bioihbjkbjnl/mcl2 huggingface dataset:
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the relative bioavailability of ALXN1840 administered orally as a single
      enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment
      B).
    


Intervention name(s): ALXN1840
Intervention type(s): Drug
Intervention description(s): Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period.
Other intervention name(s): Bis-choline Tetrathiomolybdate; Tiomolibdic Acid; WTX101 (formerly)
Intervention MeSH terms: Tetrathiomolybdate; Choline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ALXN1840; Enteric-coated tablet; Pharmacokinetics; Pharmacodynamics; Healthy
Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3)
Condition: Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator
      controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers.
      The study will compare platelet function following a prasugrel loading dose and 1 week of
      prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose
      clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who
      have coronary artery disease. Various assays of platelet function will be used in this study.
      Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12,
      Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein
      (VASP), and Thromboelastography (TEG)-platelet mapping.
    


Intervention name(s): prasugrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Oral prasugrel 60-mg loading dose, followed by 6-9 days of oral prasugrel 10-mg/day tablet maintenance dose.; Oral clopidogrel 600-mg loading dose, followed by 6-9 days of oral clopidogrel 150-mg/day tablet maintenance dose.
Other intervention name(s): LY640315; Effient; Efient
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics
      of midazolam in healthy male and female subjects.
    


Intervention name(s): Telotristat etiprate; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will receive two 250 mg telotristat etiprate tablets three times daily.; All subjects will receive 3 mg (1.5 mL oral syrup [2mg/mL]).
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Intravenous Fentanyl Prior the End of Surgery on Emergence Agitation in Paediatric Patients After General Anesthesia
Condition: Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      The propose of this study is to determine the effect of intravenous fentanyl prior the end of
      surgery on the incidence and severity of EA in pediatric patient.
    

Detailed description: 
      Emergence agitation (EA) is a common self limiting problem after emerging from general
      anesthesia (GA) especially in pediatric patients. The incidence of EA in Thai population, the
      incidences of EA 43.2% in pediatric patients aged between 2-9 years. There have been many
      studies tried to reduce the incidence of EA in various ways such as Preoperative anxiety
      reduction method and medication. Premedication, Sedative drugs and narcotic drugs were used
      to reduce the incidence of EA.
    

Intervention name(s): fentanyl; NSS
Intervention type(s): Drug; Drug
Intervention description(s): In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.; Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: emergence agitation; pediatric patient; fentanyl; incidence of emergence agitation; severity of emergence agitation; adverse outcome from intervention
Brain Imaging Technology to Examine the Effects of Meditation
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to use brain imaging technology to identify the parts of the
      brain that are activated during meditation and to compare these parts to those activated
      during other activities. This study will also determine the effects of meditation on
      involuntary functions, such as breathing.
    

Detailed description: 
      Meditation and relaxation-based interventions are becoming more widely accepted in clinical
      settings because of their low cost, low risk, and proven effectiveness as a complementary
      intervention in a wide range of diseases. Despite the success and growing use of
      relaxation-based treatments, few studies have addressed the basic mechanism by which these
      treatments work. This study will use functional magnetic resonance imaging (fMRI) to define
      the brain mechanisms underlying the meditative state, to differentiate this state from other
      states, and to determine how meditation-induced brain changes affect autonomic function.

      Participants in this study will have an fMRI brain scan. Brain activity, breathing rate, and
      heart rate will be measured while the participant engages in three different activities:
      lying quietly, meditating, and mentally generating numbers.
    

Intervention name(s): Meditation; Functional Magnetic Resonance Imaging
Intervention type(s): Behavioral; Procedure
Observational model: Defined Population
Time perspective: Other
Keywords: Meditation; Relaxation
A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis
Condition: Chronic Erosive Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic
      erosive gastritis and its therapeutic mechanism
    


Intervention name(s): Teprenone capsule and placebo of sucralfate; Sucralfate and placebo of teprenone
Intervention type(s): Drug; Drug
Intervention description(s): Teprenone 1 capsule (50mg)+placebo of sucralfate 4tab, tid×8 weeks.; Placebo of teprenone 1 capsule+ sucralfate 4 tab(1.0), tid×8 weeks
Intervention MeSH terms: Geranylgeranylacetone; Sucralfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Erosive Gastritis; Teprenone; Sucralfate
Bone Density in Patients With Schizophrenia
Condition: Schizophrenia; Alcohol Abuse
MeSH terms: Alcoholism; Schizophrenia
Study type: Observational

Summary: 
      People with chronic mental disorder such as schizophrenia and alcohol abuse are high risk
      groups for developing osteoporosis.

      To evaluate the prevalence of bone mineral density in men patients with schizophrenia with
      alcohol abuse, the investigators will compare bone mineral density between patient with
      schizophrenia with and without alcohol abuse.
    

Detailed description: 
      People with schizophrenia has been known as a high risk groups for developing osteoporosis,
      because of lack of exercise, poor nutrition and high rate of smoking. Those with alcohol
      abuse may be higher risk group than one with schizophrenia without alcohol abuse, because
      they frequently have several medical problems such as liver dysfunction, Vitamin D
      deficiency, hyperparathyroidism and those medical condition increase risk for developing
      osteoporosis. Also alcohol itself can increase bone loss too by disturbing bone remodeling
      and enhancing bone fragility. To compare the prevalence of bone mineral density in patients
      with schizophrenia with alcohol abuse to those without alcohol problem, we will investigate
      BMD in large population of Korean patients with those illnesses.
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No Intervention
Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        people with schizophrenia, gaed between 18-80 years, with no endocrine disorder
      
Keywords: Schizophrenia; Alcohol Abuse; Bone Density
A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis
Condition: Erosive Hand Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study to compare the
      safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.
    


Intervention name(s): ABT-981; Placebo for ABT-981
Intervention type(s): Biological; Biological
Intervention description(s): ABT-981 administered by subcutaneous injection; Placebo for ABT-981 administered by subcutaneous injection
Other intervention name(s): lutikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Joint diseases; Musculoskeletal diseases; Rheumatic diseases; Arthritis; Osteoarthritis, Hand
Exploration of Possible Reasons for the Discrepancy Between Expectation and Indication of Subjective Perceived Exertions
Condition: Coronary Disease; Exercise Test; Physical Exertion; Cardiac Rehabilitation; Physical Therapy
MeSH terms: Coronary Disease
Study type: Observational

Summary: 
      The 6-minute walk test is a test of physical performance in physiotherapy with lungs and
      heart patients (Pollentier 2010). However, only 8 and 11% of patients in everyday test
      situations report a score of 7 or higher on a scale of 0-10 for effort (Jehn 2009). This
      study is intended to explore, based on grounded theory, why the majority of patients do not
      assess themselves according to the almost maximum performance.
    


Intervention name(s): Questionnaire, Interview; Focus Group
Intervention type(s): Other; Other
Intervention description(s): During the stay, a study visit is arranged with the patient after the 6-minute walk test has been performed. This consists of filling out the questionnaire and an interview, which lasts about 45-60 minutes. This is carried out by the investigator on at least 5 subjects. After each interview, a list of influencing factors is kept. If new aspects continue to appear in the 5th interview, the interviews are continued (up to a maximum of the 10th subject). If no new aspects appear in the interviews from number 6 onwards, the interviews are discontinued and no further patients are recruited. The conversations are recorded with an audio recording.; The focus group is carried out first in order to identify influencing variables that may be relevant for the interview (duration 60-90 minutes).
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients from the department of cardiology in the rehabilitation centre of Klinik
        Barmelweid AG,
Pharmacokinetics of HLD200 in Children and Adolescents With ADHD
Condition: Attention-Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study was designed to assess the pharmacokinetic effects of a single dose of HLD200
      (methylphenidate hydrochloride) in children and adolescents with ADHD.
    

Detailed description: 
      This study utilized a single-center, open-label, single-treatment, fasted design to examine
      the rate and extent of absorption of evening-administered HLD200 in children (6-12 years) and
      adolescents (13-17 years) with ADHD.

      Following a screening period that included five days washout to allow for clearance of any
      prior ADHD medications, subjects were domiciled in-clinic and administered HLD200
      (B-formulation; 54 mg; oral capsule) at 9 pm under fasted conditions. Subjects were then
      observed for safety and tolerability and a total of 18 blood samples collected during a 48
      hour period (at t=0, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24, 36 and 48 hours
      post-dosing). These samples were then assayed for methylphenidate plasma concentrations and
      this data used for calculation of pharmacokinetic parameters.
    

Intervention name(s): HLD200 (methylphenidate hydrochloride)
Intervention type(s): Drug
Other intervention name(s): JORNAY PM
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open-label, single-treatment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of Renal Failure and Risk Factors in an Unreferred Healthy Population
Condition: Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      Blood sample is taken for measurement of serum creatinine, cystatin C, clone V haemoglobin,
      cholesterol, urine acid, glycemia and CRP.

      The medical file is gathered. There will be searched for an association between renal
      function and cardiovascular risk factors and risk factors by exposition to toxic substantia
      during work.
    


Intervention name(s): Taking blood sample
Intervention type(s): Procedure
Intervention description(s): A blood sample will be taken.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: No specific condition
Trial to Compare Effectiveness of 2 Insecticides in Preventing Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout
      Bioko Island to be sprayed with either a long lasting pyrethroid insecticide, K-Othrine SC
      62.5, or a bendiocarb insecticide, FICAM. Parasite prevalence in children aged 2-14 was
      measured before and after the application of insecticide.
    

Detailed description: 
      In 2013, a new long lasting pyrethroid insecticide, K-Othrine SC 62.5, that has been
      developed by Bayer AG, was used for the IRS program in Bioko Island, Equatorial Guinea, for
      the first time. This change coincided with a marked increase in parasite prevalence in 2-14
      year olds as measured in the Annual Malaria Indicator Survey (14% to 28%, respectively). In
      order to determine whether the change in insecticide caused the increase in prevalence, a
      cluster randomized control trial was designed.

      Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout
      Bioko Island. Clusters were chosen with an attempt to maximize the geographical space between
      clusters (to minimize possible residual effects from insecticides), while ensuring that areas
      with historically higher acceptance rates for Indoor Residual Spraying (IRS) were selected.
      Each cluster had a buffer zone of 300m (or halfway between clusters less than 600m apart).

      A team of 10 local surveyors conducted a baseline survey in each cluster area, measuring
      prevalence through malaria Rapid Diagnostic Test (RDT) positivity, net ownership, spray
      coverage, and hemoglobin levels. Approximately 100 children in each cluster were tested.
      These data were then used for a restricted randomization. Each cluster was then sprayed with
      either deltamethrin or bendiocarb, depending on randomization. The IRS team put equal amount
      of effort into each cluster, as determined by number of sprayers/house/day in an attempt to
      minimize bias.

      An end-line survey was conducted using an ODK Collect application in the same cluster areas.
      Prevalence was measured by RDT, and hemoglobin data was gathered. In addition, the head of
      household was asked about the acceptability to IRS and their willingness to receive the
      insecticide in a future round.
    

Intervention name(s): IRS: bendiocarb; IRS: deltamethrin
Intervention type(s): Other; Other
Intervention description(s): carbamate insecticide; Pyrethroid insecticide
Other intervention name(s): FICAM; K-Othrine SC 62.5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Short-Term Music Training and Auditory Processing in Older Adults
Condition: Music Education
Study type: Interventional

Summary: 
      Most adults experience some degree of hearing loss by age 60. Hearing aids can improve some
      aspects of peripheral hearing but the loss of the ability to clearly perceive speech in noisy
      environments remains to be a significant deficit and often reduces life quality in older
      adults. Long-term music training has been shown to enhance auditory processing and
      specifically benefit speech-in-noise perception. It is not clear however whether short-term
      participation in a musically engaged activity can benefit such abilities in older adults. The
      proposed study aims to investigate whether short-term participation in a weekly community
      choir can improve speech in noise perception and its neural substrates as measured by sensory
      auditory evoked potentials (ERPs) to speech stimuli in older adults with mild to moderate
      subjective hearing loss. Sixty participants, ages 50-65, will be recruited to partake in this
      study and will be randomly assigned to two groups: participants in the experimental group
      will join a weekly remote choir on an on-line platform (Zoom), for ten weeks, directed by a
      professionally trained conductor from USC Department of Choral Music. The group practice will
      be accompanied by individual singing lessons (online or CDs) for home practice. Participants
      in the control group will be provided with weekly remote mindfulness lessons also on an
      on-line platform. All participants will be assessed remotely pre and post intervention, with
      behavioral measures of speech in noise perception and probes assessing emotional well-being
      and life satisfaction. Changes in auditory measures and their neural correlates and overall
      quality of life will be compared between the groups. The findings from this study can provide
      preliminary data to support a larger study on the impact of music engagement in improving the
      lives of older adults.
    


Intervention name(s): Music Training - Choir participation
Intervention type(s): Behavioral
Intervention description(s): Sixty participants, ages 50-65, will be recruited to partake in this study and will be randomly assigned to two groups:
participants in the experimental group will join a weekly on-line choir via Zoom, for ten weeks, directed by a professionally trained conductor from USC Department of Choral Music. The group practice will be accompanied by individual singing lessons (online or CDs) for home practice. Participants in the control group will be provided with weekly remote mindfulness lessons also on an online platform.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Macrophages, Portal Hypertension, and Liver Function During AbbVie Treatment of Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hypertension, Portal; Hypertension
Study type: Observational

Summary: 
      Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of
      chronic viral hepatitis C infection on the macrophage specific activation marker soluble
      CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and
      metabolic liver function determined by the galactose elimination capacity (GEC) test and the
      functional hepatic nitrogen clearance (FHNC).
    


Intervention name(s): Functional Hepatic Nitrogen Clearance (FHNC); Galactose Elimination Capacity (GEC); Liver vein catheterization
Intervention type(s): Procedure; Procedure; Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic hepatitis C patients initiating direct-acting anti-viral therapy.
      
Keywords: Direct acting antiviral treatment; sCD163; Portal hypertension; Metabolic liver function; Cirrhosis
Open-label Safety Study in Adults With ADHD
Condition: Adult Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with
      Attention Deficit Hyperactivity Disorder (ADHD)
    

Detailed description: 
      To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with ADHD
      by the incidence of adverse events (AEs; or serious AEs), AEs (or SAEs) leading to
      discontinuation
    

Intervention name(s): Dasotraline
Intervention type(s): Drug
Intervention description(s): Dasotraline 4 mg, 6 mg, 8 mg, flexibly dosed, once daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the number of circulating EPC is different
      between healthy women and men.
    

Detailed description: 
      Study design: Open pilot study in health volunteers in the Hospital Saint-ANTOINE's Clinical
      Investigation Centre (CIC).

      Recruitment and course of the study: The subjects will be recruited among the CIC's pool of
      healthy volunteers. Volunteer people will then have biological and clinical baseline
      examinations. If they match the inclusion criteria, an appointment will be taken for the
      blood sample intend for the characterization of the EPC and hormonal plasma levels
      evaluation. The participation will not exceed 2 months. Young women will have to come between
      the 9th and the 11th day after the beginning of menses). A total of 150 ml of peripheral
      blood will be collected. The study will last 18 months.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      whole peripheral blood (150 ml)
    
Keywords: endothelial progenitor cells; estrogen; menopause; cardiovascular risk