bioihbjkbjnl/mcl2 huggingface dataset:
Designing an Implementation Strategy for Lung Screening and Smoking Cessation Treatment in Community Health Centers
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      Tobacco use is the leading preventable cause of death in the US and a major driver of health
      disparities. Among our tools for reducing the harms of tobacco is lung cancer screening
      (LCS). This study will combine a review of existing qualitative and quantitative data on
      barriers to lung cancer screening and smoking cessation in underserved populations, a
      quantitative analysis of predictors of lung cancer screening and smoking cessation treatment
      use among Massachusetts Federally Qualified Health Centers (FQHC)s, and a stakeholder
      advisory group to synthesize these data and select implementation strategies that reflects
      the critical determinants and the strengths and resource constraints of the Federally
      Qualified Health Centers (FQHC) context.
    

Detailed description: 
      Aim 1) To design an implementation strategy that targets critical components in the delivery
      of SCT or LCS services for patients who smoke.

      Aim 2) To assess the acceptability, appropriateness and feasibility of the implementation
      strategy among community health center staff.
    

Intervention name(s): Qualitative Group Interviews; Stakeholder advisory group
Intervention type(s): Other; Other
Intervention description(s): One time interview, 60-90 minutes; The team will meet with the stakeholder advisory group four times for 1-2 hours each
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and
      Olmesartan in healthy male volunteers
    


Intervention name(s): Rosuvastatin; Olmesartan; Rosuvastatin and olmesartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single administration of rosuvastatin 20mg tablet QD for 7 consecutive days; Single administration of olmesartan 40mg tablet QD for 7 consecutive days; Co-administration of rosuvastatin 20mg tablet and and olmesartan 40mg tablet QD for 7 consecutive days
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics, drug-drug interaction
Split-face Study: Cosmetic Botulinum Toxin Type A Injection Under Electromyography-guidance Versus Conventional Palpation Technique
Condition: Glabellar Frown Lines; Rhytides; Wrinkle; Facial Expression
Study type: Interventional

Summary: 
      The aim of this study was to compare between the conventional palpation method of botulinum
      toxin type A injection and the electromyography-guided method using clinical parameters and
      electromyography analysis.
    

Detailed description: 
      The study was conducted on 15 healthy-looking female subjects with visible glabellar rhytids
      when frowning. All participants were recruited from the outpatient clinic of Dermatology
      Department, Main University Hospital, Faculty of Medicine, Alexandria University. The mean
      age was 46.27 ± 6.31 with a range from 33 to 59 years. All 15 subjects completed the study.

      Each subject provided a right and left corrugator supercilii muscles to the study. Each
      muscle was divided into a body and a tail, each part injected separately (n=60).

      Neurotoxin injection into the corrugator body and tail by palpation method on one side and
      under EMG-guidance on the other.

      Photographs were taken both at rest, and while frowning at each visit: pre-operatively, after
      2 weeks and after 3 months.

      Clinical grading according to static and dynamic Merz glabellar frown line scales and EMG
      analysis was done at each visit: pre-operatively, after 2 weeks and after 3 months.
    

Intervention name(s): Electromyography-Needle Intramuscular Drug guidance; Botulinum toxin type A
Intervention type(s): Device; Drug
Intervention description(s): EMG-guided needle neurotoxin injection; Botulinum toxin type A injection into the Corrugator Supercilii muscle
Other intervention name(s): Electromyography-guided injection; Botulinum neurotoxin; BoNT - A; BTX - A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-Face: comparing two neurotoxin injection techniques, conventional palpation vs. EMG-guided injection.
Follow up using EMG analysis and Glabellar Merz Scales
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Botulinum Toxin; EMG-Guided Botulimun toxin injection; Cosmetic Botulinum toxin; Glabellar Merz Scale
Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS
Condition: Multiple Sclerosis, Chronic Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive
Study type: Interventional
Phase: Phase 2

Summary: 
      A multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting
      Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at
      multiple investigational study sites.
    

Detailed description: 
      An open-label study with a single treatment arm involving 20 participants with progressive MS
      at multiple investigational study sites. After providing informed consent, participants
      meeting the inclusion and exclusion criteria will be randomized and approximately 4 weeks
      later will undergo a bone-marrow aspiration (BMA). Each participants will receive three
      Intrathecal cell transplantations within 16 weeks and will be followed for 12 weeks for
      safety and efficacy.
    

Intervention name(s): NurOwn (MSC-NTF cells)
Intervention type(s): Biological
Intervention description(s): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Use of the Drug Ingaron in Patients With COVID-19
Condition: COVID-19 Respiratory Infection; Viral Pneumonia
MeSH terms: Infections; COVID-19; Respiratory Tract Infections; Pneumonia, Viral
Study type: Observational

Summary: 
      Interferon gamma is a powerful endogenous regulatory cytokine that activates the antiviral
      immune response, while it also has its own antiviral activity. The objective of this study
      was to evaluate the effectiveness of the proposed treatment regimen with Ingaron (INN:
      recombinant interferon gamma human, lyophilisate for preparing a solution for intramuscular
      and subcutaneous administration of 500,000 IU) in patients with viral pneumonia.
    

Detailed description: 
      The study drug was prescribed for therapeutic purposes according to the following scheme:

      500,000 IU s / c 1 time per day daily for 5 days. A total of 4 visits were scheduled. Visits
      0 and 1 could be combined provided that the chronological sequence of screening and
      randomization procedures was followed.

      The main stages of the study:

      screening - lasting no more than 1 day; treatment - within 10-14 days, including the use of
      the investigational medicinal product for 5 days (from the first day of the basic therapy,
      daily).

      The total duration of observation is up to 14 days. Patients who completed participation in
      the study or dropped out of the study ahead of schedule were followed up by the attending
      physician in accordance with the rules for managing such patients for a medical institution.
    

Intervention name(s): Interferon Gamma
Intervention type(s): Drug
Intervention description(s): injection form
Other intervention name(s): Ingaron; Interferon gamma human recombinant
Intervention MeSH terms: Interferons; Interferon-gamma
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with novel coronavirus infection COVID-19
      
Keywords: COVID-19 treatment; interferon gamma
Light Based Analysis of Developing Breast Tissue in Adolescent Girls: a Feasibility Study
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The proposed pilot study attempts to investigate the feasibility of Optical Spectroscopy (OS)
      as a method to quantify breast tissue composition and density in adolescent females. Our
      goals include: to assess whether adolescent girls can be instructed to assist with the OS
      measurement procedure and to determine the OS technique's ability to show breast tissue
      composition and density in adolescent breast tissue.
    

Detailed description: 
      The period between menarche and the age of first full-term pregnancy has been identified as
      being most crucial for establishing an individual's future breast cancer risk.
      Epidemiological studies further suggest exposures, such as foods and toxins, during
      adolescence to have a significant impact on the likelihood of transformation in the
      developing breast resulting in cancer later in life. Adolescent diet affects mammary
      development directly and indirectly by influencing the micronutrients and the hormonal status
      of the adolescent. The goal of this study is to investigate the feasibility of Optical
      Spectroscopy (OS), a method based on differential light scattering and absorption in tissue,
      to quantify bulk breast tissue properties in adolescent females.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Residents of Toronto, Ontario, Canada.
      
Keywords: Optical Transillumination Spectroscopy; Breast Cancer Risk
Preventing Adolescents From Entering the Juvenile Justice System
Condition: Substance Use; Delinquency
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This randomized controlled study tests an innovative juvenile diversion model that integrates
      evidence-based family therapy.Immediate and longer term effects of the family intervention
      will be compared to Services As Usual with 120 adolescents participating in Miami-Dade's
      Civil Citation Program.
    

Detailed description: 
      This study proposes to rigorously test the innovative Civil Citation Program (CCP)with an
      integrated evidence-based family intervention, Multidimensional Family Therapy[MDFT](Liddle,
      2002).

      The study sample includes youth referred to the CCP throughout Miami-Dade county and who
      according to CCP screening are rated as high risk for re-offending. Youth are 12-17 years old
      with a first or second misdemeanor charge (excluding any gang, violence, or sex crimes
      charge). Nearly all (97%) of these youth are ethnic minorities (Hispanic and African
      American). They are at risk for school failure, substance use, and chronic delinquency due to
      drug availability in their communities, poor family functioning, peer drug use/delinquency,
      and school failure / disengagement.

      120 youth who enter the Civil Citation Program and are eligible for the study will be
      assigned to one of the two interventions: CCP+SAU or the experimental intervention, CCP+MDFT.

      The study asks a classical services research question(Compton et al, 2005) - does the
      addition of a family therapy intervention, multidimensional family therapy, into an existing
      diversion program significantly enhance the program outcomes in key outcome domains:
      recidivism, substance use, delinquency, school and family functioning.
    

Intervention name(s): CCP+MDFT; CCP+SAU
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Multidimensional Family Therapy (MDFT; Liddle, 2002) is one of a new generation of multi-systems oriented family-based intervention for adolescent substance abuse and delinquency. It has demonstrated considerable success with juvenile justice youth at various stages of their involvement in the justice system. The model has demonstrated efficacy in reducing substance use and delinquency, increasing the prosocial behaviors (e.g., family functioning, school outcomes) of substance abusing and court involved adolescents.; Services As Usual community partners will provide individualized mental health counseling and psychiatric services, psychoeducational groups and substance abuse counseling.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescents; Family-Based treatment; Multidimensional Family Therapy
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
Condition: Secondary Hyperparathyroidism
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional

Summary: 
      FGF-23 is a newly described protein that is an important regulator of phosphorus in the body.
      This protein increases in people with kidney disease and people who need dialysis have very
      high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23
      levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be
      lowered in patients with kidney disease by preventing them from absorbing phosphorus from
      food. This study is designed to see what happens to levels of FGF-23 in the blood when
      patients with chronic kidney disease take medications to prevent phosphorus absorption. Since
      high levels of FGF-23 have been linked with increased rates of death in patients with
      advanced kidney disease, controlling the levels may, in the future, be a way to decrease
      heart disease in patients with kidney disease.
    


Intervention name(s): Sevelamer Carbonate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Daily renvela (800 mg tid with meals) x 12 weeks; 1 inert tablet tid x 12 weeks
Other intervention name(s): Renvela
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship
Condition: Contrast Induced Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Early Phase 1

Summary: 
      We previously demonstrated that the slope of the relationship plotting individual iodine
      loads against contrast-induced serum creatinine changes ( the load-to-damage relationship,
      LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is
      to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two
      different contrast media using serum cystatin-C changes as the LDR dependent variable.
    

Detailed description: 
      We previously demonstrated that the slope of the relationship plotting individual iodine
      loads against contrast-induced serum creatinine changes ( the load-to-damage relationship,
      LDR) characterizes the intrinsic nephrotoxicity of the contrast and it may allow for reliable
      comparative evaluations among small sized study groups randomized to different contrast
      media. The aim of the present study is to compare, through the assessment of the LDR slope,
      the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes
      as the LDR dependent variable.
    

Intervention name(s): Iobitridol 350; Iodixanol 320
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: acute kidney injury; contrast media; cystatin-C
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate and compare efficacy of 3 dose levels of
      PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic
      Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory
      measures as well.
    


Intervention name(s): PF-04236921; PF-04236921; PF-04236921; PF-04236921
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): subcutaneous injection; administered at day 1, weeks 8, 16.; subcutaneous injection; administered at day 1, weeks 8, 16.; subcutaneous injection; administered at day 1, weeks 8, 16.; subcutaneous injection; administered at day 1, weeks 8, 16
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: double-blind; placebo-controlled; multicenter; dose-ranging; efficacy; safety; lupus.
Effects of Nopal Fractions on Postprandial Glucose Regulation and Appetite Variables in Healthy Humans
Condition: Glucose Tolerance; Appetite Sensations
Study type: Interventional

Summary: 
      Postprandial effects of Nopal fractions on glucose and appetite regulation will be
      investigated in healthy humans, in a randomised controlled crossover trial
    


Intervention name(s): Nopal fractions; Test product without the active components
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nopal flour were divided in two fractions and mixed in two different test breads; Test product without the active components
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomised crossover study in healthy young adults with normal BMI
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: healthy subjects; diabetes prevention; obesity prevention
Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab
Condition: Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544)
      in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).
    


Intervention name(s): Inotuzumab Ozogamicin (CMC-544); Rituximab (Rituxan)
Intervention type(s): Drug; Drug
Intervention description(s): 1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.; 375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.
Intervention MeSH terms: Rituximab; Inotuzumab Ozogamicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell Non-Hodgkin's Lymphoma; NHL
The Effect of Potatoes on Markers of Cardiometabolic Health
Condition: Type 2 Diabetes Mellitus; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      A 2-period randomized cross-over trial will be conducted to determine the effect of
      incorporating 1 medium size potato, compared to an isocaloric portion of refined grains, on
      fasting glucose levels, insulin sensitivity, blood pressure, lipids and lipoproteins,
      arterial stiffness, body weight, gut microbiome, and dietary intake.
    

Detailed description: 
      A 2-period randomized cross-over study will be conducted. Free-living subjects will be
      provided with a potato based side dish (equivalent to one medium sized potato) or an
      isocaloric refined grain based side dish every day for 4 weeks, in random order. The
      treatment periods will be separated by a minimum two-week break. Endpoint testing will be
      conducted over two days at baseline and the end of each diet period.
    

Intervention name(s): Potato-based side dish; Refined grain-based
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks; Daily consumption of an isocaloric refined grain-based side dish for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation
Condition: Preterm Birth
MeSH terms: Premature Birth; Inflammation
Study type: Interventional

Summary: 
      The purpose of the PIINC study is to identify differences in placental inflammatory lesions
      between women participating in group prenatal care versus standard prenatal care, and
      additionally, examine whether the frequency of placental inflammatory lesions differ by race
      and income. The investigators hypothesize that women participating in group prenatal care
      will have lower pro-inflammatory profiles compared to women in routine prenatal care.
    

Detailed description: 
      This is a supplementary investigation of placental inflammatory lesions among participants
      enrolled in a randomized controlled trial comparing biomedical, behavioral and psychosocial
      outcomes among pregnant women who participate in CenteringPregnancy group prenatal care, to
      women in the traditional individual prenatal care and to investigate whether improving
      women's stress, activation and engagement will explain the potential benefits of
      CenteringPregnancy on outcomes and health disparities. The study will be conducted in a large
      prenatal care center in South Carolina. Eligible White and Black women will be recruited
      before 20 weeks of gestational age with low risk pregnancy.
    

Intervention name(s): CenteringPregnancy
Intervention type(s): Behavioral
Intervention description(s): Pregnant women whose due dates are in the same month will receive ten 2-hour group prenatal care sessions according to the standard curriculum provided by the Centering Healthcare Institute.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pregnancy