bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu
      season.
    

Detailed description: 
      This was a Phase II prospective, single-blind to dose, randomized study that compared the
      immunogenicity of subjects receiving half-dose Fluzone® compared to full-dose Fluzone®,
      2004-2005 formulation. 1440 healthy subjects, ages 18-64 years old and not currently
      indicated for influenza vaccination under the interim ACIP guidelines, were divided into 8
      strata based on age, gender, and previous exposure to influenza vaccine, and randomized to
      receive either half-dose (0.25mL) Fluzone® or full-dose (0.5mL) Fluzone® by intramuscular
      injection into the deltoid muscle.
    

Intervention name(s): Fluzone® (Aventis Pasteur inactivated influenza vaccine)
Intervention type(s): Biological
Intervention description(s): A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza
Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in
      Postherpetic Neuralgia.
    


Intervention name(s): DWP05195; DWP05195; DWP05195; Control
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, oral administration, 100mg; Tablets, oral administration, 200mg; Tablets, oral administration, 300mg; Tablets, oral administration, Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus
Condition: Positive Regulation of Oxidative Stress Process
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two
      months) as an adjunct to scaling and root planing in chronic periodontitis patients with type
      2 diabetes mellitus.
    

Detailed description: 
      This study is a randomized double blinded clinical trial which was performed to assess the
      efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root
      planing in chronic periodontitis patients with type 2 diabetes mellitus. The primary outcome
      measures were Serum MDA, CRP and Hb1AC. The secondary outcomes were modified gingival
      index(GI), Probing pocket depth(PPD), and Clinical attachment level(CAL). All the outcomes
      were measured at baseline, 2 months and 6 months.

      The results were that the Lycopene with scaling and root planing group gave:

      Statistically significant results in reducing Mean serum MDA levels at 2 months and 6 months
      respectively.
    

Intervention name(s): Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day; Scaling and root planing
Intervention type(s): Drug; Device
Intervention description(s): Lycopene 8mgms taken orally ,one per day for two months.; Scaling and root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus
Other intervention name(s): rhodopurpurin,non-provitamin A carotenoid,; Nonsurgical periodontal therapy, Conventional periodontal therapy.
Intervention MeSH terms: Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes, Periodontitis, Oxidative stress, Antioxidant
Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency
Condition: Chronic Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to analyze the effects of Kinesio Taping on gastrocnemius muscle
      activation during gait and on Range of ankle motion in postmenopausal females with Chronic
      Venous Insufficiency in initial stages in comparison to a placebo control group.
    

Detailed description: 
      Chronic Venous Insufficiency (CVI) is a very common disease. Patients with this pathology
      present peripheral muscle pump impairment and restricted range of ankle motion. Few data are
      available on the use in chronic venous insufficiency patients of Kinesio Taping, a physical
      therapist's elastic dressing that permits action on muscle activity and joint range.
    

Intervention name(s): Kinesio Taping; Placebo kinesio taping
Intervention type(s): Other; Other
Intervention description(s): The participants were randomly assigned to an experimental group, to received Kinesio Taping application for gastrocnemius muscle enhancement and functional correction of the ankle.The treatment was performed three times a week during a 4-week period.; Placebo-control group received treatment with a sham Kinesio Taping protocol to enhance gastrocnemius muscle function and dorsal ankle flexion.The strips used in this group did not follow the principles of tension and anatomic distribution of Kinesio technique.The treatment was performed three times a week during a 4-week period
Other intervention name(s): Neuromuscular tape; Neuromuscular taping placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic Venous Insufficiency; Kinesio Taping; Electromyography; Range of ankle motion
Intubation Time With Low Dose Rocuronium
Condition: Intubation; Difficult
Study type: Interventional

Summary: 
      The investigators hypothesized that increasing the cardiac output by use of atropine in
      children might result in a reduction of the intubation time needed to facilitate tracheal
      intubation.
    

Detailed description: 
      The investigators hypothesized that increasing the cardiac output by use of atropine in
      children might result in a reduction of the intubation time needed to facilitate tracheal
      intubation. Therefore, the purpose of this study was to determine TimeEI with a low dose of
      esmeron (rocuronium) (0.3 mg.kg-1) for achievement of successful tracheal intubation
      conditions during intravenous (i.v.) anaesthesia using propofol and alfentanil in children
      and to determine whether administration of i.v. atropine (atropine sulphate) (10 μg.kg-1)
      during anaesthesia induction reduced these times.
    

Intervention name(s): Atropine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Anaesthesia was induced with alfentanil 10 μg.kg-1, propofol 2.5 mg.kg-1 and rocuronium 0.3 mg.kg-1.
Atropine(atropine sulphate) 10 μg.kg-1, intravenous injection during induction After 120 sec of atropine injection, record intubating condition; Anaesthesia was induced with alfentanil 10 μg.kg-1, propofol 2.5 mg.kg-1 and rocuronium 0.3 mg.kg-1 Normal saline intravenous injection during anesthetic induction After 120 sec of normal saline injection, record intubating condition
Other intervention name(s): Atropine sulfate
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Intubation time; Atropine; Propofol anesthesia
Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of the study was to examine whether normalizing of the pH by acidification
      through topical treatment helps to strengthen the skin barrier, to induce epidermal
      differentiation and to reduce inflammation in healthy individuals.
    

Detailed description: 
      Previous studies have shown that an emollient adjusted to pH 4 has favorable effects to the
      skin of aged individuals. The objective of the study was to examine whether normalizing of
      the pH by acidification through topical treatment helps to strengthen the skin barrier, to
      induce epidermal differentiation and to reduce Inflammation. The effect of a cosmetic
      oil-in-water (O/W) emulsion adjusted to pH 4 in comparison to the same emulsion adjusted to
      pH 5.8 on the integrity of the skin barrier and the mechanical stability was examined in
      healthy volunteers from age 18 to 75 years.
    

Intervention name(s): WO 5000; WO 5001
Intervention type(s): Other; Other
Intervention description(s): WO 5000; WO 5001
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Exploratory, Randomized, Double-blind (regarding the two test products), Intra-individual comparison
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      A controlled, randomized study on the treatment of schizophrenic psychosis with cannabidiol,
      a phytocannabinoid is performed. This approach is based upon recent findings indicating that
      the human endogenous cannabinoid system is significantly involved in the pathogenesis of
      schizophrenia. Our group has shown, for example, that Δ9-tetrahydrocannabinol (Δ9-THC) is
      able to provoke schizophrenia-like psychotic symptoms in healthy volunteers. This, as well as
      the capability of Δ9-THC to exacerbate productive psychotic symptoms in schizophrenic
      patients, has recently been confirmed by others. Furthermore, we found that the en-dogenous
      brain constituent anandamide, an endogenous Δ9-THC agonist, is significantly elevated in the
      CSF of schizophrenic patients. Cannabinergic substances such as anandamide may enhance
      dopaminergic neurotrans-mission by increasing dopamine turnover. They may also influence the
      onset or course of schizophrenia by as yet unidentified mechanisms We seek to investigate the
      efficacy of cannabidiol in the treatment of schizophrenic and schizophreniform psy-choses,
      because there is evidence that CB1 antagonists such as SR141716 and cannabidiol have
      antipsychotic effects comparable to those of classic neuroleptic drugs. Furthermore,
      cannabidiol is well tolerated showing few side effects in humans. Cannabidiol may serve as an
      antipsychotic medication that is not primarily based upon an antidopaminergic but upon
      different mechanisms, especially anticannabinergic ones. It may therefore be an effec-tive
      medication in at least a subgroup of schizophrenic and schizophreniform patients and may be
      expected to show additional anxiolytic effects and only minor side effects.

      The control condition in this parallel design will be an established neuroleptic treatment
      with amisulpride that is primarely an antidopaminergic drug. Thus, we will study not only the
      antipsychotic efficacy of cannabidiol, but we will also compare the effects of both treatment
      strategies on side effects and neuropsychological functioning.
    


Intervention name(s): Cannabidiol; Amisulpride
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, 3 times daily, 200 mg, 4 weeks; Capsules, 3 times daily, 200 mg, 4 weeks
Intervention MeSH terms: Cannabidiol; Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study on Single Administration and Dose Increment of Recombinant Human Serum Albumin/Erythrocyte Fusion Protein for Injection
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study was to evaluate the safety of rHSA/EPO to healthy subjects and to
      investigate the pharmacokinetic characteristics of rHSA/EPO in healthy subjects, and to
      obtain preliminary pharmacokinetic parameters.
    

Detailed description: 
      This experiment was a single-center clinical study with randomized, open, positive drug
      control and single dose increment. The test group will be conducted in the order of
      incremental dose from 150μg to 1200μg 5 dose groups, with 1 positive control groups (EPIAO).
      After 7 days of administration, the researchers looked at the drug safety tolerance of the
      test to determine whether to proceed with the next higher dose group test.
    

Intervention name(s): Recombinant human serum albumin/erythropoietin fusion protein; Recombinant erythropoietin injection (CHO cells)
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection at Day1; Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection at Day1
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recombinant human erythropoietin
Clinical Follow Up of a Fissure Sealant Placed With Different Adhesive Protocols: 2-Year Randomized Split Mouth Study
Condition: Fissure Sealant Loss; Caries
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the retention rates of a fissure sealant placed
      using different adhesive protocols over 24 months.Twenty-four subjects with no restoration
      and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different
      adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants
      were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse
      adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with
      acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a
      table of random numbers. Two other calibrated examiners, independently evaluated the sealants
      at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of
      caries formation being present or absent and retention using the following criteria:
      1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was used to
      evaluate differences in retention rates among the sealants for each evaluation period.
    

Detailed description: 
      Dental caries, which can be encountered by individuals throughout their lives, is one of the
      most chronic diseases worldwide. Researches have mainly been focusing on the prevention of
      tooth caries with the awareness of this fact. The use of fluorides as well as pit-and-fissure
      sealants are the most common preventive applications against caries progression.Modern
      adhesives combine conventional conditioning, priming and bonding steps (etch-and-rinse
      adhesives) together into one or two bottle (self-etch adhesives) to ease adhesive protocols.
      However, it is still suspicious whether modern self-etch adhesives have equal bonding
      capacity to the conventional etch-and-rinse systems. Therefore, clinical trials are necessary
      to evaluate long-term adhesive performance of self-etch adhesives compared to the
      conventional etch-and-rinse ones.
    

Intervention name(s): acid-etch; self-etch adhesive; etch-and-rinse adhesive; self-etch adhesive after acid-etch
Intervention type(s): Other; Other; Other; Other
Intervention description(s): acid-etch; Self etch (7th generation ) bonding agent; Total etch bonding agent (5th generation); acid etch + self-etch adhesive Self etch (7th generation ) bonding agent
Other intervention name(s): Adper Easy bond 3M ESPE; Single BondTM, 3M ESPE; acid etch + self-etch adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: fissure sealant; etch and rinse; self etch
An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits
Condition: Traumatic Brain Injury With Persistent Cognitive Deficits
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients who completed the 12-week double blind protocol may enter this 26-week, open-label
      extension. This extension will give patients who complete the study an opportunity to receive
      treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive
      deficits related to traumatic brain injury. This extension will enable further evaluation of
      patients, as well as analyses to be conducted examining response to treatments in the
      original drug and placebo groups.
    


Intervention name(s): Rivastigmine
Intervention type(s): Drug
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Traumatic brain injury, head trauma, rivastigmine, cognitive deficits
Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      Spaulding Rehabilitation Hospital is conducting a research study evaluating the effectiveness
      of the brain-training product, MUSE, an EEG-guided neurofeedback device designed to assist in
      cultivating a relaxed, attentive state of mind during meditation. The investigators study
      aims to evaluate whether such a tool could be useful in treating persistent traumatic brain
      injury symptoms such as inattention, impulsivity, irritability, or dysregulated mood.
    

Detailed description: 
      Twenty subjects in total will participate in this study. Subjects will be randomized to
      focused-attention meditation training with or without the neurofeedback device, MUSE.
      Subjects will be asked to practice ~10 min of daily meditation for 6-8 weeks.
      Neuropsychological testing will be performed at the beginning of the study and after six
      weeks of training. At this time point, those randomized to the non-MUSE group will be given a
      device and asked to train for an additional two weeks. At the conclusion of the study, all
      subjects will also undergo a brief telephone or in-person exit interview regarding their
      experiences using the MUSE device.

      Primary endpoint: change in Neurobehavioral Symptom Inventory

      Secondary endpoints: change in the following: Wechsler Adult Intelligence Scale-IV Digit Span
      and Symbol-Digit Coding, Trail-Making Test, Beck Anxiety Inventory, Beck Depression
      Inventory, Cognitive and Affective Mindfulness Scale-Revised, percentage of EEG activity
      associated with alpha, beta, or theta activity.
    

Intervention name(s): EEG neurofeedback-assisted meditation; Non-EEG feedback-assisted meditation
Intervention type(s): Device; Device
Intervention description(s): meditation with auditory feedback regarding EEG status; meditation without auditory feedback regarding EEG status
Other intervention name(s): MUSE; MUSE without EEG feedback
Intervention MeSH terms: Alprostadil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: traumatic brain injury
A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to
      Rabeprazole 10mg in healthy volunteers.
    

Detailed description: 
      This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics
      characteristics of AD-214 10/600mg compared with administration of Rabeprazole 10mg in
      healthy volunteers.
    

Intervention name(s): AD-214 10/600mg; Rabeprazole 10mg
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet administered before the breakfast during 7 days; 1 tablet administered before the breakfast during 7 days
Other intervention name(s): Test drug; Reference Drug
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Outcome Parameters in Laser Rhytide Treatment
Condition: Skin Aging
Study type: Interventional
Phase: Phase 4

Summary: 
      We previously published a comparative split-face study which has shown a significant, albeit
      moderate, effect of ablative fractional laser treatment. While indicating that a single
      session with fractional ablative lasers can be effective in the treatment of peri-orbital
      wrinkles, the trial also revealed substantial disagreement between the different end points
      (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a
      patient-related index it could not be included in the aforementioned split-face trial; the
      present study therefore attempts to further elucidate the patient-related benefit of a single
      fractional ablative laser treatment session as well as carefully analyse the respective
      correlations between the outcome parameters employed.
    


Intervention name(s): Fractional carbon dioxide laser treatment; Fractional Er:YAG laser treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): With the CO2 laser (Fraxel Re:pair, Solta Medical Inc., Hayward, CA), patients received two passes at 15 mJ (1st pass) and 20 mJ (2nd pass), respectively, with a total density of 20 %. We employed 'pin-point bleeding' and serosanguinous exudate as a clinical end point. The pulse duration was 10 msec.; The Er:YAG laser (MCL 30 Dermablate, Asclepion Laser Technologies GmbH, Jena, Germany) was used in 4 passes with a total fluence of 60 J/cm² and pulse stacking (6 stacked pulses); the pulse duration was 400 μsec.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Laser surgery; Profilometry; Fitzpatrick wrinkle score; Patient Benefit Index; Patient satisfaction