
Kesuting Syrup in the Treatment of Corona Virus Disease 2019 (COVID-19)
Condition: COVID-19 Pneumonia; Cough
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is an exploratory study, aiming to explore the preliminary efficacy and safety of
      Kesuting Syrup in the treatment of novel coronavirus pneumonia. It is planned to include a
      total of 200 cases. Kesuting Syrup test group: Lianhua Qingwen Granules control group = 1:1,
      each 100 cases in each group.
    

Detailed description: 
      This trial is a randomized, open-label, parallel-controlled clinical trial of active
      drugs.With reference to"Diagnosis and Treatment Protocol for COVID-19(Trial Version 9)",
      Lianhua Qingwen Granules have been recommended for mild and common patients during the
      medical observation period and clinical treatment period of the new coronavirus. The purpose
      of the experiment is preliminary evaluate the clinical efficacy and safety of Kesuting syrup
      in the treatment of COVID-19 (Light) .
    

Intervention name(s): Kesuting syrup; LianHuaQingWen Granules
Intervention type(s): Drug; Drug
Intervention description(s): Conventional treatment + Kesuting Syrup, take orally, 20 ml once, three times a day.Conventional treatment refer to "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 or later)". Except for the test drugs, during the observation period, it is prohibited to use other Chinese and Western medicines for cough and phlegm elimination for treatment. If combined use is required, it shall be recorded truthfully.; Conventional treatment + LianHuaQingWen Granules, orally, 1 bag at a time, 3 times a day.Conventional treatment refer to "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9 or later)".Except for the test drugs, during the observation period, it is prohibited to use other Chinese and Western medicines for cough and phlegm elimination for treatment. If combined use is required, it shall be recorded truthfully.
Other intervention name(s): Kesuting Tangjiang; Lianhua Qingwen Keli
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Kesuting syrup; COVID-19
Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the bioavailability (the rate and extent to which the active
      ingredient or active moiety is absorbed from a drug product and becomes available at the site
      of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule
      formulation.
    


Intervention name(s): neratinib
Intervention type(s): Drug
Intervention description(s): HKI-272
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study was to assess the safety and immunogenicity of extended
      treatment with DAC HYP. This evaluation included the following major components:

        -  An assessment of safety and immunogenicity of extended treatment with DAC HYP when
           administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in
           Study 201.

        -  An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.

        -  An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP
           after a 6-month washout period.

        -  An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects
           who previously received placebo during Study 201.

      The secondary objective is to assess the durability of the effect of DAC HYP on multiple
      sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans
      and clinical MS relapses.
    

Detailed description: 
      This study, an extension to Study 205MS201 (NCT00390221), will evaluate the long-term safety,
      efficacy, and immunogenicity of DAC HYP in MS. In Study 205MS201, study treatment was
      scheduled to stop at the Week 52 visit. This extension study will provide for the initiation
      of active therapy with DAC HYP among participants who received placebo during Weeks 0 through
      52 in 205MS201. In addition, participants who received active therapy with DAC HYP during
      Weeks 0 through 52 in Study 205MS201 will continue DAC HYP therapy or resume DAC HYP therapy
      after a 6-month washout period in this study.
    

Intervention name(s): BIIB019 (Daclizumab High Yield Process); Placebo
Intervention type(s): Biological; Drug
Intervention description(s): SC injection; Placebo SC injection
Other intervention name(s): Daclizumab HYP; DAC HYP
Intervention MeSH terms: Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MS; Multiple Sclerosis
Oxytocin and the Social Brain
Condition: Social Psychology
Study type: Interventional
Phase: Early Phase 1

Summary: 
      It has long been established that interpersonal relationships can have a profound impact on
      health and well-being. Yet, the investigators are still learning about the complex biological
      processes that contribute to positive social interactions and the ability to develop and
      maintain social relationships. Recent research has begun to focus on oxytocin, a neuropeptide
      that is naturally produced in the hypothalamus, because administration of this neuropeptide
      has been associated with increased trust, generosity, empathy, cooperation, memory of social
      stimuli (e.g., faces), and brain activity in neural regions associated with social and
      emotional processes. To date, several aspects of oxytocin's effects on social behavior have
      been unexplored. As such, the overarching goal of this project is to examine the effects of
      intranasal oxytocin on several tasks involving social processes. In addition, the
      investigators will explore associated neural activity through functional magnetic resonance
      imaging (fMRI). Understanding how oxytocin influences these aspects of social functioning
      will help to inform research that has begun to establish the potential for use of this
      neuropeptide in education as well as psychiatric disorders such as autism spectrum disorders
      and schizophrenia that are characterized by social deficits.

      The investigators hypothesize that compared to placebo, oxytocin will improve deception
      detection, increase empathy and altruism, and enhance responses to photo stimuli of primary
      caregivers. These effects will manifest in behavioral and neural activity. It is also
      hypothesized that main effects will not be found for oxytocin, but rather, analyses of
      relevant moderators will elucidate these findings.
    


Intervention name(s): Intranasal oxytocin; Intranasal placebo
Intervention type(s): Drug; Drug
Intervention description(s): Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).; Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter.
Other intervention name(s): Syntocinon nasal spray; Glycerine solution
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Peyronie's Disease Treatment Protocol
Condition: Peyronie's Disease
MeSH terms: Penile Induration
Study type: Interventional
Phase: Phase 1

Summary: 
      Treatment of Peyronie's disease remains difficult. The purpose of this study is to test the
      safety and efficacy of a new compound to treat this disease.
    


Intervention name(s): H-100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): H-100 is a new compound to be applied to Peyronie's disease tissue with the intention of reducing disease symptoms.; Placebo is an established, standard compound to be applied to Peyronie's disease tissue that will have no effect on disease symptoms.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Peyronie's; Peyronie's disease; Treatment; Clinical Study
Cognition, Age, and RaPamycin Effectiveness - DownregulatIon of thE mTor Pathway
Condition: Cognitive Impairment, Mild; Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Evaluation of central nervous system penetration of orally administered Rapamune (RAPA) in
      older adults with Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD) and
      investigate associated safety, tolerability, target engagement, cognition, and functional
      status as initial proof-of-concept study
    

Detailed description: 
      This study is an open-label pilot study of orally administered RAPA to measure its target
      engagement in Cerebrospinal Fluid (CSF) and blood, and to establish the feasibility and
      safety of RAPA treatment in older adults with MCI and early stage AD as initial
      proof-of-concept for a larger Phase 2 clinical trial.
    

Intervention name(s): Rapamune
Intervention type(s): Drug
Intervention description(s): Sirolimus 1mg capsules
Other intervention name(s): Sirolimus
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and
      effectiveness of different doses of MK-6096 in the treatment of participants with primary
      insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior
      to placebo in improving sleep efficiency (SE) as measured by PSG on Night 1 and at the end of
      4 weeks of treatment (Week 4).
    


Intervention name(s): MK-6096; Dose-matched Placebo to MK-6096
Intervention type(s): Drug; Drug
Intervention description(s): MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.; Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Controlled Study of ONO-5046Na in Patients With Acute Respiratory Failure Associated With Community-Acquired Pneumonia
Condition: Community-acquired Pneumonia
MeSH terms: Pneumonia; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of ONO-5046Na in patients
      with acute respiratory failure associated with community-acquired pneumonia
    


Intervention name(s): ONO-5046Na; ONO-5046Na
Intervention type(s): Drug; Drug
Intervention description(s): twenty four hour infusion at 0 mg/kg/hr for 14 days; twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days
Intervention MeSH terms: Sivelestat; Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-5046Na; acute respiratory failure; community-acquired pneumonia
Study of Complication Rates Associated With PICC for Left vs Right
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional

Summary: 
      Peripherally inserted central catheter (PICC) are catheters that are placed mainly in the
      arms, but which pass in the veins to beside the heart. They are associated with occasional
      complications due to infection or blockage of the vein that they are in. The investigators
      want to investigate whether PICCs in the right arm have lower complications than those in the
      left. This difference in complication rates has been noticed in most other forms of central
      venous access.
    


Intervention name(s): Follow up of complications
Intervention type(s): Other
Intervention description(s): Follow up for complications leading or not to removal (occlusion, accidental removal, infection, catheter related thrombosis, leaking, pain...)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Catheterisation, Central Venous; Catheters, Indwelling
Femoral Rotation and Patellar Positioning After TKA
Condition: Knee Osteoarthritis; Joint Pain; Joint Instability; Patella Disorder; Knee Pain Chronic; Prosthetic Complication
MeSH terms: Arthralgia; Joint Instability
Study type: Observational

Summary: 
      Analysis of patellar positioning in the trochlear groove after TKA with and without the use
      of dynamic tensioner.
    

Detailed description: 
      It appears that by precisely adjusting femoral component rotation and its relation to soft
      tissues in the area we can achieve better function of the patellofemoral joint and thus
      reduce the occurrence of anterior knee pain. Achieving proper femoral component rotation is
      challenging, as the bony landmarks are difficult to identify. This goal may be accomplished
      by using a dynamic tensioner - a device that intraoperatively measures joint gap stiffness in
      extension and 90 degrees flexion. This is especially important in knees with high grade
      arthritis and limb malalignment, where ligaments' and tendons' efficiency is affected.The aim
      of this study was to analyze patella positioning in the trochlear groove on CT scans of
      patients undergoing TKR with use of a dynamic tensioner and compare it to the ones undergoing
      standard measured-resection technique. Secondary outcome was to assess the frequency of
      anterior knee pain, range of motion and patient-reported outcome 3 and 12 months after the
      surgery.
    

Intervention name(s): Use of dynamic tensioner
Intervention type(s): Other
Intervention description(s): Assessment of femoral component rotation with a use of a dynamic tensioner in extension and 90 degrees of flexion. The tensioner was put between tibial plane cut and posterior condyles of the femur and tensioned to the same thickness of insert as in the full extension
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive series of patients in age over 60 with 3rd/4th grade of Kellgren - Lawrence
        osteoarthritis scale.
Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves
Condition: Cholecystitis; Cholelithiasis
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Observational

Summary: 
      Comparing the use of surgical robotics during a Cholecystectomy, comparing different
      platforms and approaches (multi port verses single port).
    

Detailed description: 
      This study is a restrospective review of charts, including operating room notes as well as
      operating room documentation of procedures. Currently there are numerous methods considered
      to be the Standard of Care in the surgical treatment of Cholecystitis, or Cholelithiasis,
      including Open Surgery, Laparoscopic, and Robotic Assisted Laparoscopic Surgery. This study
      retrospectively reviews the intraoperative and post operative clinical outcomes of
      Laparoscopic and Robotic Assisted Surgery at U.C. Davis Medical Center to: 1) establish the
      role of robotics in laparoscopic surgery, and 2) to assess the learning curve by surgeons.
    

Intervention name(s): Cholecystectomy
Intervention type(s): Procedure
Intervention description(s): Single Port and Multi-Port approaches trans-laparoscopic approaches with or without the use of the daVinci Surgical Robotic System.
Other intervention name(s): daVinci Surgical Robotic System
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients which have undergone a robotic assisted laparoscopic cholecystectomy
      
Keywords: Cholecystitis; Cholelithiasis
Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH
Condition: Molar Incisor Hypomineralisation
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Aims: Comparison of injection pain with lidocaine and articaine in children with MIH .

      Comparison of the efficacy of lidocaine and articaine during treatment of MIH molars.

      Design: A randomized, controlled, crossover, double-blind clinical study including twenty
      cooperative children, aged 6-12years old
    

Detailed description: 
      Background and Aims: Effectively achieving anesthesia is one of the difficulties a dentist
      faces when treating MIH molar There are no studies comparing the effectiveness of lidocaine
      and articaine in MIH molar Design: A randomized, controlled, crossover, double-blind clinical
      study including twenty cooperative children , aged 6-12 years old Each child will receive
      either lidocaine or articaine at their ﬁrst or second visit.
    

Intervention name(s): Lidocaine 2%; Articaine 4%
Intervention type(s): Drug; Drug
Intervention description(s): The child will be injected with lidocaine 2% and After 10 minutes the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and pain after injection and treatment will be evaluated using the Wong-Baker FACES pain rating scale; The child will be injected with 4% Articaine and After 10 minutes the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and face scale
Other intervention name(s): A; B
Intervention MeSH terms: Lidocaine; Carticaine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, controlled, crossover, double-blind clinical study, Comparison of articaine 4% and lidocaine 2%
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: the local anesthesia; Lidocaine 2%; Articaine 4%; children; MIH molars.