bioihbjkbjnl/mcl2 huggingface dataset:
Use of Ixmyelocel-T (Formerly Vascular Repair Cells [VRC]) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and efficacy of autologous Vascular Repair
      Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb
      ischemia.

      The double-blind study is expected to enroll 150 patients, randomized into two patient
      groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the
      affected limb; the control group will receive intramuscular injections with an electrolyte
      solution (without cells). Both groups will receive the standard of care appropriate for their
      medical condition.
    

Detailed description: 
      The study will assess the safety and ability of Aastrom TRC autologous bone marrow cells to
      restore peripheral blood flow affected by critical limb ischemia.

      Peripheral arterial disease (PAD), also known as Peripheral Vascular Disease (PVD), occurs
      when peripheral arteries are damaged by arterial hypertension and/or by the formation of
      atherosclerotic plaques. PAD is a chronic disease that progressively constricts arterial
      circulation of limbs. The term critical limb ischemia (CLI) is used for all patients with
      chronic ischemia rest pain, ulcers, or gangrene in limbs attributable to objectively proven
      PAD. These sequelae represent the end stage of PAD. PAD is associated with several other
      clinical conditions, i.e. hypertension, cardiovascular disease, hyperlipidemia, diabetes,
      tobacco use, obesity and stroke.

      The double-blind study is expected to enroll 150 patients, randomized into two patient
      groups. The treatment group will receive intramuscular injections of the TRC product into the
      affected limb; the control group will receive intramuscular injections with an electrolyte
      solution (without cells). Both groups will receive the standard of care appropriate for their
      medical condition.
    

Intervention name(s): Ixmyelocel-T; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): IM injection; IM Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Peripheral Arterial Disease; Critical Limb Ischemia; Ischemia; Peripheral Vascular Disease; ixmyelocel-T
Tenofovir in HIV/HBV Coinfection
Condition: HIV Infection; Hepatitis B Coinfection
MeSH terms: Infections; Hepatitis B; Coinfection; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the effectiveness of 3 different treatment regimens in
      reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B
      (co-infection)
    

Detailed description: 
      A randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in
      antiretroviral naïve subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).
      Plus, a 12 week viral kinetic sub-study comparing a sub-group of the patients on Clinical
      Trial A with a group of therapy naïve HBV mono-infected subjects (Substudy A1)
    

Intervention name(s): Tenofovir; Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tenofovir; Lamivudine; Zidovudine; Efavirenz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B; HIV; Treatment Naive
Effects of Vitamin D Dose and Genotype of the Binding Protein in Infants and Children
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the vitamin D binding protein genotype
      influences circulating vitamin D levels and if it may have functional consequences on vitamin
      D activity.
    

Detailed description: 
      Vitamin D has recently been the subject of much attention. Advantages to the prevention of
      vitamin D deficiency (VDD) in young children are obvious: acutely, hypocalcemic seizures may
      occur in VDD, and rickets can result in long-term skeletal deformities. Previous research has
      emphasized the importance of identifying optimal supplementation doses and appropriate target
      thresholds for circulating 25-hydroxyvitamin D (25-OHD), the best described marker of vitamin
      D status. The timely next step is to objectively establish effective doses for the prevention
      of VDD, without creating risk from overzealous supplementation, in a population
      representative of those most at risk for overt disease.

      Although the primary role of vitamin D is considered to be its effect on intestinal calcium
      absorption, enormous variability of fractional calcium absorption in relation to 25-OHD
      levels exists. We provide evidence that a significant component of this variability is
      genetic in nature and in particular, relates to vitamin D binding protein (DBP) genotype.

      The aggregate data suggest that the critical mechanism for the development of nutritional
      rickets is reduction in availability of calcium to the skeleton, which is largely determined
      by vitamin D status and intestinal calcium absorption. Our proposal focuses on the
      establishment of a workable definition of vitamin D deficiency in an underserved and highly
      vulnerable population and to assess the impact of genetic variance in VDR and DBP as factors
      to be considered in the recommendation of vitamin D status assessment, taking into account
      the outcome of 25-OHD level, and in additional studies, potential functional consequences of
      vitamin D related to both its classical and non-classical effects.
    

Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): Vitamin D (either 400 IU vs 1000 IU) given orally each day
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D Deficiency; VDD; Vitamin D Supplementation; Vitamin D Binding Protein; DBP; Nutritional rickets; rickets; 25hydroxyvitamin D; 25OHD; 1,25OH2D; vitamin D metabolites; PTH; vitamin D homeostasis
Prenatal Consult With Illustrated Literature
Condition: Premature Birth; Prenatal Stress
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The overall purpose of this study is to determine whether implementing a 'Prenatal Consult
      Bundle' to the existing prenatal consult, including provision of sample questions, added
      discussion points and handouts, and a return visit, will decrease parental anxiety and
      improve information recall. Additionally, this study will determine if this effect is further
      increased with the use of illustrated literature.
    

Detailed description: 
      This study will be a prospective randomized control trial. Seventy participants will be
      enrolled for the 'Standard' consult. These women will receive a questionnaire 6-24 hours
      after their consult. Then 140 participants will be randomized to either the 'Standard
      Upgrade' or 'Illustrated Upgrade' arm. Randomization will additionally be stratified based on
      estimated gestational age. These participants will receive an upgraded consult implementing
      the 'Prenatal Consult Bundle' which emphasizes the parents' role and follow up, with or
      without an illustrated handout. These participants will receive the same questionnaire 6-24
      hours after their consult. Demographic information collected will include maternal age,
      gravidity, use of magnesium, social support and health literacy. All data will be collected
      to assess whether either arm of the consult 'upgrade' reduces anxiety or improves knowledge
      retention after the prenatal consult. Analyses will be completed using Statistical Analysis
      Software (SAS) using appropriate statistical testing.
    

Intervention name(s): Illustrated handout at prenatal consult; Standard Prenatal Consult
Intervention type(s): Other; Other
Intervention description(s): Illustrated consult group will be given an illustration paper describing the majority of the issues discussed at the prenatal consult; Standard prenatal consult
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Study of LY2409021 in Participants With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or
      placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if
      this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study
      includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve
      screening within 30 days of the start of the study as well as telephone consultations within
      5 days after discharge from the CRU.
    


Intervention name(s): LY2409021; Placebo; Glucagon
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered via intramuscular injection
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of 3 Dosage Strengths of Almotriptan Malate (AXERT®) in the Treatment of Acute Migraine in Adolescents
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate
      (AXERT®) in treating acute migraine headaches in adolescents. Amotriptan malate (AXERT®) is
      approved for use in the treatment of acute migraine headache with or without aura in adults.
      In this study, adolescents will be given a single dose of study medication to treat one
      migraine headache.
    

Detailed description: 
      Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache
      with or without aura in adults. Other studies have shown that almotriptan is effective and
      well tolerated in adults. Migraines in teenagers/adolescents are very similar to migraines in
      adults, except that the duration is usually less in adolescents (they last 1 to 24 hours in
      adolescents). This study will evaluate the usefulness of almotriptan malate (AXERT®) in
      treating acute migraine headaches in adolescents. This is a randomized, double-blind,
      parallel-group, and placebo-controlled study. During a 30-day run-in period, patients will
      treat their migraines as they normally would. During this time, the frequency and severity of
      headaches will be recorded. At the second visit, patients will be randomized (like with the
      toss of a coin) to a treatment group to receive one oral dose of almotriptan malate (AXERT®)
      6.25, 12.5, or 25 milligrams or placebo. Approximately the same number of patients will be
      assigned to each of the four treatment groups. Patients will take this one-time dose when the
      next migraine of at least moderate severity occurs. Patients will record assessments in a
      diary for up to 24 hours after the study drug is given to help determine the drug's effect on
      headache pain intensity. Patients will return for a third visit within 2 to 14 days from
      taking the study medication. A physical examination, electrocardiogram (a painless test of
      the heart), and laboratory tests will be performed at the first and third visits. The
      objective of this study is to determine the effectiveness and tolerability of 3 dosage
      strengths of almotriptan malate (AXERT®) in adolescents with migraine headaches.

      Almotriptan oral tablets, 6.25, 12.5, or 25 milligrams, or placebo
    

Intervention name(s): almotriptan malate
Intervention type(s): Drug
Intervention MeSH terms: Almotriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: pain; Migraine; aura; headache
Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Thoracotomy
Condition: Postoperative Analgesia; Retrolaminar Block; Ultrasound-guided Erector Spinae Plane Block; Thoracotomy
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Comparing efficacy of Ultrasound-guided Erector Spinae Plane Block versus Retrolaminar Block
      for Postoperative Analgesia in Patients Undergoing Thoracotomy
    

Detailed description: 
      Thoracotomy is one of the most painful surgical procedures. The reported incidence of
      persistent pain after thoracic surgery (post thoracotomy pain syndrome) has been reported in
      20%-70% of patients. Inadequately treated post thoracotomy pain can have several negative
      consequences. Therefore, pain relief is essential to facilitate coughing and deep breathing
      and to promote early mobilization.

      Thoracic epidural analgesia and thoracic paravertebral block are strongly recommended
      techniques for managing post thoracotomy pain to reduce opioid use and the related adverse
      effects as hypoventilation, depression of cough reflex, nausea and vomiting. However, they
      can be technically challenging to perform and are associated with up to 15% failure rate in
      Thoracic epidural analgesia and potential risk of pneumothorax in thoracic paravertebral
      block.

      Erector spinae plane block is a relatively novel ultrasound-guided regional technique. Its
      application in patients with chronic thoracic neuropathic pain and acute surgical pain has
      been described by Forero et al.

      Retrolaminar block is an easy and safe analgesic technique. It has been reported to be
      satisfactory for post-operative analgesia after breast surgery.

      To our knowledge there is no clinical studies, comparing the effectiveness of both blocks on
      postthoracotomy pain, has been reported.
    

Intervention name(s): Ultrasound-guided Erector Spinae Plane Block; Retrolaminar Block; Control
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): ultrasound-guided ipsilateral Erector Spinae Plane Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).; ultrasound-guided ipsilateral Retrolaminar Block (20 ml (19ml bupivacaine 0.25% plus 1ml dexamethasone 4mg)).; General anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomly allocated into 3 equal groups (Control group, Ultrasound-guided Erector Spinae Plane Block group, Retrolaminar Block, 20 patients each) through sealed envelopes.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model,
      this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy
      subjects.
    


Intervention name(s): TG-0054
Intervention type(s): Drug
Intervention description(s): 0.10, 0.14, 0.28, 0.56, 1.12, 2.24, 3.14, and 4.40 mg/kg of TG-0054/placebo via 15 min IV infusion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
Condition: Coronary Artery Disease
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in
      the body that make platelets stick together. These platelets may be important in the
      initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin
      maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in
      platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the
      current study is designed to determine whether paroxetine will decrease COAT-platelet
      production in normal volunteers and patients with cardiovascular disease.
    


Intervention name(s): Paxil-CR
Intervention type(s): Drug
Intervention MeSH terms: Paroxetine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacological Cognitive Enhancement
Condition: Fluid Inteligence; Modafinil; Healthy Young Subjects; Resting State Networks
Study type: Interventional
Phase: Early Phase 1

Summary: 
      There is growing debate on the use of drugs that can promote cognitive enhancement.
      Amphetamine-like drugs have been employed as cognitive enhancers, but all of them have
      important side effects and may induce addiction. In our study, we will investigate the use of
      modafinil which, in recent years, has been proposed as cognitive enhancer. Modafinil appears
      to have less side effects compared to amphetamine-like drugs and we will analyzed whether the
      drug can influence cognitive performances and the brain resting state network activity of
      healthy young subjects.
    

Detailed description: 
      Subjects will be included in a double-blind, placebo-controlled study in which a single dose
      (100 mg) of modafinil will be administered. Both groups will be, before and three hours after
      administration of drug or placebo, tested for neuropsychological performances with the
      Raven's Advanced Progressive Matrices II set (APM).

      Resting state functional magnetic resonance (rs-fMRI) will be also employed, before and after
      three hours, to study changes in the activity of resting state brain networks. Finally, with
      Diffusion Tensor Imaging (DTI) we will evaluate the structural connectivity of the two
      groups.
    

Intervention name(s): Modafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.; Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.
Other intervention name(s): Provigil; Code name: Modafinil; serial number:74507491
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: RsfMRI, brain plasticity, cognitive enhancer
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Condition: Gingival Diseases
MeSH terms: Gingival Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a
      4-day brushing regiment
    


Intervention name(s): Fluoride; Triclosan/Fluoride toothpaste; Fluoride; Fluoride; antibacterial plant extract
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Brush twice daily; Brush twice daily; Brush twice daily; Brush twice daily; Brush twice daily
Other intervention name(s): honokiol; Honokiol
Intervention MeSH terms: Honokiol; Triclosan; Anti-Bacterial Agents; Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Screening Scottish Swimmers for Asthma and Rhinitis
Condition: Asthma; Rhinitis
MeSH terms: Rhinitis; Asthma
Study type: Observational

Summary: 
      The Scottish National and District swimming teams will be screened for asthma and rhinitis
      using both mannitol challenge and sport-based exercise challenge.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): this is a screening study, not an interventional study
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The Scottish national and district swimming teams
      
Keywords: asthma; rhinitis; swimmers; mannitol