bioihbjkbjnl/mcl2 huggingface dataset:
Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and
      vomiting (CINV) are still common and are among the most distressing side effects of
      chemotherapy. Aprepitant is commercially available in Canada as capsules. An oral liquid
      aprepitant formulation would be ideal for oral administration to patients unable to swallow
      capsules.
    


Intervention name(s): Aprepitant Capsule 125 MG; Aprepitant oral suspension 20 mg/mL
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period; Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period
Intervention MeSH terms: Aprepitant; Fosaprepitant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Pre-eclampsia and Biochemical Markers
Condition: Detection of Preeclampsia Complications
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Observational

Summary: 
      In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney
      impairment characteristics, a recent study demonstrated that the serum levels of NGAL
      increased at the end of the second trimester in women who subsequently developed
      pre-eclampsia compared to the control group.

      This correlates well with the endothelial damage that occurs during pre-eclampsia and thus
      NGAL can be considered as a promising marker in predicting both early and late onset
      pre-eclampsia. It may be required to combine one or more biomarker with NGAL to increase the
      precision, and sensitivity for detection of risk and reliability of using biomarkers for
      pre-eclampsia.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women after 20 weeks
Pilot Study of the Effect of Iron Fortified Rice in Iron Deficient Anemic Women
Condition: Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      The purpose of this study is to see if rice enriched in iron will help women with
      iron-deficient anemia restore their blood counts more efficiently than the standard rice not
      enriched with iron.
    

Detailed description: 
      The study will consist of 1 screening visit and 3 study visits. The two-week study will be
      scheduled to be between menses.

      You will then be assigned to eat regular rice dishes or rice dishes fortified with iron for
      the two-week period. The assignment to the rice group will be made randomly (like flipping a
      coin). Your chance of being in either rice group will be 50:50. You will be given 14 frozen
      rice meals in styrofoam containers to take home. You will be expected to eat two rice dishes
      per day for the next study week and to bring the empty containers to your next study visit.
    

Intervention name(s): Non-fortified rice; Iron-fortified Rice
Intervention type(s): Other; Other
Intervention description(s): Consumption of 2 servings of Non-fortified rice per day in women with iron deficiency anemia and measure serum iron and transferrin at baseline and end of study.; Consumption of 2 servings of Iron-fortified rice per day in women with iron deficiency anemia and measure serum iron and transferrin at baseline and end of study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Iron deficiency anemia; rice
Robot-Assisted Motivating Rehabilitation
Condition: Stroke; Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to examine how a novel robot technology designed for eventual use
      as a home therapy can improve arm function after stroke.
    

Detailed description: 
      Typically, after brain damage due to a stroke, the affected arm is weak and suffering from
      some of paralysis. As a result, adults with this condition are unable to move their impaired
      arm well during their activities of daily living. Our research is focused on understanding
      how best to improve the ability of the arm to move after brain damage due to a stroke. We
      have implemented novel robot technology designed for eventual use as a home therapy device
      and have used software and hardware technologies to design activities that can assess the arm
      ability and engage the person during therapy. We will study how the prolong use of this
      device with simple, functional, and engaging activities improve the arm's movement ability
      and sustain motivation to use the arm over repeated therapy sessions and away from
      supervision.

      Overall, we will establish whether using our technology to perform tasks that are more or
      less game-like and functionally relevant to driving will make a difference in the impaired
      arm after stroke. Two groups of stroke survivors will be followed while they complete
      therapy. We have three main aims. In aim #1, we will determine whether therapy using
      functional tasks compared to simple rote tasks lead to significant increases in the use of
      the arm during therapy and the arm improvements experienced by the subjects after the
      therapy. In aim #2, we will measure how each group engage in the more and less functional
      therapy and monitor their effort and enjoyment during training. This aim will help us to
      determine the value of more fun training. In aim #3, we will upgrade our technology for use
      in the home therapy environment and follow some subjects to determine if the results change
      in under supervised condition (at home)
    

Intervention name(s): TheraDrive Assistive Device; Rote Therapy versus Fun Therapy
Intervention type(s): Device; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Robotics; Rehabilitation; Upper Extremity; CVA
OLP-1002 is Being Studied in the Treatment of Pain.
Condition: Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary objective of the study is to assess the safety and tolerability of single and
      multiple subcutaneous doses of OLP-1002 in healthy subjects.
    

Detailed description: 
      The exploratory objectives of the study are to evaluate the pharmacodynamic effect of
      OLP-1002 following single subcutaneous doses in healthy volunteers using a capsaicin pain
      model, and to monitor the effects of a single subcutaneous doses of OLP-1002 on cardiac QT
      interval. Where possible, single and/or multiple subcutaneous dose pharmacokinetics of
      OLP-1002 in healthy subjects will be determined.
    

Intervention name(s): OLP-1002 (Test): Part A, Single Ascending Dose; OLP-1002 (Test): Part B, Multiple Ascending Dose; Placebo: Placebo Part A, Single Ascending Dose; Placebo: Placebo Part B, Multiple Ascending Dose
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 µg, 3 µg, 6 µg, 12 µg, 20 µg, 40 μg, 80 μg, 160 μg; Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg; Subcutaneous Injection: Placebo; Subcutaneous Injection: Placebo x 5
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a double-blind, randomized, placebo-controlled, single and multiple subcutaneous dose study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pain; Pain Injection
Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
Condition: Infant Behavior; Pain, Acute; Physiological Stress; Breast Milk
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      The study purposes are to compare the effects of different combinations of sensory
      interventions on newborns' pain responses, physiological distress (heart rate and oxygen
      saturation), and crying event during heel stick procedures.
    

Detailed description: 
      Newborns undergo many necessary invasive procedures for routine care, but these treatments
      may cause stress and pain. The study purposes are to compare the effects of different
      combinations of sensory interventions on newborns' pain responses, physiological distress
      (heart rate and oxygen saturation), and crying event during heel stick procedures. This study
      was a prospective, randomized controlled trial. Infants were recruited by convenience
      sampling in a baby room of a medical center in northern Taiwan from September in 2017 to
      September in 2018. Newborns who met the criteria were recruited by blocked random to three
      treatment groups: (1)Gentle touch + Verbal comfort, (2) Smell + gentle touch + Verbal
      comfort, (3) Smell + Taste + Touch + Verbal comfort. Pain response was measured by the
      Neonatal Infant Pain Scale (NIPS). The physical distress events were measured by the abnormal
      heart rate and oxygen saturation event, and crying event. All data were collected 5 minutes
      before heel-stick (baseline), during heel-stick and in recovery status.
    

Intervention name(s): GT+VC; Smell; Taste
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Gentle touch and verbal comfort,; Smell breast milk; Taste breast milk
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to assess the long term safety of treatment with
      tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease
      (ADPKD). The secondary objective is to assess the pharmacodynamics, pharmacokinetics, and
      efficacy of tolvaptan in the same participant population.
    

Detailed description: 
      Tolvaptan has been demonstrated to delay the decline of kidney function in adults with
      rapidly progressing ADPKD (chronic kidney disease [CKD] stages 1 to 3) as measured by
      estimated glomerular filtration rate (eGFR) and Total Kidney Volume (TKV).

      This trial will be the first trial of tolvaptan in children and adolescents with ADPKD.

      Participants in this study will be randomly assigned to one of two groups in Phase A;
      tolvaptan or placebo. Participants will have an equal chance of being assigned to either
      treatment group and will be stratified by age and gender into the following cohorts:

        -  Female participant ages 12 to 14 years, inclusive

        -  Female participant ages 15 to 17 years, inclusive

        -  Male participant ages 12 to 14 years, inclusive

        -  Male participant ages 15 to 17 years, inclusive

      Phase (A) of this study will last 12 months. After that time, all participants who qualify
      will be assigned tolvaptan and will be treated with tolvaptan for 24 months (Phase B).

      A qualified participant is defined as one who has completed Phase A on investigational
      medicinal product (IMP), is willing to continue in the trial, and who does not have any
      adverse events (AEs), which would require IMP discontinuation.

      Participants in this study will be required to make monthly visits to the study clinic and
      will be closely monitored over the course of the study.
    

Intervention name(s): Tolvaptan; Tolvaptan Matching-placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tolvaptan spray-dried, immediate release tablets; Tolvaptan matching-placebo tablets
Other intervention name(s): OPC-41061
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autosomal Dominant Polycystic Kidney Disease; ADPKD; Tolvaptan; Renal cysts; Chronic Kidney Disease; Genetic Kidney Disease
Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients
Condition: Hearing Loss, Binaural; Hearing Loss, Monaural
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      Communication on telephone is challenging for people with hearing loss. For hearing aid
      users, for instance, the inventions for improving speech intelligibility on the phone range
      from an integrated tele coil and individual hearing programs to specially designed phone
      devices. No formal studies involving these devices have been carried out with CI users.

      Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate
      different hearing solutions for communication on telephone in terms of intelligibility and
      ease of use.
    

Detailed description: 
      Communication on telephone is challenging for people with hearing loss, due to a number of
      factors:

        -  The lack of visual cues (lip-reading),

        -  The lack of binaural abilities,

        -  The presence of (loud) background noise in a variety of listening situations,

        -  A modified speech signal due to reduced frequency bandwidth and

        -  Difficulties coupling the phone to the CI. For hearing aid users, for instance, the
           inventions for improving speech intelligibility on the phone range from an integrated
           tele coil and individual hearing programs to specially designed phone devices.

      No formal studies involving these devices have been carried out with CI users.

      Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate
      the different hearing solutions for communication on telephone in terms of intelligibility
      and ease of use:

        -  Phonak DECT - cordless telephone for HA-, CI- users and bimodal users

        -  Phonak EasyCall - accessories for Bluetooth capable mobile telephones for HA-, CI- and
           bimodal users

        -  Phonak DuoPhone - streaming function, which provides the speech signal to both ears
    

Intervention name(s): standard telephone setting; DECT; EasyCall; DuoPhone
Intervention type(s): Device; Device; Device; Device
Intervention description(s): without streaming function; cordless telephone (streaming to both hearing devices); accessories for Bluetooth capable mobile telephones (streaming to both hearing devices); streaming function, which provides the speech signal to both ears
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hearing Aid Usage (monaural, binaural); Cochlear Implant Usage (monaural, binaural); Hearing Aid and Cochlear Implant Usage (monaural)
Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in
      children.
    

Detailed description: 
      This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent
      influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing
      6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not
      repeated.

      Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day
      28 then after Day 180-210 following the vaccination.
    

Intervention name(s): Vaccination with FLUVAL P
Intervention type(s): Biological
Intervention description(s): Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant.
Dose: 0.25 ml (total 3 μg HA), single dose.
Other intervention name(s): Influenza; Pandemic vaccine; Prevention; Influenza vaccine; Influenza in humans; Vaccination of children
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Pandemic vaccine; Seasonal vaccine; Prevention; Influenza vaccine; Influenza in humans; Pandemic influenza in humans; Influenza vaccine for children
Bioequivalence Study of 4 mg Glimepiride Tablet
Condition: Glimepiride BE Study in Healthy Volunteers Under Fasting Condition
Study type: Interventional

Summary: 
      This was a randomized, single blind, two-period, two sequence cross-over study under fasting
      condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test
      and reference formulations).
    

Detailed description: 
      The participating subjects were required to have an overnight fast; and in the next morning
      they were given orally either one tablet of 4 mg glimepiride as the test drug (produced by PT
      Dexa Medica) or one tablet of 4 mg glimepiride (Amaryl®, Sanofi Aventis) as the reference
      drug with 200 mL water.

      Blood samples were drawn immediately before taking the drug (control), and at 0.5, 1, 1.5, 2,
      2.5, 3, 3.5, 4.5, 6, 9, 12, 18 and 24 hours after drug administration. Immediately after drug
      administration, subjects were administered 100 ml of 10% glucose at approximately 0.5, 1.5,
      2, 2.5, 3.5, and 4.5 hours. In addition, 20% glucose solution was given to any subject who
      exhibited symptoms of hypoglycaemia. One week after the first drug administration (wash-out
      period), the procedure was repeated using the alternate drug.

      The plasma concentrations of glimepiride were determined by high performance liquid
      chromatography with ultraviolet detection (HPLC-UV). The pharmacokinetic parameters assessed
      are AUCt, AUCinf, Cmax, tmax, and t1/2.
    

Intervention name(s): Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica; Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis
Intervention type(s): Drug; Drug
Intervention description(s): In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.; In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.
Other intervention name(s): Amaryl®, manufactured by PT Sanofi Aventis
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: sulphonylurea; anti-hyperglycaemic; bioavailability; bioequivalence; glimepiride; pharmacokinetics
A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin
      (OT) augmentation, in young adults with autism spectrum disorders. Participants will be
      randomly assigned to receive either a social skills-focused CBT intervention or a stress
      management/relaxation training CBT intervention. Participants will also be randomized to
      receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The
      design of the study will enable examination of the efficacy of CBT for young adults with
      autism spectrum disorders. The design of the study will also allow examination of whether
      oxytocin enhances the efficacy of CBT.

      The investigators will perform functional (fMRI) and structural (MRI) imaging with all
      participants prior to treatment. This will enable examination of the relations between
      measures of brain function and structure, and improvements in target symptoms over the course
      of treatment. The aim is to discover whether there are neural characteristics that can
      identify which participants with autism spectrum disorders are most likely to respond to CBT
      interventions and/or oxytocin treatment.
    


Intervention name(s): Oxytocin; Social Skills focused CBT; Stress management/relaxation training; placebo drug
Intervention type(s): Drug; Behavioral; Behavioral; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism spectrum disorder; social skills deficits; cognitive behavioral therapy; oxytocin; young adult
Study to Assess Pharmacokinetic (PK), Bioavailability & Food Effect of MR902 Compared With Immediate Release (IR) Morphine Sulphate Oral Solution
Condition: Opioid Substitution Treatment
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess bioavailability of a single dose of MR902 and to assess the effect of food
      on absorption
    

Detailed description: 
      Volunteers will receive a single dose of the investigational drug on 2 occasions and a
      reference drug on 1 occasion. Volunteers will be randomised to one of two groups, each group
      receiving a different dose strength of MR902 in fed and fasted state.

      The study involves a screening visit 21 days before first dosing and 3 overnight stays in 3
      study periods, and a post-study medical visit.

      Volunteers will receive naltrexone to reduce anticipated opioid side effects.
    

Intervention name(s): MR902; IR morphine sulphate
Intervention type(s): Drug; Drug
Other intervention name(s): IR morphine sulphate 10 mg/mL solution
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
VLDL-triglyceride Under Acute Hyperinsulinaemia
Condition: Obesity
MeSH terms: Hyperinsulinism
Study type: Observational

Summary: 
      The purpose of the study is to investigate and compare the lipid metabolism in lean and obese
      individuals. We want to investigate the effect of postprandial hyperinsulinaemia on
      VLDL-triglyceride metabolism
    


Intervention name(s): Food (fat free meal)
Intervention type(s): Dietary Supplement
Intervention description(s): Fat free meal (40% of REE)
Sampling method: Non-Probability Sample
Study population: 
        Males with diabetes from departments out-patient clinic. Control group of healthyt
        volunteers
      
Biospecimen description: 
      specimen of muscle specimen of adipose tissue
    
Keywords: VLDL; Kinetics; Hyperinsulinaemia; Obesity