bioihbjkbjnl/mcl2 huggingface dataset:
Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at
      least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol
      (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment
      with FP/SAL in normal clinical practice compared with patients not switched.
    

Detailed description: 
      To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at
      least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol
      (FP/SAL; Seretide®) in matched asthma patients switching to BDP/FOR following treatment with
      FP/SAL in normal clinical practice compared with patients not switched. To evaluate
      respiratory outcomes for Fostair in comparison to Seretide using a UK primary care database
      (in patients switched for cost rather than clinical reasons).
    

Intervention name(s): FP/SAL; BDP/FOR
Intervention type(s): Drug; Drug
Other intervention name(s): Seretide®; Fostair® 100/6
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients are diagnosed with asthma or COPD and aged between 18-80 years with all 61-80
        year olds being non-smokers only
      
Keywords: Primary care; Asthma management; Real-world; Observational; Fostair; Seretide
Hair2Go Label Comprehension and Usability Study
Condition: Hair Removal
Study type: Interventional

Summary: 
      The purpose of this study is to test label comprehension and usability of the hair removal
      device in 60 male and female participants. The study population will represent the US
      demographic distribution of skin types and will include varying levels of literacy.
    

Detailed description: 
      This will be a single-visit study consisting of two phases: Phase I - assessing label
      comprehension and Phase II - usability. For Phase I, subjects will be asked to review the
      outer packaging of the mē device. Each subject will be taken through an interview which will
      evaluate messages on the external product labeling regarding product use and self-selection
      criteria. Subjects, who are not self-excluders and/or contraindicated for use of the device
      will continue with Phase II of the study. This usability phase will consist of watching the
      instructional DVD, reading the User Guide and then performing a skin sensitivity test.
      Subjects will be expected to self-administer the hair removal treatment in a simulated
      home-use environment under observation of the study personnel. The users will have a
      telephone in the room and may call a phone number and request assistance while performing the
      treatment, simulating the toll-free hotline that will be available to consumers in commercial
      use.
    

Intervention name(s): Hair2Go
Intervention type(s): Device
Intervention description(s): Treatment with the device once under observation
Other intervention name(s): Mē my elōs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: hair reduction; hair removal; hair clearance
Safety and Efficacy Study of NV-101 in Dental Patients
Condition: Soft Tissue Anesthesia (Numbness)
MeSH terms: Hypesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was:

        -  to determine if NV-101 accelerates recovery from numbness compared to placebo

        -  to evaluate safety of NV-101
    

Detailed description: 
      This was a randomized, double-blind, placebo-controlled, multi-center study. One hundred
      twenty-two patients aged 10-58 requiring treatment with one of four routine dental procedures
      were enrolled. The investigators were licensed dentists in private practice. Each patient
      received one or more conventional injections of either articaine with epinephrine, lidocaine
      with epinephrine, prilocaine with epinephrine, or mepivacaine with levonordefrin. Local
      anesthetics were injected into no more than 2 sites. Injections of local anesthetic placed
      within 4mm of each other constituted the same site. The injection(s) of study drug were made
      at or near the completion of the dental procedure and were required to be not earlier than 20
      minutes after, and not later than 70 minutes after, the most recent injection of local
      anesthetic. Patients received an injection of study drug (1.8 mL) in each site at which local
      anesthetic had been injected (i.e. no more than 2 sites).

      Patients self-evaluated the return of normal sensation in the lip, tongue, nose, and chin by
      palpations at 5-minute intervals beginning 1 minute before the study drug injection and
      continuing for a minimum of 3 hours and until they achieved the return of normal sensation in
      lip, tongue, nose, and chin.

      Safety was assessed by the use of a Holter monitor, vital signs, pain ratings, and physical
      examinations including oral cavity examinations.
    

Intervention name(s): NV-101 (phentolamine mesylate solution)
Intervention type(s): Drug
Intervention MeSH terms: Phentolamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Phase 1 Test-retest Evaluation of [18F]MNI-958 PET
Condition: Healthy Volunteers; Alzheimer Disease; Progressive Supranuclear Palsy
MeSH terms: Alzheimer Disease; Supranuclear Palsy, Progressive
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall goal of this protocol is to evaluate [18F]MNI-958 also known as APN-0000455 or
      PM-PBB3, a tau targeted radiopharmaceutical.
    

Detailed description: 
      The overall goal of this protocol is to evaluate [18F]MNI-958 also known as APN-0000455 or
      PM-PBB3, a tau targeted radiopharmaceutical. The specific objectives are:

        -  To measure the dynamic uptake and washout of [18F]MNI- 958 in brain using positron
           emission tomography (PET) in patients with Alzheimer's disease, Progressive Supranuclear
           Palsy and healthy volunteers.

        -  To measure blood metabolites of [18F]MNI-958 and perform kinetic modeling to assess its
           ability to measure tau protein in brain using the tracer plasma concentration or a
           reference region as indirect input.

        -  To obtain test/retest reliability of the tracer binding parameters in patients with
           Alzheimer's disease, Progressive Supranuclear Palsy and healthy volunteers.

        -  To acquire safety data following injection of [18F]MNI-958.
    

Intervention name(s): [18F]MNI-958
Intervention type(s): Drug
Intervention description(s): Subjects will undergo PET imaging using [18F]MNI-958, a PET radioligand for imaging tau.
Other intervention name(s): [18F]Florbetapir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HV; AD; PSP
Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)
Condition: Cystinosis
MeSH terms: Cystinosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Cystadrops® is currently indicated in adults and children from 2 years of age diagnosed with
      cystinosis with corneal crystal accumulation observed.

      However administration of Cystadrops® in patients below 2 years old could be of value for
      these patients and prevent the crystal deposit. It is the reason why as part of the
      Cystadrops® pediatric investigational plan (PIP), RECORDATI Rare Diseases committed to
      conduct a clinical study to assess Cystadrops® safety and efficacy in the pediatric
      population from 6 months to less than 2 years old.
    


Intervention name(s): Mercaptamine
Intervention type(s): Drug
Intervention description(s): Patients will be treated with 1 drop in each eye 4 times a day, at the same dose and regimen than the one indicated in adults and children from 2 years of age.
Intervention MeSH terms: Cysteamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure
Condition: Obesity
Study type: Observational

Summary: 
      This study is a prospective, multi-center, single-arm study evaluating the SIPS procedure.
      Subjects who meet the eligibility criteria will be considered for study participation and
      will be followed through 12 months.
    

Detailed description: 
      SIPS is a single-anastomosis duodeno-intestinal switch procedure. Preliminary data from
      Sanchez-Pernaute et al. (Surg Obes Relat Dis 2013;9:731) indicates that this procedure is
      safe, quick to perform, and offers good results for treatment of both morbid obesity and its
      metabolic comorbidities. CovidienTM plans to further investigate this procedure and has
      proposed a prospective clinical study to obtain data on subject outcomes through 12 months
      following the SIPS procedure.
    

Intervention name(s): SIPS the stomach, intestinal, pylorus, sparing procedure
Intervention type(s): Procedure
Intervention description(s): Bariatric Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective, multi-center, single-arm study. Patients who have elected to undergo
        bariatric surgery using the SIPS procedure (according to patient and investigator
        assessment and standard of care) will be evaluated for eligibility.
Clinical Application of Novel Panels for Early Precision Diagnosis and Relapse Prediction in High-risk Leukemia
Condition: Leukemia, Acute
MeSH terms: Leukemia
Study type: Observational

Summary: 
      Based on the investigator's previous data on risk classification for acute leukemia,the
      investigators will design a set of panels to detect the gene expression and genomic variants
      (SNPs, mutation, insertion, deletion and fusion genes, etc), and identify the high-risk
      subtypes of acute leukemia, such as Ph-like acute lymphoblastic leukemia. Furthermore, the
      target therapy (Tyrosine Kinase Inhibitors,et.al) will be used to treat the identified
      patients. In addition, more sensitive minimal residual disease (MRD) detection technology
      will be designed and used to detect the MRD in patients to early predict the disease relapse.
    

Detailed description: 
      patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk
      markers, reflactory and relapsed patients.
    

Intervention name(s): High-risk subtype detection panels
Intervention type(s): Diagnostic Test
Intervention description(s): The designed detection technology were used to identify the high-risk patients cohort.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with acute leukemia (newly diagnosis)
      
Biospecimen description: 
      Patients' samples from bone marrow
Probiotics to Prevent Relapse After Hospitalization for Mania
Condition: Bipolar Disorder; Schizoaffective Disorder
MeSH terms: Recurrence; Bipolar Disorder; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine if taking a probiotic supplement versus a placebo
      will lower rates of relapse and improve the clinical course among participants who have been
      hospitalized for mania. Relapse and clinical course are measured by time to
      re-hospitalizations, new mood episodes, and changes in mood-related symptoms.
    


Intervention name(s): Probiotic Supplement; Inert Compound
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic Supplement 1 tablet by mouth daily; Probiotic identical placebo 1 tablet by mouth daily
Other intervention name(s): Probio-Tec
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mania; manic episode; mixed episode; bipolar disorder; schizoaffective disorder; probiotics; probiotic supplement; relapse prevention; new mood episode; re-hospitalization
Preoperative Gastric Ultrasound in Paediatric
Condition: Anesthesia
Study type: Observational [Patient Registry]

Summary: 
      The presence of gastric contents makes an aspiration event more likely , and as a result,
      preoperative fasting guidelines are designed to provide adequate time for gastric emptying in
      patients undergoing surgery. this study will be conducted to assess the gastric volume and
      content with the help of ultrasound in fasted pediatric patients scheduled for elective
      surgeries
    

Detailed description: 
      it is unknown how many patients have gastric volumes that place them at increased risk of
      aspiration despite adequate fasting.

      There is a growing interest in the use of bedside ultrasonography to assess gastric content
      and volume. It has been suggested that the gastric antrum in particular can be assessed
      reliably by sonography.

      hence, this study will be conducted to assess the gastric volume and content with the help of
      ultrasound in fasted pediatric patients scheduled for elective surgeries which will help to
      detect accuracy of preoperative fasting hours.
    

Intervention name(s): gastric ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): preoperative gastric ultrasound will be done for all patients to estimate gastric volume by measuring the antral cross sectional area and also, know the type of gastric content
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        paediatric patients aged 6-12 years old,both sex, ASA physical status I and II
Balance and Mild Traumatic Brain Injury (TBI)
Condition: Brain Concussion; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this pilot project is to determine whether using one inertial sensor on the
      waist during routine clinical balance testing (i.e. Balance Error Scoring System (BESS)),
      will be a more immediate, objective, reliable and sensitive way to measure and quantify
      balance deficits in individuals with mild Traumatic Brain Injury (mTBI).
    

Detailed description: 
      The purpose of this pilot project is to gather preliminary data to determine whether using
      one inertial sensor at the waist during the BESS could provide the examiner with a more
      immediate, objective, reliable and sensitive way to quantify deficits in postural control in
      the post-concussive population. The investigators hypothesize that the metrics obtained from
      the iSWAY will be better able to distinguish mTBI subjects from control subjects than the
      standard clinical assessment. The specific aims are:

        1. To determine test-retest and inter-rater reliability of the clinical BESS compared to
           the instrumented BESS test.

        2. To determine if an instrumented BESS can distinguish mTBI from age-matched control
           subjects better than the commonly used BESS and to determine the best metrics of sway to
           separate groups.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy controls or individuals with mild Traumatic Brain Injury (mTBI) or concussion.
      
Keywords: mTBI; concussion; mild Traumatic Brain Injury; balance; sensors
Role of HIV on Glutathione Synthesis and Oxidative Stress
Condition: HIV Infection; Erythrocyte Glutathione Deficiency
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      HIV infection is associated the development of increased oxidative stress and deficiency of
      glutathione (GSH), the dominant endogenous antioxidant protein, but the underlying mechanisms
      contributing to GSH deficiency are hitherto unknown. Furthermore GSH metabolism has not been
      studied in HIV patients, in whom the burden of risk factors promoting oxidative stress is
      highest. Our previous studies in non-HIV human subjects with diabetes-related oxidative
      stress and GSH deficiency have demonstrated that the latter is due to decreased synthesis of
      GSH. Importantly, short-term dietary supplementation with the simple GSH precursor
      amino-acids cysteine and glycine, boosted GSH synthesis and cellular concentrations,
      corrected GSH deficiency, and reduced oxidative stress and oxidant damage. The current
      proposal will study whether (1) defective synthesis underlies GSH deficiency in patients with
      HIV, and will test a simple, inexpensive and rational therapy based on protein
      supplementation to improve GSH synthesis and concentrations and lower markers of oxidative
      stress and oxidant damage in these patients; (2) study if correction of GSH deficiency is
      asssociated with any changes in (a) impaired mitochondrial fuel oxidation in the fasted and
      insulin stimulated states; (b) insulin sensitivity; (c) body composition and anthropometry;
      (d) forearm muscle strength; (e) plasma biochemistry, and (f) quality of life indices in
      these subjects.
    


Intervention name(s): Cysteine (as n-acetylcysteine) and glycine; Cysteine/glycine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cysteine and glycine will be supplemented at doses of 0.81 mmol/kg/d and 1.31 mmol/kg/d for 2 weeks each; Subjects will receive oral dietary amino-acids (cystiene as n-acetylcysteine, and glycine)
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine; Glycine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men
Condition: HPV Vaccine Acceptability
Study type: Interventional
Phase: Phase 4

Summary: 
      The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV)
      vaccine acceptability among college men based on the Health Belief Model through focus
      groups, (2) triangulate focus group results with a prior quantitative study in developing an
      intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3)
      test the efficacy of the above intervention based on the Health Belief Model by comparing it
      to a knowledge-based intervention. Approximately five focus groups with ten participants in
      each group with college students in the ages 18-25 years will be conducted at a large
      Midwestern University for the qualitative piece. Data will be analyzed for categories and
      triangulated with previous study to develop a theory based intervention. For the quantitative
      piece a randomized controlled design with 45 participants in each arm (theory based
      intervention and knowledge based intervention) will be implemented.
    

Detailed description: 
      Up to this date, there was a lack of qualitative research on vaccine acceptability among men
      and theory-based interventions that promote HPV vaccination among men. A few studies have
      been conducted with parents and physicians regarding HPV vaccination with girls, and a few
      regarding women's awareness and acceptability. Results indicated increasing awareness of HPV,
      informing costs and benefits associated with the vaccine, and perceived susceptibility. Based
      on this information, it is crucial to obtain a further understanding of knowledge, awareness,
      and predictors related to HPV and its vaccination in men. Information obtained can be
      utilized in developing an intervention to increase intentions of taking the HPV vaccine.
      Refining results will lead to a standardization of an intervention that can be implemented
      across college campuses.
    

Intervention name(s): HPV vaccine acceptability
Intervention type(s): Behavioral
Intervention description(s): One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV; College men; HPV vaccine; Health belief model; HPV vaccine acceptance
ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the
      stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade
      I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under
      Institutional Review Board (IRB) approved protocol.
    

Detailed description: 
      This safety and feasibility study used autologous adipose-derived stromal cells, the stromal
      vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L
      scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol.
      Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells
      was the primary objective of the study. Adipose-derived stromal vascular cells were obtained
      through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's
      Solution, and injected directly into the intra-articular space with a mean of 12 million
      viable nucleated SVF cells per knee.
    

Intervention name(s): ADSC
Intervention type(s): Biological
Intervention description(s): Single injection of ADSC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADSC; osteoarthritis; knee; adipose
Effect of Music on Burden of Dental Implant Surgery
Condition: Personalized Musical Intervention
Study type: Interventional

Summary: 
      Personnalized music can decrease the burden of care.

      This experimental clinical trial examines the effect of personalized musical intervention on
      the burden of dental implant surgery. The intervention consists of a personnalized musical
      intervention and the control group consists of audio books. The burden of dental implant
      surgery will be defined by a composite variable including surgical pain, state anxiety and
      dissatisfaction with dental implant surgery.
    


Intervention name(s): Personalized music; Audio Books
Intervention type(s): Other; Other
Intervention description(s): Patients in the intervention group will listen to personalized music from the Musicare application; Patients in the active comparator group will listen to audio books
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: personalized musical intervention; experimental study; dissatisfaction; anxiety; surgical pain; burden of care; pilot randomized controlled trial