bioihbjkbjnl/mcl2 huggingface dataset:
A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics
Condition: Ipsi- and Contralateral Hypoesthesia
MeSH terms: Hypesthesia
Study type: Interventional

Summary: 
      Main of the present study was to develop a model of concomitant C-fibre block and
      sensitization eliciting spontaneous pain as well applying topical capsaicin and local
      anesthetics (LA) to examine the sensory alterations after combined C-fiber block and
      sensitization in both different application orders (sensitization of blocked C-fibers and
      block of sensitized C-fibers), compared to each of both mechanisms alone. Thereby, we expect
      stronger sensory changes during the combined substance application than during the
      monoapplication. We expect also contralateral sensory alterations mirroring the changes on
      the intervention site after the combined capsaicin and LA application, being stronger than
      after sensitization alone absent after C-fiber block alone.
    


Intervention name(s): Application of capsaicin 0.6%; Application of local anesthetics (EMLA plaster); Application of 1 capsaicin 0.6% and 2. EMLA; Application of 1. EMLA and 2. capsaicin 0.6%
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): topical application of 0.6% capsaicin on the volar forearm; topical application of EMLA on the volar forearm; topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm; topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm
Intervention MeSH terms: Anesthetics; Lidocaine, Prilocaine Drug Combination; Anesthetics, Local; Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Guiding Dose Increases in Patients Incompletely Responsive to Usual Doses of Atomoxetine
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to test the value of dose increases in patients with residual
      ADHD symptoms after treatment with the usual target dose of atomoxetine
    


Intervention name(s): Atomoxetine Hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
Condition: Essential Fatty Acid Deficiency (EFAD)
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a descriptive study designed to evaluate the propensity for hospitalized
      pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7
      up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study
      design will evaluate the safety and efficacy of using Clinolipid or Intralipid in a pediatric
      population.
    


Intervention name(s): Clinolipid; Intralipid
Intervention type(s): Drug; Drug
Intervention description(s): Lipid injectable emulsion, USP 20%; Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Essential Fatty Acids (EFA); Parenteral Nutrition; Clinolipid/Clinoleic; Parenteral Nutrition Associated Cholestasis (PNAC); Parenteral Nutrition Associated Liver Disease (PNALD); Intestinal Failure Associated Liver Disease (IFALD); Phytosterols; Intralipid; Infants/Preterm Infants; FADS1 and FADS2; Short Bowel Syndrome; Cancer Nutrition; Olive Oil Emulsion; Soybean Oil Emulsion
Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with
      an antidepressant is better than an antidepressant alone in adults with major depression.
    


Intervention name(s): L-methylfolate; Selective serotonin reuptake inhibitor (SSRI); Serotonin and norepinephrine reuptake inhibitor (SNRI)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects must have been on their respective therapies for a minimum of 60 days. L-methylfolate dosing was 7.5 mg or 15 mg daily; Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.; Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.
Other intervention name(s): Deplin
Intervention MeSH terms: Norepinephrine; Serotonin; Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Adults ages 18-70 experiencing an episode of major depression
      
Keywords: Depression; Combination therapy; antidepressant; Deplin; folate; methylfolate
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy; Diabetic Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to explore the overall safety profile and durability of efficacy
      of Engensis (VM202) in painful diabetic peripheral neuropathy.

      All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270
      visit within the prior 90 days will be approached to enroll in the long-term safety extension
      study.
    

Detailed description: 
      In the phase III VMDN-003 study, subjects received 2 treatments of either Engensis (VM202) or
      placebo administered as intramuscular (IM) injections into bilateral calves on Days 0 and 14,
      and Days 90 and 104. Primary efficacy was evaluated 90 days following the first injection.
      The growth potential for HGF make long-term follow-up important both for safety and efficacy:
      in order for Engensis to be a candidate for chronic treatment of PDPN, it must be
      demonstrated not to induce unexpected adverse events with repeated dosing; and the potential
      for reversal or stabilization of diabetic neuropathy using only one or two treatments of
      Engensis may make it especially attractive compared to current treatments which must be taken
      daily for the duration of the disease. A safety extension to the VMDN-003 study is therefore
      warranted.
    

Intervention name(s): Long-Term Follow-Up of Patients who Received Engensis (VM202); Long-Term Follow-Up of Patients who Received Placebo
Intervention type(s): Genetic; Drug
Intervention description(s): No study drug is administered in this study. Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.; No study drug is administered in this study. Patients who received Placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Long term, prospective, non-interventional, safety extension study of phase 3 trial. Double blind, randomized, placebo-controlled, multicenter study/
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetic; neuropathy; shooting pain; burning pain; pins and needles pain; foot pain; ViroMed; Helixmith; Engensis; VM202
Clinical Study for Energy Based Devices in Open Gastrectomy for Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Surgery is the first standard treatment for stomach cancer, but it still has negative factors
      such as bleeding, leakage, closure, surgery part infection and cardiovascular and lung
      complication by general anesthesia.

      electric cautery is used extensively in surgery room due to the utility of simultaneous
      severance and hemostasis. In some case, the electric current from vitality electrode may
      unexpectedly stimulate or damage nearby muscles and nerves. Ultrasonically activated shears
      (UAS) is a device to transform the protein of organ for organ incision or hemostasis. General
      advantages possibly include shortened operating time, decrease of operative blood loss, and
      relatively less damages to the normal organ. UAS is commonly used in the operation room,
      which is now considered as a secure and useful medical device for for tissue dissection and
      coagulation. Also, it is expected to lower the risk of surgery by reducing operating time and
      blood loss.

      However, clinical evidence is not sufficient for this device until now. Therefore, in this
      study,

        1. Evaluate the utility, efficacy, and safety of energy based device, in the case of open
           gastrectomy

        2. Would like to compare the following two kinds of energy based devices. A. For
           conventional monopolar electrosurgery group : dissection and sealing will be conducted
           by conventional monopolar electrocautery device B. For UAS group : dissection and
           sealing will be conducted by UAS
    


Intervention name(s): Ultrasonically activated Shears; Conventional Monopolar Electrocautery
Intervention type(s): Device; Device
Intervention description(s): Dissection and lymphovascular sealing with Ultrasonically Activated Shears; Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery
Other intervention name(s): Harmonic Scalpel, Ethicon Endo-Surgery, INC (USA); Monopolar Electrocautery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ultrasonically Activated Shear; Conventional Monopolar Electrocautery; Gastric Cancer
Effects of Tremella Fuciformis on Improvement in Cognitive-Bio-Markers of Cognitive Functions
Condition: Healthy Adults With Subjective Memory Complaints
Study type: Interventional

Summary: 
      The objective of this study is to demonstrate the cognitive enhancement effect and safety of
      Tremella Fuciformis, using the cognitive and clinical indicators (e.g. memory, attention, and
      psychomotor speed) and the latest brain imaging methods for healthy adults suffering
      subjective cognitive impairment.
    


Intervention name(s): TF 600mg; TF 1200mg; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Resolvin D1 Levels in Patients With Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The purpose of the study was to determine the levels of Resolvin D1 (RVD1) in the gingival
      crevicular fluid (GCF) and saliva of the patients with periodontitis (P) and also to
      investigate the effects of non-surgical periodontal treatments (NSPTs) on its levels.

      A total of 26 subjects (15 P, 11 healthy) were included. Clinical periodontal measurements,
      GCF and saliva samples were collected from each individual at baseline and 1 month after
      NSPTs in P group. RVD1 levels were determined by enzyme-linked immunosorbent assay (ELISA)
      method.
    


Intervention name(s): periodontal therapy
Intervention type(s): Procedure
Intervention description(s): Non surgical periodontal therapy was performed to patients with peridontitis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: gingival crevicular fluid; resolvin D1
Frovatriptan as a Transitional Therapy in Medication Overuse Headache
Condition: Medication Overuse Headache; Analgesic Overuse Headache
MeSH terms: Headache Disorders, Secondary; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will analyze the effectiveness of a medication called Frovatriptan, in the context
      of medication overuse headache (MOH). MOH is a headache that develops when pain-killers are
      taken frequently. The treatment is to stop the overuse of these pain-killers, but that can
      sometimes worsen the headache first before it gets better. We are testing Frovatriptan
      against placebo to see if it can help patients with this transition and avoid the worsening
      of the headache that can occur. We will also see if Frovatriptan can help in other ways, such
      as maintain patients free of medication overuse.
    

Detailed description: 
      A single-centre, randomized, placebo-controlled trial is proposed to assess Frovatriptan as a
      transitional therapy in patients diagnosed with medication overuse headache. Currently, there
      are no proven transitional therapies to help patients get through the detoxification process.
      Frovatriptan has not been tested as a transitional therapy in the past. This study will
      compare Frovatriptan, taken over a 10 day transitional period, to placebo. The primary
      outcome of the study will be the mean headache intensity in the 10 day transitional period in
      the Frovatriptan group as compared to the placebo group. A number of secondary and
      exploratory outcomes will also be determined and further data collection will occur at 1, 2,
      and 3 month periods. The duration of the study for the participants will be 3 months, and
      they will be asked to keep detailed headache diaries during this time. Ten days of baseline
      headache diaries will also be performed before patients can enter the study.
    

Intervention name(s): Frovatriptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 mg po bid for 10 days; 1 tab po bid for 10 days
Intervention MeSH terms: Frovatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Medication overuse headache; Rebound headache; Analgesic overuse headache; Transitional therapy; Frovatriptan; Migraine
Calcitriol in Treating Patients With a Rising PSA Level Following Treatment for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Calcitriol, a form of vitamin D, may be able to prevent or slow the growth of
      prostate cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of calcitriol in treating patients who
      have a rising PSA level following previous treatment for prostate cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the response to pulse calcitriol in patients with previously treated
      adenocarcinoma of the prostate with rising PSA levels. II. Assess the impact of this regimen
      on the slope of the PSA rise in these patients. III. Determine the qualitative and
      quantitative toxic effects of this regimen in these patients. IV. Assess the impact of this
      regimen on the quality of life of these patients.

      OUTLINE: All patients remain on a reduced calcium diet for the duration of the study. Twelve
      hours prior to treatment, patients begin drinking 4-6 glasses of extra fluid for 3 days.
      Patients receive oral calcitriol over 4 hours weekly. Treatment continues in the absence of
      disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every
      4 weeks during treatment, and at the end of the study. Patients are followed for at least 1
      month.

      PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
    

Intervention name(s): calcitriol
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Calcitriol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer
Effects of Acute Intake of Flavanols on Cerebral Oxygenation and Cognition in Young Male Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The study evaluates the impact of one acute dose of cocoa flavanols on brain oxygenation
      during a hypercapnia challenge, as well as impact on cognitive performance in young healthy
      males. It further assesses the impact of flavanols on peripheral vascular function, as
      measured by brachial Flow-mediated dilation (FMD). All participants received a high-flavanol
      cocoa intervention (185.5 mg of flavanols (-)-epicatechin and (+)- catechin) and a
      low-flavanol cocoa intervention (< 4 mg of flavanols). It is hypothesized that the
      high-flavanol intervention increases cerebral oxygenation during hypercapnia and vascular
      function in comparison to the low-flavanol intervention.
    

Detailed description: 
      Cocoa flavanols have been shown to be protective against vascular disease in humans, as
      evidenced by improvements in peripheral endothelial function (as measured by brachial
      Flow-mediated dilatation, FMD). There is also emerging evidence suggesting that flavanol-rich
      diets protect against cognitive aging, but mechanisms remain elusive. In this study the
      investigators suggest that such mechanisms might be associated with benefits within the brain
      vasculature. The aim of the present study was therefore to determine whether intake of
      flavanols enhances cerebral oxygenation in frontal cortical areas of the brain during a
      hypercapnia challenge (which is a well-established biomarker of vascular reactivity in the
      brain) to a greater extent than a low-flavanol intervention in young healthy adults.
    

Intervention name(s): High-flavanol cocoa powder; Low-flavanol cocoa powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Non-alkalized fat-reduced cocoa powder (Natural Acticoa); Alkalized fat-reduced cocoa powder (10/12 DDP Royal Dutch)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: flavanol; cocoa; brain; oxygenation; vascular; cognition; hypercapnia; functional near-infrared spectroscopy
The Use of Reminders in Implementing an E-learning Program in General Practice
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional

Summary: 
      To evaluate General Practitioners use and reuptake of an e-learning programme in diagnostic
      evaluation of dementia after an intervention consisting of three mailed reminder letters.

      There is no direct patient involvement in this study.
    

Detailed description: 
      The three mailed reminder letters will be mailed to the General Practitioners (GPs) in
      January 2007. The Periods where the e-learning programme will identify GPs using the
      programme are: Period before: November 1. and 6 weeks forward. Period after: Medio marts and
      6 weeks forward.

      All log files are kept anonymous for the principal study investigator by the Danish Medical
      Association.
    

Intervention name(s): Reminder letters
Intervention type(s): Behavioral
Intervention description(s): 3 mailed reminder letters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Heading Health Plan Implementation; Computer-Assisted Instruction; General Practice; Dementia; education
Effect of Levodopa on Postural Motor Learning in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The primary goal of this project is to gain a better understanding of whether and how
      levodopa (a common anti-Parkinson disease medication) alters postural motor learning in
      people with Parkinson disease. A secondary goal is to assess whether motor cortical
      excitability, measured via Transcranial magnetic stimulation, is related to postural motor
      learning.

      Participants with Parkinson disease will complete between 50 and 100 postural perturbations
      (via support surface translations), ON and OFF their dopamine replacement therapy (i.e.
      levodopa). Adaptation of responses to these perturbations will be tracked. Participants will
      also undergo transcranial magnetic stimulation to capture cortical excitability of the brain
      (in particular the motor cortex). Cortical excitability will be correlated to adaptation of
      stepping (i.e. postural motor learning) ON and OFF levodopa. Investigators will also capture
      postural motor learning and cortical excitability in age-matched healthy adults.

      Investigators hypothesize that dopamine will have a negative effect on postural motor
      learning, and the cortical excitability will be correlated to postural motor learning.
    


Intervention name(s): Postural perturbation
Intervention type(s): Behavioral
Intervention description(s): Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals with Parkinson Disease or age-matched healthy adults in the north west United
        States (Oregon and Washington state).
      
Biospecimen description: 
      No Biospecimens will be collected or retained
    
Keywords: Parkinson Disease; Posture Balance; Learning; Dopamine