bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose
      treatment with MK-1029 in adults with mild to moderate persistent asthma.
    


Intervention name(s): MK-1029; Placebo for MK-1029
Intervention type(s): Drug; Drug
Intervention description(s): Five (5) X 100 mg capsules, orally, once daily for 28 days; Five (5) X 100 mg capsules, orally, once daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
AZD8601 Study in CABG Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, sequential design, multicentre study
      in patients with moderately impaired systolic function undergoing CABG surgery. Twenty four
      (24) patients scheduled for elective bypass surgery will be randomized (up to approximately
      33 patients if replacements are needed). The objective is to investigate safety and
      tolerability of AZD8601 following epicardial injection in patients undergoing Coronary Artery
      Bypass Grafting (CABG) surgery with moderately impaired systolic function. At Visit 3
      patients will receive either AZD8601 or placebo as epicardial injections and will then be
      followed up at 14 days (telephone visit) and 1, 3 and 6 months (on-site) post-surgery.
    


Intervention name(s): AZD8601; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AZD8601 solution for injection, 0,5 mg/mL and 5 mg/mL will be given as 30 injections of 0.1 mg (3 mg per patient), or 1 mg (30 mg per patient) respectively on a single occasion; Placebo for AZ8601 injection for solution will be given as 30 injections per patient on a single occasion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effectiveness of Yoga@Work to Reduce Head and Muscle Pain in Office Workers
Condition: Headache; Cervical Pain; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Myalgia; Headache; Neck Pain
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the effectiveness of a workplace yoga
      intervention in reducing the frequency of pain involving the head and neck area.
    


Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): Relaxation yoga exercises, yoga breathing, yoga sound and imagery practices
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will assess the total testosterone and sex hormone-binding globulin levels in men
      with type 2 diabetes before and after continuous subcutaneous insulin infusion and
      hypoglycemic drugs treatment.
    


Intervention name(s): Insulin; Metformin; Dapagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Continuous subcutaneous insulin infusion therapy for 1 month; Continuous subcutaneous insulin infusion plus metformin (at least1000mg/day) for 1 month; Continuous subcutaneous insulin infusion plus metformin (10mg/day) for 1 month
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Effects of Snack Products on Energy
Condition: Energy
Study type: Interventional

Summary: 
      To determine the effect of snack products varying in composition, on energy in healthy adult
      subjects.
    


Intervention name(s): Snack Product; Snack Product; Snack Product
Intervention type(s): Other; Other; Other
Intervention description(s): control food product; Experimental food product containing ingredient 1; Experimental food product containing ingredient 2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
Condition: Meningitis; Meningococcemia; Pertussis; Tetanus; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Meningitis; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate the immunogenicity and safety of the concomitant
      administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.

      Primary Objective:

      To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces
      antibody responses that are similar to those observed when each vaccine is given separately.

      Secondary Objective:

      To compare the rates of injection site reactions at the Tdap injection site after Tdap and
      Menactra® vaccines are administered concomitantly to the corresponding rates of reactions
      when Tdap vaccine is administered alone.
    


Intervention name(s): T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.; Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.; Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular; Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular; Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular
Other intervention name(s): ADACEL®; Menactra®; Sterile Buffered 0.9% Sodium Chloride; Menactra®; Adacel®; Sterile Buffered 0.9% Sodium Chloride; Menactra®; Adacel®; Sterile Buffered 0.9% Sodium Chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcemia; Pertussis; Neisseria meningitidis; Tetanus; Diphtheria
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate whether the patients with Type 1 diabetes
      mellitus in sub-optimal glycemic control can achieve better glycemic control by using the
      Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus
      the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose
      (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to
      control group, after 6 months of treatment.
    


Intervention name(s): insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System); insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)
Intervention type(s): Device; Device
Intervention description(s): 6 months of pump plus continuous glucose sensing in conjunction to SMBG; insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted.
Other intervention name(s): Paradigm Real-Time Insulin Pump System; Medtronic MMT-522 or MMT-722 + MMT7707WW; Paradigm Real-Time insulin pump; Guardian Real-Time clinical; MMT-522 or MMT-722 + MMT7707WW + CSS7100
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes
Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045)
Condition: Human Immunodeficiency Virus (HIV) Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effects of multiple doses of doravirine (MK-1439) on the
      pharmacokinetics of methadone in participants requiring methadone maintenance therapy. The
      primary hypothesis is that area under the plasma concentration-time curve to 24 hours
      postdose (AUC0-24) of (R)-methadone is similar when a maintenance regimen of methadone is
      administered with or without multiple daily doses of doravirine.
    


Intervention name(s): Methadone; Doravirine
Intervention type(s): Drug; Drug
Intervention description(s): Methadone 20 to 200 mg (10 mg/mL if oral solution concentrate) oral tablet once per day.; Doravirine 100 mg oral tablet once per day.
Other intervention name(s): MK-1439
Intervention MeSH terms: Methadone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients
Condition: Multiple Myeloma; Non-Hodgkin Lymphoma; Hodgkin Disease
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study to evaluate the efficacy and safety of TG-0054 combined with G-CSF
      in mobilizing hematopoietic stem cells in patients with multiple myeloma, non-Hodgkin
      lymphoma or Hodgkin disease.
    


Intervention name(s): TG-0054 combined with G-CSF
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
REM (Risk Of Endometrial Malignancy)
Condition: Endometrial Disease
MeSH terms: Uterine Diseases
Study type: Interventional

Summary: 
      The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial
      Malignancy (REM) in women with ultrasound endometrial abnormalities.
    

Detailed description: 
      Objective: It is often difficult to distinguish a benign endometrial disease from a
      malignancy and tools to help physician are needed, in order to triage patients into high and
      low risk of endometrial cancer (EC). The purpose of this study was to obtain a predictive
      model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial
      abnormalities.Women, between 45 and 80 years, diagnosed with ultrasound endometrial
      abnormalities and scheduled to have surgery were enrolled on a prospective study at
      Department of Gynaecologic Oncology of Campus Bio-Medico of Rome. Preoperative clinical,
      ultrasound and laboratory features were taken into account. Logistic regression algorithm was
      utilized to categorize patients into low and high risk groups for EC.
    

Intervention name(s): Training set; VERIFICATION SET
Intervention type(s): Other; Other
Intervention description(s): We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative; We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: endometrial cancer; score; nomogram; ultrasound; HE4
Bundling Gentle Body Massage Along With Regular Position Change Under Phototherapy
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Interventional

Summary: 
      This study aimed to investigate the effect of bundling gentle body massage along with regular
      position change on bilirubin level and clinical outcomes among full-term neonates with
      hyperbilirubinemia under phototherapy.

      Hypothesis

      Full-term neonates with hyperbilirubinemia who receive gentle body massage along with regular
      position change exhibit less bilirubin level and better clinical outcomes than those who
      don't.
    

Detailed description: 
      A quasi-experimental study was carried out in the NICU of XX. Sixty full-term neonates were
      randomly assigned to two equal groups.

      The control group received the conventional NICU care of infants undergoing phototherapy.
      Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm).
      Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the
      neonates who were kept naked in the incubator/crib except for the reproductive organs with
      shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was
      given continuously, except while feeding and nursing for 30 minutes every 3 hours. The
      neonates' skin was cleaned with warm water without applying any sorts of ointments oils or
      creams. They were also observed for signs of dehydration.

      The intervention group received all basic routine care in addition to regular position change
      from supine to laterals under the phototherapy every two hours. They also received gentle
      body massage
    

Intervention name(s): Gentle Body message; Routine NICU Care
Intervention type(s): Other; Other
Intervention description(s): The intervention group received gentle body massage twice/day and position change from supine to lateral every two hours under the phototherapy for three consecutive days in addition to routine NICU care.; received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Hyperbilirubinemia; neonatal; Massage Therapy; Bilirubin; Stool frequency; Length of Hospital Stay
Ozone Cardiovascular Effects in Genetically Susceptible People
Condition: Healthy
Study type: Interventional

Summary: 
      Increases in air pollution are associated with increases in deaths from cardiovascular
      disease, but the investigators know little about how ozone air pollution affects the
      cardiovascular system. The investigators proposed study will determine the effects of ozone
      on blood vessel and heart function that could worsen illness in people with underlying heart
      disease. This will be accomplished by studying healthy volunteers who inhale ozone in a
      controlled clinical study, and also by studying their exposure to ozone and other pollutants
      during their normal daily activities. The investigators will study volunteers who may be at
      increased risk for the effects of ozone because of genetic susceptibility. Understanding the
      effects of ozone on the heart and circulation can help establish appropriate air pollution
      standards, and provide strategies to protect the most susceptible people.
    


Intervention name(s): Ozone
Intervention type(s): Other
Intervention description(s): All subjects will have a 3-hour exposure to clean air, a 3-hour exposure to clean air with lower ozone (0.1 ppm), and a 3-hour exposure to clean air with higher ozone (0.2 ppm). Exposures will take place at least 3 weeks apart. Order of exposure will be randomized for each subject.
Other intervention name(s): Ozone exposure; Ozone air pollution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Air pollution; Ozone; Health effects of ozone exposure
Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if PLA-695 changes the blood concentrations of
      methotrexate when administered together.
    


Intervention name(s): PLA-695
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Low Density Lipoprotein Cholesterol (CLDL) as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Cardiovascular Disease
MeSH terms: Arthritis; Arthritis, Rheumatoid; Cardiovascular Diseases
Study type: Observational

Summary: 
      The investigators hypothesize that cLDL levels are elevated in RA patients and represents an
      important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease
      (CVD) in rheumatoid arthritis (RA) patients. The purpose of this study is to improve
      understanding of the reasons for increased cardiovascular diseases (such as heart attack and
      stroke) seen in patients with rheumatoid arthritis (RA, an arthritis that causes inflammation
      and destruction of joints). Specifically, the study plans to determine whether a particular
      type of change in proteins in LDL cholesterol ("bad cholesterol") known as carbamylation is
      an important risk factor for cardiovascular diseases in RA patients. The study will utilize a
      case-control study design. A total of 120 subjects (males and females between the ages of 18
      and 80) may be enrolled in order to ensure that 100 subjects (50 RA case subjects and 50 age
      and sex matched controls) complete the study. Procedures will consist of a single visit for
      each subject during which a screening evaluation, an enrollment evaluation, and a single
      blood draw will be performed.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from the UAMS Rheumatology Clinic at the UAMS Outpatient Center,
        Little Rock, other UAMS outpatient clinics, or through advertisement at the UAMS campus
        and/or the community.
      
Biospecimen description: 
      If a subject consents, any blood samples remaining after the tests planned for this study
      will be stored indefinitely for potential future new studies. Any future new studies using
      these blood samples will require prior approval by the UAMS Institutional Review Board (IRB).
      A subject may request destruction of the stored samples at any time.
    
Keywords: Rheumatoid Arthritis; cLDL; Cardiovascular disease
A Single-Dose Pharmacokinetics Study of Tapimycin Injection
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to examine the pharmacokinetic properties of Tapimycin injection
      (piperacillin 4 g + tazobactam 0.5 g powder for injection) in healthy volunteers under
      fasting conditions.
    


Intervention name(s): Tapimycin (piperacillin 4 g + tazobactam 0.5g)
Intervention type(s): Drug
Intervention description(s): One intravenous infusion (piperacillin 4 g + tazobactam 0.5 g powder for injection) over 30 minutes/single dosing
Intervention MeSH terms: Tazobactam; Piperacillin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: The PK of Tapimycin; volunteer
Comparison of Two Behavioral Treatments for Stress Reduction
Condition: Stress
Study type: Interventional

Summary: 
      Currently there are 2 popular stress reduction courses that are widely used in the US.
      Although they use somewhat similar techniques, it is currently unknown whether or not they
      work the same way, or if they are similarly effective at reducing stress. The study will
      directly compare these 2 courses. Participants will undergo approximately 4-5 hours of
      testing before and after each 8-week course.
    


Intervention name(s): RR; MBSR
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing relaxation; A well-validated 8 week stress reduction course. Classes meet once a week for 1.5 hours. Participants will be asked to perform stress reduction techniques each night for 20 minutes throughout the entire 8-week course. Stress reduction techniques use meditative techniques that focus primarily on inducing mindfulness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stress; meditation; stress reduction; fMRI; behavioral
Influence of the Shoulder Position on the Catheter Tip Location During Infraclavicular Subclavian Approach
Condition: Catheter Tip Location
Study type: Interventional

Summary: 
      Infraclavicular approach of the subclavian veins is commonly used for central venous access.
      Aberrant locations of catheter tip are frequently quoted for this approach, but few studies
      have been performed to document the relationship between the shoulder position and catheter
      tip location. This prospective study was performed to assess the influence of the shoulder
      position on the safe and proper placement of infraclavicular subclavian catheters.
    


Intervention name(s): neutral shoulder position; lowered shoulder position
Intervention type(s): Procedure; Procedure
Intervention description(s): neutral shoulder position during infraclavicular subclavian catheterization; lowered shoulder position during infraclavicular subclavian catheterization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: catheterization success rate
Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis
Condition: Rhinitis; Allergic; Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial
      Allergic Rhinitis.
    


Intervention name(s): levocetirizine dihydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: levocetirizine dihydrochloride; Xyzal tablets