bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, non-comparative, open-label clinical trial to assess the
      Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the
      treatment of children with primary Visceral Leishmaniasis (VL) in eastern Africa. Efficacy
      and Pharmacodynamics (PD) will be assessed as secondary outcomes.

      The proposed study aims to assess whether drug exposure in children can be increased to
      equivalent adult drug exposure by using the miltefosine allometric dose given BID for 28 days
      in paediatric VL patients aged 4-12y and whether this dose is tolerable. The present study is
      also expected to provide the basis for minimum time to reach sufficient drug exposure for
      miltefosine activity to guide optimal treatment duration to be used in combination therapy
      for visceral leishmaniasis. The PK data will be assessed in this trial using a compartmental
      population PK approach.
    


Intervention name(s): Miltefosine
Intervention type(s): Drug
Intervention MeSH terms: Miltefosine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Electrical Activity of Diaphragm as a Means to Predict Extubation Success in Preterm Infants
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Observational

Summary: 
      Mechanical ventilation used to support the sick newborn infant is associated with many
      complications including the development of chronic lung disease. Limiting prolonged invasive
      ventilation remains an important strategy to decrease lung injury and prevent chronic lung
      disease. Currently, there is no objective measure available to predict readiness for removal
      of the endotracheal tube ("extubation") and discontinuing mechanical ventilation in this
      fragile population.

      The investigators propose to predict extubation success by evaluating the electrical activity
      of the diaphragm (Edi), which provides important information about the "drive" to breathing
      coming from the brain and the function of the diaphragm, two essential factors determining
      extubation readiness and success.
    

Detailed description: 
      In this observational study, very low birth weight preterm infants with RDS who require
      mechanical ventilation in first 24 hour of life will be recruited. A size appropriate
      nasogastric tube with multiple array of electrodes (Edi catheter) will be inserted in each
      eligible infant. The average EdI (Edi_avg) will be measured during mechanical ventilation
      just before extubation. All infants will be extubated to non-invasive positive pressure
      ventilation (NIPPV or CPAP) delivered through nasal cannula

      The specific aim is to determine whether there is a relationship between Edi_avg before
      extubation and the extubation success in a sample of preterm infants with respiratory
      distress syndrome (RDS). We hypothesize that Edi-avg of infants with successful extubation
      will be significantly different from the infants who fail extubation
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A convenience sample of forty(40) preterm infants less than 35 week gestation admitted in
        the ICN with the need for intubation and mechanical ventilation for respiratory distress in
        the first 24 hours of life will be recruited for this study.
      
Keywords: Preterm; RDS; Mechanical Ventilation; Extubation failure
Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Condition: Presbyopia; Refractive Errors
MeSH terms: Presbyopia; Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this study is to compare an alternative fitting guide to a current fitting
      guide for optimizing contact lens parameters and determining contact lens prescription.
    


Intervention name(s): Lotrafilcon B multifocal contact lenses; Nelfilcon A multifocal contact lenses; Delefilcon A multifocal contact lenses
Intervention type(s): Device; Device; Device
Intervention description(s): Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution; Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning; Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning
Other intervention name(s): AIR OPTIX AQUA® Multifocal; DAILIES® AquaComfort Plus® Multifocal; DAILIES TOTAL1® Multifocal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: contact lenses; presbyopia; multifocal
The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the use of fentanyl during craniotomy in two groups of brain tumor
      patients. The control group will receive standard general anesthesia with the use of fentanyl
      for intraoperative pain control and the study group will receive scalp nerve block with 0.5%
      levobupivacaine (local anesthetic) and also fentanyl for intraoperative pain control. The
      scalp nerve block might reduce the dose of fentanyl and promote faster emergence from general
      anesthesia.
    

Detailed description: 
      Fentanyl has widely been used for intraoperative analgesia for craniotomy. In craniotomy, the
      long and complex operation, the continuous infusion or repeated use of fentanyl can
      significantly delay emergence from general anesthesia. The scalp block with local anesthesia
      is widely used for awake craniotomy with great success but it is not routinely used in
      general craniotomy. In this study, the control group will receive standard general anesthesia
      with the use of fentanyl for intraoperative pain control and the study group will receive the
      addition of scalp nerve block with 0.5% levobupivacaine (local anesthetic). The scalp nerve
      block might reduce the total dose of fentanyl and promote faster emergence from general
      anesthesia.
    

Intervention name(s): Levobupivacaine; NSS
Intervention type(s): Drug; Other
Intervention description(s): L form of bupivacaine with less cardiotoxicity.; Clear intravenous fluid looks alike local anesthetic.
Other intervention name(s): Chirocaine; 0.9% NaCl or Normal saline
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: fentanyl, scalp block
Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits
Condition: Proprioceptive Disorders
MeSH terms: Somatosensory Disorders
Study type: Interventional

Summary: 
      The objective of the study is to compare, with or without wearing an elastic proprioceptive
      knee brace, the functional proprioceptive capacity of the knee in patients suffering from
      proprioceptive deficit.
    

Detailed description: 
      This proprioceptive deficit is found following various traumas or injuries such as Anterior
      Cruciate Ligament (ACL) rupture, for example.

      The use of joint stabilizers (such as knee braces) will allow an increase in sensory input
      (particularly at the level of cutaneous mechanoreceptors), and improve the biomechanics of
      the injured joint.

      The objective of the study is to compare, with or without wearing an elastic proprioceptive
      knee brace, the functional proprioceptive capacity of the knee in patients suffering from
      proprioceptive deficit.
    

Intervention name(s): proprioceptive knee brace; No knee brace
Intervention type(s): Device; Device
Intervention description(s): the patient will perform the tests with the knee brace; the patient will perform the tests without the knee brace
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, single-center, interventional, open-label, 1-day clinical investigation in a population of patients with proprioceptive knee deficiency. A randomization will be performed in order to know the order of passage of the 2 conditions: with and without wearing a knee brace.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anterior cruciate ligaments rupture; proprioceptive knee brace; rehabilitation
Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01
      after oral administration for one day in healthy male volunteer.
    


Intervention name(s): Surfolase capsule; HT-002-01
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple-Ascending Dose in Japanese Patients Bridging Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy
      Japanese and Caucasian subjects.
    

Detailed description: 
      This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy
      Japanese and Caucasian subjects. Two dose levels of rodatristat ethyl, 300 mg twice daily
      (BID) and 600 mg BID multiple doses (with a single dose lead in), will be explored in an
      ascending dose fashion with a safety review in between (Figure 1 below). Approximately 48
      subjects will be enrolled in 4 cohorts.
    

Intervention name(s): Rodatristat Ethyl 300 mg BID; Rodatristat Ethyl 600 mg BID; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, oral, 300 mg, BID 14 days; Tablets, oral, 600 mg, BID 14 days; Tablets, oral, 0 mg, BID for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multiple Ascending Dose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; PAH
Sub-chronic Effects of 5-hydroxytryptophan on Mood and Emotional Processing in Healthy Volunteers
Condition: Mood
Study type: Interventional

Summary: 
      5-hydroxytryptophan (5-HTP) is a nutritional supplement sold in many health food stores, and
      is taken in order to raise levels of serotonin in the brain. Serotonin is a neurotransmitter
      that is involved in the regulation of mood.

      Previous research has assessed the effects of raising serotonin levels using tryptophan (the
      precursor of 5-HTP) and serotonergic antidepressants on emotional processing in healthy
      volunteers. However, to date there has been no human trial investigating the effects of 5-HTP
      on emotional processing in healthy volunteers.

      Thus, the current study aims to assess the effects of 5-HTP, on emotional processing and mood
      in healthy volunteers.
    

Detailed description: 
      The serotonin precursor 5-HTP is sold as a nutritional supplement and has been used to offset
      low mood for over 30 years due to its ability to raise levels of neural serotonin. However,
      evidence for the efficiency of 5-HTP is limited and the mechanism of action of 5-HTP in
      offsetting low mood has not been well-characterised.

      The current study assessed the ability of 5-HTP to induce biases for positive emotional
      material in healthy volunteers, similar to those induced by serotonergic antidepressants and
      the nutritional supplement tryptophan. The effects of 5-HTP on subjective mood and depressive
      symptoms were also assessed.

      Participants were randomised to receive either 150mg of 5-HTP or placebo daily for 14 days.
      Depressive symptoms and subjective mood were assessed pre- and post-intervention. Emotional
      processing was assessed on the 15th day using a battery of emotionally valenced cognitive
      tasks.
    

Intervention name(s): 5-Hydroxytryptophan; Pharmaceutical grade silica
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Thirty-three participants were randomly allocated in a double-blind manner to receive either 3x50mg capsules of 5-HTP or placebo (silica) for 14 days.
5-HTP is produced commercially by extraction from the seeds of the African plant griffonia simplicifolia.; Pharmaceutical grade silica was utilized as placebo
Intervention MeSH terms: 5-Hydroxytryptophan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 5-hydroxytryptophan; Mood; Emotional Processing; Emotional Cognition; Nutritional Supplement; Low mood
The Effect of Physical Activity Autonomic Response of Autism Spectrum
Condition: Neurodevelopmental Disorders
MeSH terms: Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      This study will investigate the effect of physical activity on autism spectrum disorder (ASD)
      in individuals with ASD of different age groups through measuring the hemodynamic, heart
      activity and respiratory system parameters.
    

Detailed description: 
      One hundred participants will be included in this study. One hundred typically developed
      children or control group and one hundred children with ASD group. The age range of
      participants will be 4 - 18 years old. The participants in both control and ASD groups will
      be randomly divided into 4 subgroups according to their age (4-7 years old, 7-10 years old,
      10-13 years old and, 14-18 years old). Also, ASD group will be categorized according to the
      symptoms severity using the childhood autism rating scale (CARS). Participants will be
      excluded if they have any intellectual disability (IQ ≤ 70), co-morbid medical or psychiatric
      disorders, pervasive developmental disorders (PDD) or Attention-deficit hyperactivity
      disorders (ADHD). They will also be excluded if they are taking any medications which to
      affect cardiovascular system, respiratory system, or arousal and balance or any other
      contraindications to exercises. Wechsler Intelligence Scale for Children-Fourth Edition24
      will be used to assess the Intelligence Quotient (IQ).
    

Intervention name(s): Physical Therapy
Intervention type(s): Other
Intervention description(s): The participant will walk for 3-minutes at this speed as a warming up period. After these 3-minutes, the speed will be increased gradually up to 5-6 km/minute under the supervision of parents and therapist. The children will perform 10-minute running at this speed. After this, the cooling down exercise will be performed for 3-minutes. The speed will be decreased for 2 km/ minute and gradually stop.
Other intervention name(s): Treadmill walking program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single- blinded randomized controlled study design will be used, the exercise program will be administrated for four weeks, three times per week, and sixteen minutes per session. Heart rate, ECG, Measurements of respiration, and blood pressure will be measured three times every session: at rest before starting exercises (baseline), directly after finishing exercises, and 15 minutes after finishing exercises.
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if AMG 827 is effective compared to placebo as
      measured by change in Asthma Control Questionnaire (ACQ) composite scores.
    


Intervention name(s): AMG 827; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SC injection.; SC injection.
Intervention MeSH terms: Brodalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amgen; chronic inflammatory disease; wheezing
Evaluation of Symptoms Improvement in NSCLC Patients With First-Line Therapy of EGFR Tyrosine Kinase Inhibitor
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      This is an open-label, non-interventional, single-arm, multicenter study in a real-world
      population to assess the clinically symptom improvement and quality of life (QoL) in patients
      with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as
      the first-line treatment.

      The Primary Objective is to estimate symptom improvement rates in patients with locally
      advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the
      first-line treatment. A clinically meaningful improvement is defined as an increase from
      baseline of 2 or more points for LCS (Lung Cancer Scales) at Week 4.
    

Detailed description: 
      The Secondary Objectives are:

        1. To estimate symptom improvement rates at weeks 2 and 12

        2. To estimate mean change from baseline in overall QoL scores using the FACT-L instrument
           and LCS score at Week 2, 4 and 12.

        3. To estimate the proportion of patients exhibiting an LCS change of 7 points or more at
           weeks 2, 4 and 12.

        4. Subgroup information of symptom improvement rate, QoL and disease-related symptom scores
           by gender, smoking status, smoking pattern, WHO performance, number of metastatic sites,
           female/never smokers and patients with COPD at week 2, week 4 and week 12.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        advanced NSCLC patients who will be treated as first line treatment with EGFR-TKI
      
Biospecimen description: 
      no biospecimen collected
Effects of Music Intervention on the Brain Development of Preschool Children
Condition: Child Development
Study type: Observational

Summary: 
      The purpose of this research study is to learn more about the effects a musical intervention
      has on typical brain development in preschool-aged children.
    

Detailed description: 
      This study will advance the science on brain research in young children by determining the
      effects of a musical intervention or training on children's brain development. The study will
      investigate how regular instruction in the Suzuki-like method of violin affects brain
      structure and function over the course of approximately five (5) months in preschool-aged
      children participating in an Early Childhood/Headstart preschool program when compared to a
      control group of their peers.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in this research project will be involved with a different research project
        (Avera Family Wellness Program) investigating the effects of a family-based wellness
        approach to addressing emotional-behavioral needs of preschool-age children and their
        families. The Avera Family Wellness Program (AFWP) consists of a group of children who
        receive the family-based intervention and a group of control preschool-age children.
      
Keywords: brain; brain development; MRI; preschool children; cortical mantle thickness; hippocampal volume
A Drug-drug Interaction Trial to Evaluate the Pharmacokinetics Effect of Rifampicin on Famitinib
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to assess the effect of repeated oral doses of
      Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.

      The secondary objective of the study was to assess the safety of Famitinib given alone versus
      Famitinib co-administered with Rifampicin.
    


Intervention name(s): Famitinib capsule; Rifampicin capsule
Intervention type(s): Drug; Drug
Intervention description(s): single dose and co-administrated with Rifampicin capsule; repeated doses of Rifampicin capsule
Other intervention name(s): SHR1020; Rifampicin
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Intervention model description: Repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.
Masking: None (Open Label)
Primary purpose: Basic Science