bioihbjkbjnl/mcl2 huggingface dataset:
Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery.
Condition: Conscious Sedation; Postoperative Analgesia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      the primary objective of this study is to investigate the sedative, and analgesic effects of
      oral, or nebulized ketamine as premedication drugs, and providing postoperative analgesia for
      the preschoolers and decrease their need for systemic analgesia.The secondary objective is to
      compare each sedation technique after oral, or nebulized ketamine for safety ,and procedural
      outcomes.
    

Detailed description: 
      Preoperative communication, premedication interventions, and being accompanied by parents are
      useful methods in decreasing preoperative separation anxiety , postoperative psychological
      trauma, and ensuring smooth induction for preschoolers undergoing elective surgery.

      Procedural sedation, and analgesia was defined by O'Donnell as a drug induced state of
      decreasing awareness, pain, and memory that allowing patient continue his ,or her own
      protective reflexes, and moving purposefully( O' Donnell etal, 2003).

      Ketamine is an anesthetic drug having sedative, and analgesic properties with different
      routes of administration in children (IV, intramuscular, subcutaneous, oral, rectal,
      sublingual, intranasal, and nebulized) .

      Ketamine produces its analgesic properties in acut pain management from reversible
      antagonizing the N-methyl-D-aspartate (NMDA)receptors , reducing levels of many
      proinflammatory mediators in the acute phase, and acting on other non-NMDA pathways that
      playing important roles in pain, and mood regulation, like its effect on µ-opioid receptors,
      nicotinic, muscarinic cholinergic, ɣ-aminobutyric acid receptors, activation of high
      -affinity D2 dopamine receptors, and L-type voltage-gated calcium channels.

      The oral route is the most popular than other routes ,as it's safe, efficient, acceptable,
      and familiar for pediatric patients..

      Oral ketamine often requires higher, and frequent doses as it's bioavailability is lower
      (17-24%) compared to IV (100%),Intramuscular (93%), sublingual/transbuccal(30%),
      intranasal(25-50%),and inhaler (70%) due to extensive first pass metabolism in liver, and
      intestine.

      Ketamine inhalation is safe, rapid absorption, and affordable route of administration.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): evaluate sedative, and analgesic effects of oral or nebulized ketamine
Other intervention name(s): ketalar
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: this will be a double blind study, and utilize a convenience sample of pre-schoolers. 31 children recruited in In oral ketamine arm, and 31 children in nebulized ketamine arm
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sedation; ketamine; analgesia; pre-schoolers
Comparison of Systane Free vs. Saline in the Treatment of Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of Systane Free to Saline in decreasing
      the symptoms of dry eye after aggressive therapy. As a principal outcome measure, we are
      using the modified Schein dry eye symptomatology questionaire to determine whether any
      improvement in signs is mirrored by improvement in the Schein Score. Up to 30 dry eye
      subjects will be dosed six times per day for one month. The typical clinical signs will be
      onmitored (e.g., corneal staining) along with dyrness symptoms. The hypothesis is that an
      optimized drop, Systane Free, will be more effective than saline solution in improving dry
      eye signs and symptoms.
    


Intervention name(s): Systane Free
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: symptomatology; Schein questionnaire; fluoresceien staining
Open-label Extension to Protocol 1042-0600
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      To allow open-label extension to patients who have completed Protocol 1042-0600.
    

Detailed description: 
      This is an open-label study evaluating efficacy and safety of ganaxolone treatment in adults
      with partial onset epilepsy with or without secondary generalizations.
    

Intervention name(s): ganaxolone
Intervention type(s): Drug
Intervention description(s): liquid suspension dosed tid
Intervention MeSH terms: Ganaxolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: partial onset epilepsy; adult epilepsy; partial seizures; anticonvulsant; catamenial epilepsy; adult partial onset epilepsy
Treating Congestive Heart Failure Using a Device to Remove Cholesterol
Condition: Heart Decompensation
MeSH terms: Heart Failure
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive
      Heart Failure.

      Study hypothesis: Decreased blood viscosity from receiving LDL-apheresis will decrease
      workload on the heart and improve symptoms associated with the progression of Congestive
      Heart Failure
    

Detailed description: 
      Patients who qualify for the study will receive 7 bi-weekly LDL-Apheresis treatments with the
      Kaneka Liposorber device. Patients will assess their CHF symptoms using the KC Cardiomyopathy
      questionnaire prior to each treatment. Blood levels of certain indices related to CHF and
      safety profile labs will be drawn before and after the first and last treatment.
    

Intervention name(s): Kaneka Liposorber
Intervention type(s): Device
Intervention description(s): LDL-apheresis on a bi-weekly basis
Other intervention name(s): Liposorber LA-15 System (Kaneka, Osaka, Japan)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule
Condition: Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study was to assess and describe the booster effect of a CYD dengue vaccine
      dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule.

      Primary Objective

      - To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of
      a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in
      participants from CYD13 - NCT00993447 and CYD30 - NCT01187433 trials (participants from Group
      1 only).

      Secondary Objectives:

        -  If the primary objective of non-inferiority was achieved: To demonstrate the
           superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third
           CYD dengue vaccine injection in participants from CYD13 and CYD30 trials.

        -  To describe the immune responses elicited by a CYD dengue vaccine booster and placebo
           injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13
           and CYD30 trials in all participants.

        -  To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13
           and CYD30 participants) and immediately prior to booster or placebo injection in all
           participants.

        -  To describe the neutralizing antibody persistence 6 months, 1 year, and 2 years post
           booster or placebo injection in all participants.

        -  To evaluate the safety of booster vaccination with the CYD dengue vaccine in all
           participants.
    

Detailed description: 
      Healthy adolescents and adults who received 3 doses of the tetravalent dengue vaccine 4 to 5
      years earlier in previous CYD dengue vaccine trials (CYD13 and CYD30) received either a
      booster dose CYD dengue vaccine or a placebo on Day 0. They were evaluated for safety and
      antibody persistence of the booster injection up to 2 years post-vaccination.
    

Intervention name(s): CYD Dengue Vaccine (5-dose formulation); Placebo, NaCl 0.9%
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Fever; Dengue virus; Dengue Hemorrhagic Fever; CYD Dengue Vaccine
1.2% Rosuvastatin Gel As A Local Agent In Smokers With Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the present study was to evaluate the effects of subgingival delivery of
      Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic
      Periodontitis (CP) patients.
    

Detailed description: 
      Background: Periodontal diseases are multi-factorial in etiology, and bacteria are one among
      these etiologic agents. However, mechanical therapy itself may not always reduce or eliminate
      the anaerobic infection at the base of the pocket, within the gingival tissues. To overcome
      this, various systemic and local drug delivered antimicrobials have been used as an adjunct
      to scaling and root planing (SRP).The present study aims to explore the efficacy of 1.2%
      rosuvastatin (RSV) gel local drug delivery as an adjunct to SRP in smokers with chronic
      periodontitis (CP).

      Methods: Sixty subjects were randomly allocated into two treatment groups: SRP with placebo
      gel (group 1), SRP with 1.2% RSV gel (group 2). Clinical parameters were recorded at
      baseline, 6 and 9 months. Radiographic assessment was done using computer aided software at
      baseline, 6 and 9 months.
    

Intervention name(s): SRP plus Rosuvastatin gel; SRP plus placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): SRP followed by Rosuvastatin placement into intrabony defect; SRP followed by placebo gel placement into intrabony defect
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Circadian Rhythm of Melatonin in Burns
Condition: Sleep; Burns
MeSH terms: Burns
Study type: Observational

Summary: 
      Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children
      admitted to the burn intensive care unit.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pediatric burn patients
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
Condition: Inflammation; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease
      activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to
      placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX)
      therapy.
    


Intervention name(s): NNC0114-0006; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two i.v. (intravenous) doses administered 6 weeks apart.; Two i.v. (intravenous) doses administered 6 weeks apart.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Participation to Colorectal Cancer Screening With Fecal Occult Blood Test and Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Adherence rate to screening colonoscopy (TC) in the average-risk general population is still
      unclear. Aim of this study was to compare the uptake of TC screening with that of fecal
      occult blood (FOBT) in the general population of different Italian areas.
    

Detailed description: 
      A nationwide, population-based, multicenter, randomized trial comparing attendance to TC with
      that to FOBT was performed. Sixty-four general practitioners (GPs), overall including in
      their lists 9,889 average-risk subjects aged 55-64 years, were randomized between TC and FOBT
      screening programs. Eligible subjects were mailed a personal invitation letter co-signed by
      their GP and the coordinator of the area-reference GI centre. Attendance rate and detection
      rate for advanced neoplasia (colorectal cancer, adenoma >10 mm or with villous histology or
      high-grade dysplasia) for each arm of the study were assessed.
    

Intervention name(s): colonoscopy; faecal test
Intervention type(s): Procedure; Procedure
Intervention description(s): colonoscopy screening; faecal occult blood test for screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: average-risk subjects for
Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary
      treatment for OSA. Negative external pressure, applied over the anterior neck under the
      mandible, has shown encouraging results as an alternative therapy. This study assessed a
      variety of sizes and shapes of collars and a range of pressures for variable negative
      external pressure (vNEP) treatment in subjects having moderate OSA to identify combinations
      that improve the efficacy and comfort of this emerging therapy.

      Observations made in this study may be used to plan a more definitive follow-on
      investigation.
    


Intervention name(s): vNEP
Intervention type(s): Device
Intervention description(s): Apply vNEP therapy to the anterior surface of the throat with a variable negative pressure ranging from -20 cmH2O up to -35 cmH2O and vNEP devices of varying shapes and sizes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: negative pressure; variable negative external pressure
A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries
Condition: Femoral Artery Stenosis; Femoral Artery Occlusion; Stenosis of Popliteal Arteries; Occlusion of Popliteal Arteries
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion
      of the superficial femoral and popliteal arteries.
    

Detailed description: 
      The study will enroll patients presenting with claudication or ischemic rest pain due to
      stenotic lesions in the superficial femoral or popliteal artery and a patent outflow artery
      to the foot. After successful pre-dilatation, subjects determined by the investigator not to
      require stenting based on defined angiographic criteria will receive the BARD LTX DCB. .
    

Intervention name(s): LTX DCB
Intervention type(s): Device
Intervention description(s): Treatment with a drug-coated balloon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atherosclerosis; Superficial Femoral Artery; Proximal Popliteal Artery
DZX Mediated Insulin Suppression in Obese Men
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether there is an additive effect of metformine
      on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.
    


Intervention name(s): Placebo; Diazoxide; Metformin + Diazoxide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Diazoxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; hyperinsulinism; diazoxide; metformin
NHLBI Type II Coronary Intervention Study
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Hypercholesterolemia, Familial; Myocardial Infarction; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Hyperlipoproteinemia Type II; Hypercholesterolemia; Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether lowering of cholesterol with cholestyramine in a population with Type II
      hyperlipidemia led to a decreased rate of progression (a regression of coronary artery
      disease) as demonstrated by death, myocardial infarction, or progression of disease on
      angiography.
    

Detailed description: 
      BACKGROUND:

      There is overwhelming evidence that increased cholesterol levels are associated with
      increased risk of cardiovascular disease. This study examined whether lowering of cholesterol
      through drug therapy in people who had coronary artery disease as determined by angiography
      led to regression of the disease, again as indicated by angiography and reduction in
      mortality or nonfatal myocardial infarction. The study should be contrasted with the Coronary
      Primary Prevention Trial (CPPT), which determined whether lowering cholesterol through a
      combination of drug and diet therapy resulted in decreased cardiovascular mortality. It
      should be noted that patients in the CPPT did not have known preexisting coronary heart
      disease.

      DESIGN NARRATIVE:

      A randomized, double-blind trial, with single experimental and control groups. The
      experimental group received drug therapy (cholestyramine); the control group received
      placebo. Both groups received diet therapy. The endpoints were a significant difference in
      the progression of coronary disease as shown by angiography or a significant difference in
      new myocardial infarction or death. Patients were followed under therapy for at least 5
      years.
    

Intervention name(s): cholestyramine
Intervention type(s): Drug
Intervention MeSH terms: Cholestyramine Resin
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Effects of Dry Needling on Spasticity, Functions, Balance and Independence Level in Patients With Stroke
Condition: Stroke; CVA (Cerebrovascular Accident)
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of dry needling method in addition to
      neurodevelopmental therapy on spasticity, upper and lower extremity functions, balance and
      independence level in patients with stroke who have spasticity.
    

Detailed description: 
      The aim of this study is to investigate the effects of dry needling method in addition to
      neurodevelopmental therapy on spasticity, upper and lower extremity functions, balance and
      independence level in patients with stroke who have spasticity. In this study, goniometric
      measurement, Modified Ashworth Scale, Nine Hole Peg Test, 10 Meter Walking Test, Fullerton
      Advanced Balance Scale and Functional Independence Scale will be used for outcome
      measurement. The participants will be randomised into two groups; Group 1 will receive NDT
      and Group 2 will receive both NDT and dry needling therapy. Both groups will be given 45
      minutes of NDT, 3 sessions per week in 4 weeks period (total of 12 sessions). Group 2 will
      also receive dry needling therapy 3 sessions per week in 4 weeks period (total of 12
      sessions). Dry needling will be applied on M. Gastrocnemius, M.Quadriceps, M.Flexor Carpi
      Radialis and M.Biceps Brachii muscles. The application time on each muscle will be 60 seconds
      (sec). Fast in and fast out technique will be used for dry needling therapy. All patients
      will be measured before treatment (T1) and after treatment (T3). An inter-measurement will be
      performed after the treatment session (T2) in addition to T1 and T3 measurements in the Group
      2, to evaluate the acute effects of dry needling therapy. No additional treatment will be
      applied to the Group 1. All assessments will be performed by the same physiotherapist.
    

Intervention name(s): Neurodevelopemental therapy (NDT); Neurodevelopemental therapy (NDT) and dry needling
Intervention type(s): Other; Other
Intervention description(s): NDT treatment will be given for 45 minutes, 3 sessions per week in 4 weeks period (total of 12 sessions).; NDT treatment will be given for 45 minutes, 3 sessions per week in 4 weeks period (total of 12 sessions). Dry needling will be applied on M. Gastrocnemius, M.Quadriceps, M.Flexor Carpi Radialis, and M.Biceps Brachii muscles, 60 seconds (sec) for each muscle groups at the end of the NDT treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dry needling; neurodevelopmental therapy; spasticity; balance; functions; independence