bioihbjkbjnl/mcl2 huggingface dataset:
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
Condition: Hemophilia A; Hemophilia B; Vitamin D Deficiency
MeSH terms: Hemophilia A; Hemophilia B; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Study will look at baseline Vitamin D levels, calcium, albumin, liver enzymes, testosterone,
      osteocalcin, urine N telopeptides, bone mineral density, nutritional assessment and physical
      activity assessment of boys with hemophilia A or B (ages 2-20 yrs). Patients with low vitamin
      D levels will receive therapeutic doses of Vitamin D. At end of one year follow up studies
      will be repeated.
    


Intervention name(s): Vitamin D and calcium
Intervention type(s): Dietary Supplement
Intervention description(s): Doses will be based on Vitamin D levels
Intervention MeSH terms: Vitamin D; Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Hemophilia; Vitamin D
Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
Condition: Influenza
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the safety of a vaccine in healthy adults prior to the release of the trivalent
      vaccine (FluMist).
    

Detailed description: 
      The primary study objective is to assess the safety of a monovalent vaccine of a new 6:2
      reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist). Safety
      will be demonstrated by similar fever rates (oral temperature ≥101°F) in vaccine and placebo
      recipients.
    

Intervention name(s): AV024; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).; Placebo mist consisting of normal allantoic fluid. 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Positron Emission Tomography (PET) Study Evaluating Brain Metabolism of a Medical Food in Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine the brain metabolic effects of AC-1202 (Axona®), a medical food for
      Alzheimer's disease. Subjects who meet entry criteria will undergo H215O positron emission
      tomography prior to and 90 minutes after consumption of Axona® at baseline and then again
      after 45 days of treatment. Cognitive testing will also be conducted at baseline and day 45.
    


Intervention name(s): caprylidene; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Axona® is dosed as a 40g packet mixed into 8 oz of liquid (Ensure) for 45 days
Other intervention name(s): Axona®, AC-1202
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: dementia
Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung
      function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and
      budesonide will be inhaled once daily at one dose level each. The study duration consists of
      a baseline period (1 to 4 weeks) and a treatment period (12 weeks). The study will provide
      further data on safety and tolerability of ciclesonide.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Budesonide
Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
Condition: Hepatitis B Disease
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study was done to evaluate the effect of various adjuvants in combination with HBsAg as
      a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in
      healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the
      various adjuvanted vaccines.
    


Intervention name(s): 287615 containing HBsAg with adjuvants
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Adjuvants; HBsAg
Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      In the proposed clinical investigation, the investigational device (BabySize3D) will provide
      automated plane extraction and automated biometry measurements from 3D US volumes. The
      results obtained from the investigational software
    


Intervention name(s): 3D volume acquisitions; 2D standard measurements and 3D volumes acquisitions
Intervention type(s): Device; Device
Intervention description(s): 2 abdominal volumes 2 thigh volumes 2 head volumes; 1 abdomen circumference measurement
1 femur length measurement
1 head circumference measurement
1 bi-parietal diameter measurement
1 abdominal volume
1 thigh volume
1 head volume
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Quarantine and Telerehabilitation in Chronic Pain Patients During COVID-19 Pandemic.
Condition: Chronic Pain
MeSH terms: COVID-19; Chronic Pain
Study type: Interventional

Summary: 
      The quarantine during COVID-19 pandemic has changed daily routine. Staying at home for
      prolonged periods of time can pose a significant challenge for patients with chronic pain.
      The purpose of the current study is to investigate how the quarantine effects of psychosocial
      factors, quality of life, sleep, nutrition and physical activity in patients with chronic
      musculoskeletal pain. Another purpose is to examine whether a telerehabilitation exercise
      program is effective during the lockdown period.
    

Detailed description: 
      Participants, both male and female, with chronic musculoskeletal pain for at least 3 months
      will be included in the study. They will complete some questions about anxiety, depression,
      sleep, nutrition, quality of life, pain behavior and characteristics, illness perceptions,
      functioning and daily routine. Questionnaires will be completed twice (first and last week of
      quarantine, 40 days of duration). A group of patients will follow an exercise program during
      this time. It will be evaluated the link between the question of physical and psychological
      factors in the experience of pain in quarantine situation and, also, it will examine whether
      a telerehabilitation exercise program is effective during the lockdown period.
    

Intervention name(s): Exercise Group
Intervention type(s): Other
Intervention description(s): The group follows warm up exercise (maximum 10 minutes). This consisted of combined, breathing techniques, low-impact aerobic exercises, free range of motion exercises of upper and lower limbs and spine, and coordination-based exercises of hands and feet. Breathing techniques take regular activities such as sitting, walking, and lying down. At the end of this phase, active stretching exercises of major muscles of arm, leg and trunk were performed.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Quarantine; Musculoskeletal; Telerehabilitation; Psychosocial; Sleep; Exercise
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
Condition: Heart Transplantation; Liver Transplantation; Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid
      organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus
      through genetics will help in early attainment and maintenance of the correct dosage level in
      the early post-transplant period. This pilot dose-finding trial will help to determine a
      dosing strategy guided by genotypes and age for solid organ transplant recipients that will
      be further validated through a multi-centre trial as an immediate next step. The study
      hypothesizes that dosage levels determined through age and genotype will be attained faster
      and more accurately than the standard dosing procedures in the 14-days after the transplant.
      Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster
      recovery (tested through the kidneys' ability to clear creatine from the blood) and result in
      lower frequencies of adverse effects and rejection of the transplant.
    


Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): Tacrolimus, a calcineurin inhibitor, is the commonest immunosuppressive agent used for maintenance immunosuppression after solid organ transplantation. The mechanism of action involves binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the generation of nuclear factor of activated T-cells, a nuclear component, resulting in inhibition of transcription of lymphokines (interleukin-2, γ-interferon). The net result is the inhibition of T-lymphocyte activation.Tacrolimus is metabolized primarily by the CYP3A enzymes in the liver particularly the CYP3A5.
Other intervention name(s): Prograf
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transplant; Pediatrics; Tacrolimus; Prograf
Allogeneic Stem Cell Therapy in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem
      Cell Centre - Adipose Stem Cells (CSCC_ASC) study in heart failure patients to investigate
      the regenerative capacity of the CSCC_ASC treatment.
    

Detailed description: 
      The primary objective is to investigate the regenerative capacity of direct intra-myocardial
      injection of 100 mio. allogeneic CSCC_ASCs in patients with reduced left ventricular Ejection
      Fraction (EF) (≤45%) and heart failure in a double-blind placebo-controlled design.

      A total of 81 patients with will be enrolled in the study and treated in a 2:1 randomization
      with either CSCC_ASC or placebo (saline).

      The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months
      follow-up.
    

Intervention name(s): Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Direct intramyocardial injection of CSCC_ASC; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Attention deficit hyperactivity disorder (ADHD) patients have some problem with sustained
      attention. The dorsal anterior cingulate cortex (dACC) plays a key role for attention
      control. It has been found that the dACC has strong functional connectivity with ipsilateral
      motor area and parietal gyrus. Repetitive Transcranial Magnetic Stimulation (rTMS) is a sage
      and painless technique to activate cortical areas. The deep brain structure can be activated
      via stimulating superficial cortex by rTMS. For investigating the mechanism of sustained
      attention, this project is using functional magnetic resonance imaging (fMRI) to
      individualize the precise localization in motor area and parietal gyrus, and combining rTMS
      to activate the dACC.
    

Detailed description: 
      Healthy subject is recruiting in this project. High rTMS will be performed. The 10-Hz
      stimulation is delivered at 100% of the subject's resting motor threshold via 60 trains of
      3-s 10-Hz rTMS (30 pulses with 27-s duration per train).
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): The 10-Hz stimulation is delivered at 100% of the subject's resting motor threshold via 60 trains of 3-s 10-Hz rTMS (30 pulses with 27-s duration per train).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: fMRI; rTMS; functional connectivity
Laryngeal Mask Airway (LMA) Insertion With Sevoflurane and Remifentanil
Condition: Laryngismus
MeSH terms: Laryngismus
Study type: Interventional

Summary: 
      The purpose of this study was to determine the most suitable effect-site concentration of
      remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.
    

Detailed description: 
      For practical purposes, opioids with the ability to suppress upper airway reflexes have been
      used to facilitate insertion of the LMA during anaesthesia induction. To date, however, there
      have been no published reports addressing the use of remifentanil to facilitate LMA insertion
      during sevoflurane inhalation induction in adults. Therefore, the purpose of this study was
      to determine the most suitable effect-site concentration of remifentanil target-controlled
      infusion (TCI) for the LMA insertion during inhaled induction with 8% sevoflurane in adults.
    

Intervention name(s): Remifentanil 1; Control; Remifentanil 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): "Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.; The control group, which received an infusion of normal saline; "Remifentanil 2": "The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml.
Other intervention name(s): R1; Placebo; R2
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: laryngeal mask airway; insertion; sevoflurane; remifentanil
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This is a open label, prospective, pair comparison, randomised, multi-centre trial. The
      primary aim of this study to is to clinically validate the sensitivity and specificity of the
      Respirio Flu Test (RFT) in detecting Influenza A as compared with (a) the best available
      rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for
      identifying Influenza A infection Polymerase Chain Reaction (PCR).

      The secondary aim is to clinically validate the sensitivity and specificity of the Respirio
      Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.
    


Intervention name(s): Respirio Flu Test
Intervention type(s): Device
Intervention description(s): The Respirio Flu Test (RFT) is a rapid test for identifying whether a patient is infected with the Influenza A or B virus. The test separates the Influenza virus from the patient's nose blow sample and utilizes the same underlying technology as a pregnancy test (lateral flow/immuno-chromatography) to deliver a positive or negative result in less than 10 minutes. The RFT is easy to use, designed with a 3 step process similar to that of the home pregnancy test. Results are presented to the patient as a combination of different coloured lines, depending on whether the patient has Influenza A or B.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Influenza; Human; Orthomyxoviridae infections; RNA Virus Infections; Virus Diseases; Respiratory Tract infections; Respiratory Tract Diseases
Vitamin B12 vs B3 for Nerve Regeneration and Functional Recovery After Pediatric Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      A traumatic brain injury (TBI) is among the most frequent reasons for neurological impairment
      in young people. The investigators investigated whether vitamin B12 vs B3 therapy could
      reduce the severity of traumatic brain injury (TBI) due to their positive effects on axon
      regrowth following nerve damage. The method utilized was a series of non-random samples. With
      a 95% confidence interval and a 5% margin of error, a total sample of 300 patients was
      estimated using Epi Info. Participants in our study comprised both boys and girls with severe
      TBI ages 6 to 15 years old.

      Two groups of 300 children were recruited. B3 (16 mg/day) was administered to group 1 and B12
      (125-250 mcg/day) was provided to group 2. It is evaluated through follow-ups on a range of
      tests to evaluate cognitive capacity, sensorimotor activity and staircase test (working and
      reference memory). Pre-and post-treatment GCS measurements were conducted. Three weeks and a
      year following the treatment of TBI, children underwent neurobehavioral testing. The
      measurement of gait analysis was done. The standard error and mean of statistically examined
      data were shown by paired t-test.
    

Detailed description: 
      A traumatic brain injury (TBI) is among the most frequent reasons for neurological impairment
      in young people. The investigators investigated whether vitamin B12 vs B3 therapy could
      reduce the severity of traumatic brain injury (TBI) due to their positive effects on axon
      regrowth following nerve damage. The method utilized was a series of non-random samples. With
      a 95% confidence interval and a 5% margin of error, a total sample of 300 patients was
      estimated using Epi Info. Participants in our study comprised both boys and girls with severe
      TBI ages 6 to 15 years old.

      Two groups of 300 children were recruited. B3 (16 mg/day) was administered to group 1 and B12
      (125-250 mcg/day) was provided to group 2. It is evaluated through follow-ups on a range of
      tests to evaluate cognitive capacity, sensorimotor activity and staircase test (working and
      reference memory). Pre-and post-treatment GCS measurements were conducted. Three weeks and a
      year following the treatment of TBI, children underwent neurobehavioral testing. The
      measurement of gait analysis was done. The standard error and mean of statistically examined
      data were shown by paired t-test.
    

Intervention name(s): Vitamin B3; Vitamin B12
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin B3 upto 16 mg/day; Vit B12 upto 250 mcg per day
Intervention MeSH terms: Vitamins; Vitamin B 12; Niacinamide; Vitamin B Complex
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Study type: Interventional
Phase: Phase 3

Summary: 
      Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg
    

Detailed description: 
      Pharmacodynamic bioequivalence study after a single dose of Tiotropium Bromide Inhalation
      Powder 18 μg vs Spiriva Handihaler (Tiotropium Bromide) 18 mcg
    

Intervention name(s): Test Product - Tiotropium Bromide Inhalation Powder 18 mcg; Spiriva Handihaler (Tiotropium Bromide) 18 mcg; Placebo
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Test Product; RLD; Placebo Product
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, placebo-controlled, single dose, three-way crossover design.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study employs functional magnetic resonance imaging to compare brain activation patterns
      during a depressive episode in patients diagnosed with bipolar disorder, major depressive
      disorder, and a group of healthy control subjects. Depressed patients will be treated with a
      combination of fluoxetine and olanzapine and undergo MRI scans before, during, and after
      pharmacotherapy.
    

Detailed description: 
      The purpose of this study is to further characterize the neural correlates of affective
      processing in BD and MDD subjects using fMRI. Subjects who meet criteria for a major
      depressive episode in the context of BD (n=15); MDD (n=15) and a group of psychiatrically
      unaffected control subjects (CS, n=15) will undergo four fMRI scans while experiencing a
      temporary mood induction through the presentation of affective imagery from the International
      Affective Picture System (IAPS). Both BD and MDD subjects will receive the same combination
      pharmacotherapy to treat the depression, with fMRI data acquired before, and 1, 3, 6 weeks
      following pharmacotherapy initiation. Positive, negative, and neutral affective visual
      stimuli will be presented in a blocked design.

      Comparison(s): The effects of time and group will be analyzed in factorial models. Regions of
      interest that demonstrate significant group-by-time interactions will be further correlated
      with self-report and clinician-rated psychometric indices.
    

Intervention name(s): Fluoxetine+Olanzapine; Olanzapine; Functional Magnetic Resonance Imaging
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Olanzapine; Fluoxetine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Magnetic Resonance Imaging; Diagnostic Imaging; Mood Disorders; Major Depressive Disorder; Antipsychotic; Olanzapine; Fluoxetine