bioihbjkbjnl/mcl2 huggingface dataset:
Study Using High-Dose Single Fraction Image-Guided Radiotherapy for Metastatic Lesions to Soft Tissue Masses, Lymph Node, or Bone
Condition: Metastatic Disease
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to find out what IG-IMRT radiation dose works best for
      treatment of disease in bone or soft tissues. This protocol will study what dose level may
      work most effectively. The first part of study will treat 10 patients with 22 Gray. Gray (Gy)
      is the unit that is used to describe the dose of radiation that is being given to a person
      with cancer. After we confirm that 22 Gy is a safe and sufficient amount of radiation, we
      will then treat another group of patients with 24 Gy and so on until we reach 28 Gy. Each
      dose level starting with 24 Gy will enroll at least 20 patients per treatment site (bone,
      bowel and/or spine). Patients will be enrolled in each treatment category until 20 patients
      in each strata reach an evaluable time point of 3 months post-RT. When we understand what
      dose works best and has the least amount of bad effects, the study will then look to see how
      well the patients do after the radiation therapy. This study is trying to see how your doctor
      can best treat the cancer that has spread to the other parts of your body.
    


Intervention name(s): intensity modulated radiation therapy
Intervention type(s): Radiation
Intervention description(s): Patients will be accrued at each dose level beginning at 22 Gy with increments of 2 Gy up to 28 Gy. Patients with a soft tissue mass, lymph nodes or focal bone metastases with lesions large enough to be imaged on CT scan will be accrued. Starting at 24 Gy, patients will be stratified in to 3 treatment categories: lesions involving bone, bowel, or spinal cord. Patients will be enrolled in each treatment category until 10 patients in that cohort reach an evaluable timepoint of 3 months post-RT. The maximum accrual is 20 for 22 Gy, and 90 (30 per treatment category) for each subsequent dose level (24-28 Gy). Some of these patients have participated in the optional FLT-PET scan portion of the study. Some of these patients have under gone an optional MRI scan which take place within one hour of the radiation treatment .
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Does Single Fraction IGRT; Bone; Lymph Nodes; Soft Tissue
Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals
Condition: Heart Failure; Hypertension
MeSH terms: Hypertension; Heart Failure
Study type: Observational

Summary: 
      This study is designed to validate the use of the CoVa Monitoring System in subjects with
      implanted devices.
    

Detailed description: 
      The study had the following objectives:

        1. Verify that the CoVa Monitoring System does not interfere with implanted devices.

        2. Verify that implanted devices do not interfere with the functions of the CoVa Monitoring
           System.

        3. Verify that the CoVa Monitoring System fits on a wide variety of body types.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be from the Imperial Cardiac Clinic
      
Keywords: Hypertension; Heart Failure; Fluids
The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury
Condition: Prematurity; Oxidative Pulmonary Injury
MeSH terms: Lung Injury
Study type: Interventional

Summary: 
      Hypothesis: In this feasibility study, hyperoxemia, as approximated by transcutaneous
      hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary
      oxidative stress as demonstrated by elevation of pulmonary protein carbonyl. Furthermore,
      this oxidative stress will be directly proportional to the imposed oxygen-burden during
      resuscitation at the time of birth.

      This study will give us information regarding the magnitude of protein carbonyl elevation in
      the preterm infant. With these results we will be able to 1. establish the technique for the
      running or protein carbonyl assays and 2. calculate an appropriate sample size for a future
      randomized control trial.
    

Detailed description: 
      Immediately prior to birth, preterm infants (<= 32 weeks gestation) will be randomized to one
      of three groups: 1. Low Oxygen Burden (LOB) - initiation of resuscitation with 21% 02, II.
      Moderate Oxygen Burden (MOB) - initiation of resuscitation with 100% 02 and III. High Oxygen
      Burden (HOB) - 100% 02 used for the entire resuscitation. A pulse oximetry monitor will be
      connected to a probe on the infant's hand to measure the transcutaneous hemoglobin saturation
      with oxygen (Sp02). Adjustments to the inspired oxygen concentration will be made every 15
      seconds for infants in the LOB and MOB groups to achieve a target Sp02 range of 85-92%.
      Resuscitation will otherwise proceed as per standard of care. The intervention will end upon
      arrival in the neonatal intensive care unit.
    

Intervention name(s): titration of oxygen during resuscitation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: newborn; preterm; resuscitation; oxidative injury; protein carbonyl
Nebulizer Intervention for Minority Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if teaching parents and children to identify the child's asthma symptoms early
      and if teaching the appropriate use of a nebulizer will result in a decrease in emergency
      department visits.
    

Detailed description: 
      Nebulizer use in young children is common with prevalence of 33-71% in children under age 12
      years. Nebulizers are used primarily to administer SABA medications, (i.e., albuterol) and
      some anti-inflammatory medications (i.e., budesonide, cromolyn). Parents may prefer nebulizer
      delivery due to the inability of young children to coordinate respiration with aerosol
      delivery and many parents lack confidence in administering metered-dose inhaler (MDI)
      medications to young children. Physician preference for nebulizer administration of asthma
      medications is low, but is favored due to direct medication delivery to the respiratory
      system despite studies indicating MDIs with spacers are as effective as nebulizers in
      delivering asthma medications to young children. Although national guidelines recommend a
      nebulizer with mask for children 2 years or younger most asthma educational programs lack
      specific content addressing appropriate nebulizer technique including when and what symptoms
      to treat at home, optimal length of a nebulized medication session, prevention of SABA
      overuse and appropriate cleaning and maintenance of the device. Because the overuse of home
      nebulizer SABA medications has been associated with fatal asthma, instruction and supervision
      of nebulized rescue medication delivery in addition to appropriate preventive medication use
      may reduce asthma morbidity and mortality .

      The current study was conducted to determine the effectiveness of a home-based nebulizer
      educational intervention (NEI) for young children with asthma. The intervention was designed
      to teach early symptom recognition, appropriate medication use and nebulizer technique for
      home treatment of acute asthma episodes. Study outcomes included symptom frequency, activity
      limitation, emergency department (ED) visits and hospitalizations, appropriate asthma
      medication use and nebulizer practice. We hypothesized that children receiving the NEI would
      demonstrate improvement in appropriate nebulizer and asthma medication use and decreased
      asthma symptoms, activity limitation, ED visits and hospitalizations.
    

Intervention name(s): Nebulizer Education Intervention; Standard Asthma Education Groups
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Asthma Education; Asthma Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Pregnant Women Vaccinated Against Covid-19.
Condition: Pregnant Women Vaccinated Against Covid-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Establish a cohort of pregnant women exposed to a COVID19 vaccine, whether or not they have
      experienced an adverse event, to assess the potential effects of vaccines on the course of
      pregnancy, on the fetus or newborn and on the mother.
    


Intervention name(s): Patient's consent; Inclusion form; Adverse reaction report form.; Follow-up report form.
Intervention type(s): Other; Other; Other; Diagnostic Test
Intervention description(s): Primary enrolment will be carried out at the time of vaccination at the main vaccination sites, with the patient's consent. The agreement form filled in online includes the surname, first name, month and year of birth. This form serves as an agreement to participate in the study.; This form includes the date of the last menstrual period, vaccination data (type of vaccine, date of vaccination, 1st or 2nd injection, etc.), socio-demographic data of the pregnant woman, medical and surgical history, gynaecological and obstetrical history, a description of the current pregnancy, and the medication taken by the patient during her pregnancy....
A link to complete this form (with the unique identifier) will be sent to each woman included who has given her consent to participate.; One month after each injection of the vaccine, information will be collected on any vaccination-related adverse reactions that may impact the pregnancy (fever, hypertension, etc.) or on the onset of a Covid-19 infection,; In the 2 months following the expected delivery date, information will be collected on the outcome of the pregnancy (delivery, spontaneous abortion, etc.) and maternal clinical signs (pre-eclampsia, gestational hypertension, gestational diabetes, etc.). Before sending the link to this form, information will be sent to the second holder of parental authority. In the absence of opposition, data on the newborn will be collected (sex, height, weight, head circumference, Apgar, malformation, neonatal pathology, etc.)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any pregnant woman who has received at least one Covid-19 vaccine during her pregnancy,
        regardless of the trimester of pregnancy.
Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Haemophilus Influenzae Type B
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine
      versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea.

      Primary Objective:

      To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus,
      Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to
      acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's
      TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the
      three-dose primary vaccination.
    

Detailed description: 
      All participants will receive three primary doses of their assigned study the vaccine, on
      Days 0, 60, and 120. They will be assessed for immunogenicity on Day 0 before vaccination and
      Day 150 post-vaccination. Safety will be assessed for all participants throughout the study,
      up to Day 157.
    

Intervention name(s): PENTAXIM™: DTacP IPV//PRP~T combined vaccine; TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, intramuscular; 0.5 mL of each vaccine; intramuscular
Other intervention name(s): PENTAXIM™; TETRAXIM™; ActHIB™
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Haemophilus influenzae type B; Poliomyelitis; PENTAXIM™; TETRAXIM™
Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance
Condition: Overweight; Obesity; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Dietary protein is a key element of most effective weight loss regimens. This study will
      investigate the effects of consuming soy protein on body composition and cardiometabolic
      health within the context of an effective weight loss and maintenance program called the
      Colorado Diet.
    

Detailed description: 
      This is a randomized study involving 60 study subjects (30 per arm). Investigators plan to
      enroll 72 subjects (36 per arm) in order to allow for any potential drop outs with the goal
      of 60 study completers. Investigators will compare the efficacy of inducing weight loss of
      two treatment arms all based on the Colorado Diet. Subjects will be randomly assigned to one
      of two study arms and instructed to follow the Colorado Diet by participating in weekly
      Colorado Diet group classes (State of Slim class). There will be 4 classes of 18 subjects
      each (two classes for each treatment group). Subjects will be followed in the study for 12
      months. Subjects will be randomized into one of two treatment groups as follows:

        -  Group 1 will participate in a State of Slim group class, receive a State of Slim book
           (describing the Colorado Diet), and will then purchase food items allowed in the
           Colorado Diet from the lists of acceptable foods in the State of Slim book.

        -  Group 2 will participate in a State of Slim class, receive the State of Slim book, and
           be provided soy protein foods to be consumed as part of the Colorado Diet (subjects will
           receive up to 3 foods with approximately 20g of soy protein each, per day).
    

Intervention name(s): Soy group; Non-soy group
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are assigned either to the soy group or the non-soy group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Weight Loss; body composition; dietary protein
Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects
Condition: Inflammation; Systemic Lupus Erythematosus; Rheumatoid Arthritis; Healthy
MeSH terms: Lupus Erythematosus, Systemic; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to develop a complement system
      targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic
      autoimmune diseases.
    


Intervention name(s): NNC 0151-0000-0000; NNC 0151-0000-0000; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.; A single dose (SD), administrated s.c. (subcutaneously) at 7 dose levels; A single dose (SD), administrated i.v. (intravenous) or s.c. (subcutaneously).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neurofeedback and Working Memory Training for Children and Adolescents With ADHD
Condition: Attention Deficit Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if neurofeedback and working memory training
      improves core symptoms of ADHD in children and adolescents.
    

Detailed description: 
      This study investigates two types of Neurofeedback (NF), one well-established and
      well-researched protocol called Slow Cortical Potential NF (SCP), and a newer and less
      researched, yet popular among private clinicians, the so-called live z-score training (LZT).
      These methods are compared to working memory training (WMT) and a passive control condition,
      treatment-as-usual only (TAU). The active conditions (SCP/LZT/WMT) are delivered high
      frequent, with 5 sessions/week, for a total of 25 sessions.

      Outcomes measures are taken at Preintervention and Postintervention, as well as at a 6-month
      follow-up assessment.
    

Intervention name(s): SCP training; Live Z-score training; WM training
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AD/HD in Children and Adolescents
Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function
Condition: Gastrointestinal Dysmotility
Study type: Interventional
Phase: Phase 2

Summary: 
      Post-operative administration of ipamorelin is expected to reduce time to recovery of
      Gastrointestinal (GI) function in patients who have undergone partial small and/or large
      bowel resection.
    


Intervention name(s): Saline Solution for Injection; Ipamorelin
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV); Intravenous (IV)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, single center study to assess pharmacokinetic profiles of rotigotine after single
      dose of LY03003 and daily patch application of Neupro in Healthy Volunteers
    


Intervention name(s): LY03003; Neupro 4Mg/24Hr Transdermal Patch
Intervention type(s): Drug; Drug
Intervention description(s): LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection); neupro patch
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Psychosocial Program Impact Evaluation in Jordan
Condition: Stress, Psychological; Mental Health Impairment
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an
      innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living
      in urban settlements in Jordan. The study was conducted using two waves of data collection:
      the first featured an intervention and a matched control group, the second featured a full
      randomized control trial.
    

Detailed description: 
      This study will provide a robust evaluation of the Mercy Corps 'Advancing Adolescents, No
      Lost Generation' program that targets stress alleviation in refugee youth (12-18 years) with
      specific measures of psychosocial stress, biological stress, and cognitive function.
    

Intervention name(s): Advancing Adolescents
Intervention type(s): Behavioral
Intervention description(s): The "Advancing Adolescents" programme is a structured 8-week psychosocial intervention for adolescents in humanitarian crises, based on profound stress attunement processes. It features three elements that are widely viewed as important to support youth adjustment in contexts of complex emergencies: (i) safety: establishment of a 'safe space' within the community as a base for activities and site of protection; (ii) support: facilitation of social support and self-expression; and (iii) structured activities: access to scheduled group activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress; Insecurity; Mental Health
Corneal Epithelial Allograft From Living-related Donor for LSCD
Condition: Limbal Stem Cell Deficiency
MeSH terms: Limbal Stem Cell Deficiency
Study type: Interventional

Summary: 
      The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial
      allograft from living-related donor is more effective than limbal conjunctival allograft from
      living-related donor for ocular surface reconstruction in patients with limbal stem cell
      deficiency (LSCD).
    


Intervention name(s): Corneal epithelial allograft; Limbal conjunctival allograft; Femtosecond laser; Diamond knife
Intervention type(s): Procedure; Procedure; Device; Device
Intervention description(s): A living-related donor's epithelial flap, equal in area to the recipient's diseased cornea bed, will be created using femtosecond laser technology. This corneal epithelial allograft is then ready for transplantation on the recipient's disease eye, following removal of the recipient's scarred and diseased epithelium.; A 3- to 5- clock hour limbal-conjunctival allograft will be obtained from the living-related eye. This is then ready for transplantation on the recipient's disease eye following removal of the recipient's scarred and diseased epithelium.; A commercial femtosecond laser to create a particular shaped graft for transplantation; A diamond knife to create a particular shaped limbal graft for transplantation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ethyl Eicosapentanoic Acid (Ethyl-EPA) for Treating Major Depression
Condition: Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the effectiveness of ethyl-eicosapentanoic acid
      (ethyl-EPA), an omega-3 fatty acid, in treating depression.
    

Detailed description: 
      Evidence suggests that omega-3 fatty acids may help reduce symptoms of depression. This study
      will determine whether ethyl-EPA, an omega-3 fatty acid, can be used safely and effectively
      to treat major depression.

      Participants will be randomly assigned to receive either ethyl EPA-containing pills or
      placebo daily for 8 weeks. Each week, participants will be asked to complete questionnaires
      which will be used to assess the severity of their depression.
    

Intervention name(s): Ethyl-eicosapentanoic acid (ethyl-EPA)
Intervention type(s): Drug
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Fatty Acids, Omega-3; Antidepressive Agents; Eicosapentanoic Acid