bioihbjkbjnl/mcl2 huggingface dataset:
Sex Differences in Early Brain Development; Brain Development in Turner Syndrome
Condition: Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Observational

Summary: 
      Relative risk for many psychiatric disorders differs dramatically in males and females.
      Early-onset disorders, such as autism, occur more often in males; other conditions, such as
      schizophrenia, occur at similar rates in males and females, but the sexes differ in
      expression. It has been hypothesized that the prevalence and expression of these disorders is
      related to sex differences in brain development. X-chromosome effects and early exposure to
      gonadal hormones are strong candidates for a causal role. The aims of the research are (1) to
      characterize sex differences in brain development from birth to age 2; (2) to test whether
      brain development is altered in infants with Turner syndrome, a well-defined genetic disorder
      resulting from the partial or complete loss of one of the sex chromosomes. To address aim 1,
      high resolution MRI, including diffusion tensor imaging (DTI), will be used to characterize
      sex differences in brain development from birth to age 2 in a longitudinal cohort of 250
      children. To address aim 2, high resolution MRI, including DTI, will be used to compare brain
      development in 70 infants with Turner syndrome (X monosomy) to matched controls from aim 1.
      The investigators hypothesize that sex differences in gray and white matter development and
      in white matter maturation as assessed by DTI will be present during the first 2 years of
      life and that children with TS will exhibit abnormal gray and white matter development in the
      neonatal period.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Control subjects are recruited from the Prenatal Diagnostic Clinic at UNC-Chapel Hill,
        which performs over 12,000 prenatal ultrasound scans a year. Please note that all pregnant
        women in North Carolina are referred for an ultrasound at gestational age 18 weeks as part
        of routine prenatal care. Subjects with Turner syndrome are identified through the UNC
        Turner Syndrome clinic, through advertisements with relevant local and national support
        groups such as the Turner Syndrome Society, and through genetic counselors and other
        relevant health professionals throughout the United States.
      
Biospecimen description: 
      For participating children with Turner Syndrome, subjects may participate in an optional
      blood draw for DNA extraction and hormone assays.
Strategies to Improve Asthma and Treatment of Asthma in Canadians
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Our study will enroll 644 randomly-selected Canadians who have been diagnosed with asthma by
      a physician within the previous five years. It will be determined what diagnostic tests were
      initially performed to make this diagnosis. Participants will undergo lung function testing
      over 6-8 weeks to determine their respiratory status and to confirm they have asthma.
      Participants may be followed up to one year depending on their test results.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Canadians diagnosed with Asthma and 18 years of age and older.
Salivary Flow Rate and Oral Function
Condition: Food Comminution; Jaw Movements
Study type: Observational

Summary: 
      The purpose of this study was to investigate if salivary flow rate is important to maintain
      adequate oral functions.
    

Detailed description: 
      Hyposalivation may damage oral functions. Therefore, the aim of this study was to evaluate
      whether patients under hyposalivation present damaged mastication and speech. Forty subjects
      composed 2 groups: Control (C) and hyposalivation (H). Masticatory performance (MP) was
      carried out using artificial material and a 10-sieve method. Mandibular movements during
      speech were obtained using a 3D jaw-tracking device. Neither mastication nor speech have been
      impaired by low salivary flow rate.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Forty subjects were selected (20 male and 20 female) among people seeking for dental
        treatment, students and staff of Piracicaba Dental School.Saliva collection was performed
        for all subjects, and indivuduals with normal salivary flow rate composed the control
        group. Hyposalivation group group, otherwise, was composed by subjects taking 0.5-0.7
        mg/kg/day for at least one month prescribed by a dermatologist.
      
Keywords: Saliva; Mastication; Communication
Trazodone in Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to collect preliminary information on the effect of low doses of
      trazodone on pain intensity in patients with painful diabetic neuropathy and to evaluate the
      neuropathic pain symptoms, anxiety, sleep, quality of life, safety and tolerability.
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled, double-dummy, dose finding, parallel
      group, multicentre, international, prospective, pilot study.

      The present study is planned to assess the efficacy and the safety of an 8-week treatment
      period with low doses of trazodone (30 mg daily or 60 mg total daily, respectively)
      administered to patients affected by painful diabetic neuropathy.

      Gabapentin will be administered together with the investigational drug in open label
      conditions in order to assure an effective pharmacological treatment to all patients. A slow
      titration of gabapentin will be applied in this trial in order to control possible side
      effects when co-administered with trazodone.
    

Intervention name(s): Trazodone 20 mg; Trazodone 10 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration of trazodone 20 mg (corresponding to 10 drops of trazodone hydrochloride 6% oral solution), three times a day, for 8 weeks. Trazodone total daily dose: 60 mg.
After the 8-week treatment period, patients will receive trazodone 10 mg (corresponding to 5 drops of trazodone hydrochloride 6% oral solution) three times a day for 1-week tapering period in double blind conditions.; Oral administration of trazodone 10 mg (corresponding to 5 drops of trazodone hydrochloride 6% oral solution), three times a day, for 8 weeks. Trazodone total daily dose: 30 mg.
In order to maintain the study double-blind conditions,patients randomized in this group will be co-administered with placebo oral solution (5 drops).
After the 8-week treatment period, patients will receive placebo oral solution three times a day for 1-week tapering period in double blind conditions.; Oral administration of placebo oral solution (10 drops) three times a day, for 8-week treatment.
After the 8-week treatment period, patients will receive placebo oral solution three times a day for 1-week tapering period in double blind conditions.
Other intervention name(s): Trittico®; Trittico®
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo controlled, double-dummy, dose finding, multicentre, international, prospective, pilot study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Trazodone; Placebo; Gabapentin; Neuropathic pain
The 'Hidden' Biological Impact of Vitamin D Deficiency: a Biomarker Study; Part 2
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators major aims are to: determine the vitamin D status of a group of young,
      apparently healthy adults in Hong Kong; examine inter-relationships between vitamin D status
      and biomarkers of DNA damage and repair, oxidative stress, inflammation and endothelial
      health; and, in part 2 of the study, investigate effects of improvement in vitamin D status
      on these biomarkers and other measures of well-being in those young adults shown to be
      deficient in vitamin D.
    

Detailed description: 
      In this part 2 of the study the investigators will investigate the effect of vitamin D
      supplementation on biomarkers of these 'hidden' changes in apparently healthy young adults.
      The investigators will also explore the effect of improvement in vitamin D status in young
      apparently healthy adults in regard to muscular strength and response time, glucose control,
      a hormone that is linked to vitamin D (parathyroid hormone (PTH) ) and mood.
    

Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): 2400 units per day for 3 months
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Europe. The aim of the trial is to compare two methods of
      injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin
      detemir associated with insulin aspart given twice daily in either separate or mixed
      injections and to investigate if there is any clinical impact in choosing one regimen over
      another.
    


Intervention name(s): insulin detemir; insulin aspart; insulin detemir; insulin aspart
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart; Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir; Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin aspart; Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin detemir
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer
Condition: Thyroid Neoplasms
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The cyclotron production model of Tc-99m pertechnetate (CPERT) has received significant
      validation in the independent expert review conducted by Natural Resources Canada (NRCan) in
      the follow up to the Chalk River crisis. The University of Alberta's Edmonton PET Centre and
      the Edmonton Radiopharmaceutical Centre is a cyclotron / radiopharmacy unit, providing a
      safe, cost effective, unsubsidized, and reliable supply of radiopharmaceuticals to hospitals
      and clinics in Edmonton and northern Alberta. A Phase I study is proposed to show safety of
      CPERT as well as comparability with generator-produced Tc-99m pertechnetate (GPERT) in
      subjects with well differentiated thyroid carcinoma post-thyroidectomy and prior to planned
      I-131 Iodide treatment.
    

Detailed description: 
      Patients who have had a thyroidectomy for cancer routinely have a Tc-99m Pertechnetate
      (GPERT) scan at the Cross Cancer Institute to check for thyroid tissue remnants prior to
      radioactive iodine therapy. The first 10 subjects will receive a CPERT whole body scan, and
      and 20 subsequent case-matched controls (2 for each CPERT subject, matched for age and
      gender) will receive a GPERT whole body scan. CPERT safety will be assessed by pre-injection
      and post-imaging collection of vital signs and blood samples (haematology and biochemistry).
      Adverse event collection will be done for both CPERT and GPERT subjects. The whole body
      biodistribution pattern of CPERT will be qualitatively compared to GPERT by two independent
      and blinded Nuclear Medicine physicians.
    

Intervention name(s): CPERT; GPERT
Intervention type(s): Drug; Drug
Intervention description(s): Single 340 MBq CPERT scan in first 10 subjects; Single 340 MBq GPERT scan in up to 20 case-matched controls
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: 99mTc Pertechnetate; thyroidectomy
Study to Investigate the Pharmacokinetics and Safety of Cadazolid in Patients With Clostridium Difficile Infection
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The study investigated the pharmacokinetics, safety, and tolerability of cadazolid in
      subjects with severe Clostridium difficile diarrhea (CDAD) and whether this influenced the
      quantity of cadazolid absorbed into the systemic circulation.
    


Intervention name(s): Cadazolid
Intervention type(s): Drug
Intervention description(s): Cadazolid was provided as dry powder for oral suspension (Amber glass bottles of 60 mL). The powder was reconstituted with tap water by a pharmacist immediately prior to dispensing to subjects.
Other intervention name(s): ACT-179811
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Cadazolid; ACT-179811; Pharmacokinetics; Safety; Tolerability
A-Mode vs PalmScan Ultrasonography: Biometric Measurements.
Condition: Axial Length (AL); Anterior Chamber Deep (ACD); Lens Thickness (LT)
Study type: Observational

Summary: 
      Ultrasonography has become a critical ancillary test in the clinical practice of
      ophthalmology. It is commonly used as a standardized method for assessing intraocular
      biometry. The PalmScan ultrasonography (PsU) is a portable A-scan device that uses the same
      principles as the standard A-scan. The aim of the study is to compare the reliability of
      their measurements, in order to use them indistinctively.
    


Intervention name(s): PalmScan A2000 ultrasonography system (Micro Medical Devices, Calabasas, CA); Standard A-mode ultrasound (Eye Cubed™, Ellex, Adelaide, Australia).
Intervention type(s): Device; Device
Intervention description(s): PalmScan biometric measurements; A-mode biometric measurements group
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients who need axial length calculation.
Brown Adipose Tissue Activity and Age
Condition: Obesity; Ageing
MeSH terms: Obesity
Study type: Observational

Summary: 
      In this study the investigators aim to investigate whether the sympathetic stimulation of
      BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed
      tomography computed tomography scan, differs between young and elderly subjects, as an
      explanation for the diminished metabolic brown adipose tissue activity in the elderly.

      The investigators hypothesis is that sympathetic nervous system activity in the elderly is
      diminished as compared to their younger counterparts as an explanation for the diminished
      metabolic brown adipose tissue activity in the elderly.
    

Detailed description: 
      The sympathetic nervous system is the primary activator of Brown Adipose Tissue.

      Elderly are known to have less metabolically active brown adipose tissue as compared to their
      younger counterparts.

      The reason for this diminished metabolic brown adipose tissue activity is unknown.

      However, a lower sympathetic nervous system activation to brown adipose tissue in the elderly
      might explain a diminished metabolic brown adipose tissue.

      Therefore, in this study, both the sympathetic nervous system activation to brown adipose
      tissue and the metabolic activity will be measured in young and older subjects.

      sympathetic nervous system activity will be measured using 123I-metaiodobenzylguanidine
      single-photon emission computed tomography computed tomography scans, metabolic activity will
      be measured using 18F- fluorodeoxyglucose positron emission tomography CT scans.
    

Intervention name(s): 18-FDG PET CT scan and 123I-MIBG SPECT scan
Intervention type(s): Other
Intervention MeSH terms: Fluorodeoxyglucose F18
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy Caucasian Males
      
Keywords: Brown adipose Tissue; Ageing; Sympathetic Nervous Stimulation; Obesity
A Phase 1 Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this phase1 study is to investigate the pharmacokinetics, safety and
      tolerability of a single oral dose of SA001 and its active metabolite in healthy male
      volunteers.
    

Detailed description: 
      This study consists of Part 1 followed Part 2.

      Part 1 (Dose escalation study, SA001 60mg~300mg dose group) The part 1 is a dose escalation
      study. The starting dose is SA001 60mg, and the maximum dose is 300mg. Each dose group is
      assigned to SA001 or Placebo in a ratio of 3:1. The pharmacokinetics, safety and tolerability
      of SA001 and its metabolite are investigated after a single oral administration on the
      fasting state.

      Part 2 (Single dose and food effect study, SA001 120mg and 300mg dose group) The purpose of
      this part 2 is to evaluate the food effect of a high-fat diets(HFDs) on the single oral dose
      pharmacokinetics of SA001 and its metabolite.
    

Intervention name(s): SA001 60mg or Placebo; SA001 120mg or Placebo; SA001 180mg or Placebo; SA001 240mg or Placebo; SA001 300mg or Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Study Drug: SA001 60mg
Comparator: Placebo
Cohort 1 in the part 1 (Dose escalation study); Study Drug: SA001 120mg
Comparator: Placebo
Cohort 2 in the part 1 (Dose escalation study) and part 2 (Food effect study); Study Drug: SA001 180mg
Comparator: Placebo
Cohort 3 in the part 1 (Dose escalation study); Study Drug: SA001 240mg
Comparator: Placebo
Cohort 4 in the part 1 (Dose escalation study); Study Drug: SA001 300mg
Comparator: Placebo
Cohort 5 in the part 1(Dose escalation study) and part 2 (Food effect study)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effects of the Shared-decision Making Training Program
Condition: Competence
Study type: Interventional

Summary: 
      The goal of this intervention study is to test the effectiveness of a training program for
      hospital-based midwives. The main questions it aims to answer are: •Does SDM combined EBP
      training improve midwives' SDM and EBP competency? • What are factors related to SDM
      competency in midwives? Participants will participate in a 20-hour training program,
      including lectures and hands-on practice sessions. Researchers will compare groups that
      receive SDM training with or without EBP training to see if there are changes in midwives'
      SDM and EBP competency.
    

Detailed description: 
      This study aimed to evaluate the effect of SDM training program, with or without EBP, on the
      level of midwives' SDM and EBP competency. This randomized controlled trial recruited
      participants from 18 departments of an obstetrics and gynecology hospital in Vietnam. 72
      midwives (36 in each group) and 404 patients were required. Eligible midwives were ones who
      provided the hands-on care of patients for at least three months, were licensed to practice
      midwifery, and were willing to participate in the study. Each participating midwife conducted
      three encounters with real patients who were conveniently selected. Patients at least 18
      years old, having SURE test scores less than 4, and willing to participate in the study were
      invited. Patients requiring emergency medical attention were excluded. The intervention group
      received a tailored training program that combined SDM with EBP, while the control group
      received SDM training alone. The outcomes related to SDM (measured by SDM-Q-Doc, SDM-Q-9,
      DSC, OPTION5, DSAT10, and 4HCS) and EBP (measured by HS-EBP) were evaluated at baseline, Week
      2, and/or Week 4.
    

Intervention name(s): SDM-EBP training
Intervention type(s): Other
Intervention description(s): A 20-hour tailored SDM combined with EBP training program consisting of a seven-hour lecture and a four-hour hands-on practice session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: shared-decision making; evidence-based practice; midwife