bioihbjkbjnl/mcl2 huggingface dataset:
Willingness to Participate in Clinical Trials Among Black and African Americans
Condition: Researcher-Subject Relations
Study type: Interventional

Summary: 
      Despite significant racial disparities in health outcomes, racial minority groups in the
      United States are not adequately represented in clinical trials, and clinical trial results
      published in major medical journals often underreport racial demographic data of
      participants. Lack of diversity in clinical trials threatens the generalizability of study
      results and reduces the ability of minority groups to benefit from medical advancement and
      innovation. Prior studies show that Black men are more likely to engage in preventive
      services when there is racial concordance with their healthcare provider. There is minimal
      literature about how racial concordance or diversity in clinical trial leadership impacts
      study enrollment. This project examines whether patients' willingness to participate in
      randomized clinical trials differs based on the characteristics of the investigator.
    

Detailed description: 
      We plan to recruit subjects and randomly assign them to one of four treatments. In each
      treatment arm, the subject will view a photograph of a real NIH investigator. We
      experimentally vary treatment along two dimensions: whether the sender is Black or white and
      whether the sender is male or female.

      Our primary aim is to assess whether the subject's stated willingness to participate in a
      clinical trial led by the investigator. Our secondary aim is to assess whether the subject is
      a more objective measure of interest in signing up for information on other clinical trials.
      To assess mechanisms, we will ask the respondent to rate the subject's perceived
      trustworthiness and quality of the investigator. In addition, we will also assess the
      subject's perceived attractiveness and age of the investigator as well as the subject's risk
      aversion, altruism, time preference, and general trust.
    

Intervention name(s): Black Respondents Exposure to a Photo
Intervention type(s): Behavioral
Intervention description(s): Black survey respondents will be randomly assigned to one of four treatments. In each treatment arm, the subject will view a photo of an NIH investigator. We experimentally vary treatment along two dimensions: whether the investigator is a man v. woman and whether the man is white vs. black. We will survey participants' willingness to participate in a clinical trial and how their initial response is impacted by other characteristics such as perceived trustworthiness and quality.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Africa, Europe and North America. The purpose of the trial is to
      investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1
      diabetes.
    


Intervention name(s): liraglutide; liraglutide; liraglutide; placebo; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.; Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being carried out to see if ZD1839 is effective in treating metastatic breast
      cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.
    


Intervention name(s): Gefitinib; Tamoxifen
Intervention type(s): Drug; Drug
Other intervention name(s): Iressa; Nolvadex
Intervention MeSH terms: Tamoxifen; Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Breast cancer; metastatic breast cancer
Reproducibility of Brain MRI
Condition: Reproducibility of Results
Study type: Observational

Summary: 
      The aim of this study is to assess the reproducibility over time of functional and structural
      magnetic resonance imaging, as well as specific biomarkers in plasma in healthy volunteers
      before and after a two-hour rest. This design mimics the timing of repeated scans and blood
      sampling before and after two hours of anaesthesia in subsequent substudies of the protocol,
      'Neuroplasticity Induced by General Anaesthesia'.
    

Detailed description: 
      In the study 'Neuroplasticity Induced by General Anaesthesia', the investigators intend to
      explore the effects of general anaesthesia on the brain by state-of-the-art magnetic
      resonance imaging (MRI).

      MRI data - especially changes in functional MRI recordings - may theoretically depend on a
      variety of physiological variables such as cerebral blood flow, cerebral blood volume, and
      cerebral metabolic oxidative rate of oxygen, and may thus also be affected by pharmacological
      agents. However, to interpret data it is important to know the inherent variability of the
      scans.

      This first substudy therefore aims to determine the reproducibility of the MRI recordings
      without administration of pharmacological agents. Another aim of the study is to ensure
      feasibility of the design before embarking on the more resource-demanding substudies in
      anaesthetised subjects.

      In this substudy, the investigators will perform the same MRI measurements as in the main
      study; rather than undergoing two hours of general anaesthesia, the volunteers will be
      subjected to two hours of undisturbed rest.

      Each participant goes through a pre-study interview and physical examination to ensure that
      the participant is healthy and suitable for participation.

      For each participant, the study consists of three study days:

      Day 0: Baseline MRI and blood tests. Intervention. Two hours of post-intervention care
      followed by post-intervention MRI and blood tests.

      Day +1 (the day after Day 0): MRI and blood tests. Day +7 (one week after Day 0): MRI and
      blood tests.

      All MRI scans will be performed with a 3 Tesla Philips Achieva d-stream with a 32-channel
      receive head coil.

      Blood tests: Haemoglobin, sodium, potassium, white blood count, C-reactive protein (CRP), S
      calcium-binding protein 100b (S100b), neuron-specific enolase (NSE), interleukin-1 (IL-1),
      IL-6, IL-8, IL-10, IL-18, tumor necrosis factor Alpha (TNF-Alpha) and transforming growth
      factor beta (TGF-beta).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy young volunteers
      
Biospecimen description: 
      Plasma
    
Keywords: Magnetic Resonance Imaging; Diffusion Tensor Imaging; Reproducibility of Results; Feasibility Study; Healthy Volunteers
A Study to Assess Immunity to Specific Microbial Antigens in Healthy Smokers and Non-smokers and in Subjects With Stable COPD
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional

Summary: 
      The present study aims to assess the natural immunity to specific microbial antigens in
      healthy subjects and in subjects with stable COPD aged between 45-75 years.
    


Intervention name(s): Blood collection; Swab collection; Sputum collection
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.; Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).; Sputum collection at Day 0 and at exacerbation visits (COPD subjects)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Chronic Obstructive Pulmonary disease (COPD)
Study Investigating the Use of Intravenous Fluids With Dextrose for Dehydrated Children
Condition: Gastroenteritis; Dehydration
MeSH terms: Gastroenteritis; Dehydration
Study type: Interventional

Summary: 
      Infants and young children often become infected with gastroenteritis leading to vomiting and
      diarrhea. This can lead to dehydration, one of the most common complaints in the Pediatric
      Emergency Department. These children are often in need of treatment with intravenous (IV)
      fluids. While the investigators know that IV fluids work, it is not clear which type or how
      much fluid is the best amount to give. Currently, the most common type of IV fluid given is
      salt water, also called normal saline.

      In contrast to adults, infants and young children with dehydration often have a build up of a
      certain type of acid in their blood which can perpetuate the nausea, vomiting, and general
      malaise associated with gastroenteritis. The investigators feel that giving these children IV
      fluids with lots of sugar (in addition to the salt) reduces the acid more rapidly than giving
      just salt water alone. In a prior study, the investigators have shown that children who
      receive lower amounts of sugar in the IV fluids return to the Emergency Department more often
      for a second visit. Based on this study, the investigators believe that children who receive
      the sugar-salt solution will do better than children who receive just normal saline.

      The investigators will determine if the sugar-salt solution is better by giving equal numbers
      of children the sugar-salt solution and normal saline and then see what happens to each
      child. The investigators will monitor who needs to be admitted, how much each child vomits,
      how much each child drinks, and also the level of acid in the blood before and after getting
      the IV fluid. After the study is completed, the investigators can compare the two different
      groups (children who received the sugar-salt solution versus children who received normal
      saline alone) to determine if one group had greater improvement and better clinical outcome
      than the other.
    


Intervention name(s): 5% dextrose in normal saline
Intervention type(s): Other
Intervention description(s): Subjects will be randomized to receive a intravenous fluid bolus of 5% dextrose in normal saline or normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Passive Microwave Radiometry (MWR) and AI for COVID-19 Complications Early Diagnostics of Lungs
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      World Health Organization (WHO) declared COVID-19 it as a global pandemic. It becomes clear
      that the virus spreading mostly deadly due to limited to access to diagnostics tests and
      equipment. Traditional radiography and CT remain the main methods of the initial examination
      of the chest organs. Now, most of the diagnostics has been focused on PCR, chest x-Ray/CT
      manifestations of COVID-19. However, there are problems with CT due to infection control
      issues, the inefficiencies introduced in CT room decontamination, and lack of CT availability
      in LMIC (Low Middle Income Countries). Passive microwave radiometry (MWR) is a cheap,
      non-radioactive and portable technology. It has already been used for diagnostics of cancer,
      and other diseases. The investigators have tested if MWR could be used for early diagnostics
      of pulmonary COVID-19 complications.

      This was a randomized controlled trial (195 subjects) to evaluate the effectiveness of
      diagnostics using MWR in patients with pneumonia caused by COVID-19 while they are in
      hospitals of Kyrgyzstan, and healthy individuals.

      The investigator have measured skin (IR) and internal (MWR) temperature by recording passive
      electromagnetic radiation through the chest wall in the projection of the lungs at 30
      symmetrical points on both sides. Pneumonia and lung damage were diagnosed by X-RAY/CT scan
      and doctor's final diagnosis (pn+/pn-). COVID-19 was determined by PCR test (covid+/covid-).

      Overall, the study suggests that the use of MWR is a convenient and safe method for screening
      diagnostics in COVID-19 patients with suspected pneumonia. Since MWR is an inexpensive, it
      will ease the financial burden for both patients and the countries, especially in LMIC
    


Intervention name(s): Passive Microwave Radiometry
Intervention type(s): Diagnostic Test
Intervention description(s): The MWR2020 (ormer RTM-01-RES) device is a unique commercially available CE marked device. It is registered in UK MHRA MDN 40802 as Microwave thermography system for clinical studies. The device is already registered in Kyrgyzstan for breast cancer diagnostics. During the 1980-90s there were several works on identification of excess of microwave emission due to fluid in lungs (on phantoms) which could be indication of inflammatory, process, cancer and other lung disorders.Later results were confirmed by clinical studies for lung cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trials
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: CT - scan; X-Ray; MWR
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children
Condition: Pandemic H5N1 Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived
      influenza vaccine in children.
    


Intervention name(s): Adjuvanted H5N1 pandemic influenza vaccine
Intervention type(s): Biological
Intervention description(s): Comparison of two doses of aH5N1c vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza, Pandemic, H5N1, Children
Semirigid Cervical Collar and Nasotracheal Intubation by Glidescope in Cervical Spine Surgery
Condition: Orthosis
Study type: Interventional

Summary: 
      Effect of semirigid cervical collar during nasotracheal intubation by Glidescope in the
      elective cervical spinal surgical patients: a study of clinical predictors and outcomes
    

Detailed description: 
      Clinically used cervical orthoses can effectively limit cervical spine motion in all
      direction and provide protection. Among them, the restriction by Miami semirigid collar was
      superior, with the least tissue-interface pressure of neck. It is one of the most used
      semirigid collars for patients' protection in the operating theatre. However, the presence of
      the semirigid collar was shown to result in a poorer view at laryngoscopy, possibly due to a
      reduction in mouth opening. Nasotracheal intubation is sometimes applied in cervical spinal
      surgeries for those receiving anterior approach for a higher cervical spine (C3) level, and/
      or combined with a short neck, or due to surgeon's preference. Glidescope minimizes cervical
      movements during laryngoscopy, facilitates nasotracheal intubation than direct laryngoscopy
      and requires less technical skill than fiberoptic tracheal intubation. The investigation was
      to assess the effect of cervical collar on nasotracheal intubation and potential hazard
      factors of prolonged time for nasotracheal intubation with Gildescope in patients scheduled
      for elective cervical spinal surgery.
    

Intervention name(s): Miami cervical collar
Intervention type(s): Device
Intervention description(s): Collar group is put on the Miami cervical collar.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients are randomized into one of the two group: the collar group or the non-collar group before anesthetic induction. In the collar group, the patient was put on a Miami cervical collar and then anesthetic induction and nasotracheal intubation are performed. the non-collar group receive the same anesthetic care without a collar as a control.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: cervical collar, nasoendotracheal intubation, glidescope
Biomarkers in Vascular Ehlers-Danlos Syndrome
Condition: Vascular Ehlers-Danlos Syndrome
MeSH terms: Ehlers-Danlos Syndrome; Ehlers-Danlos Syndrome, Type IV; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to determine whether patients with vascular Ehlers-Danlos
      syndrome present significant and specific changes of arterial endothelial and smooth muscular
      cell signalling/secretion, in comparison to matched healthy volunteers and patients with
      spontaneous arterial dissections.
    

Detailed description: 
      Vascular Ehlers-Danlos syndrome is a rare inherited disease which confers exceptional organ
      fragility in seamingly healthy young adults. The disease is caused by a mutation in the
      COL3A1 gene encoding type III collagen, critical to ensure physical resistance to mechanical
      stress of hollow organs. The disease results in increased tissular fragility, responsible of
      spontaneous arterial ruptures and dissections and spontaneous bowel perforations. The
      life-expectancy of patients with vascular Ehlers-Danlos syndrome is reduced by these
      recurring accidents. The exact mechanisms that trigger arterial accidents are unknown. Recent
      findings suggest a possible deleterious effect of inflammation and a possible dysregulation
      of the TGF-beta pathway. Thus, the purpose of this study is to identify further alterations
      in vascular endothelial and smooth muscular cell signalling/secretion, and to confirm
      previously suggested mechanisms of arterial accidents in vEDS patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with vascular Ehlers-Danlos syndrome and patients with spontaneous dissection(s)
        will be recruited from the French National Referral Centre for Rare arterial diseases,
        Hopital Europeen Georges Pompidou, Paris, France. Healthy volunteers will be recruited by
        the clinical investigations center, Hopital Europeen Georges Pompidou, Paris, France
        (random community sample).
      
Biospecimen description: 
      Serum, Plasma
    
Keywords: Biomarkers; Ehlers-Danlos syndrome, vascular type; Pathophysiology
Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT
Condition: Unexplained Infertility; Polycystic Ovarian Syndrome; Anovulatory
MeSH terms: Polycystic Ovary Syndrome; Infertility
Study type: Interventional

Summary: 
      The main purpose of this study is to test the effectiveness of nimodipine in preventing a
      luteinizing hormone (LH) surge in women undergoing ovulation induction with clomiphene
      citrate. It is important to prevent the premature LH surge in controlled ovarian stimulation
      to allow adequate recruitment of follicles, proper maturation of a dominant follicle before
      ovulation, and effectively time insemination with semen to allow fertilization of a mature
      egg to occur.

      The investigators are also conducting this study to determine medication side effect profile
      (including lightheadedness or dizziness from low blood pressure or rapid heart rate,
      headache, and nausea), patient treatment compliance, and clinical pregnancy (positive
      pregnancy test and ultrasound evidence of fetal heart rate). Finally, LH and follicle
      stimulating hormone (FSH) serum levels will be measured to determine effect of nimodipine on
      these hormones.

      As a calcium channel blocker, nimodipine has been shown to block calcium mediated release of
      gonadotropin releasing hormone in animal and preliminary human studies. The investigators
      hypothesize that nimodipine, a calcium channel blocker, will prevent or delay the LH surge
      during controlled ovarian stimulation cycles using clomiphene citrate in subfertile patients
      undergoing assisted reproduction with intrauterine insemination (IUI).
    

Detailed description: 
      After enrollment, subjects will be randomized to Placebo Comparator or Active Comparator. All
      subjects will receive Clomid 100 mg for 5 days for the purpose of ovarian follicle
      recruitment. Intervention will be initiated once ovarian follicle maturation has been
      documented (≥1 ovarian follicle size of ≥ 17mm) and the absence of a premature LH surge has
      been confirmed - this will be classified as intervention day 0. Subjects will receive their
      assigned comparator (Placebo or Active) according the schedule below:

        -  Intervention Day 0 - noon / afternoon / bedtime (3 doses)

        -  Intervention Day 1 - morning / noon / afternoon / bedtime (4 doses)

        -  Intervention Day 2 - morning (1 dose) Serum hormone levels and ultrasound examination
           will occur on days 0,1 and 2 for all subjects.
    

Intervention name(s): Placebo; Nimodipine
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; oral administration
Other intervention name(s): Nimotop
Intervention MeSH terms: Nimodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment