bioihbjkbjnl/mcl2 huggingface dataset:
Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      The purpose of this research study is to determine whether or not computed tomography (CT)
      scans performed on patients with symptoms of chronic rhinosinusitis (CRS) but without any
      physical signs of the disease will (1) prove to be less expensive in the treatment and
      evaluation as compared to current practices, (2) avoid the use of unnecessary antibiotic
      prescriptions, and (3) provide a more efficient way to diagnose conditions in patients who
      have had CRS ruled out as a cause.

      The investigators hypothesize that current guidelines, when applied to subjects with symptoms
      of CRS in the absence of physical signs may be associated with (1) increased unnecessary
      prescription of antibiotics, (2) delay in further essential workup, and (3) increased overall
      health care costs.
    


Intervention name(s): Pre-treatment Sinus CT Scan; Post-treatment Sinus CT Scan
Intervention type(s): Procedure; Procedure
Intervention description(s): Pre-treatment Sinus CT Scan; Post-treatment Sinus CT Scan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Chronic rhinosinusitis; Chronic sinusitis; CRS
Evaluation of the Animated Cartoon-aided Teaching of Intranasal Corticosteroid Allergic Rhinitis
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      Correct methods and compliance of intranasal corticosteroid (INCS) is very important for the
      treatment of allergic rhinitis (AR). The animated cartoon-aided teaching of INCS
      administration was created to decrease workload of health care professionals. The aim of this
      study is to compare the achievement of the children with AR in using INCS between the group
      which were instructed by animated cartoon-aided teaching or oral presentation without
      demonstration.
    

Detailed description: 
      The study was a prospective randomized control trial in children aged 5 - 16 years with
      moderate to severe intermittent or persistent AR who had never used INCS. The patients were
      randomly divided into 2 groups; 1) Teaching how to use INCS by oral presentation and 2) by
      animated cartoon-aided teaching. Successful achievements were recorded when the patients were
      able to use INCS (all five-point checklists) correctly. If they were unable to use the INCS
      correctly after the first teaching, the same instruction would be repeated and the second
      assessment would be performed.
    

Intervention name(s): score before teaching; score immediately after teaching; score 3 months after teaching
Intervention type(s): Other; Other; Other
Intervention description(s): score the check-point of correct INCS usage before teaching; score the check-point of correct INCS usage immediately after teaching; score the check-point of correct INCS usage 3 months after teaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: animated cartoon-aided teaching; oral presentation; allergic rhinitis; intranasal corticosteroid; how to use intranasal corticosteroid
Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia
Condition: Vitamin D Supplements; Tuberculosis; Sputum; Cytokines; Immunity
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      Hypothesis

      That improving vitamin D status among TB patients will speed the pace of bacteriological
      cure, and will enhance immune responses to TB infection
    

Detailed description: 
      Tuberculosis (TB) will be the world's largest single cause of death from infection for the
      30-year period between 1990 and 2020. More than 95% of TB cases, and deaths due to TB, occur
      in developing countries. Mongolia is one of the countries with the highest tuberculosis
      burdens in the Western Pacific region. In addition, vitamin D deficiency is endemic in
      Mongolia. We propose to determine the efficacy of vitamin D supplements, as an adjunct to
      multidrug therapy, in enhancing the anti-microbial immune response to TB, a finding that
      could lead to the development of shorter drug regimens, and thus more efficient and effective
      TB treatment protocols.

      We propose to conduct a double blind, placebo controlled, randomized clinical trial to test
      the effect of a daily vitamin D supplementation on the ability of subjects to control TB
      infection.

      The Primary Endpoint: The primary endpoint will be: time to sputum culture conversion from
      positive to negative. The number of days to sputum conversion will be measured, in both the
      intervention and control groups, starting on the date that treatment is begun. Sputum samples
      will be collected and cultured every two weeks thereafter. The date of conversion from
      positive to negative, for each subject, will be the date halfway between the date of the last
      culture-positive sputum and the first culture-negative one.

      Secondary Endpoints:

      Bacteriologic secondary endpoints, cell-mediated immune function endpoints and BMI.
    

Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea
Condition: Migraine With and Without Aura
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This proof-of-concept study compares side-by-side low-dose naltrexone and acetaminophen
      combination to sumatriptan in the acute treatment of migraine.
    

Detailed description: 
      The study consists of a screening visit, outpatient treatment of a moderate or severe
      migraine attack with a single dose of the study drug within 8 weeks, and End-of-Study Visit
      2-7 days after dosing.
    

Intervention name(s): Naltrexone and Acetaminophen Combination; Sumatriptan 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treat a single Qualified Migraine attack.; One capsule contains Sumatriptan 100 mg and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.; One capsule contains a sham for component A and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.
Intervention MeSH terms: Acetaminophen; Sumatriptan; Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Weight Stigma in Women Who Are Obese: Assessing How an Acute Exposure to Stigma Negatively Impacts Cardiovascular Health
Condition: Stigma, Social; Obesity; Cardiovascular Disease Risk Factor; Blood Pressure
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The current study examined the influence of an acute weight stigma exposure on cardiovascular
      reactivity among women with obesity and high blood pressure and women with obesity and normal
      blood pressure.
    

Detailed description: 
      The current study examined the influence of two video exposures, one containing scenes of
      weight stigma (STIGMA) and the other non-stigmatizing neutral (NEUTRAL) scenes, on
      cardiovascular reactivity as assessed by resting BP and ambulatory blood pressure (ABP) and
      heart rate (HR), among women with obesity and high BP (HBP) or normal BP (NBP). The
      investigators hypothesized that as a result of STIGMA compared to NEUTRAL, cardiovascular
      reactivity would be significantly greater immediately upon watching the video and persist
      outside of the laboratory over ambulatory conditions in women with obesity and HBP compared
      to women with obesity and NBP.
    

Intervention name(s): Stigma Video Exposure; Neutral video exposure
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The participants watched a 10 minute video on a computer screen that consisted of brief clips from popular television shows that depicted women with overweight and obesity and evoked negative weight-based stereotypes (e.g., clumsy, loud, and lazy). Both the high blood pressure and normal blood pressure arms participated in this intervention.; The participants watched a 10 minute video on a computer screen that consisted of a series of clips depicting neutral scenes (e.g., insurance commercials). Both the high blood pressure and normal blood pressure arms participated in this intervention.
Other intervention name(s): STIGMA; NEUTRAL
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants were randomized using www.randomization.com to either STIGMA at Visit 2 and NEUTRAL at Visit 3, or NEUTRAL at Visit 2 and STIGMA at Visit 3.
Masking: Single (Participant)
Primary purpose: Prevention
Influenza and Text Messaging in Pregnancy
Condition: Pregnancy
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      A randomized, controlled clinical trial to assess whether text messaging to an outpatient
      obstetric population can improve maternal influenza vaccine uptake.
    

Detailed description: 
      History and the 2009 H1N1 influenza pandemic suggest that both seasonal and pandemic
      influenza infections impart disproportionate morbidity and mortality among gravidas. The
      influenza vaccine represents a viable, preventive health intervention to mitigate disease
      burden for gravidas and their neonates. Despite the safety and efficacy of influenza
      vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide. Barriers to
      influenza vaccination during pregnancy include patient concerns about vaccine safety and
      unappreciated risk of influenza infection. Cellular phone text messaging has emerged as an
      innovative technology with advantages of ubiquity, rapid, confidential information
      transmission, and low cost. Text messaging may represent an effective way to educate pregnant
      women about their particular vulnerability to influenza infection and enhance influenza
      vaccine uptake. We propose a randomized, controlled clinical trial to assess whether text
      messaging to an outpatient obstetric population can improve maternal influenza vaccine
      uptake.
    

Intervention name(s): influenza and general health information; general health information
Intervention type(s): Other; Other
Intervention description(s): Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver. These messages will contain general health information as well as information regarding influenza and the importance of vaccination during pregnancy.; Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Pregnancy; Influenza Vaccination
Functional Magnetic Resonance Imaging (fMRI) Findings in Children With Early Exposure to General Anesthesia
Condition: Exposed to Anesthesia
Study type: Observational

Summary: 
      General anesthetic medications have been shown to cause neuronal cell death in the brains of
      infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and
      appear to have similar mechanisms of toxicity in the immature rodent brain. Functional MRI
      (fMRI) is a technique developed for mapping brain activation and has been utilized to examine
      how the brains of children with a history of early exposure to ethanol function differently
      from children without such a history. This study will utilize fMRI to look for specific
      changes in brain activation patterns in children with a history of early exposure to general
      anesthesia, as compared to children without such exposure.
    


Intervention name(s): fMRI
Intervention type(s): Other
Intervention description(s): fMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children from Nationwide Children's Hospital
      
Keywords: Children; before; the age of 2 years
A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, prospective, single dose study will evaluate the pharmacokinetics and safety
      of Tamiflu (oseltamivir) in volunteers on dialysis and in volunteers with a creatinine
      clearance from 10 to 30 mL/min. Volunteers will receive a single oral dose of Tamiflu.
    


Intervention name(s): Tamiflu (oseltamivir); Tamiflu (oseltamivir)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of Tamiflu in volunteers on dialysis; Single dose of Tamiflu in volunteers with creatinine clearance from 10 to 30 mL/min
Intervention MeSH terms: Oseltamivir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
Condition: Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in
      the treatment of pain following third molar extraction in comparison to single doses of
      placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.
    


Intervention name(s): effervescent ibuprofen tablets; effervescent Aspirin plus Vitamin C tablets; ibuprofen tablets; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Aspirin; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: dental pain; analgesic; NSAID; ibuprofen; aspirin
Exploratory Study Using Positron Emission Tomography With TS-121 and [11C]TASP0410699 in Healthy Adult Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the binding of a novel tracer, [11C]TASP0410699,
      using Positron Emission Tomography (PET) scans with or without dosing of TS-121
    


Intervention name(s): TS-121; [11C]TASP0410699; Positron Emission Tomography (PET)
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Oral; Intravenous radiotracer; Imaging scanning procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PET; Receptor Occupancy
Effects of Exercise Behavior Modification on Plasma Adiponectin and Insulin Resistance in High Risk Subjects of Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Insulin Resistance
Study type: Interventional

Summary: 
      Investigators hypothesized home-based exercise intervention was beneficial to those who have
      had diabetic risk factor for type 2 diabetes mellitus
    

Detailed description: 
      This randomized clinical trial was designed to investigate whether a home-based exercise
      could improve adiponectin levels, exercise behavior and metabolic risk factors (insulin
      resistance, metabolic components and physical fitness) in subjects with at least a diabetic
      risk factor for type 2 diabetes mellitus. Participants were randomly allocated to either a
      control group or a home-based exercise group. All participants were evaluated for outcome
      measures at baseline, and at 3-month 6-month and 9-month follow-up after engaging in the
      intervention.
    

Intervention name(s): Physical activity promoting intervention; General instruction and education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An interview with a physiotherapist
An exercise video specially designed by this study including warm-up, aerobic, cool-down and stretching exercises, and/or a simple exerciser to use at home
An individualized home-based exercise program based on the Health Belief Model and Transtheoretical Model
The daily record to check their body weight, exercise mode and duration
Proper diet, caloric intake calculation, metabolic risk factors and prevention of diabetes were taught and a guide book was provided that included all the above mentioned details
Telephone reminders of healthy lifestyle including the ways of overcoming barriers of regular exercise every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule; Oral instruction and written general education information about weight control, proper diet and regular exercise in a one-page education brochure that was similar to the way used in the outpatient clinic
Telephone reminders of healthy lifestyle every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule
Without individualized exercise program and interview with a physiotherapist
Other intervention name(s): Home-based exercise; Exercise behavior modification; General advice; Medical education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: diabetes; physical activity; adiponectin; metabolic risks; exercise; primary prevention
Safety Study of Peptide Cancer Vaccine To Treat HLA-A*24-positive Advanced Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, immune response and
      clinical efficacies of HLA-A*2402 restricted epitope peptides CDCA1 and KIF20A emulsified
      with Montanide ISA 51 for advanced small cell lung cancers.
    

Detailed description: 
      The investigators previously identified three novel HLA-A*2402-restricted epitope peptides,
      which were derived from two cancer-testis antigens, CDCA1 and KIF20A, as targets for cancer
      vaccination against lung cancer. In this phase I trial, the investigators examine using a
      combination of these two peptides the safety, immunogenicity, and antitumor effect of vaccine
      treatment for HLA-A*2402-positive advanced small cell lung cancer patients who failed to
      standard therapy.
    

Intervention name(s): HLA-A*2402-restricted CDCA1 and KIF20A peptides
Intervention type(s): Biological
Intervention description(s): Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle. Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
Other intervention name(s): CDCA1 and KIF20A
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CDCA1; KIF20A; lung cancer; vaccine; HLA-A*2402
Impact of Spa Treatments on the Consumption of Care in Children
Condition: Respiratory Disease; Otorhinolaryngologic Diseases; Dermatologic Disease
MeSH terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Skin Diseases
Study type: Observational

Summary: 
      Children represent 1.2% of the spa population in France. Spa treatments, including climatic
      stays, are mainly prescribed for children in the context of respiratory, otorhinolaryngology
      and dermatological conditions. The benefits after spa treatments are the improvement of the
      symptoms of the pathology, the quality of life and in particular the reduction of drug
      exposures.

      Few authors have recently investigated the impact of spa treatments on the health of children
      and society, while care has changed significantly in recent years. Moreover, no real-life
      study of a large sample of children seems to have been conducted in this area. The present
      study plan to conduct a pharmacoepidemiology study on medico-administrative databases of the
      "observational study" type, in real life.
    


Intervention name(s): Drug consumption
Intervention type(s): Drug
Intervention description(s): number of Daily Defined Doses (DDDs) of medications prescribed and given to children in connection with the indication of the spa treatment
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This pharmacoepidemiology study of the "observational study" type, in real life, will
        concern children aged 1 to 15 living in France at the time of the study. It will be
        conducted at the departmental level of the Haute-Garonne through the use of the APPLE
        database (PrescriptiOns Medicines Mother Children) and at the national level through the
        use of the database. EGB (General Sample of Beneficiaries).
      
Keywords: drug consumption
A Safety and Pharmacokinetic Study of Proellex®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg
    

Detailed description: 
      This is an open-label, single-center, outpatient, unblinded, multi-dose study of the safety
      and pharmacokinetic properties of Proellex®. Six female subjects will each receive seven
      daily doses of Proellex® in separate, rising doses. Dosing must be accomplished between
      menstrual periods. The first six women will complete the 100 mg visit schedule before the
      next six women will begin the 150 mg visit schedule. Blood will be collected at pre-dose, and
      at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24 and 36 (Day 7 only) hrs post-dose on Day 1 and
      Day 7. Subjects will be allowed to leave the clinic between the 12 and 24 hr and the 24 and
      36 hr PK blood draws. Subjects will be discharged from the study after a one month follow-up
      visit. Safety will be assessed throughout the study.
    

Intervention name(s): Proellex
Intervention type(s): Drug
Intervention description(s): Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days
Other intervention name(s): Telapristone acetate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics