bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects
Condition: Bioequivalance
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the bioequivalence, pharmacokinetic (PK) profile, and safety and
      tolerability of Iron Sucrose (Test Product) relative to that of Venofer® in healthy subjects.
    


Intervention name(s): Iron Sucrose Injection; Venofer Injection
Intervention type(s): Drug; Drug
Intervention description(s): USP 100 mg/5 mL (20 mg/mL), solution for IV injection, 100 mg unit dose strength; (Iron Sucrose 20 mg/mL), solution for IV injection, 100 mg unit dose strength
Intervention MeSH terms: Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Measurement of Body Fat in Infants
Condition: Brown Adipose Tissue; Body Composition
Study type: Observational

Summary: 
      Up to 10 infants will complete the study aimed to establish a technique for measuring whole
      body adiposity and brown adipose tissue in infant subjects using dual energy x-ray
      absorptiometry and magnetic resonance imaging, respectively.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Up to 10 healthy, full term infants aged 14 to 28 days old at enrollment with no
        contraindications to MRI will be recruited to Pennington Biomedical Research Center to
        participate in this study which includes two study visits to be completed within 1-10 days
        apart.
      
Keywords: neonates; brown adipose tissue; body composition
Evaluation of QTc Interval by Continuous Holter ECG Recording in Antipsychotic Drug-treated Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the utility of continuous Holter ECG recording with
      automated, computerized data analysis for measuring antipsychotic-related QTc prolongation
      during a 24-h period under clinical conditions
    


Intervention name(s): Holter Monitor
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Measurement of HTL0016878 in Cerebrospinal Fluid
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, open-label, randomised, single oral dose study to determine the concentration of
      HTL0016878 in CSF and plasma in healthy male subjects following dosing with HTL0016878 10 mg
      or 20 mg oral solution
    

Detailed description: 
      Up to 24 healthy subjects will be enrolled into 4 groups, with 6 subjects per group. Each
      subject will be randomised to receive a single oral dose of 10 mg or 20 mg HTL0016878
      solution and will have a single CSF sample taken via lumbar puncture at either 2 or 6 hours
      post-dose. Pharmacokinetic blood sampling and safety measures will continue until 24 hours
      post-dose.
    

Intervention name(s): HTL0016878
Intervention type(s): Drug
Intervention description(s): Oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebrospinal Fluid
A Study to Evaluate the Immunogenicity of Quadrivalent LAIV (MEDI8662) in Adults 18 to 49 Years of Age
Condition: Healthy or Stable Underlying Chronic Medical Condition
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to show that quadrivalent live attenuated influenza vaccine
      (Q/LAIV-BFS; MEDI8662) was at least as immunogenic as two different forms of the commercial
      vaccine, FluMist, by comparing the strain-specific antibody levels in the blood.
    

Detailed description: 
      The primary objective of this study was to determine the immunologic noninferiority of
      MEDI8662, a quadrivalent live attenuated influenza vaccine (Q/LAIV) (delivered intranasally
      using the blow-fill-seal [BFS] delivery system) (Q/LAIV-BFS) to two trivalent formulations of
      licensed FluMist (delivered intranasally using the Becton Dickinson [BD] Accuspray™ device)
      by comparing the strain-specific geometric mean titers (GMTs) post dosing.
    

Intervention name(s): Q/LAIV-BFS (MEDI8662); FluMist/B/Yamagata; FluMist/B/Victoria
Intervention type(s): Biological; Biological; Biological
Intervention description(s): A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0.; FluMist/B/Yamagata - 0.2 mL dose at Day 0; FluMist/B/Victoria - 0.2 mL dose at Day 0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients
Condition: Hemiplegia; Stroke
MeSH terms: Stroke; Hemiplegia
Study type: Interventional

Summary: 
      Gait impairment remain one of the main problem for hemiplegic stroke patients. After the 6
      first months, stroke patients are classically described with moderate or no improvement.
      Here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular
      strengthening program with conventional physiotherapy delivered by the local physiotherapist
      of the patient, in a very ecological way.
    

Detailed description: 
      Gait impairment remain one of the main problem for most of chronic hemiplegic stroke
      patients. After the 6 first months, stroke patients are classically described with moderate
      or no improvement for motor skills. However, physiothertapy is very often delivered to try to
      increase motor performance. Here, we want to compare the effectiveness of a flexor and
      extensor paretic knee muscular strengthening program with conventional physiotherapy
      delivered by the local physiotherapist of the patient, in a very ecological way. Patients
      will be randomly affected to one group with the same amount of physiotherapy (at least 3
      times weekly for 6 weeks). Assessment will be done blindly by another physiotherapist,
      before, after the 6-week treatment and 6 weeks later to evaluate immediate and remaining
      benefits of each treatment.
    

Intervention name(s): Muscular Strengthening for paretic knee flexor and extensor; conventional physiotherapy
Intervention type(s): Procedure; Other
Intervention description(s): thrice a week during 6 weeks; trice a week during 6 weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; hemiplegia; gait; Strengthening; Physiotherapy
Sequencing T-cells in Type I Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this study is to investigate CD8 + T-cell receptor (TCR) repertoire
      differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy
      controls.
    

Detailed description: 
      Using a systems biology approach by combining high-throughput sequencing, cytometry, gene
      expression, transcriptome profiling, HLA typing, single cell analysis, and TCR affinity
      assays, the investigators will define a set of immune metrics for the prediction or early
      diagnosis of disease that is superior to the current examination of auto-antibodies, which is
      a fairly late stage in the disease development. This can also be used to guide therapy in
      advanced disease.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Endocrinology clinic patients currently receiving treatment for Type II Diabetes
      
Biospecimen description: 
      Whole blood
Mindfulness, Yoga, and Cardiovascular Disease
Condition: Cardiovascular Disease; Stress; Anxiety; Depression
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      In this study, we will conduct a preliminary, yet comprehensive evaluation of Mindfulness and
      Yoga, as compared to an exercise and education-based stress-reduction program. and
      simultaneous evaluation of the effect of an 8 week program of Mindfulness, 12 weeks of Yoga
      practice, and 12 weeks of an exercise and education-based program.

      105 otherwise healthy individuals, who have cardiovascular risk factors and mild to moderate
      stress or anxiety will be randomly assigned to one of the three intervention groups: an 8
      week program of Mindfulness, 12 week program of Yoga practice, and 12 week exercise and
      education-based group program. All subjects will perform daily practice that will continue
      after the weekly sessions end, allowing a follow up assessment at 24 weeks. Self-reported
      mood and psychological distress and physiological indicators of function of the ANS and
      stress hormones will be assessed at baseline, 8 weeks, 12 weeks and 24 weeks. Blood and urine
      samples will be collected at baseline and 8 weeks to determine levels inflammatory and
      atherosclerosis markers.

      We anticipate that the study will provide information on the efficacy of the Mindfulness and
      Yoga interventions as stress-reduction practices, variability in potential markers for
      activation of the brain/cardiovascular system connections, and preliminary estimates of
      effect size for each of these markers. Thus, the study will provide the data needed for
      designing a future study that will rigorously address these questions in a larger, randomized
      trial of Mindfulness and Yoga in patients with cardiovascular risk.
    


Intervention name(s): Mindfulness Meditation; Yoga; Exercise, Relaxation, and Health Education
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.; The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises.; The Exercise, Relaxation and Health Education program will consist of a 90 min group session that will include simple relaxation (such as progressive muscle relaxation) and light stretching exercises, group support, and discussions of various health topics and on stress reduction.
Other intervention name(s): MBSR; Progressive muscle relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mindfulness; Meditation; Yoga; Inflammatory Markers
A Study of the Cardiac Effects of ALXN1840 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of a supratherapeutic dose of ALXN1840 on the heart rate
      (HR)-corrected QT interval (QTc) in healthy adult participants. Moxifloxacin will be used as
      the active control.
    

Detailed description: 
      This is a randomized, 3-treatment, 3-period, 6-sequence, crossover, placebo- and
      active-controlled, double-blind for ALXN1840, open-label for moxifloxacin, in healthy adult
      participants. Participants will be domiciled in the clinic for 7 days during Treatment Period
      1 and for 6 days during Treatment Period 2 and 3. A single oral dose of each treatment
      (ALXN1840, matching ALXN1840 placebo, or moxifloxacin) will be administered on Day 1 of each
      period following an overnight fast of at least 10 hours. There will be a minimum 14-day
      washout between study intervention administrations for each treatment period. Cardiodynamic,
      pharmacokinetic, and safety assessments will be performed at certain times during the study.
      An end-of-study visit will occur 14 days (±2 days) after the last dose.
    

Intervention name(s): ALXN1840; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ALXN1840 (120 milligrams) will be administered orally (supratherapeutic dose).; Placebo will be administered orally.; Moxifloxacin (400 milligrams) will be administered orally.
Other intervention name(s): WTX101; Bis-choline tetrathiomolybdate; Tiomolibdate choline; Placebo-matching ALXN1840
Intervention MeSH terms: Moxifloxacin; Tetrathiomolybdate; Choline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a 3-treatment, 3-period, 6-sequence, crossover study in healthy adults.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Electrocardiogram; Cardiac Repolarization; ALXN1840; Optimized QT Correction; QT Interval Correction; Thorough QT; QT Correction by Fridericia; Individual QT Correction; Wilson Disease
Pediatric Open-Label Extension Study
Condition: Schizophrenia; Autism; Bipolar Depression
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, 104-week, multicenter, extension study designed to evaluate the
      long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or
      80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the
      preceding studies, D1050301, D1050325, and D1050326
    


Intervention name(s): Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Intervention type(s): Drug
Intervention description(s): Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed
Other intervention name(s): Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Autism; Lurasidone; Latuda
Esomeprazole (NEXIUM) vs. Surgery
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      The study investigates the efficacy of long-term treatment of esomeprazole compared to
      anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to
      treatment failure.
    


Intervention name(s): esomeprazole; Laparoscopic fundoplication (surgery)
Intervention type(s): Drug; Procedure
Intervention description(s): 40 mg oral tablet administered daily; Surgery
Other intervention name(s): Nexium®
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acid reflux disease; Gastroesophageal Reflux Disease
CE-US in Renal Transplantation
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      Acute allograft dysfunction is often observed in the first weeks after kidney
      transplantation. Renal biopsy is universally considered the gold standard procedure for
      differential diagnosis of acute allograft dysfunction secondary to intraparenchymal causes.
      Kidney biopsy, however, is an invasive procedure that is time and cost consuming. Moreover,
      it may but not contribute to clinical diagnosis in about 10% of cases because of the
      impossibility to perform the analysis or of inadequacy of the biopsy sample. Availability or
      readily applicable non-invasive procedures might therefore allow increasing the performance
      of differential diagnosis of allograft dysfunction. In the recent years, a novel US imaging
      technique, namely contrast-enhanced ultrasound (CE-US),has been developed. The agent used in
      this study, Sonovue microbubbles consist of a central sulphur hexafluoride core with a
      surrounding phospholipid monolayer and last for several minutes in the systemic circulation
      before spontaneous degradation with absorption of the gaseous component by the lungs and the
      phospholipid shell by the liver. With the use of gasfilled microbubbles that act as
      scatterers within the blood stream and the development of low-MI ultrasound techniques that
      allow the visualization of the bubbles without destroying them, it is possible to improve the
      depiction of vessels and have access to structural and functional information on the
      microcirculation. Moreover SonoVue microbubbles are not nephrotoxic and can be safely used to
      evaluate kidney disfunction.

      Thus, whether a. different patterns of parenchymal perfusion detected by CE-US can be
      associated with different patterns of renal graft involvement during acute renal function
      deterioration and b. whether, conversely, different patterns of parenchymal perfusion
      detected by CE-US may help predicting different patterns of renal involvement will be
      investigated in 20 deceased or living donor kidney graft recipients.
    


Intervention name(s): Contrast-enhanced ultrasound (CE-US); SonoVue
Intervention type(s): Procedure; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Renal Transplant; Contrast-enhanced ultrasound; Acute allograft rejection
Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether extended-release oxymorphone hydrochloride
      taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts
      cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB)
      tests, to a greater extent than when taking under conditions of fasting.
    

Detailed description: 
      Oxymorphone 40 mg ER affects cognitive performance similarly within 3 hours post dose,
      whether given on an empty stomach or after a high-fat meal, suggesting that the altered
      pharmacokinetics, fed versus fasting and as described above, is not relevant for the
      medication's impact on cognition. Hence, the direction for oxymorphone ER to be dosed at
      least 1 hour before or 2 hours after eating, at least from a cognitive perspective, may be
      without merit.
    

Intervention name(s): Oxymorphone ER
Intervention type(s): Drug
Intervention description(s): 40 mg qd twice
Other intervention name(s): Opana ER
Intervention MeSH terms: Oxymorphone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid tolerant; chronic pain
Quality of Life in Postmenopausal Women Who Are Receiving Either Exemestane or Anastrozole With or Without Celecoxib for Stage I, Stage II, or Stage IIIA Primary Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Quality-of-life assessment in postmenopausal women who are receiving hormone
      therapy for breast cancer may help to determine the effects of treatment on these patients
      and may improve the quality of life for future breast cancer patients.

      PURPOSE: This clinical trial is studying quality of life of postmenopausal women who are
      receiving either exemestane or anastrozole with or without celecoxib for stage I, stage II,
      or stage IIIA primary breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare treatment-related symptoms using the Functional Assessment of Cancer
           Therapy-Endocrine Symptoms (FACT-ES) questionnaire in postmenopausal women with
           receptor-positive stage I, II, or IIIA primary breast cancer undergoing treatment with
           exemestane vs anastrozole with or without celecoxib on protocol CAN-NCIC-MA27.

      Secondary

        -  Compare health-related quality of life using the FACT-ES questionnaire in patients
           treated with these regimens.

        -  Determine the extent to which differences in treatment-emergent symptoms affect overall
           quality of life in patients treated with these regimens.

      OUTLINE: This is a multicenter, companion study. Patients receive treatment on CAN-NCIC-MA27.

      Health-related quality of life and treatment-related symptoms are assessed using the
      Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire at
      baseline and at 3, 6, 12, and 24 months.

      PROJECTED ACCRUAL: A total of 1,253 patients will be accrued for this study.
    

Intervention name(s): quality-of-life assessment
Intervention type(s): Procedure
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, double-blind, placebo-controlled, single and multiple
      dose escalation phase 1 study. The objective of this study is to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in
      healthy subjects
    


Intervention name(s): SHR-1819; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SHR-1819 will be subcutaneously administered with different dose levels;; Placebo will be subcutaneously administered with different dose levels;
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Safety and Immunogenicity of Fluzone® in Healthy Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To describe the safety of the 2004-2005 pediatric formulation of the inactivated,
      split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with
      the Package Insert, in children aged ≥ 6 months to < 36 months.

      To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine
      Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in
      children aged ≥ 6 months to < 36 months
    

Detailed description: 
      To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from
      healthy children receiving the 2004-2005 formulation of the inactivated, split-virion
      influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA),
      Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).
    

Intervention name(s): Influenza Vaccine 2004-2005 Paediatric Formulation; Influenza Vaccine 2004-2005 Paediatric Formulation
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL (Day 0 and Day 28), Intramuscular; 0.25 mL (Day 0 and Day 28), Intramuscular
Other intervention name(s): Fluzone®; Fluzone®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Fluzone® vaccine; Infants; Toddlers