bioihbjkbjnl/mcl2 huggingface dataset:
Mother-to-infant Bonding and Prematurity Are Associated With Sensory Processing at 12 Months of Age
Condition: Preterm; Sensory Disorder; Attachment Disorder
MeSH terms: Sensation Disorders
Study type: Observational

Summary: 
      Establishing a strong bond between mother and infant is crucial for fostering healthy
      relationships in the future. This research sought to investigate the correlation between
      mother-to-infant bonding and sensory processing, as well as the connection between
      prematurity and sensory processing in 12-month-old infants.
    

Detailed description: 
      At the age of four months, mothers will utilize the Mother-Infant Attachment Scale (MIBS) to
      evaluate the bonding between themselves and their infants. Subsequently, at 12 months old,
      the sensory processing abilities of the infants will be assessed using the Test of Sensory
      Functions in Infants (TSFI). The study will encompass both preterm and term-born children.
    

Intervention name(s): Assessment
Intervention type(s): Behavioral
Intervention description(s): Sensory processing skills of children in the preterm and term groups will be evaluated. Additionally, the attachment between mother and baby will be evaluated.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Preterm and term children aged 12 months
Lumbar Disc Space Height in Young Disc Herniation and Degeneration Patients
Condition: Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Low Back Pain
MeSH terms: Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Low Back Pain
Study type: Observational

Summary: 
      As low back pain (LBP) imposes a heavy socioeconomic burden, early detection of pathologic
      intervertebral disc change in young adults holds high clinical relevance as a common
      structural cause of LBP. The investigators therefore assessed the feasibility of using X-ray
      disc space height measurements as a predictive evaluation method of lumbar disc herniation
      (LDH) and degeneration in LBP patients in their early 20s.
    


Intervention name(s): x-ray, MRI
Intervention type(s): Radiation
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients visiting Jaseng hospital of Korean Medicine, a spine specializing Korean medicine
        hospital designated by the Korean ministry of health and welfare, from January, 2010 to
        October 2014
      
Keywords: X-Rays; Magnetic Resonance Imaging; Sensitivity and Specificity
A Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-54416076 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of
      JNJ-54416076 and any associated metabolite(s) (in Part 1) and safety, tolerability and PK of
      JNJ-54416076 when co administered with food compared to administration in fasting condition
      (in Part 2).
    

Detailed description: 
      This is a Phase 1, single-center, first-in-human study consists of 2 parts : a) Single
      Ascending Dose part and b) PK-Food Effect part. Part 1 is a randomized (the study medication
      is assigned by chance), double-blind (neither the Investigator nor the participant know the
      treatment), sequential cohort, single ascending oral dose study. Part 1 will assess the
      safety, tolerability, and PK of single ascending doses of JNJ-54416076 in healthy male
      participants. It will consist of 8 cohorts of 8 healthy participants. Within each cohort, 6
      participants will be randomly assigned to JNJ-54416076 treatment, and 2 participants will be
      randomly assigned to placebo treatment. The total study duration for each participant in Part
      1 will be up to approximately 5 weeks. Part 2 is a randomized, open-label (all people know
      the identity of the intervention), 2-period crossover study. Part 2 will assess the effect of
      food on the pharmacokinetics of JNJ-54416076. Each participant in Part 2 will receive 2 doses
      of JNJ-54416076 (one dose in the fasted state and an identical dose in the fed state). The
      dose selected for Part 2 will be selected based on the preliminary safety and PK data in Part
      1. The total study duration for each participant in Part 2 will be up to approximately 7
      weeks. Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-54416076; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-54416076 suspension will be administered orally.; Placebo solution will be administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ-54416076; Ascending Dose
Better Asthma Outcomes: Lowering Tobacco Smoke Exposure
Condition: Lung Diseases; Asthma
MeSH terms: Asthma; Lung Diseases
Study type: Interventional

Summary: 
      To improve disease outcomes through reduction in secondhand tobacco smoke exposure of
      children with asthma
    

Detailed description: 
      BACKGROUND:

      Secondhand tobacco smoke (SHS) exposure increases asthma morbidity in children. Efforts to
      reduce exposure have had mixed results. This study is a randomized controlled trial of an
      exposure reduction intervention, with objective feedback to parents on the child's exposure
      based on urine cotinine measurement, and counseling tailored to the child's specific exposure
      sources/locations and parental readiness to take specific actions to reduce exposure from
      each source/location. This trial involves 350 SHS-exposed children with persistent asthma,
      3-12 years of age, receiving care from the Kaiser Health Care Program in Northern California.
      Primary outcomes over the 18 months of follow-up will be asthma acute care utilization and
      urine cotinine/creatine ratio. Changes in controller medication adherence will be evaluated
      using a pharmacy-based dispensing index.

      DESIGN NARRATIVE:

      Primary objective: To evaluate the efficacy of a behaviorally-based,
      cotinine-feedback-and-monitoring program designed to reduce SHS exposure in an 18-month
      randomized controlled trial (RCT) with 350 children with persistent asthma, 3-12 years of
      age, in comparison with usual medical care.

      Secondary objectives: 1) to investigate the behavioral mechanisms that mediate between the
      intervention and associated improvements in asthma outcomes, and 2) to determine the
      influence of initial caregiver stage of change with regard to smoking practices on response
      to the intervention.

      Hypotheses:

        1. Disease outcomes: A behaviorally-based, individually-tailored intervention that
           emphasizes SHS exposure reduction, provides sequential feedback to the parent on the
           child's urine cotinine level, and is tailored to the parent's stage of change with
           regard to smoking practices will be associated with decreased asthma crisis care
           utilization and improvements in secondary disease outcomes over an 18-month follow-up
           period when compared with usual medical care.

        2. ETS exposure: The SHS reduction intervention will be associated with lower SHS exposure
           at follow-up (assessed by urine cotinine/creatinine ratio), compared with usual medical
           care.

        3. Mechanism: Decreases in urine cotinine/creatinine ratio will be instrumental in
           intervention-associated improvements in asthma crisis care utilization.
    

Intervention name(s): SHS reduction intervention based on social cognitive learning theory
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment
Implementation and Evaluation of Care Coordination in Linkage to Care for Hepatitis C Following Release From New York City Jails
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      This study assesses the impact of a hepatitis C care coordination program on rates of linkage
      to hepatitis C care following release from New York City jails. Adult patients (age 18 years
      and above) with chronic Hepatitis C infection at Bellevue Hospital Center 19 North prison
      clinic from July 1, 2015 through December 31, 2016 will be offered participation in a
      transitional care coordination program. The rates of linkage of these individuals following
      release from jail will be compared to a historical cohort of adult patients with chronic
      Hepatitis C infection at the 19 North prison clinic from January 1, 2014 through June 31,
      2015.
    


Intervention name(s): Research transitional care coordination
Intervention type(s): Behavioral
Intervention description(s): Though care coordination was offered to all HCV positive inmates who are approached,the care coordination will still constitute a research intervention that requires informed consent, rather than a new uniform standard of care, to allow maximum autonomy for this incarcerated population.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males and gender self-identified females age 18 or over with HCV infection seen in
        Bellevue's 19N prison Infectious Diseases clinic.
Diurnal Variation in Rectal Diameter
Condition: Constipation
MeSH terms: Constipation
Study type: Observational

Summary: 
      The purpose of the study is to determine the diurnal variation of rectal diameter in healthy
      and constipated children using transabdominal ultrasound.
    


Intervention name(s): Transabdominal ultrasound
Intervention type(s): Procedure
Intervention description(s): Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Constipated children are recruited from the outpatient clinic at Kolding pediatric
        department. A list of patients which have been given the diagnose constipation are drawn
        from the computer and reviewed. Children between 4-12 years who fulfill the Rome III
        criteria of constipation and have been taking PEG maintenance treatment at least 1 month,
        are contacted by telephone for possible participation in the study.

        Healthy participants without constipation or other diseases affecting the gastrointestinal
        tract were recruited among the employees of the Department of Pediatrics at Kolding
        Hospital.

        Written informed consent was obtained from both parents before any procedures were
        initiated.
      
Keywords: constipation; children; healthy; rectal diameter
AMG 151 Amgen Protocol Number 20100761
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel
      group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated
      with metformin for at least 3 months prior to randomization.
    


Intervention name(s): AMG 151; Placebo; Metformin; AMG 151; AMG 151; AMG 151; AMG 151; AMG 151
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug: AMG 151 50 mg BID; Placebo; Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.; Drug: AMG 151 100 mg BID; Drug: AMG 151 200 mg BID; Drug: AMG 151 100 mg QD; Drug: AMG 151 200 mg QD; Drug: AMG 151 400 mg QD
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; mellitus; metformin
Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis
Condition: Allergy
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms
      and rescue medication usage
    


Intervention name(s): 100 IR grass pollen allergen extract tablet; 300 IR grass pollen allergen extract tablet; 500 IR grass pollen allergen extract tablet; Placebo tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One sublingual tablet daily during 4 months before pollen season and during pollen season; One sublingual tablet daily during 4 months before pollen season and during pollen season; One sublingual tablet daily during 4 months before pollen season and during pollen season; One sublingual tablet daily during 4 months before pollen season and during pollen season
Other intervention name(s): Sublingual immunotherapy tablet; Sublingual immunotherapy tablet; Sublingual immunotherapy tablet; Sublingual placebo tablet
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sublingual immunotherapy; Grass pollen tablet; Allergic rhinoconjunctivitis
Setmelanotide in a Single Patient With Partial Lipodystrophy
Condition: Hypertriglyceridemia; Obesity
MeSH terms: Lipodystrophy; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this single patient study is to assess the safety and efficacy of
      setmelanotide as a treatment of severe metabolic abnormalities resulting from LD, especially
      refractory hypertriglyceridemia leading to recurrent bouts of pancreatitis.
    

Detailed description: 
      This is a single-patient study to assess the safety and efficacy of setmelanotide in a unique
      patient with partial LD and severe metabolic abnormalities, most notably refractory
      hypertriglyceridemia leading to recurrent pancreatitis despite ongoing plasmapheresis
      treatment.
    

Intervention name(s): Setmelanotide
Intervention type(s): Drug
Intervention description(s): daily subcutaneous injection
Other intervention name(s): RM-493
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor in Paediatric Patients With Sickle Cell Disease
Condition: Investigation of Platelet Aggregation in Paediatric Patients With Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase II dose-ranging study is to investigate pharmacokinetic (PK) and
      pharmacodynamic (PD) properties of various doses of ticagrelor followed by 4 weeks of
      twice-daily treatment in paediatric patients with sickle cell disease
    

Detailed description: 
      This is a multicenter, open-label, dose-ranging study of ticagrelor followed by a double
      blind, placebo-controlled extension phase in paediatric patients with sickle cell disease
      (SCD).

      Part A: Patients will be randomised 1:1 to receive one of two dosing schedules consisting of
      two single weight-adjusted doses of ticagrelor. Pharmacokinetic (PK) parameters and
      pharmacodynamic (PD) measurements will be determined following each dose. Platelet
      aggregation will be measured using the VerifyNow™ P2Y12 assay.

      Following these 2 single doses, all patients will receive open-label one-week treatment with
      ticagrelor twice daily to determine tolerability prior to randomisation into Part B.

      Part B: In this part patients will be randomised (2:1 ratio) to ticagrelor twice daily or
      placebo for a 4-week treatment phase.

      During the study, patients will be followed for the occurrence of vaso-occlusive crisis (VOC)
      and for other disease manifestations such as daily pain, analgesic use and complications of
      SCD.
    

Intervention name(s): Ticagrelor Dose 1a + Dose 2a; Ticagrelor Dose 1b + Dose 2b
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor Dose 1a and ticagrelor Dose 2a single doses + 1 week ticagrelor repeated dosing followed by 4 weeks repeated dosing ticagrelor or placebo.; Ticagrelor Dose 1b and ticagrelor Dose 2b single doses + 1 week ticagrelor repeted dosing followed by 4 weeks repeated dosing ticagrelor or placebo.
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: sickle cell anemia; paediatric
APG-1387 Study of Safety, Tolerability ,PK/PD in Patients With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Multiple Ascending Dose study to Explore the Tolerability, Safety and
      Pharmacokinetics/Pharmacodynamics of APG-1387 in Chronic Hepatitis B Patients.
    

Detailed description: 
      APG-1387 is a potent, bivalent small-molecule IAP antagonist. This study is multi-center,
      single-agent, open-label, Phase I dose-escalation study of APG-1387.

      This study has a 4-dose-schedule which is escalated one by one after confirming safety in the
      previous lower dose schedule. A total of 60 subjects with Chronic Hepatitis B will be
      participated in the study. APG-1387 will be administrated via intravenous infusion, once a
      week for consecutive 4 weeks as one cycle.The start dose is 7mg. 3 patients' cohorts will be
      evaluated, the dose of APG-1387 will be increased in subsequent cohorts, to 12mg, 20 mg, 30
      mg, 45 mg accordingly. 3 patients in 7mg,12mg cohorts and 6 patients in 20mg, 30mg and 45mg
      cohorts will be recruited. If there is any one of the following event is observed within 28
      days of the first dose of APG-1387, the recruitment will be hold and a discussion on MTD dose
      level will happened.1 ≥1/2 patients experience ≥Grade 2 toxicities[CTCAE 4.0.3] related or
      possibly related with APG-1387 and with clinical manifestation. 2 ≥1/3 patients experience
      ≥Grade 3 toxicities[CTCAE 4.0.3] related or possibly related with APG-1387.3 any SAE related
      or possibly related with APG-1387. Expansion study will be designed to explore primary
      efficacy and safety after the dose escalation study. The expansion number and dosage will be
      decided according to the results of each cohort.(no more than 36 patients).
    

Intervention name(s): APG-1387 for Injection
Intervention type(s): Drug
Intervention description(s): Multiple dose cohorts, 30 minute IV infusion, once weekly for 4 weeks .
Intervention model: Single Group Assignment
Intervention model description: dose escalation study
Masking: None (Open Label)
Primary purpose: Treatment
An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of GSK2269557 administered in addition
      to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic
      Obstructive Pulmonary Disease (COPD). Additionally study will also assess safety,
      tolerability and pharmacokinetic data. The total duration of the study will be 13-14 weeks
      including screening, treatment period and a follow up visit. Subjects will receive once daily
      study treatment administration starting on Day 1. Study is planned to recruit approximately
      120 subjects such that approximately 100 subjects complete the study.
    


Intervention name(s): GSK2269557; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dry powder for inhalation via DISKUS 'device' with unit dose strength of 500 micrograms (mcg) per actuation with total dose of 1000 mcg daily; Dry powder for inhalation via DISKUS 'device'
Intervention MeSH terms: Nemiralisib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: functional respiratory capacity; High-resolution computed tomography; GSK2269557; acute exacerbation of COPD; lung capacity
Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy
Condition: Melanoma (Skin); Melanoma Stage IV; Melanoma, Uveal; Melanoma, Mucosal
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The study hypothesis is that new imaging agents [203Pb]VMT01 and [68Ga]VMT02 can be safely
      used in humans without independent biological effect and can be used to image melanoma tumors
      expressing the melanocortin sub-type 1 receptor (MC1R) by SPECT/CT and PET/CT imaging
      modalities respectively.
    

Detailed description: 
      This is a first-in-human study evaluating the suitability of [203Pb]VMT01 for SPECT/CT
      imaging and [68Ga]VMT02 for PET/CT imaging of MC1R-expressing metastatic melanoma. Study
      results will provide foundational data to develop imaging and dosing for future therapeutic
      trials of [212Pb]VMT01 for the treatment of metastatic melanoma.

      The study will be a cross-over study with the participants serving as their own comparator.
      Participants with positive FDG-PET scans for stage IV (or inoperable stage III) metastatic
      melanoma will undergo SPECT/CT scans utilizing [203Pb]VMT01 followed a few weeks later by
      PET/CT scans utilizing [68Ga]VMT02, or vice versa. The order of the imaging agents will be
      randomly assigned.
    

Intervention name(s): [203Pb]VMT01; [68Ga]VMT02
Intervention type(s): Drug; Drug
Intervention description(s): Diagnostic imaging radiopharmaceutical; by intravenous infusion; Diagnostic imaging radiopharmaceutical; by intravenous infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Melanoma; Theranostic; Radiopharmaceutical; Radiotherapy; Alpha-Particle; Diagnostic; Metastatic; Single Photon Emission Computed Tomography (SPECT); Positron Emission Tomography (PET); Melanocortin Receptor Sub-type 1 (MC1R); VMT01; VMT02; Pb-203; Ga-68; Cancer; Immunohistochemistry (IHC)