bioihbjkbjnl/mcl2 huggingface dataset:
Cardiovascular Radiologic and Metabolic Assessment in HIV: An Investigation of Pathophysiology
Condition: HIV; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Background:

      - Antiretroviral therapy has increased the lifespan of people with human immunodeficiency
      virus (HIV), but recent research suggests that people with HIV also have an increased risk of
      developing cardiovascular disease. To better understand the prevalence and effects of heart
      disease in people with HIV, researchers are interested in comparing heart imaging and
      metabolism studies to see if there are differences between HIV-positive and HIV-negative
      people.

      Objectives:

      - To study metabolism and heart function in people with HIV compared with healthy
      HIV-negative volunteers.

      Eligibility:

      - Individuals at least 18 years of age who either have been diagnosed with HIV or are healthy
      HIV-negative volunteers.

      Design:

        -  Participants will be evaluated with a physical exam, detailed medical history, and
           routine blood and urine tests including HIV testing.

        -  Participants will have the following imaging scans:

        -  Cardiac magnetic resonance imaging (MRI) to study the health of the heart and blood
           vessels

        -  Magnetic resonance spectroscopy (MRS) of the heart, liver, and skeletal muscle

        -  Cardiac computerized tomography (CT) scan to measure calcium levels in the heart and
           nearby arteries

        -  Dual-energy x-ray absorptiometry (DEXA) scan to measure body fat and muscle mass.

        -  Stable isotope infusion to evaluate how the body processes fat (which will require an
           overnight stay before the test)

        -  Participants will also have blood tests, an echocardiogram, and an electrocardiogram to
           evaluate heart function.
    

Detailed description: 
      HIV is now a chronic infection as patients with access to antiretroviral therapy have
      significantly improved life expectancies. Patients with HIV also have an increased risk of
      cardiovascular disease. Thus, cardiovascular disease is an important potential co-morbidity
      for patients living with HIV. The current proposal will perform a detailed cardiovascular
      assessment using state-of-the-art imaging techniques to evaluate intramyocardial lipid as
      well as coronary artery disease and myocardial function in a cohort of 100 HIV infected
      patients and 30 healthy volunteers as controls. This is an early exploratory cross-sectional
      study designed to both assess the burden of disease and apply novel techniques in this unique
      population.
    

Time perspective: Other
Keywords: Cardiac Imaging; MR Spectroscopy; HIV; Lipid Metabolism; HIV Infection; Cardiovascular Disease; HIV Infections
A Phase I Study of Modified Vaccinia Virus Ankara (MVA-B) in Healthy Volunteers at Low Risk of HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to study a modified pox viral vector considering:

        1. HIV subtype B accounts for the most frequent virus strain in Europe and North America,
           as well as in many parts of the world.

        2. This novel vaccinia construct expressing HIV subtype B gag, pol, env and nef antigens is
           to be studied in humans for the first time.
    


Intervention name(s): MVA-B; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef)
-~ 1 x 10e8 pfu/ml
3 immunisations at week 0, 4 and 16; -3 immunisations at week 0, 4 and 16
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Low risk HIV infection; HIV Seronegativity; HIV Preventive Vaccine
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make
      the body build an immune response to kill tumor cells. Biological therapies such as
      denileukin diftitox may be able to deliver cancer-killing substances directly to melanoma
      cells. Combining vaccine therapy with biological therapy may kill more tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of combining vaccine therapy with
      denileukin diftitox in treating patients who have stage III or stage IV melanoma.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of vaccination with autologous dendritic cells pulsed with tumor
           and influenza antigen peptides with or without ex vivo CD40-ligand and denileukin
           diftitox, in terms of tumor-specific T-cell response, in patients with HLA-A1- and/or
           HLA-A2.1-positive stage III or IV melanoma.

        -  Determine the safety and tolerability of these vaccinations in these patients.

        -  Determine tumor response in patients treated with these vaccinations.

      OUTLINE:

        -  Phase I (Administration of denileukin diftitox and vaccinations #1 to #4): Patients
           undergo leukapheresis for collection of peripheral blood mononuclear cells (PMBC). PBMC
           are processed for the generation of dendritic cells (DC) to be used for vaccinations. DC
           are pulsed with HLA-A1- and HLA-A2.1-restricted peptides derived from
           melanoma-associated tumor antigens. DC are pulsed with or without ex vivo treatment with
           CD40-ligand. Patients receive denileukin diftitox IV for 3 consecutive days before the
           first vaccination. Patients receive 4 pulsed DC vaccinations subcutaneously (SC) on days
           1, 14, 42, and 70 in the absence of disease progression or unacceptable toxicity.

      Patients who show a tumor response (at least stable disease) may receive vaccination #5 and
      further booster vaccinations.

        -  Phase II: DC are generated and pulsed as in phase I. Patients receive up to 6 additional
           booster pulsed DC vaccinations SC on days 126, 184, 268, 356, 520, and 692 in the
           absence of disease progession or unacceptable toxicity.

      Patients are followed for 10 years.

      PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12
      months.
    

Intervention name(s): Dendritic cell vaccine plus denileukin difitox
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent melanoma; stage IV melanoma; stage IIIA melanoma; stage IIIB melanoma; stage IIIC melanoma
Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men
      with idiopathic osteoporosis.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients
      self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo
      for a period of 2.5 years.

      Patients are followed regularly for unacceptable toxicities.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): human parathyroid hormone
Intervention type(s): Drug
Intervention MeSH terms: Hormones; Parathyroid Hormone
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: disease-related problem/condition; osteoporosis; rare disease
Effects of Portion Size and Energy Density of a Single Meal in Preschool Children
Condition: Feeding Behaviors
Study type: Interventional

Summary: 
      This study investigates the effect of varying both energy density and portion size of all
      foods at lunch on preschool children's intake. The foods used in this study are
      commercially-available, commonly-consumed foods with typical variations in energy density.
      The primary aim of the study is to investigate the independent and combined effects of energy
      density and portion size on preschool children's intake at a meal composed of foods typically
      served to this population.
    


Intervention name(s): Varying meal energy density and portion size
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effectiveness of T-shaped Toothbrush
Condition: Oral Hygiene
Study type: Interventional

Summary: 
      This study evaluated the effectiveness of two manual toothbrushes, the T-shaped toothbrush
      (Denson™, Malaysia) and a conventional toothbrush (Kid's Soft Toothbrush, Colgate) in
      removing plaque and maintaining gingival health among 8-10-year old children.

      Brushing demonstration was provided at baseline and reinforced at 2 weeks and 1 month
      interval.Plaque scores and gingival scores were measured at 2 weeks and 1 month and 3 months
    

Detailed description: 
      T-shaped toothbrush (Denson™, Malaysia) was introduced that is designed to efficiently clean
      and reduce gingival inflammation. Unlike most common conventional manual toothbrush, this new
      toothbrush was designed to employ a vertical motion on all tooth surfaces which simulates the
      natural up and down movement of the hand, suggesting that this makes the brushing process to
      be more controlled and stable.

      One hundred and ten participants were assigned randomly to conventional toothbrush (Kid's
      Soft Toothbrush, Colgate) as a control group, while another half were assigned the T-shaped
      toothbrush (Denson™, Malaysia) as an experimental group.

      Gingival status was scored using the Loe and Silness Gingival Index 25. The amount of plaque
      was scored using the modified Quigley and Hein Plaque Index (TQHI) 26. Both indices were
      recorded at 6 sites around all the teeth (mesiobuccal, midbuccal, distobuccal, mesiopalatal,
      midpalatal, distopalatal). All teeth were included except teeth with prosthetic crowns or
      cervical restorations.

      One hundred children completed the study.
    

Intervention name(s): Brushing demonstration using T shaped toothbrush; Brushing demonstration using conventional toothbrush
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month; Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: toothbrush; plaque removal; gingival health
A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the
      Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects
    


Intervention name(s): EDP-305; Oral Contraceptive
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3; Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3
Other intervention name(s): ethinyl estradiol [EE] and norgestimate [NGM])
Intervention MeSH terms: Ethinyl Estradiol; Norgestimate; Contraceptive Agents; Contraceptives, Oral; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: OC DDI, drug-drug interaction, oral contraceptive
PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
Condition: Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary

      - To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma
      after second period of treatment

      Secondary

        -  To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract
           infections symptoms through patient evaluation of fever or respiratory presence after
           second period of treatment

        -  To evaluate loss of working or study days after second period of treatment

        -  To evaluate the safety and tolerability of Pulmonarom in the population under study
    


Intervention name(s): Bacterial Lysates; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bacterial Lysates ampoules 3 mL, oral route, daily for 10 days, followed by 30 days free of medication and then 10 days of administration of the drug; placebo controlled
Intervention MeSH terms: Broncho-Vaxom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Use of the FAST (Focused Abdominal Scan for Trauma) Scan by Paramedics in Mass Casualty Incidents
Condition: Mass Casualty
Study type: Interventional

Summary: 
      Initially a group of paramedics will be trained to perform FAST (Focused Abdominal Scan for
      Trauma) scans. The paramedics will then enter a simulated mass causality incident and triage
      patients. Volunteers in the study will include peritoneal dialysis patients ("non stable")
      and non-peritoneal dialysis patients ("stable"). They will use the ultrasound to perform FAST
      scans on the patients to determine which subjects are "stable" and which are "unstable"
      patients. They will record which patients they consider need transport first. This data will
      be used to evaluate accuracy and speed of the FAST scan. When the paramedic identifies free
      fluid within the volunteer, they will be able to make the decision to upgrade these patients
      and ultimately transport them more quickly. The paramedics will be evaluated for time and
      accuracy with the FAST scan.
    

Detailed description: 
      Ultrasound and the FAST (Focused Abdominal Scan for Trauma) scan is currently being used in
      the Emergency Department to help evaluate trauma patients. In the field a paramedic will use
      the START (Simple Triage Rapid Treatment) triage procedure to evaluate many patients and to
      help decide which patients are more critical and therefore need to be transported first. This
      study aims to create a mass casualty environment through the use of 10 volunteers who are on
      peritoneal dialysis and 10 patients who are not.
    

Intervention name(s): SonoSite Ultrasound; SonoSite Ultrasound
Intervention type(s): Procedure; Procedure
Intervention description(s): Will be moulaged to resemble a peritoneal dialysis patient. Paramedics will scan the abdomen and determine it there's fluid within.; Paramedics will scan the abdomen and determine it there's fluid within.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Effect of Pulsed Electromagnetic Field and Pulsed Ultrasound in Treating Knee Osteoarthritis
Condition: Osteo Arthritis Knee; Ultrasound Therapy; Complications
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study will be carried out to combine the effect of PEMF and PUT on pain, function, and
      ROM in patients with knee OA.
    

Detailed description: 
      Osteoarthritis (OA) is one of the most frequent illnesses in the world, affecting the knee
      joint in particular. Osteoarthritis of the knee is the most common cause of physical
      limitations and a decline in quality of life. OA of the knee affects 250 million individuals
      worldwide (3.6 percent of the population). According to the World Health Organization's study
      on the global burden of illness, knee OA is expected to become the eighth-most

      Ultrasound is one of the most often utilized and misunderstood treatment techniques.
      Ultrasound can help in the treatment or rehabilitation of musculoskeletal problems when
      utilized appropriately. When it is administered wrongly, however, the therapy provides little
      benefit at best, and at worst, the desired physiological effects are restricted or hindered.

      Electrotherapy is frequently used for the treatment of different musculoskeletal disorders,
      The most common types of electrotherapy are ultrasound (US), iontophoresis, laser therapy,
      electromagnetic therapy, and transcutaneous electrical nerve stimulation (TENS). To our
      knowledge, no previous clinical trials have combined the effectiveness of PEMF and PUST in
      the treatment of knee OA. Therefore, this study will be conducted to combine the efficacy of
      PEMF and PUST in the treatment of knee osteoarthritis.
    

Intervention name(s): Pulsed Ultrasound; Pulsed Electromagnetic field; Traditional exercise program; Sham Pulsed US & Electromagnetic field
Intervention type(s): Device; Device; Other; Device
Intervention description(s): Active US therapy will be administered using a device 4cm², 1- MHz US with a sound-head area of effective 4cm, radiating area of 3.5 to a beam non-uniformity ratio of cm². 5:1, and a therapeutic dose of approximately 112.5J/ That is, the pulsed US will be delivered for 9.5 minutes with a peak intensity of 1W/cm² at a 20% duty cycle, to achieve a spatial-temporal average intensity of 0.2W; The patient's knee will be placed between 2 plates coil applicator generating a magnetic field intensity of 1.5 mT and a frequency of 75Hz.; Stretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening; The patients will receive Sham Pulsed US & Electromagnetic field.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin
      Lispro.

      The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects
      with type 1 diabetes under a dose of 0.8 U/kg.

      This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period
      cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes
      mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of
      BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate
      dosing visits.
    


Intervention name(s): BioChaperone® Combo; Humalog® Mix25
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 0.8U/kg body weight injected subcutaneously (under the skin); Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lung Function and Airway Inflammation in Portland Cement Workers
Condition: Airway Inflammation; Peripheral Blood Inflammation Markers; Cement Dust Exposure
MeSH terms: Inflammation
Study type: Observational

Summary: 
      The aim of the study is to examine inflammation in the airways and in peripheral blood, in
      workers in a cement plant i Norway.
    

Detailed description: 
      OBJECTIVE: Former studies have presented conflicting data on the association between exposure
      to Portland cement dust and respiratory effects. Our goal is to examine inflammation in the
      airways and in peripheral blood in subjects exposed to cement-dust.

      METHODS: All non smoking, dust exposed, workers from one department in the largest cement
      plant in Norway, are invited to participate. The workers will perform spirometry and induced
      sputum (IS) after a period of regular work with cement dust exposure, and again after a
      minimum of 5 days without exposure. Information on respiratory symptoms, allergy and former
      respiratory disease will be given on a self-reported questionnaire. IS was performed and
      processed as described by Pin et al. Differential cell counts will be carried out.
      Inflammatory markers in induced sputum and in peripheral blood will be measured. We want to
      use a crossover design were the cases are used as their own controls, but we will also
      include external controls.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Workers from Norways largest cement plant
      
Biospecimen description: 
      Induced sputum samples and blood samples
    
Keywords: Cement dust exposure; Induced sputum; Airway inflammation; Peripheral blood inflammation markers
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia
Condition: HIV Infections; Cytopenias
MeSH terms: HIV Infections; Anemia
Study type: Interventional

Summary: 
      To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or
      advanced AIDS related complex (ARC) and anemia secondary to their disease.
    


Intervention name(s): Epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Masking: Double
Primary purpose: Treatment
Keywords: Recombinant Proteins; Erythropoietin; Acquired Immunodeficiency Syndrome; Anemia; AIDS-Related Complex; Zidovudine