bioihbjkbjnl/mcl2 huggingface dataset:
Screening for Lung Cancer in the HIV Patient
Condition: Lung Cancer in the HIV Patient; HIV Infections; HIV Seropositivity; Lung Cancer
MeSH terms: HIV Seropositivity; Lung Neoplasms
Study type: Observational

Summary: 
      That computed tomography (CT) screening of HIV-seropositive heavy smokers will detect early
      stage lung cancer at significantly higher rates than what is currently being observed.
    

Detailed description: 
      The study design is that of a prospective cohort study in which 200 smoking participants will
      be recruited from an existing HIV-seropositive cohort of 800 patients (the Human Oral
      Papillomavirus Etiology (HOPE) Study). Participants will be enrolled from the Johns Hopkins
      HIV (Moore) Clinic and the resources of the Johns Hopkins Adult Outpatient General Clinical
      Research Center (GCRC) and pilot project funding from the Lung Cancer SPORE will be utilized
      to fund the costs of the CT scans. An interdisciplinary team with expertise in HIV-associated
      malignancy, CT screening, lung cancer surgery, HIV infection, epidemiology and biostatistics
      has been assembled to test the hypothesis by accomplishing the following Specific Aims:
    

Intervention name(s): CT Scan with Spirometry
Intervention type(s): Device
Intervention description(s): During the screening and later during the five annual study visits the patients will be scheduled to undergo total of five CT scans. The first CT scan will take place at the beginning of the study and then each year for a period of five years.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-positive participants enrolled from the Johns Hopkins HIV (Moore) Clinic, as well as
        from the existing HIV-seropositive cohort of 800 patients (the Human Oral Papillomavirus
        Etiology (HOPE) Study).
Study of Post-Training Supports for Health Workers in Benin
Condition: Malaria; Pneumonia; Diarrhea; Measles; Malnutrition
MeSH terms: Malnutrition; Diarrhea
Study type: Interventional

Summary: 
      The objective of this study was to determine the effectiveness and cost-effectiveness of a
      package of interventions to support health workers in Benin (in West Africa) who had been
      trained to use Integrated Management of Childhood Illness guidelines (i.e., guidelines
      intended to improve the treatment of childhood illnesses).
    

Detailed description: 
      Integrated Management of Childhood Illness (IMCI) is a child health strategy in developing
      countries with a goal of improving the treatment of illnesses at first-level health
      facilities through the use of clinical practice guidelines. The World Health Organization
      (WHO) recommends implementing the guidelines with an 11-day training course. There is a
      concern that health workers might not master all aspects of the guidelines and that health
      worker performance may deteriorate over time. In 1999, Benin (in West Africa) was planning to
      implement IMCI. In response to concerns about how well health workers would follow IMCI
      guidelines, interventions were designed to support health workers after IMCI training: 1)
      regular supervision of health workers; 2) supervision of supervisors; 3) job aids; and 4)
      non-financial incentives for health workers. These interventions were intended to be used
      together. The objective of this study was to determine the effectiveness and
      cost-effectiveness of the package of interventions to support IMCI-trained health workers in
      Benin.
    

Intervention name(s): Health worker supports (supervision, job aids, incentives)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Benin; child health; developing country; health services research; health worker performance; Integrated Management of Childhood Illness
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
Condition: Candidiasis; Candidemia
MeSH terms: Infections; Candidiasis; Mycoses; Candidemia
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study we will measure the concentration of the drug called voriconazole which is used
      to fight infections caused by fungus in children who usually are cancer patients and have
      their immune system down. Since we know the dose in adults, and we think we know the matching
      doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that
      goes into the system with what we know works in adults. We give the drug by a needle directly
      into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we
      draw a little bit of blood at certain times to measure the drug in it.
    


Intervention name(s): voriconazole (Vfend)
Intervention type(s): Drug
Intervention description(s): Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h
Notes:
If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.
(IV = Intravenous; POS = Powder for oral suspension)
Other intervention name(s): UK-109,496; Vfend; voriconazole
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open-Label; Pharmacokinetics; Intravenous to oral switch; Safety; Voriconazole; Immunocompromise; Children; High Risk For Systemic Fungal Infection.
The Heat Study: 2 Year Lifestyle Intervention in Overweight Women to Encourage Weight Management
Condition: Obesity; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine the most cost effective programme for overweight
      and obese individuals to maintain weight loss over a 2 year period.
    

Detailed description: 
      Although short term weight loss is often achievable in overweight individuals, long term
      maintenance is generally poor. The researchers urgently need new information regarding the
      most cost effective programme(s) for maintenance of weight loss. This study will recruit 200
      women and compare two approaches for providing support: one with intensive health
      professional support, the other peer group support facilitated by a research nurse with
      frequent 'weigh- ins'. The researchers will also compare two different diets one a high
      carbohydrate, high fibre, low glycaemic index diet versus one relatively high in
      monounsaturated fat and protein and low in glycaemic load.
    

Intervention name(s): Lifestyle: diet and exercise intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight; Diet; exercise; maintenance
In Vitro Maturation Induction of Oocytes From a Woman With Syndrome of Repeated Oocyte Maturation Failure in Vitro
Condition: Oocyte Maturation Failure
Study type: Observational

Summary: 
      Donated oocytes is from a patient with repeated oocyte maturation failure in IVF cycles.
      Cytoplasm of matured metaphase II oocyte and active MPF were injected into the donated
      oocytes.
    

Detailed description: 
      The study reported a woman with syndrome of repeated oocyte maturation failure where there is
      repeated production of immature oocytes.She underwent two IVF cycles in other hospital. All
      oocytes obtained were immature and the treatment were stopped.She underwent her third try in
      our hospital. The couple gave their informed consent: ICSI will be performed if maturation
      occurred, otherwise, the treatment would be stopped and the oocytes would be donated for
      study if the oocytes were not matured after 24 hours of culture. After ovarian
      hyperstimulation,14 oocytes were obtained. None of them was matured. The cycle was canceled
      and the oocytes were donated for study.To induce the immature oocytes in vitro, oocytes were
      1)cultured in follicular fluid containing matured metaphase II oocyte; 2) performed
      intracytoplasmic sperm injection (ICSI) to induce intracellular Ca2+]i oscillations;
      3)injected with active maturation promoting factor (MPF), 4)injected with cytoplasm of
      matured metaphase II oocyte.
    

Intervention name(s): no intervention
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        a patient with repeated oocyte maturation failure in IVF cycles
      
Keywords: oocyte maturation failure; Maturation induction in vitro
Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      RT-CoV-2 is a Phase I, open-label, dose escalation multicenter clinical trial to assess
      safety and immunogenicity of the candidate Coronavirus disease (COVID-19) vaccine GRAd-COV2
      in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based
      on a novel replication defective Gorilla Adenovirus and encodes for SARS-COV-2 Spike protein.
    

Detailed description: 
      RT-CoV-2 is a Phase I, open-label, dose escalation multicenter clinical trial to assess
      safety and immunogenicity of the candidate Coronavirus disease (COVID-19) vaccine GRAd-COV2
      in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based
      on a novel replication defective Gorilla Adenovirus and encodes for SARS-COV-2 full length
      prefusion stabilized Spike protein. GRAd-COV2 is developed and manufactured by ReiThera Srl.

      This study will evaluate a singular intramuscular administration of GRAd-COV2 at 3 dose
      levels: 5e10, 1e11, 2e11viral particles (vp). There will be 6 study arms for a total of 90
      healthy volunteers, divided into 2 cohorts of age, 18-55y and 65-85y, respectively.

      Participants will be followed up for 24 weeks after vaccination. Follow up includes safety
      and immunogenicity assessment. Follow up visits will occur at day2, then 1, 2, 4, 8, 12, 24
      weeks after vaccination.

      The primary objective is to evaluate the safety and reactogenicity of a single dose
      vaccination schedule of GRAd-COV2 across 3 dosages in healthy younger and older adults. The
      secondary objective is to evaluate humoral and cellular immunogenicity.
    

Intervention name(s): GRAd-COV2
Intervention type(s): Biological
Intervention description(s): Single intramuscular administration.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Phase I, open-label, dose escalation, clinical trial to assess the safety and immunogenicity of the candidate GRAd-COV2 vaccine in 90 healthy volunteers aged 18-55 years and elderly volunteers aged 65-85 years. The vaccine will be administered intramuscularly once in time.
Masking: None (Open Label)
Primary purpose: Prevention
LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
Condition: HIV; Sexually Transmitted Diseases; Risk Reduction; Pre-Exposure Prophylaxis
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This study is testing the acceptability and feasibility of a highly interactive mobile
      application (app) to promote HIV/sexually transmitted infection (STI) testing and uptake of
      pre-exposure prophylaxis (PrEP) among young men who have sex with men (YMSM).
    

Detailed description: 
      Using the Information-Motivation-Behavior Skills (IMB) model, we have developed LYNX, a
      highly interactive mobile app to promote accurate risk perception and increase HIV/STI
      testing and linkage to PrEP among young men who have sex with men (YMSM). Key components of
      the app include Sex Pro (a personalized HIV risk score), a sex diary to facilitate accurate
      data collection; HIV/STI testing information and reminders; access to home HIV/STI testing
      options; a geospatial-based locator of HIV/STI testing sites and PrEP clinics; PrEP
      information and videos; and online PrEP navigation.

      This study is part of the iTech NIH U19, which has an overall goal to develop innovative
      technology-focused interventions addressing the HIV prevention and care continuum for youth.
    

Intervention name(s): LYNX Mobile App
Intervention type(s): Behavioral
Intervention description(s): Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrEP; HIV Testing; STI Testing; Mobile app; Technology; Young men who have sex with men
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess potential benefits associated with both intermittent (use for 3 weeks, remove for 1
      week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR
      use among women either with BV or at high risk for BV. The investigators will also recruit
      women who are HSV2-infected.
    


Intervention name(s): NuvaRing
Intervention type(s): Drug
Intervention MeSH terms: NuvaRing
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HSV-2; Contraceptive Vaginal Ring
A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      Testosterone replacement treatment is the most effective way of treating hypogonadism in men.
      Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study
      will evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also
      assess safety of the product.
    


Intervention name(s): Testosterone MD-Lotion
Intervention type(s): Drug
Intervention description(s): Administered Topically
Other intervention name(s): LY900011; Axiron
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Palatability of Experimental Cigarettes - Study 2
Condition: Smoking
Study type: Interventional

Summary: 
      Smoking remains a leading cause of preventable disease and premature death worldwide.
      Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half
      of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine
      in cigarettes to the point that they are rendered non-addictive can potentially be an
      effective public policy measure that can significantly reduce tobacco-related mortality and
      morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking
      Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product
      standards including placing limits on the allowable nicotine content of cigarettes.
      Currently, no reduced nicotine cigarettes are available that will allow studying the
      feasibility of this policy measure. The National Institute on Drug Abuse has contracted with
      Research Triangle Institute to assist in the development of cigarettes with varying nicotine
      content that can be made available to researchers. They have established a contract that will
      result in the manufacture of 9 million cigarettes to be distributed to the research
      community. Prior to full production, the palatability and nicotine intake of these cigarettes
      in smokers must be determined.
    

Detailed description: 
      Phase 3: This descriptive study will use a between subjects, double blind design. This study
      will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research
      assistants will be blind to the cigarette type.
    

Intervention name(s): Low level nicotine cigarette; Intermediate nicotine level cigarette; High level nicotine cigarette
Intervention type(s): Other; Other; Other
Intervention description(s): smoke the study cigarette exclusively for one week; smoke the study cigarette exclusively for one week; smoke the study cigarette exclusively for one week
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: smoker; smoking; nicotine levels; tobacco; nicotine
Dose-dependent Effects of Blueberry Polyphenols on Endothelial Function in Healthy Individuals
Condition: Endothelial Function
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of acute blueberry polyphenol intake on
      endothelial function of healthy volunteers. Specifically, the investigators plan to perform a
      randomised, double blind, cross-over human intervention trial using a blueberry drink to
      investigate the dose-dependent effects of blueberry polyphenols on blood vessel function
      using Flow mediated dilation (FMD) to measure endothelial function. The study will not only
      measure the acute effects of flavonoid ingestion on vascular reactivity but will also assess
      plasma polyphenol metabolite levels.
    


Intervention name(s): Freeze-dried blueberry powder dissolved in water; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Wild blueberry freeze-dried powder dissolved in water; Macro- and micro-nutrient matched control in water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: flow-mediated dilation; blueberry polyphenols; dose-dependency
Risk Perception of Periodontal Disease
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      This study aimed at understanding the impact of educational pamphlet on Risk Perception of
      Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian
      outpatient dental clinic
    

Detailed description: 
      This study aimed at understanding the impact of educational pamphlet on Risk Perception of
      Periodontal Disease using A Randomised Clinical Trial model among patients in a Nigerian
      outpatient dental clinic. The outcome will help activate a success oriented periodontal
      disease prevention model
    

Intervention name(s): Exposure
Intervention type(s): Behavioral
Intervention description(s): Exposure to pamphlet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Shrinking the Size of the Tobacco Power Wall
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The overall aim of this research is to experimentally evaluate the extent to which reducing
      the size of the tobacco power wall and the number of tobacco product units displayed
      influences tobacco use risk in adolescents.
    

Detailed description: 
      This experiment will take place in the RAND StoreLab (RSL), a life-sized replica of a
      convenience store that we developed to evaluate how altering aspects of tobacco promotion at
      POS influences tobacco use risk during simulated shopping experiences. The study will use a
      between-subjects design, in which adolescents are randomly assigned to shop in the RSL under
      one of three conditions: (1) Large power wall/ multiple product units displayed; (2)
      Medium-sized power wall/multiple product units displayed; and (3) Small power wall/single
      product units displayed. We will consider the effect of these power wall alterations on risk
      of use of four classes of tobacco products: cigarettes, electronic nicotine delivery devices,
      cigarillos, and smokeless tobacco.
    

Intervention name(s): Tobacco power wall size and tobacco products displayed
Intervention type(s): Behavioral
Intervention description(s): The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess the effect of namilumab, a GM-CSF inhibitor, on the clinical response
      in subjects with axial spondyloarthritis. Subjects will receive treatment with either
      namilumab or placebo.
    

Detailed description: 
      A phase 2a proof-of-concept, randomised, double-blind, placebo-controlled study to evaluate
      the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given
      over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including
      those previously exposed to anti- TNF therapy (NAMASTE study).
    

Intervention name(s): Placebo; Namilumab
Intervention type(s): Biological; Biological
Intervention description(s): Placebo solution for subcutaneous injection.; Namilumab solution for subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Exercise Training Intensity in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this randomized clinical trial is to compare the effect of moderate versus
      high intensity exercise training on physical fitness and physical function in patients with
      type 2 diabetes. The research hypothesis is that high intensity exercise training will be
      superior to moderate intensity on such outcomes in individuals with type 2 diabetes.
    


Intervention name(s): High Intensity Exercise Training; Moderate Intensity Exercise Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): High intensity resistance and aerobic training
Resistance training is performed 2 days per week for 3 months
Aerobic training is performed on the same days as resistance training and 1 additional day per week.; Moderate intensity resistance and aerobic training
Resistance training is performed on 2 days per week for 3 months.
Aerobic training is performed on the same days as resistance training and 1 additional day per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment