bioihbjkbjnl/mcl2 huggingface dataset:
Personalized Nutrition Advice for Optimizing Dietary Calcium Intake in MS Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The main objective of this study is to measure effectiveness at 6 months of personalized
      dietary advice versus dietary counseling via delivery of a standard advice sheet for
      optimizing dietary calcium intake (assessed by a food survey based on CIQUAL* data) in MS
      patients with ambulatory monitoring.

      *CIQUAL Data: Table of nutritional food composition available on the ANSES (National Agency
      for Sanitary Security of Food, Environment and Labour) website, published by the Observatory
      of the Nutritional Quality of Foods. This table includes 1,500 sheets of 58 nutritional
      components. The data is integrated into the software for calculating ingesta (DATAMEAL) at
      the Nîmes University Hospital.
    

Detailed description: 
      The secondary objectives of this study is to compare the two groups in order to:

      A- correlate the impact of the recommendations by sheet or consult with disability, cognitive
      status, fatigue, depression, quality of life of patients with MS.

      B- assess the prevalence of diet changes as an alternative therapy for lactose intolerance in
      the population and to correlate these changes with dietary calcium intake at baseline
      (assessed by a food survey based on CIQUAL* data).

      C- assess calcium intake of the patients included via the self-administered frequency
      questionnaire QALCIMUM® on day 0 and 6 months and to compare them with data obtained by the
      food survey based on data from CIQUAL.

      D- correlate calcium intake of the patients with vitamin D levels at inclusion and establish
      a biological collection of blood samples from the population.
    

Intervention name(s): Individual dietary consultations; Dietary advice sheet
Intervention type(s): Procedure; Procedure
Intervention description(s): Individual dietary consultations with a dietician will be held at inclusion, month 1 and month 3. Consults consist of a personal interview where the dietician delivers comprehensive information to the patient on how to optimize calcium intake and reduce the risk of fractures; the dietician questions the subject on his/her diet and reassesses the quality and quantity of calcium intake during the 3 days preceding the consultation through a survey calculation software based on data from CIQUAL.; At the beginning neurological consult, patients will be delivered a dietary advice sheet called "Grio".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or
      affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated
      topically with P-3058 nail solution according to the appropriate treatment schedule.
    


Intervention name(s): P-3058
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
Condition: Neisseria Meningitidis; Meningococcal Infections
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted among adolescents in Saudi Arabia who previously received one
      dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine.
      This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and
      W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax®
      (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal
      antibody responses.
    


Intervention name(s): Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine; Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine; Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Subcutaneous; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Mencevax®; Menactra®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: N meningitidis
The Foot Exercises in Patellofemoral Pain
Condition: Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome; Pronation Deformity of the Foot; Exercise; Pain; Biomechanics; Functionality
MeSH terms: Patellofemoral Pain Syndrome; Congenital Abnormalities; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the additional effects of Short Foot Exercises on
      pain, biomechanical characteristics and functionality of lower extremity in patients with
      patellofemoral pain.
    


Intervention name(s): SFE; Exercise
Intervention type(s): Other; Other
Intervention description(s): The 'short foot exercise' has been described as a means to isolate contraction of the plantar intrinsic muscles.; Exercises which improves muscle strength, ROM...
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Patellofemoral pain; foot deformity; foot pronation; short foot exercise
Evaluation of Neurotoxic Effect of Sevoflurane-Based AnaesthesiaGuided by Short-Term Olfactory Identification
Condition: Neurotoxic Effect of Sevoflurane-Based Anaesthesia
MeSH terms: Neurotoxicity Syndromes
Study type: Observational [Patient Registry]

Summary: 
      Nowadays there is increasing doubts about the safety of anesthesia . Anesthesiologists have
      to console the worried patients, who are anxious about the potential risks of
      anesthetic-induced brain damage, by suggesting that any detrimental effects would be
      "mild".Anesthetics are responsible for postoperative taste and odor defects and cognitive
      dysfunction.
    

Detailed description: 
      Aims: The aim of this study is to assess the effect of isoflurane, sevoflurane, propofol and
      regional anesthesia on the olfactory threshold, olfactory identification and endocrine
      regulation of associative memory in the postoperative period in old age group.

      Methods: 600 patients (> 60years ) fulfilling the criteria of the American society of
      anesthesiologists and II status were selected for this prospective single-blinded randomized
      controlled study. Patients were randomized into one of four groups to receive regional
      anesthesia (control group), general anesthesia with sevoflurane, general anesthesia with
      isoflurane and total intravenous anesthesia with propofol.

      Mini-Mental State Examination (MMSE), olfactory threshold, and olfactory identification were
      tested at 12 hours preoperatively (T0), at 3 hours postoperatively (T1) and at the time of
      discharge or postoperative 3 days (T2). In addition, serum melatonin levels were estimated at
      T0 and T1.

      N-butyl alcohol was used to test the olfactory threshold and the Pocket Smell Test TM series
      (PSTs) was used to test olfactory identification. Data were analyzed using the one-way
      analysis of variance, Kruskal-Wallis or Mann-Whitney tests.
    

Intervention name(s): Sevoflurane
Intervention type(s): Drug
Intervention description(s): Assess the effect of isoflurane, sevoflurane, propofol and regional anesthesia on the olfactory threshold, olfactory identification and endocrine regulation of associative memory in the postoperative period in old age group.
Other intervention name(s): Isoflurane; Propofol
Intervention MeSH terms: Propofol; Sevoflurane; Isoflurane
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Six hundred patients of both sex with inclusion following criteria: American Society of
        Anaesthesiologists I and II physical status aged from 60 to 75years scheduled for elective
        surgery with the anticipated duration of 100-120 min (surgical procedures included hernia
        repair, varicose vein surgery, incisional hernia repair, minor gynecological procedures,
        lower limb orthopedic procedures, and minor urological procedures)
      
Keywords: General anesthesia.; neurotoxicity,; olfaction,; olfactory identification.; sevoflurane.
Rivastigmine as a Treatment for Methamphetamine Dependence
Condition: Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the effects of treatment with rivastigmine on craving produced by experimental
      administration of methamphetamine.
    

Detailed description: 
      We recently completed a double-blind placebo-controlled human laboratory study demonstrating
      that treatment with a low dose of the acetylcholinesterase (AChE) inhibitor rivastigmine
      reduced methamphetamine (METH)-induced craving (see Preliminary Studies, Fig. 2). This
      finding is consistent with the preclinical report indicating that the AChE inhibitor
      donepezil reduced METH-seeking behavior in rats following exposure to a non-contingent dose
      of METH (Hiranita et al. 2006). To extend our clinical findings, we propose a 3-year human
      laboratory study to evaluate effects of higher doses of rivastigmine on METH-induced craving
      and on self-administration of METH. Our recently completed work indicates that 3mg
      rivastigmine attenuated METH-induced craving in the laboratory. Given that higher dosages of
      this produce greater inhibition of nicotinic acetylcholine (ACh) receptors (in the treatment
      of Alzheimer's disease), it is reasonable to predict that 6mg and 12mg will have more
      pronounced effects on craving and other measures of reinforcement. This human laboratory
      study is a critical next step in the evaluation of rivastigmine as a potential treatment for
      METH dependence. We propose to include only participants exhibiting METH-induced craving by
      screening potential participants prior to admission (criterion based upon Preliminary
      Studies, Fig. 5). Selection of participants demonstrating METH-induced craving will
      facilitate assessment of effects of rivastigmine on craving. The project has the following
      objectives:

      Primary Objective: To characterize the effects of treatment with rivastigmine (0, 3, and 6
      mg) on craving produced by experimental administration of METH (0, 15 and 30mg, IV).

      Secondary Objective: To characterize the effects of treatment with rivastigmine (0, 3, and 6
      mg) on choices for METH exhibited in a self-administration paradigm (0 and 5mg, IV).
    

Intervention name(s): Placebo; Rivastigmine; Rivastigmine
Intervention type(s): Other; Drug; Drug
Intervention description(s): Administration of placebo pill; Participants will be randomized to rivastigmine (1.5 mg bid) for 6 days of each phase.; Participants will be randomized to rivastigmine (3 mg bid) for 6 days of each phase.
Other intervention name(s): Sugar pill; Exelon; Exelon
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Methamphetamine; Rivastigmine
A Bioequivalence Study Between Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 Inhalation Powder/GSK in Healthy Volunteers
Condition: Bioequivalence
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study between two inhaler products of fixed dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder
    

Detailed description: 
      A bioequivalence study of a single dose of the fixed-dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder administered from Fluticasone
      propionate 100 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent
      Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 100/50 mcg inhalation powder/GSK
      (reference-R) in healthy volunteers under fasting conditions. The study will be one-center
      crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
    

Intervention name(s): Test Product; Reference Product
Intervention type(s): Drug; Drug
Intervention description(s): 2 inhalations in one study period; 2 inhalations in one study period
Other intervention name(s): Fluticasone propionate 1000 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals; ADVAIR DISKUS 100/50
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: bioequivalence; fluticasone propionate; salmeterol xinafoate; ADVAIR
The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation
Condition: Adverse Effect
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy of dezocine pretreatment on
      dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).
    

Detailed description: 
      Dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given
      intravenously. The major clinical manifestations are pruritus and pain，and the incidence vary
      between 38%-71%. Some patients undergo spontaneous remission, while others develop into
      severe pain or pruritus. Dezocine, a new synthetic opiate agonist-antagonist, has been used
      for the treatment of pain and pruritus, but its role in relieving dexamethasone induced
      perineal irritation has not been studied yet. The aim of this study was to investigate the
      efficacy of dezocine pretreatment on dexamethasone induced perineal irritation.
    

Intervention name(s): dezocine; normal saline
Intervention type(s): Drug; Other
Intervention description(s): receive dezocine 0.1 mg/kg; receive matching placebo (equal volume of normal saline)
Intervention MeSH terms: Dezocine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dezocine; Dexamethasone 21-phosphate; Pain; Pruritus
Combined Bleaching Technique: Efficacy and Tooth Sensitivity
Condition: Tooth Bleaching; Tooth Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated
      with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching
      application under two different time protocols, and dentifrice containing arginine 8% and
      carbonate calcium use. One hundred eight participants who meet the study inclusion criteria
      will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine
      and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color.
      The data collected will be submitted to the factorial statistical analysis for evaluation of
      color and chi-square test for tooth sensitivity (α = 5%).
    

Detailed description: 
      This study will be conducted under the CONSORT recommendations. After approval by the Ethics
      Committee for Research duly registered, the trial will be conducted in the clinic of dental
      school at the Federal University of Goias located in Goiania. One hundred eight participants
      108 volunteers will be selected on the criteria that qualify inclusion and exclusion from the
      study will be reported all volunteers were examined not qualify under the criteria for
      inclusion as part of the initial according to CONSORT recommendations .

      After signing the signed an informed consent form all volunteer participants will receive a
      dental prophylaxis with pumice and water in a rubber cups for the removal of extrinsic stains
      two weeks before the beginning of tooth whitening.
    

Intervention name(s): Combined Bleaching(2x20); Combined Bleaching(2x20) with arginine; Combined Bleaching (1x20); Combined Bleaching(1x20) with arginine; 8% arginine and calcium carbonate
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Drug
Intervention description(s): one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.; one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.; one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.; one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.; using during all the treatment.
Other intervention name(s): dentifrice containing carbonate arginine
Intervention MeSH terms: Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acetazolamide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
Condition: Headache; Migraine
MeSH terms: Headache
Study type: Interventional

Summary: 
      In this study the investigators will research the hypothesis that the drug Acetazolamide
      induce headache and dilation of cerebral arteries and increase the cerebral blood flow in the
      areas of the brain supplied by these arteries.
    

Detailed description: 
      To investigate headache score and accompanying symptoms during and after infusion of
      acetazolamide.

      With magnetic resonance imaging the investigators will investigate changes in regional
      cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), diameter of
      MCA, the Internal carotic artery (ICA), the superficial temporal artery (STA) and the Medial
      Meningeal artery (MMA).
    

Intervention name(s): Acetazolamide
Intervention type(s): Drug
Intervention description(s): 1 g diluted in 10 ml saline, i.v. bolus injection.
Other intervention name(s): Diamox
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Acetazolamide; Headache; Migraine
Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients.
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple Sclerosis (MS) is often characterized by the presence of balance and cognitive
      impairments. Cognitive functions play a key role in balance control. Simultaneously
      performing cognitive tasks decreases walking and balance ability (Dual-Task cost).
      Rehabilitative treatment of patients with MS does not have to consider separately the motor
      and cognitive aspects. Video-Game Therapy (VGT) is a novel tool that allows a multimodal
      training approach. VGT typically provides augmented feedback during training that can
      contribute to learning motor skills. The main objective of this exploratory study will be to
      test the effects of a commercially available VGT on balance and cognitive function in
      ambulatory MS patients compared to a standardized balance platform training (BPT). Secondary,
      we will explore the effects of VGT and BPT on other domains that are usually impaired in MS
      population and that can be improved by motor rehabilitation, such as psychological
      well-being, fatigue and Quality of Life.
    


Intervention name(s): Video game therapy; Balance platform therapy
Intervention type(s): Device; Device
Intervention description(s): Video game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA).; Balance/rebalancing, postural stability and weight-shifting exercises with and without visual feedback will be administered using a balance platform (Biodex Medical Systems, Inc., Shirley, NY).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Video game therapy; Balance; Cognitive functions; Dual tasking
Neuronal Correlates of Neurexan® Action in Mildly to Moderately Stressed Probands
Condition: Acute Stress Reaction
MeSH terms: Fractures, Stress; Stress Disorders, Traumatic, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the effect of Neurexan® on the brain response when
      participants undergo an emotional stressful condition in verum compared to placebo.
    

Detailed description: 
      A randomized placebo-controlled, double-blind, two-period crossover study with an explorative
      design. 40 healthy males aged 31-59 years will be included in the study. Participant
      allocation to either Neurexan® or Placebo at study start is randomized with a ratio of 1:1,
      i.e. 20 Neurexan® first to 20 Placebo first individuals. Participants receive totally three
      tablets of either Neurexan® or Placebo per treatment period orally.
    

Intervention name(s): Neurexan®; Placebo
Intervention type(s): Drug; Other
Intervention description(s): There are two experimental conditions; in one condition participants receive Neurexan® and the second condition they receive Placebo for oral administration (three tablets) in a cross over design. In the experimantal arm participants will receive verum on DAY1/PERIOD 1 and will receive placebo on DAY2/PERIOD 2.; There are two experimental conditions; in one condition participants receive Neurexan® and the second condition they receive Placebo for oral administration (three tablets) in a cross over design. In the comparator arm participants will receive placebo on DAY1/PERIOD 1 and will receive verum on DAY2/PERIOD 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment