bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Condition: Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this randomized control trial is to test the impact of provitamin A carotenoid
      biofortified maize meal consumption on maternal and infant vitamin A status.
    

Detailed description: 
      Vitamin A deficiency remains a major public health problem in low and middle income
      countries. Approximately 50% of Zambian children are thought to be affected. This randomized
      control trial will test the efficacy of provitamin A carotenoid biofortified maize meal
      consumption as a strategy to improve vitamin A status among lactating Zambian mothers and
      their infants. The investigators will enroll up to 255 mother/infant pairs to a three-month
      study, during which they will receive one of the following three interventions: 1)
      conventional white maize, 2) provitamin A carotenoid biofortified orange maize, or 3)
      preformed vitamin A fortified white maize.
    

Intervention name(s): Conventional white maize; Provitamin A carotenoid biofortified maize; Preformed vitamin A fortified maize
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Women and their infants will receive 2 meals/day prepared with conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks; Women and their infants will receive 2 meals/day prepared with provitamin A carotenoid biofortified orange maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks; Women and their infants will receive 2 meals/day prepared with preformed vitamin A fortified, conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
Intervention MeSH terms: Vitamin A; Beta Carotene; Provitamins; Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy
Condition: Hemiparesis; Cerebral Palsy
MeSH terms: Muscle Weakness; Paralysis; Cerebral Palsy; Paresis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if a modified protocol of constraint-induced
      movement therapy (CIT) is effective in rehabilitation treatment of arm paresis in children
      with cerebral palsy. In these children one main problem the non-use of the affected arm. Many
      studies showed that the non-use phenomenon can by reversed by the CIT, a rehabilitation
      program consisting of 15 days of restraining the unaffected arm plus a daily intensive (6
      hours/day) physiotherapy training of the paretic arm. The present study aims at evaluating if
      a shortened CIT protocol (restraining device plus only 2 weekly hours of physiotherapy) is
      effective in improving use and function of children paretic arm
    


Intervention name(s): Modified Constraint-induced movement therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Rehabilitation; Children; Cerebral Palsy; Arm; Paresis
Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease
Condition: Parkinson's Disease With End of Dose Wearing Off
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with
      end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and
      entacapone.
    

Detailed description: 
      This was a prospective, multi-center, randomized, open-label study with blinded raters to
      evaluate the effects of immediate versus delayed switch to carbidopa/levodopa/entacapone on
      motor function and quality of life in patients with Parkinson's disease with end-of-dose
      wearing off.
    

Intervention name(s): Carbidopa/levodopa/entacapone
Intervention type(s): Drug
Intervention description(s): Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone.
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone; Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease, tremor
The Effect of Physical Fatigue on Different Balance Tests and Brain Activity in a Healthy Population
Condition: Physical Fatigue; Return to Sport; Injury Prevention; EEG; Brain Activity; Balance
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The main objective of this project is:

      1. To assess the influence of physical fatigue on brain functioning during a balance and
      reaction time task in a healthy population. In a later stage, these experiments could be
      carried out in a clinical context (e.g. in an ankle sprain population).

      The researchers will use a randomized, placebo controlled, counter-balanced, cross-over
      design. Twenty healthy subjects will visit the lab 3 times. On the first visit
      (familiarisation trial), the investigators will collect the participants' characteristics.
      The participants will also be familiarized to the procedures and materials of the experiment
      during this first visit. The second and third visit contain the experimental setup and will
      proceed as follows: first, the participants will fill in a pre-test checklist, a mental
      fatigue scale (M-VAS) and motivation scale. In the mean time a little blood will be collected
      from the ear lobe to determine lactate and glucose levels; also, blood pressure will be
      checked.

      Next, the subjects will carry out a Y-balance test and a balance reaction-time test. Session
      rate of perceived exertion (SRPE) is measured to indicate how fatigued the participants feel
      due to the test battery; also, M-VAS is collected once more, as well blood lactate, glucose
      and blood pressure. These measures are followed by either a physical fatigue inducing task
      (Modified 30 seconds Wingate protocol) or time-matched control task (sitting on the bike
      without pedalling). Afterwards, researchers will collect blood lactate, glucose and blood
      pressure two times more; participants have to fill in M-VAS (2x), perform the same Y-balance
      test and balance reaction time test, and fill in the SRPE scale one more time. Heart
      frequency and EEG will be measured continuously during the trials.
    


Intervention name(s): Physical Fatigue; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Maximal cycling effort for 30s (Wingate modified); time-matched task (sitting on the bike without pedalling)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Combined Medication for Improved Analgesia in Superficial Pain
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This research study is being done to assess if a combination of medications can enhance the
      relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The
      investigators also want to find out if certain genes may be linked to individual differences
      in experienced efficacy of pain killers. The combination of medications under investigation
      is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug
      Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain
      types of poisoning, heartbeat problems, and other diseases but atropine is not approved to
      treat pain. However, atropine has been used for many years in different European countries to
      treat painful conditions such as stomach cramps.This research study will compare diclofenac
      and atropine to placebo.
    


Intervention name(s): Diclofenac and Atropine combination drug; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Diclofenac will be associated with a small dose of atropine 1.2mg; For each capsule of active medication, a capsule of placebo will be provided, identical looking.
Other intervention name(s): Analgesic drug; Combination drug; Test drug; Diclofenac and atropine; Atropine and diclofenac; Placebo control for the active medication
Intervention MeSH terms: Diclofenac; Atropine; Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Bioequivalence (BE) Study in Healthy Subjects
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4
      milligrams per milliliter [mg/mL]) compared with 2 capsules of atomoxetine (25 mg per
      capsule) in healthy adult male Japanese subjects.
    


Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention description(s): Administered orally, once.
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between Vapocoolant Spray and Eutectic Mixture of Local Anesthetics in Reducing Pain From Spinal Injection
Condition: Adult Patient Undergoing Elective Surgery With Spinal Anesthesia
Study type: Interventional

Summary: 
      This study aimed to evaluate the effect of vapocoolant spray and EMLA in reducing pain from
      spinal injection
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study
      and randomized into two groups (Vapocoolant spray group and eutectic mixture local
      anesthetics (EMLA) group). Intravenous (IV) cannulae with Ringer Acetate fluid, non-invasive
      blood pressure monitor, and pulse-oxymetry were set on the subjects in the operation room.
      Vital signs were recorded. Patients were positioned in sitting position and were instructed
      to flex their head and bend their back. Identification of intervertebral space L4-5 were
      performed. Asepsis and antisepsis procedure were performed. The Vapocoolant spray group
      received vapocoolant spray at a distance of 10 cm for 2 seconds and we waited for 10 seconds.
      The EMLA group received EMLA cream which consisted of 2.5% lidocaine and 2.5 % prilocaine in
      2 ml of water/oil emulsion and then they received tegaderm as the dressing for 45-60 minutes
      before the cream was wiped off. Spinal injection using 27G needle were performed after the
      intervention to each groups. Needle bevels were aligned parallel to dura fibres. Patients'
      visual analog score (VAS) and movements were recorded. Evaluation was only done in the first
      injection attempt, and was followed until the depth of the needle was around 5 mm. After the
      injection was successfully performed, patients' position were changed into supine position.
      Evaluation and recording were performed by person who was blinded from the intervention.
      Vital signs were recorded for every 3 minutes in the first 15 minutes, and then every 5
      minutes until the end of the procedure.
    

Intervention name(s): Vapocoolant spray, EMLA
Intervention type(s): Drug
Intervention description(s): Subjects were given vapocoolant spray to reduce pain from spinal injection; subjects were given EMLA to reduce pain from spinal injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Ultrasonographic Assessment of Stomach in Two Different Fasting Guidelines
Condition: General Anesthesia
Study type: Interventional

Summary: 
      Oral carbohydrate loading until 2 h before surgery is well known to be effective in
      facilitating postoperative recovery and reducing complications, by maintaining homeostasis.
      However, there are still concerns in implementing this as a universal fasting guideline,
      because of the risk of pulmonary aspiration. Therefore, we designed this study to compare the
      two preoperative fasting guideline: (1) keep fasted from midnight until surgery, and (2) oral
      carbohydrate beverage 800 mL from midnight until 2 h before surgery.
    


Intervention name(s): preoperative oral carbohydrate loading
Intervention type(s): Dietary Supplement
Intervention description(s): Carbohydrate beverage (12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg) 800 mL is given to the NO-NPO group until 2 hours before surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Video Education Intervention in the Emergency Department
Condition: Pain
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if an educational video viewed during the Emergency
      Department visit will improve parent knowledge of pain management, reduce parent anxiety, and
      change their use of analgesics at-home after discharge from the Emergency Department.
    

Detailed description: 
      This study will investigate the use of a video instruction for parents just prior to
      discharge on pain treatment for their child. The investigators plan to investigate the effect
      of the video on knowledge because educational modules in the form of videotapes have been
      shown to be an effective method to improve a parent's knowledge about pain management prior
      to surgical procedures. Because parental anxiety has a significant impact on a child's
      experience of pain and video education has been shown to reduce parent anxiety before a
      procedure, the investigators will also evaluate if parental anxiety is reduced. Whether or
      not a short video will change the behavior of parents or their satisfaction with the outcome
      at home has not been investigated and will be an exploratory hypothesis for this study. This
      research will be a first step towards optimizing the outpatient care for common diagnoses in
      the Emergency Department.
    

Intervention name(s): Pain management video; Falls Prevention Video
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6-minute video; 6-minute video
Other intervention name(s): Fall Prevention Video
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pediatric; pain
Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets
      under fasted conditions
    


Intervention name(s): protriptyline
Intervention type(s): Drug
Intervention description(s): 10 mg tablet
Other intervention name(s): Vivactil
Intervention MeSH terms: Protriptyline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of the olfactory stimulation intervention on
      the people with mild to moderate dementia. We recruit 28 participants who has been diagnosed
      with mild to moderate dementia from 2 day care centers in Taipei. They are randomly assigned
      to three groups, including the olfactory intervention group, game comparison group, and
      control group. Beside the control group, the participant with two other groups were required
      to attend twelve weeks intervention (twice a week, thirty minutes for one section). Every
      participants completed the olfactory test, both paper-pencil and computer-based examination
      for cognition, blood test and psychological measurement before and after the intervention.
      The results showed that the participant in olfactory intervention group significant improved
      score in the LOTCA-G examination, and the Aβ1-42 concentration of the blood test significant
      increase in the control group; furthermore, the olfactory intervention group is lowest
      concentration among three groups in the Tau concentration of the blood test via ANCOVA
      analysis.
    


Intervention name(s): board game comparison; olfactory stimulation intervention
Intervention type(s): Other; Other
Intervention description(s): The group used 24 board games popular among the elderly population in Taiwan, including Noah's Ark, Splash Attack, Pengoloo, Speedy, and Zingo. Because some games were too complicated for the participants to play, some game rules were modified into more simple and directive thinking.; The group used 15 flavors of essential oil (i.e., lavender, rosemary, sweet orange, lemongrass, mint, and hinoki) and essence (i.e., lemon, coffee, peach, magnolia, chocolate, jasmine, strawberry, pomelo, and passion fruit), purposefully selecting two to three flavors for each session. Because some flavors are familiar to the participants and some are not, the familiar flavors were initially used to trigger memory. The unfamiliar flavors (i.e., lavender, rosemary, sweet orange, and lemon) were used in later sessions because those were recognized as having potential effects on cognitive function
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Intra-procedure Music on Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of intra-procedure music intervention on
      procedural anxiety, physiological stress and sedation requirements in patients undergoing
      moderate sedation procedures. Study participants will be randomly assigned into two groups:
      1. Control - standard care without music intervention. 2. Intervention - standard of care
      plus music intervention. The State-Trait Anxiety Inventory questionnaire will be provided
      pre, intra and post procedure to all subjects in addition to an exit survey.
    


Intervention name(s): Music
Intervention type(s): Other
Intervention description(s): Intra-procedure music through headphones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Infliximab and Methotrexate in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      There is a great individual variability of pharmacokinetic of infliximab in patients treated
      for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate
      (MTX), others have not.

      Thus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties
      of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.
    


Intervention name(s): infliximab
Intervention type(s): Drug
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Pharmacokinetic Study to Compare Two Formulations of Paracetamol
Condition: Fever; Headache Disorders; Pain
MeSH terms: Headache Disorders; Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast
      release in fasted state.
    


Intervention name(s): Paracetamol
Intervention type(s): Drug
Intervention description(s): 500 mg immediate release paracetamol formulations
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eplerenone in HIV Associated Abdominal Fat Accumulation
Condition: HIV
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle
      modification to affect sugar metabolism, body fat distribution, and cardiovascular health in
      HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that
      aldosterone, a hormone that regulates salt and water balance, is increased in association
      with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals,
      aldosterone appears to be higher in individuals with increased belly fat, and increased
      aldosterone appears to be strongly associated with impaired sugar metabolism. In this study,
      the investigators will test the effects of eplerenone, which is a medication that blocks the
      actions of aldosterone, along with lifestyle modification. The investigators hypothesize that
      eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce
      fat accumulation in liver and muscle.
    

Detailed description: 
      The study is 12 months long, with two phases. In the initial, 6-month phase, volunteers are
      randomly assigned to receive either eplerenone or placebo (an inactive pill). In addition,
      all volunteers will receive counseling about healthy diet and lifestyle, and will be asked to
      follow guidelines for a healthy level of physical activity. In the second 6-months of the
      study, all volunteers will continue to receive lifestyle modification and all will receive
      eplerenone.
    

Intervention name(s): Eplerenone and lifestyle; placebo and lifestyle
Intervention type(s): Drug; Other
Intervention description(s): eplerenone 50mg by mouth daily as well as lifestyle counseling; placebo pill daily and lifestyle counseling
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV-infection; eplerenone; aldosterone; visceral fat; lipodystrophy
Study of ACE-536 in Healthy Postmenopausal Women
Condition: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find out whether ACE-536 can be safely given to patients.
      This study will also look to see if ACE-536 increases red blood cells, the cells that carry
      oxygen in the body.
    


Intervention name(s): ACE-536; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15.; Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15.
Intervention MeSH terms: Luspatercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment