bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Inulin-type Fructans on Constipated Children.
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The main objective of this Pilot study was to assess the beneficial effects of a daily
      supplementation with Orafti inulin-type fructans in 2-5 year old constipated children The
      study is primary aimed to develop a feasibility study to assess the beneficial effect of
      inulin-type fructans in the described population with regard to the adequate criteria for a
      larger trial. Secondary objectives are to obtain data about the feasibility of the protocol
      (as pilot study). To obtain data useful to perform sample size calculations for a big study
      designed specifically to investigate the beneficial effect of inulin-type fructans in the
      treatment of constipated children.

      Study design and subjects: Double-blind, randomized, placebo-controlled parallel group trial;
      where 2-5 year-old constipated children received inulin-type fructans or the same amount of
      placebo (maltodextrin) during 6 weeks. The study protocol was approved by the local Ethical
      Committees.

      Outcomes: primary outcome was stool consistency. Secondary outcomes were: stool frequency,
      gastrointestinal symptoms (abdominal pain and pain during defecation), additional medication
      required (yes/no), and colonic transit time. Stool samples at baseline, end of intervention
      and after follow-up were obtained in order to be analysed to know about the microbiota.
      Dietary intake was also recorded at baseline, end of intervention and after follow-up.

      Principal subject inclusion criteria: Subjects were recruited if fulfil the Rome III
      constipation criteria (Mainly hard stools plus stool retention, or pain, or low frequency).
      Principal subject exclusion criteria: Age under 2 or over 5 years, diapers use, use of
      laxative during the study and 2 weeks before, use of pre- probiotics or antibiotics during
      the study and 4 weeks before, organic causes of defecation disorders, other metabolic or
      renal abnormalities or mental retardation, no parent's command of any local language.
    


Intervention name(s): OraftiR inulin-type fructans; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of NT 201 Doses in the Treatment of Platysma Prominence
Condition: Platysma Prominence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of NT 201 in adults with
      moderate to severe platysma prominence.
    


Intervention name(s): NT 201; NT 201 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Clostridium botulinum neurotoxin type A (150 kiloDalton [kD], free of complexing proteins) powder for solution for injection.; NT 201 Matching-placebo.
Other intervention name(s): IncobotulinumtoxinA; Xeomin/Bocouture; Xeomin Cosmetic; Xeomeen
Intervention MeSH terms: incobotulinumtoxinA; Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Performance of Short- and Long-term Baseplates for Attaching the Marco Recorder
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The purpose of this clinical investigation is to test the safety and performance of short-
      and longterm Baseplates constructed with different types of biocompatible adhesives.
    


Intervention name(s): Baseplates with two types of adhesives are tested: 3M 1522 & Nitto ST-2410WD; Baseplates with two types of adhesives are tested: Amparo 130002 & 3M 2480
Intervention type(s): Device; Device
Intervention description(s): Baseplates with two different types of adhesives are placed behind the ears; One baseplate with one of the two types of the adhesive behind each ear; Baseplates with two different types of adhesives are placed behind the ears; One baseplate with one of the two types of the adhesive behind each ear
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: crossover in first part, parallel in second part
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, open-label, randomized, cross-over, pharmacokinetic study designed to determine
      the effect of meals of various amounts of fat given immediately prior to dosing on the
      pharmacokinetics of oral testosterone undecanoate. Approximately 20 hypogonadal subjects will
      be dosed for a 14 day run-in period. This will be followed by a randomized sequence of five
      periods over a 6 day confinement period. Subjects will receive a randomly ordered sequence of
      breakfast meals containing various amounts of fat, fasting, 15 g, 30 g, 45 g and a high fat
      breakfast consistent Guidance for Industry on Food-Effect Bioavailability and Fed
      Bioequivalence Studies.
    

Detailed description: 
      This is a Phase 2, open-label, randomized, cross over, pharmacokinetic study. Subjects will
      initially be dosed for 2 weeks (Run-In Phase) to allow suppression of endogenous testosterone
      production, while allowing the oral TU to reach steady state. The subjects will then be
      confined to a clinical unit in which they undergo the PK Phase of the study. During the PK
      Phase of the study, subjects will undergo a five-period cross-over in which oral TU is dosed
      twice daily. Subjects will dose in the morning and in the evening immediately prior to
      protocol-defined meals. The protocol-defined breakfasts will contain various levels of fat
      including 15 g, 30 g, 45 g, a breakfast consistent with the fat and calorie content of the
      high-fat breakfast consistent with recommendations in the Guidance for Industry on
      Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002), or while fasting
      (with no meal until 4 hours post-dose). Subjects will be randomized to a designated sequence
      of the protocol-defined breakfasts, or the fasted state. The subjects will be required to
      consume the entire breakfast within 20 minutes during the PK Phase. The protocol-defined
      evening meal will be required to be consumed within 20 minutes. The 5 meal periods will occur
      on sequential days.

      Approximately twenty (20) subjects will be enrolled in order to ensure completion of 16
      subjects.
    

Intervention name(s): Oral Testosterone Undecanoate
Intervention type(s): Drug
Intervention description(s): All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, randomized, 5-period crossover food effect study
Masking: None (Open Label)
Primary purpose: Basic Science
Carpal Tunnel Syndrome, Right/Left Judgement
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Observational

Summary: 
      The discrimination of the right/left side of the body is related to the integrity of the
      motor and somatosensory areas at the cortical and subcortical levels. Although some studies
      have shown that there may be an effect on the right/left representation at the cortical and
      subcortical levels in cases that cause severe neuropathy and neuropathic pain, this effect
      has not been proven in milder neuropathies. In this study, the effect on right/left side
      discrimination will be investigated even in cases with carpal tunnel syndrome. Additionally,
      the investigators aimed to assess the relationship between right/left discrimination and
      symptom severity.
    

Detailed description: 
      The left/right discrimination is a motor imagery task that involves viewing images of a body
      part and determining whether each image belongs to the left or right side of the body or if
      it rotates towards it. Some studies have shown that there may be an effect on the right/left
      representation at the cortical and subcortical levels in cases that cause severe neuropathy
      and neuropathic pain, this effect has not been proven in milder neuropathies, such as carpal
      tunnel syndrome. In this study, the relationship between right/left decision accuracy will be
      compared with control subjects. The investigators will assess the relationship between
      right/left judgment and symptom severity, two-point discrimination, and handgrip force.

      The hypothesis of the study are:

        1. The right/left discrimination accuracy is less than the control subjects.

        2. Right/left discrimination is in relationship with symptom severity, two-point
           discrimination, and handgrip force.
    

Intervention name(s): Nerve conduction study; Montreal Cognitive Assessment Test
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Participants with carpal tunnel syndrome will consist of individuals whose diagnosis has been confirmed by an electrophysiological study.
Participants in the control group will consist of those who have been confirmed not to have carpal tunnel syndrome by nerve conduction study.; Montreal Cognitive Assessment Test evaluates eight separate cognitive functions. Thirty is the highest score. The scores equal to or above 26 are considered normal cognitive function.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Carpal Tunnel Syndrome
      
Keywords: Carpal tunnel syndrome, body schema
The Addition of Whole Grains to the Diets of Middle-school Children
Condition: Healthy
Study type: Interventional

Summary: 
      The Dietary Guidelines for Americans recommend that children and adolescents "consume
      whole-grain products often; at least half the grains should be whole grains." Few, if any
      studies, examine the benefit of whole grains on the health of adolescents. The purpose of
      this study is to determine if adolescents eating diets rich in whole grains vs. diets rich in
      refined grains (i.e., a typical diet) have improved markers of digestive and immune health.
    

Detailed description: 
      Middle-school students will be recruited and randomized to receive >/=80 g of whole grains
      (>/=5 servings) or similar foods made with refined grains each day for six weeks. Based on
      treatment group, subjects will be provided either whole grain or refined grain foods and
      snacks. They will be instructed on how to use these foods to replace other foods already
      contained in the diet. Stool, blood, and saliva samples will be obtained at baseline and at
      study end to examine the microbiota and markers of digestive and immune health. Daily records
      will be maintained by the students to assess bowel habits and compliance. It is anticipated
      that whole grains will increase stool bulk resulting in increased stool frequency and softer
      stools. Additionally, fermentation of the fiber within the colon will alter the microbiota
      profile. Because the majority of the immune system resides within the gastrointestinal tract,
      improved balance of the intestinal microbiota may prime the immune system thus contributing
      to improved immune defense.
    

Intervention name(s): Whole grain diet; Refined grain diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects were told to consume three different kinds of study food each day. The goal was an intake of greater than or equal to 80 g of whole grains per day.; The refined grain food products were matched as closely as possible to the foods contained in the whole grain diet. Subjects were told to consume three different kinds of study food each day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Adolescent; Whole grain; Digestive health; Dietary fiber; Grain; Microbiota; Inflammation; Mucosal Immunity
Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly
      dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg
      etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be
      more convenient for most patients. This once-weekly regimen is used in countries outside of
      Japan.
    


Intervention name(s): etanercept
Intervention type(s): Drug
Intervention description(s): Period A: Weeks 1-4: Etanercept 25mg (25mg vial)bi-weekly (BW); Period B: Weeks 5-12: Etanercept 50mg (50mg vial) weekly (QW)
Intervention MeSH terms: Etanercept
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Migration Potential of Xeomin® Compared to Two Other Botulinum Toxin Type A Products
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Xeomin® is a Botulinum neurotoxin type A preparation free of complexing proteins, i.e. free
      of bacterial proteins other than the active toxin. Injected into the muscle, Xeomin® causes
      local weakening. Botulinum toxin type A is used for certain neurological and aesthetic
      treatments. This study will investigate the migration potential of Xeomin®.
    

Detailed description: 
      Conducted in Europe
    

Intervention name(s): Botulinum neurotoxin type A, free of complexing proteins
Intervention type(s): Drug
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Keywords: No condition; healthy volunteers
Testing Protocol for Cold-sensing Fibers
Condition: Pain
Study type: Interventional

Summary: 
      This project aims to evaluate whether electrical stimulation can modulate the cold detection
      threshold and the cold pain threshold. The hypothesis is that different electrical
      stimulation will either decrease or increase the cold threshold depending on the shape of the
      electrical stimulus. If a combination of electrical stimuli and cold stimuli could be used,
      this could lead to a novel method for estimating the excitability properties of cold-sensing
      fibers. The sub-project takes place in 1 session (1.5 hours).
    


Intervention name(s): Electrical stimulation
Intervention type(s): Other
Intervention description(s): At the beginning of the session, an electrode will be attached to the participant's ankle. Electrical stimulation will be applied to estimate the electrical perception threshold. This threshold will be used as condition stimuli when different thermal thresholds are assessed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep
Condition: Dexmedetomidine Induced Sedation
Study type: Interventional

Summary: 
      The investigators are doing this research study to find out how and where dexmedetomidine, a
      sedative anesthetic, acts in the brain. The investigators will do this by using a machine
      that records the brains electrical activity, called an electroencephalogram (EEG), and brain
      imaging scans to look at the brain.
    


Intervention name(s): dexmedetomidine
Intervention type(s): Drug
Intervention description(s): The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli.
Other intervention name(s): precedex
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dexmedetomidine; Sleep; MRI-PET; EEG
Sleepiness and Driving Performances in Adults With Attention-Deficit/ Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Sleepiness; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The Attention Deficit/ Hyperactivity Disorder (ADHD) is a developmental disorder which
      affects 3 to 5 % of school age children. This disorder persists in the adulthood for 60 % of
      subjects. Children with ADHD are sleepier during the day than normal children. However, there
      is no information concerning the diurnal sleepiness of adults with ADHD and the impact of
      this sleepiness on their driving capacity. The investigators postulate that the negative
      impact of ADHD is due to an awakening disorder which adds to the attentional disorder. The
      aim of this study is to estimate both the sleepiness by a Maintenance Wakefulness Test (MWT)
      and the capacity to drive in adults with ADHD.
    

Detailed description: 
      The main objective of this study is to estimate both the sleepiness by a Maintenance
      Wakefulness Test (MWT) and the capacity to drive in adults presenting an ADHD. Duration of
      participation for each patients will be 7 days. Four days after inclusion, patients will have
      to stop all psychostimulant treatment. Participants will then spend 24 hours (on days 6 and
      7) at the "Groupe d'Etudes Neurophysiologie Pharmacologie Sommeil et Sommnolence"(GENPPHASS)
      in the "Centre Hospitalier Universitaire"(CHU) of Bordeaux. During this time, they will
      undergo complete polysomnography.The next day, they will perform a Maintenance Wakefulness
      Test (MWT). A neuropsychological evaluation of one hour will also be done. Finally, a driving
      test on a simulator will be performed.

      Study significance: patients will benefit from an objective exploration of their sleep (with
      possibly, a sleep disorder discovery) and from a specific treatment. This study will
      demonstrate the necessity to investigate daytime function (sleepiness and performance) and
      the sleep quality of patients with ADHD. It will also demonstrate that part of the adults
      with ADHD handicap is based on an awakening disorder which adds to the attentional disorder.
    

Intervention name(s): Polysomnography; Maintenance Wakefulness Test; Neuropsychological evaluation; Driving test on a simulator
Intervention type(s): Other; Other; Behavioral; Other
Intervention description(s): Sleep study monitoring; Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.; Neuropsychological evaluation for cognitive functions study; Driving simulator test during wich a camera register different parameters as the position of the vehicle.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Attention Deficit Disorder / Hyperactivity (ADHD); Cognition; Sleepiness; Driving
A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors
Condition: Stimulation in the Ovary
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy and safety of two new patterns of
      controlled ovarian hyperstimulation (defined as total number of picked up eggs). This study
      will be performed in egg donors but these new patterns will be implemented in fertility
      preservation patients.
    


Intervention name(s): Early luteal phase; Late follicular phase -COH-
Intervention type(s): Procedure; Procedure
Intervention description(s): We will administer in the tenth day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.; We will administer in the 20th day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metaphase II; Ovarian stimulation; Egg donors
An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain
Condition: Other Acute Pain
MeSH terms: Emergencies; Acute Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness, the safety, and the tolerability
      of intranasal ketorolac (Sprix) in relieving acute pain in adults ages 18-65 who come to the
      ED seeking care. Considering all ED visits, pain is the most common chief complaint. Giving
      intranasal ketorolac (Sprix) after stomach and dental surgeries has been shown to be safe and
      effective, but no studies have investigated the use of intranasal ketorolac (Sprix) for the
      treatment of acute pain in the ED.

      Ketorolac (Sprix) has several advantages over other drugs commonly given for pain, including
      opioids. Ketorolac (Sprix) is non-addicting and has fewer side effects than opioids. The
      administration of ketorolac (Sprix) by other methods, such as IV, intramuscular shot, and
      oral pill form, has been shown to be safe and effective in treating acute pain.

      This study is being done to find out if giving ketorolac (Sprix) as a single dose nasal spray
      will have the same benefit in decreasing patient's pain.
    

Detailed description: 
      Adults between the ages of 18-65 were being seen in the emergency department of a single
      large tertiary care hospital with acute pain (moderate to severe 4-10 NRS scale). Those who
      met inclusion criteria were approached. Informed written consent was obtained from all
      participants. The study was approved by local Institutional Review Board (IRB). Demographics
      (age, gender, ethnicity) were recorded. Baseline pain scores on NRS were obtained prior to
      administration of the drug. Pain scores (NRS) after administration of the drug (intranasal
      ketorolac) were recorded. All adverse events/side effects were recorded. Data was obtained
      for the time the individual patient was in the emergency department being treated.
    

Intervention name(s): intranasal ketorolac
Intervention type(s): Drug
Intervention description(s): 15 mg
Other intervention name(s): Sprix
Intervention MeSH terms: Ketorolac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 18 years and older,; previously healthy; men and nonpregnant women; emergency department