bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber
Condition: Allergic Rhinitis; Allergy to Pollen; Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      The aim of this study is to assess the nasal and conjunctival response in subjects allergic
      to birch pollen during controlled exposures in the ALYATEC environmental exposure chamber
      (EEC)
    

Detailed description: 
      This is a single-center, single-blind, placebo-controlled study. The first part of the study
      consists of 6 exposure sessions in Alyatec EEC, including placebo and birch pollen allergen
      exposures.

      The second part of the study involves in-field evaluations of rhinitis and conjunctivitis
      symptoms during birch pollen season.

      Alyatec environmental exposure chamber, also called allergen challenge chamber, allows to
      evaluate allergic symptoms in standardized and reproducible conditions. All the metrological
      parameters (temperature, air flow, hygrometry ...) are controlled as well as the allergen
      concentration diffused in the room.

      This enables to induce and observe rhinitis, conjunctivitis and asthma symptoms for up to 20
      patients at the same time, in a reproducible way and without the potential perturbations or
      contaminations of the natural environment.

      The current study aims to get specific information about allergic symptoms induced in the
      Alyatec EEC chamber in patients sensitized to birch pollen allergen.
    

Intervention name(s): Exposure to placebo; Exposure to allergen
Intervention type(s): Other; Other
Intervention description(s): Patients are exposed to a placebo for 4h in the Alyatec EEC; Patients are exposed to birch pollen allergens for 4h in the Alyatec EEC
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Environmental Exposure Chamber; Allergen Exposure Chamber; Allergen provocation test; Birch pollen
Protective Effect of N-acetylcysteine Against From Ototoxicity
Condition: Hearing Loss, Extreme
MeSH terms: Hearing Loss; Deafness; Ototoxicity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Peritonitis is currently one of the leading complications of continuous ambulatory peritoneal
      dialysis (CAPD). Aminoglycosides and vancomycin are used in the treatment of CAPD peritonitis
      despite their potential risk for ototoxicity. NAC is a molecule used in the treatment and
      prophylaxis of many diseases related to oxidative stress. The aim of this study was to
      examine whether ototoxicity due to antibiotics used in the treatment of CAPD peritonitis can
      be prevented by N-acetylcysteine
    

Detailed description: 
      NAC, a thiol-containing antioxidant because of this,we want to investigate antioxidant
      status.
    

Intervention name(s): N-acetylcysteine
Intervention type(s): Drug
Intervention description(s): N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ototoxicity; aminoglycoside; vancomycine; peritoneal dialysis; peritonitis
Interleukin-2 in Treating Patients With Mycosis Fungoides
Condition: Lymphoma
MeSH terms: Mycoses; Lymphoma; Mycosis Fungoides
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.

      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients who
      have mycosis fungoides.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose and toxicity of interleukin-2 in patients with
           stage IIB-IV mycosis fungoides.

        -  Determine the response rate of patients treated with this regimen.

        -  Determine the immunologic response to this regimen in peripheral blood leukocytes and
           serum of these patients.

      OUTLINE: This is a dose escalation study.

      Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 during weeks 1-3 and on days
      1-3 and 5 during week 4. Treatment repeats every 4 weeks for 4 courses.

      Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience
      dose-limiting toxicity. Six additional patients receive IL-2 at 1 dose level preceding the
      MTD.

      Patients are followed at least 3 times during year 1 and then annually thereafter.

      PROJECTED ACCRUAL: A total of 16-30 patients will be accrued for this study.
    

Intervention name(s): aldesleukin
Intervention type(s): Biological
Intervention MeSH terms: Aldesleukin
Primary purpose: Treatment
Keywords: stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome
Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated
      levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are
      available during maturation.

      This randomized, double-blind, placebo-controlled trial investigated the effect of 6 months
      supplementation with carnitines and other micronutrients on sperm quality in 104 subjects
      with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen
      analyses were done at the beginning and end of the treatment. In addition to main analyses,
      post-hoc analyses for age and body mass index (BMI) were carried out. Results were
      interpreted by dividing the population into two age and BMI classes.
    


Intervention name(s): Proxeed; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Treatment with dietary supplement for male infertility for Proxeed Arm; Treatment with placebo for Placebo Arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intravenous Immunoglobulins for Post-Polio Syndrome
Condition: Post-polio Syndrome
MeSH terms: Postpoliomyelitis Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Postpolio syndrome is a condition that affects many polio survivors years after the acute
      infection and causes symptoms to increase or new symptoms to develop. Proinflammatory
      cytokine production within the central nervous system (CNS) indicates an underlying
      inflammatory process, amenable to immunomodulatory therapy. In this study the investigators
      sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves
      the disease.
    


Intervention name(s): intravenous immunoglobulins; Saline solution
Intervention type(s): Biological; Biological
Intervention description(s): One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days; Placebo
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
AV650 Drug-Drug Interaction Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects that paroxetine and fluvoxamine have on
      the way the body distributes, breakdowns and eliminates AV650. In addition, information about
      any side effects that may occur will also be collected.
    


Intervention name(s): AV650; Fluvoxamine; Paroxetine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fluvoxamine; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Effects of Sleep Extension on Glucose Metabolism in Chronically Sleep Deprived Individuals
Condition: Sleep Extension; Glucose Metabolism
Study type: Interventional

Summary: 
      This is a randomized cross over study of the effect of 2-week sleep extension in chronically
      sleep deprived non-diabetic individuals on glucose metabolism.
    


Intervention name(s): Sleep extension
Intervention type(s): Behavioral
Intervention description(s): Sleep extension by 1 hour for 2 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Performance of Voluntary Opening and Closing Body Powered Prostheses
Condition: Upper Limb Amputation
Study type: Interventional

Summary: 
      This study will compare the functional performance of voluntary opening (VO) and voluntary
      closing (VC) body powered prostheses. We hypothesize that the ability to sense cable tension
      and produce progressively higher pinch from shoulder force will result in advantages for the
      VC terminal device (TRS, Grip 3) in terms of proprioception and overall function. The
      specific aims of this clinical trial are to:

        1. Determine if accommodation with a VC Grip 3 prehensor will result in reduced
           compensatory motion during activity.

        2. Determine if accommodation with a VC Grip 3 prehensor will result in improved function
           in activities of daily living.
    

Detailed description: 
      To evaluate the performance of the prehensors, subjects will complete a randomized A-B
      crossover study with a subjective follow-up. Two subject categories will be evaluated: 1.)
      healthy non-amputees, and 2.) unilateral transradial amputee subjects who currently use, or
      are interested in using a body-powered prosthesis. We anticipate data collection data with 10
      non-amputee subject, and 8 amputee subjects.
    

Intervention name(s): Hosmer 5XA voluntary opening hook; TRS Grip 3 voluntary closing hook
Intervention type(s): Device; Device
Intervention description(s): Voluntary opening prosthetic terminal device ("hand"); Voluntary closing prosthetic terminal device ("hand")
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amputation; transradial; prosthesis; terminal device
Hand Lateralization by Using EEG Analysis Method in Amputees
Condition: Body Image
Study type: Interventional

Summary: 
      Studies on the improvement of body image or body perception have proven their effectiveness
      in different clinical situations such as pain management and chronic pain treatment. The aim
      of this study is to evaluate the hand lateralization cognitive task by recording
      Electroencephalography (EEG) signals from different personal perspectives in amputees. In
      this study, the paradigm in which personal perspectives are evaluated over the hand
      lateralization task will be applied to amputees and healthy volunteer participants. Data will
      be recorded via EEG and Eprime software program.
    

Detailed description: 
      The aim of this study is to evaluate the hand lateralization cognitive task by recording
      Electroencephalography (EEG) signals from different personal perspectives in amputees.

      In this study, the paradigm in which personal perspectives are evaluated over the hand
      lateralization task will be applied to amputees and healthy volunteer participants.

      It was planned to enroll two groups to the study. One group is named "amputees" the other one
      is "control". Control group will be matched in terms of age and gender with the amputees
      group. Before hand lateralization test, participants will be evaluated regarding eligible
      criterias and EEG paradigm regarding hand lateralization will be performed for each
      participant.

      Both groups (Amputees and Control) will complete "hand lateralization program" for at least
      10 days. The test will be sent each day on an online system. Participants' performances will
      be recorded via online system.

      Following 10-day period, EEG paradigm regarding hand lateralization will be performed for
      each participant, again.

      Before and after comparisons will be analyzed. Data will be recorded via EEG and Eprime
      software program.

      EEG-Event Related Oscillation (power spectrum, phase locking) analysis will be performed for
      each frequency bands: alpha, theta, beta, gamma.

      Eprime analysis will be performed for the data of reaction time and accuracy rate.
    

Intervention name(s): Hand Lateralization Test
Intervention type(s): Behavioral
Intervention description(s): Before hand lateralization test, participants will be evaluated. Both groups (Amputees and Control) will complete hand lateralization test for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system. After hand lateralization test, participants will be evaluated.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EEG; mental rotation; hand lateralization; hand recognition; amputees; body schema
CBT Group for Adolescents With ADHD: a Randomized Controlled Trial
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This is the first randomized controlled study that tests the efficacy of a
      cognitive-behavioral group therapy (CBT) on adolescents with ADHD who were in pharmacological
      treatment but still presented persistent symptoms.
    

Detailed description: 
      A multicenter, randomized rater-blinded controlled trial was carried out in a sample of 119
      adolescents (15-21 years) and was conducted between April 2012- May 2014. Patients were
      randomly assigned to 12 group manualized cognitive-behavioural group therapy sessions (n=45)
      or a waiting list control group (N=44). Primary outcomes were assessed by a blind evaluator
      (ADHD Rating Scale, Clinical Global Impression Scale for Severity, Global Assessment
      Functioning) before and after treatment as well as by self-report and parent informant
      ratings.
    

Intervention name(s): Psychopharmacological treatment; CBT group
Intervention type(s): Drug; Behavioral
Intervention description(s): methylphenidate or atomoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: cognitive-behavioral therapy, adolescents, ADHD.
Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome
Condition: Radiologically Isolated Syndrome (RIS); Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Syndrome
Study type: Interventional

Summary: 
      This study aims to investigate the prevalence of subclinical oculomotor disorders in a
      population of patients with radiologically isolated syndrome.
    


Intervention name(s): Neurological consultation
Intervention type(s): Other
Intervention description(s): study of horizontal, vertical, reflex and voluntary saccades, and of horizontal and vertical ocular pursuit by a BrainTracker eye-oculography system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Determination of Protein Requirement in Elderly Male Subjects >75 Yrs Old
Condition: Healthy
Study type: Interventional

Summary: 
      Minimal data are available on protein requirements throughout the lifespan. Currently
      available recommendations are based on nitrogen balance data. The limitations of the nitrogen
      balance method have been well described. Importantly, nitrogen balanced underestimates
      requirements.

      The current dietary reference intake (DRI) requirement for healthy adult males is based on
      the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was
      reanalyzed statistically by Rand et al. and he concluded that the protein requirement of
      healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO,
      our group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and
      1.2 g/kg/day (mean and RDA).

      Currently there are no studies on protein requirement in the elderly. In a recent nutrition
      survey conducted by national health and nutrition examination survey (NHANES), the authors
      concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0
      g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on
      the calculations used for ideal body weight some older adults could be getting higher or
      lower than requirement. There is no scientifically derived protein estimate for older adults.
      Therefore there is a need to measurer protein requirement in that population.

      The goal of this study therefore is to measure the protein requirement of male elderly
      subjects > 75 years using the indicator amino acid oxidation (IAAO) technique.

      Hypothesis:

      The investigators hypothesize the protein requirement in elderly male subjects will be lower
      (0.85-1.05 g/kg/day) than that established in young healthy males ( 0.93 - 1.2g/kg/day).
    


Intervention name(s): Protein intake
Intervention type(s): Dietary Supplement
Intervention description(s): On the study day, the diet will be provided as free amino acids, with calories made up by a liquid diet and protein free cookies. Protein intakes will be varied as 0.2, 0.5, 0.7, 0.9, 1.0, 1.2, 1.5, 1.8, 2.0 g/kg/day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study consisted of a two year dose blinded phase during which patients received one of
      five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched
      to open label treatment with siponimod 2mg for approximately a further 3 years. It will
      provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient
      population
    

Detailed description: 
      This study was prematurely discontinued after approximately 5 years. The decision to
      prematurely discontinue the study was not taken due to safety-related concerns, rather due to
      a decision to focus the development of siponimod in MS on a different population.
    

Intervention name(s): BAF312
Intervention type(s): Drug
Intervention description(s): BAF312 was supplied in film-coated tablets in strengths of 5, 4 ,2, 1, .5 and .25 mg. The actual doses taken were 10, 2, 1.25, .5 and .25 mg taken orally once a day.
Other intervention name(s): siponimod
Intervention MeSH terms: Siponimod
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This extension study was originally set up as a 2 year dose-blinded extension study to maintain blinding of ongoing Core study. Study was later amended to include a subsequent Open-Label treatment phase after Core study was unblinded. During the Dose-Blinded phase of the extension study patients received the same dose from the Core study. Patients who received placebo in Period 1 during the Core Study were equally randomized to 1 of the 3 active doses of siponimod used during Period 1 (0.5, 2.0, or 10 mg) and patients who received placebo in Period 2 were equally randomized to 1 of the 2 active doses of siponimod used during Period 2 (0.25 mg or 1.25 mg).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BAF312; siponimod; Multiple Sclerosis; Relapsing remitting Multiple Sclerosis; Demyelinating Autoimmune Diseases; MS; RRMS; inflammatory disease
An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of steady-state telotristat ethyl on the
      pharmacokinetics (PK) of single-dose fexofenadine in healthy subjects.
    


Intervention name(s): Fexofenadine; Telotristat etiprate
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will receive 180 mg fexofenadine; All subjects will receive 500 mg (2 X 250 mg tablets) telotristat etiprate tablets three times daily
Intervention MeSH terms: Fexofenadine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Two Handed Jaw-thrust on Postoperative Sore Throat After Double-lumen Endotracheal Tube Insertion
Condition: Lung Surgery
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      This investigation is planned to compare the incidence and severity of postoperative sore
      throat according to the use of two-handed jaw thrust maneuver in patients undergoing
      double-lumen endotracheal intubation.
    


Intervention name(s): Two-handed jaw thrust; Conventional intubation
Intervention type(s): Procedure; Procedure
Intervention description(s): The assistant applied two-handed jaw thrust when intubating with double-lumen tube endotracheal tube.; The attending anesthesiologist provided intubation with double-lumen tube endotracheal tube without two-handed jaw thrust.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: intubation; pharyngitis