bioihbjkbjnl/mcl2 huggingface dataset:
Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
Condition: HIV Infections; Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare two flu vaccines to determine their safety and
      ability to stimulate an immune response in HIV infected children and adolescents. This study
      will also determine how often and how long people who receive a vaccine are able to spread
      flu vaccine virus to other people.
    

Detailed description: 
      Influenza virus infections are common among children, particularly during the winter season.
      The infections are often mild, but more serious cases can cause a number of complications,
      including respiratory illnesses and bacterial infections. HIV infected children may have an
      increased risk for developing influenza-related bacterial complications, and influenza
      infections among this population may lead to more rapid disease progression. The current
      standard of care for HIV infected children is vaccination with an inactivated influenza
      vaccine (IAIV). However, IAIV is limited in its ability to stimulate the immune systems of
      HIV infected children with advanced disease. FluMist, a cold-adapted live attenuated
      influenza vaccine, is both immunogenic and effective in HIV infected children; unfortunately,
      FluMist is associated with viral shedding, a period of time when the influenza virus used to
      produce the vaccine may be transmitted to other people. This study will compare the safety
      and immunogenicity of IAIV and FluMist in HIV infected children and adolescents. This study
      will also determine the prevalence and duration of FluMist viral shedding in HIV infected
      children and adolescents who have received the vaccination.

      Participants in this study will be randomly assigned to one of two arms. Arm A participants
      will receive FluMist; Arm B participants will receive IAIV. A single immunization will occur
      on Day 0 of the study. Arm A participants will have study visits on Days 3, 14, and 28 or
      home visits on Days 3 and 14. Participants in Arm B will have a study visit on Day 28. A
      physical exam will be performed at the initial study visit; blood will be collected at study
      start and at each visit thereafter. Phone calls will be made to participants throughout the
      study. All participants will have a final study visit after 6 months.
    

Intervention name(s): Cold-adapted live attenuated influenza vaccine (FluMist); Inactivated influenza vaccine (IAIV)
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: FluMist; Influenza Vaccine; Adolescent; Treatment Experienced
Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
Condition: Raynaud's Disease
MeSH terms: Raynaud Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of a topical gel
      formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate
      to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to
      autoimmune diseases, such as scleroderma.
    


Intervention name(s): Topical organogel with nitroglycerin
Intervention type(s): Drug
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Raynaud's Phenomenon; Raynaud's Disease; Scleroderma; Raynaud's Disease Secondary to Scleroderma; Raynaud's Disease Secondary to Other Autoimmune Disease
BrightPoint Reflectometer Device Study
Condition: Epidural Placement
Study type: Interventional

Summary: 
      Participants are being asked to participate in this study because they are having an epidural
      placed for labor. This human clinical trial has been designed to evaluate the use of the
      BrightPoint Reflectometer Device (AKA BrightPoint device) as secondary confirmation of Loss
      of Residence (LOR) for lumbar epidural placement by an experienced clinician. For this study,
      participants will be randomized to receive an epidural by an experienced clinician either
      with or without the use of the BrightPoint device. Epidurals performed as a part of this
      study will be done in a manner similar to how epidurals are currently performed in the
      hospital. The epidural space will be entered using usual loss of resistance technique for all
      patients. If the BrightPoint device is used, it will be as secondary verification of entry
      into the epidural space.
    


Intervention name(s): BrightPoint
Intervention type(s): Device
Intervention description(s): Data from the BrightPoint device during epidural placement will be collected in real time on a tablet with pre-programmed software including tissue color and light reflectance with time stamps of when epidural space is entered as voiced by clinician per LOR.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Labor; Epidural
Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization
Condition: Bankart Lesion
MeSH terms: Bankart Lesions
Study type: Interventional

Summary: 
      The risk of recurrence and chronic instability after an initial episode of anterior
      glenohumeral dislocation is high, the risk is higher the younger the patient is.

      Most patients with recurrences develop this instability during the first 2 years.

      Several studies have shown that an initial arthroscopic surgical treatment (Bankart
      intervention) decreased the risk of recurrence and therefore of chronic instability, but this
      attitude is not usual in France and none randomized study comparing intervention of
      arthroscopic Bankart and immobilization was published by a French team.

      The primary objective was to evaluate at 2 years the efficacy on the rate of recurrent
      instability of the first-line arthroscopic repair of prior capsulo-labral lesions compared to
      conservative treatment by immobilization for patients under 25 years having an initial
      episode of anterior glenohumeral dislocation

      Material and method : We conducted a randomized controlled, open-label, parallel-group study
      (conservative treatment group by immobilizing VS surgical treatment group) in patients aged
      18 to 25 with anterior glenohumeral primo luxation. Patients were clinically reassessed at 2
      years with functional scores (WOSI, DuplayWalch, DASH), mobility and instability recurrence.

      Hypothesis: reduction of the recurrence rate in the surgically treated group
    


Intervention name(s): Bankart repair; Immobilization interne rotation
Intervention type(s): Procedure; Procedure
Intervention description(s): Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.; Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glenohumeral dislocation; Arthroscopic; capsular lesions
Mutation Detection of EBUS-TBNA Specimens Using NGS
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The objective of the study was to compare the value of routine gene testing and
      next-generation sequencing (NGS) in detecting gene mutations of small specimens obtained by
      endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and get the knowledge
      of how many EBUS-TBNA samples were adequate for NGS.
    

Detailed description: 
      Some gene mutations can direct individualized treatment. The routine gene testing of EGFR,
      ROS1 and ALK is direct sequencing, Reverse transcription quantitative real-time polymerase
      chain reaction (RT-QPCR) and fluorescent in situ hybridization (FISH) or immunohistochemistry
      (IHC). Next-generation sequencing (NGS) is a new technique, which is more sensitive than
      routine techniques. So we decided to compare the value of gene testing between routine method
      and NGS in EBUS-TBNA specimens and get the knowledge of how many EBUS-TBNA samples were
      adequate for NGS.

      The study was designed as a prospective and single center study. Seventy patients will be
      enrolled into the study and the clinical data of the patients, including his smoke history,
      cancer history, occupation exposure and so on, will be collected and recorded in a case
      report form. For the patients recruited in the study, the lymph nodes suspected to be
      malignant will be obtained by EBUS-TBNA. Samples will be sent to Pathology Department of
      Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed
      with nonsquamous NSCLC, routine gene testing of EGFR, ROS1 and ALK will be performed. And the
      rest tissues will be extracted with DNA and performed gene mutations using NGS for these
      qualified DNA samples.
    

Intervention name(s): Routine gene testing; Next-generation sequencing
Intervention type(s): Procedure; Procedure
Intervention description(s): For those diagnosed with nonsquamous NSCLC, routine gene testing including EGFR, ROS1 and ALK will be performed.; For those diagnosed with nonsquamous NSCLC and have done routine gene testing, NGS will be perform on those that have adequate rest tissues.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gene testing; Endobronchial ultrasound (EBUS); Next-generation sequencing (NGS); Small biopsies
Congestive Heart Failure Weight Study
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Early morning weights to monitor CHF patient's fluid status is common practice but there is a
      lack of evidence that this is the best practice. The purpose of this study is to determine if
      there is a difference in net weight gain or loss for hospitalized patients with CHF who are
      weighed in the evening instead of early morning.
    

Detailed description: 
      This is a quasi-experimental pilot study with prospective cohort design. Study subjects will
      be weighed in the early morning and then again in the evening for a minimum of three days.
      Analysis will be accomplished on data by analysis within-subjects data utilizing the paired t
      test. Other data to be collected includes dates of hospitalization, demographics, dose and
      timing of medications, lab results and documentation of comorbid conditions.
    

Intervention name(s): Weigh subjects on a scale in the standing position
Intervention type(s): Procedure
Intervention description(s): Subjects will stand on a scale in the mornings, and the evenings for 3 days while hospitalized.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: CHF; congestive heart failure
Prevalence Assessment and Characterization of Psychological Disorders Associated With Hypobetalipoproteinemia
Condition: Hypobetalipoproteinemia
MeSH terms: Hypobetalipoproteinemias; Mental Disorders
Study type: Observational

Summary: 
      Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic
      of LDL-C metabolism. Clinical manifestation range from asymptomatic patients to metabolic
      (fatty liver, diabetes) or psychiatric disorders still unrecognized. HYPOPSY research, aims
      to evaluate prevalence of hypobetalipoproteinemia, and to characterize specific related
      psychiatric disorders.
    

Detailed description: 
      Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic
      of LDL-C metabolism (Low Density Lipoprotein - Cholesterol) whose incidence is measured from
      1: 500 to 1: 1000. These heterozygous individuals may be asymptomatic or present some
      clinical (fatty liver, diabetes) or psychiatric manifestations still unrecognized. Moreover,
      these individuals have mostly a longevity syndrome and cardiovascular protection. The FHBL is
      often due to mutations of the APOB (APOlipoprotein B), major component of LDL, VLDL (Very Low
      Density Lipoprotein) and chylomicrons, and in some cases, loss-of-function mutations of the
      serine protease PCSK9, endogenous inhibitor of the LDL receptor.

      HYPOPSY research, aims to evaluate, in a population with psychiatric disorders, the
      prevalence of hypobetalipoproteinemia, and to characterize specific related psychiatric
      disorders.
    

Intervention name(s): Hypobetalipoproteinemia diagnosis (LDL-C ≤ 50 mg/dL without hypolipidemic treatment)
Intervention type(s): Other
Intervention description(s): LDL-C dosage.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted in mental Disorders Unit in Nantes University Hospital
A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
Condition: Kidney Failure, Chronic Therapy; Hemodialysis
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of
      intravenously administered Soluble Ferric Pyrophosphate
    

Detailed description: 
      -  A total of 48 healthy volunteers will be studied.

        -  Depending on the safety profile at completion of the highest dose cohort, an additional
           2 cohorts of subjects may be studied.

        -  Doses of SFP may be modified, depending on the PK and safety findings at each dose
           level.

        -  Cohorts may be dropped for safety or tolerability after discussion with the sponsor.

        -  There will be 6 active and 2 placebo subjects in each study cohort.

        -  Subjects in Cohorts 1-3 will receive ascending doses of SFP by intravenous infusion over
           4 hours.

        -  Subjects in Cohorts 4-6 will receive ascending doses of SFP by intravenous infusion over
           12 hours.

      All subjects will be confined in the CRC for 1 day prior to study drug administration and for
      2 additional days for safety assessments and completion of test procedures.
    

Intervention name(s): soluble ferric pyrophosphate; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): SFP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Soluble Ferric Pyrophosphate, Pharmacokinetics, Iron, Hemodialysis
Effect of Mulligan'Mobilization With Movement on Pain, Disability and Range of Motion in Patients With Knee Osteoarthritis
Condition: Physical Fittness
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      we tested the effect of adding the mobilization with movement to the traditional physical
      therapy program on pain, ROM and functional disability in patients with knee OA.

      study hypothesis: there will be no significant difference between traditional physical
      therapy program and the mobilization with movement plus the traditional physical therapy
      program on pain, ROM and functional disability in patients with knee OA
    


Intervention name(s): joint mobilization with movement; traditional physical therapy program
Intervention type(s): Procedure; Procedure
Intervention description(s): I.R, stretching exercises, strengthen exercises
Other intervention name(s): Muligan's technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mobilization with movement,knee osteoarthritis,
A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, two part, open-label, crossover study in healthy adult
      subjects to assess the effect of up to three formulations on the relative bioavailability of
      GSK2248761 100mg administered with and without food. Part A will evaluate two new
      formulations compared to the current formulation. Part B will evaluate one additional
      formulation if the bioavailability of the two formulations in Part A do not meet
      pre-specified criteria. Safety evaluations and serial PK samples will be collected during
      each treatment period. A follow-up visit will occur 7-10 days after the last dose of study
      drug.
    


Intervention name(s): GSK2248761 formulation 1; GSK2248761 reference formulation; GSK2248761 formulation 3; GSK2248761 formulation 2 or 4
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100mg GSK2248761 formulation 1- fasted 100mg GSK2248761 formulation 1 - with food (moderate fat meal); GSK2248761 100mg Gelucire reference capsule with food; 100mg GSK2248761 formulation 3 fasted 100mg GSK2248761 formulation 3 with food (moderate fat meal); 100mg GSK2248761 formulation 2 or 4 - fasted 100mg GSK2248761 formulation 2 or 4 - with food (moderate fat meal)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV, relative bioavailability, food effect, GSK2248761, healthy subjects; HIV Seronegativity
Dapagliflozin Effects on Epicardial Fat
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on
      the fat of the heart.
    


Intervention name(s): Dapagliflozin; Metformin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.; 500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL; Placebo pill taken once daily to mimic Dapagliflozin
Other intervention name(s): Farxiga
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: epicardial fat; diabetes; dapagliflozin
Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blind placebo-controlled clinical investigation into the efficacy and
      tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.
      The primary outcome is the change in 6-minute walk distance from baseline to week 12.
    

Detailed description: 
      Patients who have been on a stable dose of 125 mg twice daily (bid) of bosentan or any stable
      dose of sildenafil for at least three months prior to study start were randomized to either
      treprostinil inhalation solution or matching placebo.

      Administration of study medication was performed by inhalation with the OPTINEB™ ultrasonic
      nebulizer.

      The proposed dosing regimen was four times daily-upon awakening, at midday, evening (dinner
      time) and bedtime.

      After a patient has completed the twelve-week study period, they were given the option of
      enrolling into an open-label extension study.
    

Intervention name(s): Inhaled treprostinil; Placebo inhalation solution
Intervention type(s): Drug; Drug
Intervention description(s): Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil.; Doses are titrated to 9 breaths four times daily.
Other intervention name(s): Tyvaso; Placebo
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension
Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      The study will evaluate the clinical utilization of skin Cholesterol (SC) for cardiovascular
      risk assessment in asymptomatic individuals at low, intermediate and high risk based on
      Framingham global risk estimates.

      Preliminary studies have suggested that SC is an easy to measure, noninvasive marker of
      cardiovascular risk. This study is intended to provide further data in support of broader
      clearance by the Food and Drug Administration for the use of SC as a tool to identify
      asymptomatic patients at increased risk of cardiovascular disease. Currently, SC testing is
      cleared for use as part of risk assessment in subject suspected of having significant
      multi-vessel disease.

      The current study data will be used to support the use of SC testing as part of
      cardiovascular risk assessment in subjects without suspected coronary artery disease (CAD).
    

Detailed description: 
      -  The primary objective of the study will be to determine the relationship between skin
           cholesterol levels and carotid artery intima-media thickness (CIMT), a surrogate marker
           for atherosclerotic burden used as the "gold standard" comparator.

        -  Secondary objectives of the study will be to compare the skin cholesterol levels with
           other markers of CAD as HDL cholesterol, Apo B, hsCRP, and lipoprotein-association
           phospholipase A2.

        -  Another objective is to determine the relationship between skin cholesterol levels and
           the presence of carotid plaques detected by ultrasound.
    

Intervention name(s): Skin Cholesterol Testing
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Skin Cholesterol; Carotid Plaque; Carotid Intima-Media Thickness
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed
      dyslipidemia to study the effects of ER niacin/laropiprant on lipids.
    


Intervention name(s): Comparator: simvastatin; niacin (+) laropiprant; Comparator: atorvastatin calcium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): simvastatin (20mg to 40mg) for 12 weeks.; One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.; atorvastatin calcium (20mg to 40mg) for 12 weeks.
Other intervention name(s): Zocor®; MK0524A; atorvastatin
Intervention MeSH terms: Niacin; Atorvastatin; Simvastatin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment