bioihbjkbjnl/mcl2 huggingface dataset:
Revaccination With Subunit Influenza A/Vietnam/1203/2004 (H5N1) Vaccine
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether having received an H5 vaccine in the past
      primes the immune system to respond rapidly to another dose of H5 vaccine. One hundred
      seventeen participants in a previous vaccine study (involving the A/Hong/Kong/97 virus)
      during the fall of 1998 at the University of Rochester will be eligible to enroll in this
      study. Participation in this study will up to 64 days and will involve donation of small
      samples of blood 7, 28, and 56 days after vaccination.
    

Detailed description: 
      This is an open label, phase I evaluation of a single dose of an investigational inactivated,
      subunit influenza A/Vietnam/1203/2004 (H5N1) vaccine in subjects who were previously
      vaccinated with a vaccine made from an antigenically distinct variant of H5N1. The study is
      designed to determine whether immunization with an antigenic variant can prime for responses
      to a single dose of vaccine representing the current pandemic threat. The primary objective
      is to determine the ability of a priming dose of rec H5 HA 1997 vaccine administered 7 years
      previously to result in booster responses to an inactivated subunit influenza
      A/Vietnam/1203/2004 (H5N1) vaccine. The secondary objectives are to 1) determine the safety
      of a booster dose of intramuscular inactivated subunit influenza A/Vietnam/1203/2004 (H5N1)
      vaccine in healthy adults, previously vaccinated with rec H5 HA 1997 vaccine and 2) evaluate
      the relationship between priming, levels of antigen-specific memory B and T cells , and the
      response to reactivation. The study will be performed at a single site, and will enroll as
      many previously vaccinated subjects as are available and eligible, up to a maximum of 117.
      Subjects will receive a single intramuscular dose of 90 mcg of the inactivated subunit
      influenza A/Vietnam/1203/2004 (H5N1) vaccine. Blood for assessment of antibody responses will
      be obtained before and at time points after vaccination. Subjects participating in the
      optional sub study will also have blood obtained for enumeration of memory B and T cells.
      Subjects will be followed for solicited adverse events for 7 days by memory aids and for 56
      days for unsolicited adverse events. This study is linked to DMID protocol 08-0059.
    

Intervention name(s): Influenza A/Vietnam/1203/2004 (H5N1; sanofi pasteur)
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: revaccination, vaccination, influenza, H5N1 vaccine
Nutritional Therapy for Diabetic Cardiomyopathy
Condition: T2DM (Type 2 Diabetes Mellitus)
MeSH terms: Cardiomyopathies; Diabetic Cardiomyopathies; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The goal of this study is to determine if nutritional therapy can effectively treat/prevent
      T2DM and its consequent cardiomyopathy.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with known T2DM and who are not taking exogenous insulin.
      
Biospecimen description: 
      blood samples
To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics
      of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine
      as Individual Tablets in Healthy Male Volunteers
    

Detailed description: 
      After subjects have signed informed consent voluntarily, they go through screening period for
      within 21 days.

      As period I, subjects of A Group take fimasartan and amlodipine at 1st day and subjects of B
      Group take fimasartan/amlodipine combination at 1st day.

      And then, after wash out for 14 days, as period II, subjects of A Group take
      fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and
      amlodipine at 15th day.

      At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,
      3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36
      times in total).

      At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5,
      3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36
      times in total).
    

Intervention name(s): Fimasartan; Amlodipine; Fimasartan/Amlodipine combination
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fimasartan
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine non-inferiority in seroconversion and to compare
      the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous
      virus strain and several wild types strains after completion of vaccination course.
    


Intervention name(s): ChimeriVax™-JE vaccine; JE-VAX® vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, subcutaneously; 1.0 mL, subcutaneously
Other intervention name(s): ChimeriVax™-JE; JE-VAX®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Japanese encephalitis; ChimeriVax™-JE; JE-VAX®
Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      Osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time.
      The purpose of this study is to determine the safety and effectiveness of nitroglycerin
      ointment for the treatment of osteopenia in postmenopausal women.

      Study hypothesis: On average, participants in the base therapy cohort who receive placebo
      ointment control and calcium/vitamin D will lose more bone density than participants in the
      nitroglycerin cohort over the 36-month period.
    

Detailed description: 
      Imbalance in the activities of osteoclasts (cells responsible for bone loss) and osteoblasts
      (cells responsible for bone formation) may lead to fractures, osteopenia, and osteoporosis in
      postmenopausal women. During postmenopause, decreased estrogen levels and decreased nitric
      oxide production occur; estrogen replacement therapy has been shown to restore serum nitric
      oxide levels to normal. Reversing nitric oxide deficiency by using nitroglycerin may prevent
      further bone loss. The Nitroglycerin as an Option: Value in Early Bone Loss (NOVEL) study
      will test the safety and efficacy of nitroglycerin ointment for the treatment of osteopenia
      in postmenopausal women.

      Patients will be enrolled in the study for 3 years and will be randomly assigned to one of
      two groups. The first group will receive nitroglycerin ointment, while the second group will
      receive placebo ointment. All patients will be given a calcium supplement with vitamin D to
      be taken daily, and will be instructed to rub the given ointment on their skin daily. Study
      visits will occur at Month 2 and every six months after Month 2. Phone interviews will be
      conducted with patients every 2 months throughout the study.
    

Intervention name(s): Nitroglycerin ointment; Calcium supplement with vitamin D
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin D; Nitroglycerin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Human Female; Osteoporosis; Postmenopausal; Nitric Oxide; Nitroglycerin; Calcium; Vitamin D
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to assess the safety and efficacy of two doses of IV
      palonosetron each administered as a single dose for the prevention of postoperative nausea
      and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years
      inclusive undergoing surgical procedures requiring general endotracheal inhalation
      anesthesia.
    


Intervention name(s): palonosetron; palonosetron
Intervention type(s): Drug; Drug
Intervention description(s): palonosetron IV 1 mcg/kg; palonosetron 3mcg/kg IV
Intervention MeSH terms: Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative Nausea and Vomiting; palonosetron; pediatric
The Impact of Pancreatic Islet Cell Allotransplantation on Cognitive Function in Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      In patients with Type 1 Diabetes Mellitus, hypoglycemia (low blood sugar) is the
      rate-limiting step to achieve glucose level control. As a result, understanding the body's
      responses (including the brain's response) to hypoglycemia is essential for the effective
      treatment of patients with T1DM. The purpose of this research is to determine whether
      pancreatic islet cell allotransplantation to restore normoglycemia (normal blood glucose
      levels) in Type 1 Diabetic patients with hypoglycemia unawareness alters brain fuel
      utilization and cognitive performance under euglycemic (blood sugar at 100 mg/dl) and
      hypoglycemic (blood sugar at 50 mg/dl) conditions. Three groups of subjects will be studied:
      (1) T1DM patients with a history of severe hypoglycemia and/or hypoglycemia unawareness who
      have been selected for pancreatic islet cell allotransplantation; (2) T1DM patients who also
      have a history of severe hypoglycemia and/or hypoglycemia unawareness; (3) nondiabetic
      subjects. All subjects will undergo identical testing including: (a) screening; (b)
      neuropsychological testing; (c) and functional magnetic resonance imaging (fMRI) during
      euglycemic and hypoglycemic conditions.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing pancreatic islet cell allotransplantation at the University of
        Minnesota

        Patients who are seen at Diabetes Clinics at Yale School of Medicine

        Nondiabetic, healthy subjects from New Haven and surrounding communities
      
Keywords: Diabetes Mellitus, Type 1; Hypoglycemia; Pancreatic Islet Cell Allotransplantation
Metabolomics Approach After Acute Intake of Grumixama Juice
Condition: Healthy
Study type: Interventional

Summary: 
      Investigate the bioavailability of the main flavonoid, their colonic transformation and
      untargeted metabolites by an metabolomic approach following acute intake of a grumixama juice
      by humans.
    

Detailed description: 
      The grumixama is a sweet and little cherry native of the South and Southeast regions of the
      Atlantic Forest of Brazil rich in phenolic compounds, mainly anthocyanins and ellagitannins.
      The objective of this study is Investigate the bioavailability of the main flavonoid, their
      colonic transformation and untargeted metabolites by an metabolomic approach following acute
      intake of a grumixama juice by humans.

      Fifteen healthy subjects consumed grumixama juice at single dose, and urine and plasma
      samples were collected at different time points over 24 h period. The metabolites were
      analyzed by LC-ESI-MSn, LC-Q-TOF plasma and urine were also analyzed using untargeted
      metabolomic approach for amino acids and organic acids by GCMS.
    

Intervention name(s): Intake of grumixama juice
Intervention type(s): Dietary Supplement
Intervention description(s): In the morning of experimental day after 10 h fasting, the volunteers have been collect the first urine in the morning and it was collected the blood before the intake of grumixama juice, after they drink the juice (0 min), it was collected blood at the times: 15 min, 30 min, 60 min,120 min, 240 min and 24 h; and it was also collected urine at the period: 0 -1h, 1 - 2h, 2 - 4h, 4 - 6 h, 6 - 12 h, 12 - 14 h, the first urine in the morning in the second day (24 h). During the period in the first 4 h of experiment the volunteers only intake the juice.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Grumixama; Urolithins; Anthocyanins; Metabolomic Approach; Ellagitannins; Subjects
Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease
Condition: Bowen's Disease
MeSH terms: Bowen's Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Er:YAG ablative fractional laser-assisted methyl aminolevulinate photodynamic therapy
      (AFL-PDT) has shown significantly higher efficacy and a lower recurrence rate at 12 months
      than methyl aminolevulinate photodynamic therapy (MAL-PDT) for treatment of Bowen's disease
      (BD). However, long-term follow up data are not available.
    

Detailed description: 
      To compare the long-term efficacy and recurrence rates of AFL-PDT and standard MAL-PDT for
      the treatment of lower extremity BD.
    

Intervention name(s): lidocaine-prilocaine 5% cream application; 2940-nm Er:YAG AFL pretreatment; methyl-aminolevulinate application; Illuminating using red light-emitting diode lamps
Intervention type(s): Drug; Device; Drug; Device
Intervention description(s): The lesions were then cleansed with saline gauze, and a lidocaine-prilocaine 5% cream (EMLA®; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area for 30 min under occlusion; After the anesthetic cream was removed, AFL was performed using a 2940-nm Er:YAG AFL (Joule; Sciton, Inc., Palo Alto, CA, USA) with a 500 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse; Immediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm; 3M, Co., Saint Paul, MN, USA) for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light.; Each treatment area was then separately illuminated using red light-emitting diode lamps (Aktilite CL128; Galderma S.A., Bruchsal, Germany) with peak emission at 632 nm and a total light dose of 37 J/cm2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later. During the illumination, patients were asked to evaluate pain intensity using an 11-point visual analog scale.
Intervention MeSH terms: Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination; Aminolevulinic Acid; Methyl 5-aminolevulinate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ablative fractional laser; photodynamic therapy; protoporphyrin IX; methy-aminolevulinate
Contour Neurovascular System - European Pre-Market Unruptured Aneurysm
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and
      performance of the Contour Neurovascular System™ ("Contour").

      The purpose of the study is to document safety and performance of the Contour in treatment
      for patients with intracranial aneurysms (IA). The data from the study will be reported as a
      Pre-Market study to the Notified Body to support CE Mark approval.
    

Detailed description: 
      Contour Neurovascular System™ European Pre-Market Unruptured Aneurysm Study (CERUS) initiated
      enrollment in October 2018 to assess the safety and effectiveness of the Contour
      Neurovascular System ("Contour") in treatment of intracranial aneurysms (IA) with the
      intended indication for endovascular embolization of saccular IA. This prospective,
      single-arm, multicenter study was conducted to document the safety and performance of the
      Contour in treatment for patients with an IA.
    

Intervention name(s): Contour Neurovascular System
Intervention type(s): Device
Intervention description(s): The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise Oscillatory Breathing and Sildenafil in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Exercise oscillatory breathing (EOB) is a ventilatory abnormality that occurs in
      approximately 20% of heart failure (HF) patients and carries a very unfavourable prognosis.

      Pathophysiology seems quite complex and putative mechanisms include increased pulmonary
      capillary pressure and pulmonary vasoconstriction, circulatory blood-flow fluctuations in the
      pulmonary arterial system and instability of ventilatory control.

      Inhibition of the phosphodiesterase 5 (PDE5) isoenzyme favourably regulates pulmonary
      vascular tone and permeability through over signaling of the endothelial nitric oxide
      pathway. The investigators tested the hypothesis that sildenafil would reverse the EOB
      pattern in patients with HF and pulmonary hypertension.
    


Intervention name(s): Sildenafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sildenafil, 50 mg 3 times/day; Placebo
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PDE5-inhibition; exercise ventilation; heart failure; sildenafil; pulmonary hemodynamics
Effects of Psycho-education of Patients With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose for this study is to determine whether psycho-education in groups is more
      effective than individual psycho-education for patients with bipolar disorder.
    

Detailed description: 
      The main aim of the study is to compare the effects of psycho-education in groups with short
      individual psycho-education.

      It is a randomized controlled trial including Bipolar 1 and 2 patients in a stable euthymic
      phase. 42 or 43 patients will receive group education in 10 weekly sessions and then a
      session every third month for two years. 42 or 43 patients will receive three individual
      sessions of education. Symptoms, admittances to hospital and function will be followed for
      two years.
    

Intervention name(s): individual education; Group education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): individual sessions of psycho-education; group psycho-education in 10 weekly sessions and then a session every third month for two years
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Psycho-education
24-hour Blood Pressure Measurements and Ischemic Conditioning
Condition: Blood Pressure
Study type: Interventional

Summary: 
      To determine if 24-hr ambulatory blood pressure monitoring effects endothelial function, we
      will measure flow-mediated dilation before and after the blood pressure monitoring (ischemia
      conditioning).
    

Detailed description: 
      Reestablishing blood flow (reperfusion) to organs that had their blood supply restricted
      (ischemia) can cause damage to the vasculature via injury and tissue death resulting in
      endothelial dysfunction. This ischemia-reperfusion (blood flow occlusion and resupply)
      triggered injury can be reduced or prevented by preceding brief periods of ischemia called
      preconditioning. Properly-performed preconditioning can exert a powerful protection against a
      subsequent sustained period of ischemia in a variety of organs in the body including the
      heart, kidney, and skeletal muscle. Preconditioning protocol involves repeated brief
      inflation and deflation of a blood pressure cuff. In many of human cardiovascular research
      studies, it is common to measure endothelial function and ambulatory (24-hour) blood
      pressure. The ambulatory blood pressure device takes repeated blood pressure readings every
      15-30 minutes during the daytime and 30-60 minutes at night. It is possible that repeated
      bouts of inflation/deflation of the blood pressure cuff could induce preconditioning effects
      and influence endothelial function. Therefore, in the proposed study we aim to address this
      hypothesis.
    

Intervention name(s): Ambulatory (24-hour) Blood Pressure
Intervention type(s): Device
Intervention description(s): Unlike casual blood pressure measurements, 24-hour ambulatory blood pressure monitoring provides an insight into blood pressure changes in everyday life and an estimate of the overall blood pressure load exerted on the cardiovascular system over 24 hours. Blood pressure recordings over a 24-hour period of normal daily activity will be made using a noninvasive ambulatory monitor (Spacelabs, Redlands, WA). The ambulatory system will be calibrated against a mercury sphygmomanometer, and the cuff will be programmed to inflate automatically every 15 min from 6 AM to 11 PM and every 20 min between 11 PM and 6 AM. For each individual subject, the nighttime period will be defined as the time when the subject goes to bed at night until rising in the morning. Daytime will be defined as the remainder of the 24-hour period. Daytime and nighttime states will be monitored by an Actiwatch (Mini-MItter, Bend, OR), a watch-like device placed on the wrist that measures gross motor activity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other