bioihbjkbjnl/mcl2 huggingface dataset:
Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
Condition: Insomnia; Attention Deficit Hyperactivity Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared
      to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age,
      inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
    

Detailed description: 
      This is a multi center, randomized, double blind, placebo controlled, fixed dose study of
      eszopiclone in pediatric subjects 6-17 years of age, inclusive, with ADHD associated
      insomnia. Subjects will be randomized at approximately 1:1:1 to either low dose oral
      eszopiclone (1 mg for children ages 6-11 years, 2 mg for adolescents ages 12-17 years), high
      dose oral eszopiclone (2 mg for children ages 6-11 years, 3 mg for adolescents ages 12-17
      years) or placebo. This study was previously posted by Sepracor Inc. In October 2009,
      Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's
      name was changed to Sunovion Pharmaceuticals Inc.
    

Intervention name(s): eszopiclone; eszopiclone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years; 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years; 1 tablet per day for 12 weeks
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypnotic; Eszopiclone; Attention Deficit/Hyperactivity Disorder; Insomnia; Children; Adolescent; Polysomnography; Actigraphy
Cognitive Distraction on Food Intake: Randomized Crossover Exploratory Study
Condition: Obesity; Weight, Body
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      This study determined effects of a cognitive distraction on amount, preference, and memory of
      food consumed and perceptions of fullness, hunger, and enjoyment of food in a healthy
      young-adult population. A randomized controlled crossover study of 119 healthy adults,
      assigned to begin in either the distracted or control condition, was conducted.
    

Detailed description: 
      Environmental distractions have been shown to affect eating patterns. Influences of food
      environments on consumption patterns and not simply food choices are becoming increasingly
      clear for their contributions to energy intake. Of particular interest is the presence of
      distraction. It has been postulated that when distracted, individuals are inclined to
      consumer more than when not distracted. However, how distraction and memory impact subsequent
      food choice and preference is less well known. A Rapid Visual Information Processing (RVIP)
      task was applied to distract individuals while eating; food intake and food behaviors were
      measured after RVIP distraction and compared to food intake and food behaviors without
      distraction in the same individuals.
    

Intervention name(s): Rapid Visual Information Processing task; None or Control condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A series of numbers appeared on a computer screen at a rate of one per minute. Each participant was required to identify any series of three consecutive odd or even numbers by hitting the space bar on the keyboard. The task lasted 15 minutes and included a 1-minute practice session before food being served. Participants were instructed to eat at will while completing the computer task.; Participant were instructed to eat at will during a 15-minute duration.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized controlled crossover study where participants were assigned to begin in the distracted or control condition. One week later, participants completed the opposite condition.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Distraction; Eating behavior; Fullness; Hunger; Ingestive behavior; Rapid visual information processing
Salmonella Conjugates CVD 2000: Study of Responses to Vaccination With Trivalent Salmonella Conjugate Vaccine to Prevent Invasive Salmonella Disease
Condition: Risk Reduction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled interventional study. The main purpose of this
      research is to test the safety and measure the immune response of the trivalent vaccine
      against invasive Salmonella disease. The vaccine will be tested over a range of doses.
    


Intervention name(s): Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation; Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength Formulation; Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength Formulation; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): One dose of the full-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The full-strength conjugate vaccine consists of 25 mcg of each conjugate; Salmonella Enteritidis, Salmonella Typhimurium, and Salmonella Typhi Vi.; One dose of the half-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The half-strength conjugate vaccine consists of 12.5 mcg of Salmonella Enteritidis, 12.5 mg of Salmonella Typhimurium, and 25 mcg of Salmonella Typhi Vi.; One dose of the dilutional half-strength conjugate vaccine is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The dilutional half-strength conjugate vaccine consists of 12.5 mcg of each conjugate; Salmonella Enteritidis, Salmonella Typhimurium, and Salmonella Typhi Vi.; One dose of placebo is administered via an intramuscular injection in to the deltoid muscle on Study Day 1. The placebo consists of sterile phosphate-buffered saline (PBS) solution containing polysorbate 80, and 2-phenoxyethanol preservative.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study of HuCNS-SC Cells in Patients With Infantile or Late Infantile Neuronal Ceroid Lipofuscinosis (NCL)
Condition: Neuronal Ceroid Lipofuscinosis
MeSH terms: Neuronal Ceroid-Lipofuscinoses
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with infantile or late infantile NCL have either a reduced amount of, or are
      missing, the palmitoyl protein thioesterase 1 (PPT1) enzyme or the tripeptidyl peptidase 1
      (TPP-I) enzyme. Human central nervous system stem cells (HuCNS-SC) are an investigational
      product derived from human brain cells. HuCNS-SC have been shown to survive and migrate
      within the brains of mice. When grown in the laboratory, HuCNS-SC have been shown to produce
      the PPT1 and TPP-I enzymes. In mice missing the PPT1 enzyme, HuCNS-SC have been shown to
      increase the amount of this enzyme in the brain, to reduce the amount of abnormal storage
      material in the brain, and to prevent the death of some neurons (a type of cell) in the
      brain.

      Participation in this study will involve screening assessments, surgery to implant HuCNS-SC,
      medication to suppress the immune system, and a series of follow-up assessments. The length
      of time from the start of screening through to the last follow-up visit will be approximately
      13 months, with frequent visits to the study center during this time. After completion of
      this study, patients will be monitored for an additional 4 years under a separate long term
      follow-up protocol.
    


Intervention name(s): Surgery to implant human CNS stem cells (HuCNS-SC); Medication to suppress the immune system
Intervention type(s): Procedure; Drug
Intervention description(s): single dose; Immunosuppression for 12 months post transplant
Other intervention name(s): HuCNS-SC
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NCL; INCL; LINCL; Batten disease; Infantile Neuronal Ceroid Lipofuscinosis (INCL); Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL)
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm
      study which will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with
      placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving
      medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following
      additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier
      (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The
      total duration of this study for each participant is approximately 70 weeks including
      screening, run-in, treatment, and follow-up.
    


Intervention name(s): MSTT1041A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MSTT1041A will be administered as subcutaneous injections.; Placebo matched with MSTT1041A.
Other intervention name(s): RO7187807
Intervention MeSH terms: Astegolimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Brain Imaging Study of Acupuncture in Chronic Low Back Pain
Condition: Low Back Pain; Back Pain Lower Back Chronic; Low Back Pain, Recurrent
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      We are doing this research study to learn about how acupuncture treatment works. This study
      is being done to look at changes in the brain, NOT to treat pain. We want to learn about
      brain activity during acupuncture. We will look at brain activity when a heating device
      touches the skin of a subject before and after the subject has acupuncture, to see what
      changes.
    


Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): A licensed acupuncturist will perform acupuncture for two 30 minute sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Acupuncture; fMRI; CLBP; Pain; Low Back Pain; Back Pain
Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Previous reports demonstrated that dexmedetomidine could reduce the incidence of
      postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for
      ajuvant drugs for preventing and reducing PONV. So investigator want to study about the
      effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.
    

Detailed description: 
      Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce
      the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been
      commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to
      study about the effect of dexmedetomidine only or combined with dexamethasone for preventing
      PONV.
    

Intervention name(s): Dexmedetomidine; Dexmedetomidine and dexamethasone; Control
Intervention type(s): Drug; Drug; Drug
Intervention description(s): administration of dexmedetomidine only; administration of dexmedetomidine and dexamethasone; administration of normal saline
Other intervention name(s): DO; DD; OO
Intervention MeSH terms: Dexamethasone; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Turkish Version of the Medial Tibial Stress Syndrome Score
Condition: Medial Tibial Stress Syndrome
MeSH terms: Medial Tibial Stress Syndrome; Syndrome
Study type: Observational

Summary: 
      The medial tibial stress syndrome (MTSS) score was originally developed in Dutch to assess
      severity of disease relative to patient-reported outcome, particularly patients with MTSS.
      The purpose of this study was to translate and cross-culturally adapt the MTSS score into
      Turkish and investigate its psychometric properties.
    

Detailed description: 
      The medial tibial stress syndrome (MTSS) score was originally developed in Dutch to assess
      severity of disease relative to patient-reported outcome, particularly people with MTSS. The
      purpose of this study was to translate and cross-culturally adapt the MTSS score into Turkish
      and investigate its psychometric properties. Fourty-eight individuals with MTSS will include.
      Within a 7-day period after the first assessment, the participants completed the Turkish
      version of the MTSS score to evaluate test-retest reliability.

      Cronbach's alpha (α) was used to assess internal consistency. Construct validity was examined
      total score of PCS domain of SF-36-Tr with MTSS-Tr total score in the first visit. Concurrent
      validity was examined by evaluating the relationship between pain level and Detmer's
      classification with MTSS score in the first visit. The pain level of the patient assessed
      with visual analog scale (VAS) score.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will include 48 patients diagnosed with medial tibial stress syndrome (MTSS) by
        the sports medicine physicians in İzmir Bozyaka Training and Research Hospital, Tepecik
        Training and Research Hospital and Ege University. The individuals who volunteers and meets
        the inclusion criteria will be included in the study.
Motor Learning and tDCS in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The present study sought to examine the efficacy of single session transcranial direct
      current stimulation applied over the primary motor cortex in people with Parkinson's disease
      on sequential motor learning performance.
    

Detailed description: 
      Parkinson's disease is characterised by deficits of motor control triggered by impaired basal
      ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor
      symptoms of Parkinson's disease, the ability to learn a sequence of movements is also
      compromised and poses a significant barrier to effective rehabilitation. In healthy
      individuals, transcranial direct current stimulation applied over the primary motor cortex
      during motor task practice has been shown to significantly improve motor learning compared to
      placebo conditions. The present study sought to examine the effect of a single session of
      transcranial direct current stimulation applied over the primary motor cortex in people with
      Parkinson's disease on sequential motor learning performance. Participants learnt two finger
      tapping sequences, with task difficulty indexed by sequence length, and task consolidation
      further examined using a dual-task paradigm. Task related cortical haemodynamic activity was
      recorded using functional near-infrared spectroscopy.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad.
Stimulation is phased in with a 30 second ramp up period prior to the specified stimulation period and phased-out with a ramp down of the current following the specified stimulation period. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off for during the specified stimulation period.
Other intervention name(s): tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; Transcranial direct current stimulation; Motor sequence learning
Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Heart failure with preserved ejection fraction or HFpEF, represents nearly 50% of all heart
      failure cases and is particularly common in the elderly. The disease has no current treatment
      options. Symptoms typically occur during exertion or exercise and is likely the result of
      increased cardiac and pulmonary congestion as a result of impaired diastolic function.
      Istaroxime is a novel activator of SERCA2a, an important regulator of calcium uptake within
      the myocyte. We will test the hypothesis that Istaroxime will improve diastolic function
      during exercise in HFpEF patients which in turn will reduce cardiac and pulmonary congestion.
    

Detailed description: 
      About half of all elderly patients with a diagnosis of congestive heart failure have
      apparently normal systolic function, so called "heart failure with a preserved ejection
      fraction" or HFpEF. To date, no effective therapy for HFpEF has been found, in part because
      of failure to discern key pathophysiologic pathways.

      An extensive amount of pre-clinical work has identified that altered sarcoplasmic reticulum
      (SR) Ca2+ uptake, storage, and release play a major role in the changes in cardiac relaxation
      associated with aging, especially regarding sequestration of Ca++ by the sarcoplasmic
      reticular Ca++-ATPase (SERCA2a), which causes cardiac muscle relaxation by reducing cytosolic
      Ca++. Istaroxime is a relatively new drug that augments lusitropic function by upregulating
      SERCA2a activity in the heart.

      Because of the clear importance of slowed relaxation in HFpEF, and the evidence that
      depressed SERCA2a activity contributes to the slowed relaxation with aging, the proposed
      study may be establish the "impairment of SERCA2a" hypothesis as a mechanism of impaired
      relaxation in HFpEF subjects.
    

Intervention name(s): Istaroxime; Exercise
Intervention type(s): Drug; Other
Intervention description(s): Subjects will be given Istaroxime, a novel SERCA2a activator one hour prior and during exercise.
Other intervention name(s): exercise
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two separate groups of subjects (senior controls and patients with HFpEF) receiving istaroxime
Masking: Single (Participant)
Primary purpose: Basic Science
Development of an Effective Home-based-exercise-strategy
Condition: Osteoarthritis, Hip; Total Hip Arthroplasty
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Osteoarthritis is one of the most common chronic diseases of the musculoskeletal system in
      elderly. Patients with osteoarthritis experience pain, stiffness and loss of mobility. Due to
      ageing Western societies in the coming decades the number of elderly with osteoarthritis will
      progressively increase. Osteoarthritis is a common indicator for a Total Hip Arthroplasty
      (THA). A hip replacement is one of the most successful orthopedic surgeries. However, with
      regard to the postoperative rehabilitation a lot can be improved. The current situation after
      a THA is that physical therapy in the Netherlands is not prescribed by default. Patients are
      resigned from the hospital and receive home exercises. However, it is not clear whether
      patients actually carry out these exercises and whether they perform the exercises correctly.
    


Intervention name(s): Home-based rehabilitation program
Intervention type(s): Other
Intervention description(s): The duration of the program is 12 weeks. Patients start the program within 7 days after of the surgery. Patients perform exercises independently at home using the tablet PC for instructions. The program includes strengthening and walking exercises based on increasing the muscle force, balance, and functionality. The exercises comprise movements that train abductors, flexors, and extensors of the affected hip. The content of the program is based on previous research and on guidelines from the American Association of Orthopaedic Surgeons. For the rest, the program is designed in line with the most recent guidelines from the Royal Dutch Society for Physical Therapy. Patients are asked to exercise at least 5 days a week, with rest days on Thursday and Sunday. Strengthening exercises will be performed 3 times a week. The instructions for the exercises will be provided by videos on the tablet PC, which patients have to imitate.
Intervention model: Single Group Assignment
Intervention model description: A twelve-week home-based exercise strategy will be offered to patients after their discharge from the hospital. This home-based exercise strategy will be delivered by means of videos on a tablet-pc and consist of specified exercise instructions for improving muscle strength, balance and functional movements.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Total hip arthroplasty; Physiotherapy; Osteoarthritis; Usual care; Home-based rehabilitation program
Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids.
      To do this, a randomized crossover intervention study with 3 14-day periods (control diet,
      milk diet, cheese diet) will be conducted in 16 young males. Fasting blood samples will be
      collected before and after each period, and fecal samples will be collected for the last 5
      days in each period.
    


Intervention name(s): Dietary intervention (without dairy products); Dietary intervention (high milk content); Dietary intervention (high cheese content)
Intervention type(s): Other; Other; Other
Intervention description(s): Control diet without dairy products; Diet with a high content of milk (~1200 mg Ca/d from milk); Diet with a high content of cheese (~1200 mg Ca/d from cheese)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obesity prevention; appetite regulation; hyperlipidemia