bioihbjkbjnl/mcl2 huggingface dataset:
Feel Breathe, Restriction Device Ventilatory Nasal
Condition: Mouth Breathing; Restrictive Breathing Pattern
MeSH terms: Respiratory Aspiration; Mouth Breathing
Study type: Interventional
Phase: Phase 1

Summary: 
      It has patented a restriction and filtering device ventilatory nasal flow FeelBreathe with
      the aim of increase nasal airflow resistance, therefore the objective was to examine the
      effects of FeelBreathe with lung ventilation and gas exchange during exercise.
    

Detailed description: 
      Background: Different devices are currently used to train inspiratory muscles, thus showing
      an increase in the physical performance. It is a control trial to investigate the effects of
      a new restriction and filtering device ventilatory nasal flow (FeelBreathe).

      Methods: A total of 27 trained male caucasian subjects (age: 32.5 ± 7.23 years) were
      recruited from different sports clubs. Measurement of maximum static inspiratory pressure
      were taken before exercise testing and an incremental test in cycle ergometer to volitional
      fatigue for the determination of gas exchange data. Each subject performed three identical
      submaximal exercises at 50% of ventilatory thresholds under different breathing conditions:
      1) oronasal breathing 2) nasal breathing and 3) nasal breathing with Feel Breathe,
      Restriction and Filtering Device Ventilatory Nasal Flow.

      Discussion: Researchers try to find if the new device called FeelBreathe causes changes in
      the lung ventilation and gas exchange during exercise. If the results show altered breathing
      pattern and cardiometabolic variables, FeelBreathe could be used to training respiratory
      muscles.
    

Intervention name(s): Feel Breathe, restriction device ventilatory nasal
Intervention type(s): Device
Intervention description(s): The Feel Breathe (FB) consisted of a small adhesive strip that is placed across the bridge of the nose during exercise. The FB was place following procedures for placement as indicated by the manufacturer's directions, while the placebo nasal, was placed over the nostrils of the subject, without interfering nasal breathing; thus, nasal airflow resistance was not increase. Each subject was required to perform three identical submaximal exercises with intensity at 50% VT1-VT2 under different breathing conditions. The breathing conditions were: oronasal, nasal and FB breathing. All participants performed three trials of stable load (50% VT1-VT2) for 10 minutes in the three conditions mentioned above, setting the cadence at 70-75 rpm, and controlling the same in all three exercise conditions.
Other intervention name(s): Restriction device ventilatory nasal. PCT/ES2010/000429.; Feel Breathe. Registro: N0299875-0.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Restriction device ventilatory nasal flow; oronasal breathing; nasal breathing.
A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      This is a school-based, cross-sectional study to assess the incidence and prevalence, risk
      factors of myopia among schoolchildren in both eye-use environment, eye-use habits,
      lifestyle, and family and subjective factors before and during COVID-19. Large population and
      representative study subjects. Environmental exposure and daily within and out-of-school
      activities will be evaluated in a random subgroup.
    

Detailed description: 
      Myopia is the most common refractive error and a major reason for reducing uncorrected visual
      acuity among schoolchildren. It was reported that during COVID-19, home confinement resulted
      in a significant increase in myopia due to the changed lifestyle of schoolchildren
      dramatically. However, it is unclear which kind of risk factors should be the first to bear
      the brunt before and during COVID-19. And which factors should be emphasized and confronted
      as the optimum strategy for myopia prevention and control? This cohort study aims to
      determine the risk factors, prevalence, and incidence of myopia, and SE changes among
      schoolchildren before and during COVID-19, hence identifying the factors that impact the
      onset and progression of myopia.

      This is a 3-year cross-sectional study. This study plans to enroll 126,810 participants (aged
      6-18 years) from Tianjin, China. All grade students from 10 regions of Tianjin City, China
      will be analyzed. Over a 3-year follow-up period, students will receive detailed eye
      examinations annually and complete questionnaires about eye-use environment, eye-use habits,
      lifestyle, and family and subjective factors. In a 5% random sample size of this cohort
      study, outdoor activity, light intensity, eye use habits, and eye use environment data will
      be obtained using objective measuring devices. Myopia was defined as spherical equivalent
      refractive (SER) of ≤ -0.5D.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All 6-18-year students with no significant systemic or eye diseases are eligible for vision
        screening
Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
Condition: Cervical Intraepithelial Neoplasia; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine
      expressed in E. coli.

      The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce
      higher antibody and at the same time caused less adverse events.

      The secondary purpose of this study is to to evaluate the safety and immunopersistence of the
      study vaccine.
    

Detailed description: 
      Totally 1600 healthy women of 18-25 years of age were enrolled. The participants were
      randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV)
      vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule. The
      women were actively monitored for adverse events for 1 month after each injection. Severe
      adverse events during the trial were followed up. Serum samples from all the subjects would
      be collected on day 0, 7m, 24m, 48m and 72m to evaluate the immunogenicity and
      immuno-persistency.
    

Intervention name(s): 30μg HPV; 60μg HPV; 90μg HPV; Hepatitis B vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.; Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.; Participants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen; Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human Papilloma Virus 16; Human Papilloma Virus 18; vaccine; Cervical Intraepithelial Neoplasia; cervical Cancer
Phase 2 Study of NX9 for Delineation of Bowel Anatomy
Condition: GI Carcinoma; GI Disorders
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate marking and distention of the bowel of the oral contrast agent, NX9,
      at CT of the abdomen and pelvis, VLDCT with no contrast will be followed by VLDCT with NX9
      contrast followed by CT with NX9 and standard IV contrast. Eligible subjects will have cancer
      or other GI disorders for which CT is typically used to assess their disease. This is an open
      label study with efficacy evaluated in a masked fashion following completion of the entire
      study. Results of the NX9 scans will not be used for treatment decisions. PK will be
      evaluated in a subset of subjects at a single center.
    


Intervention name(s): NX9 Oral Contrast Agent
Intervention type(s): Drug
Intervention description(s): Distension and marking of the bowel lumen will be compared between the 1st and 2nd scan. Ability to see IV contrast enhancement will be assessed on the 3rd scan in relationship to the 2nd scan.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.
Condition: Microparticle; Endometriosis; Laparoscopy
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Study objective: To evaluate serial generation of microparticles (MPs) after laparoscopic
      stripping or CO2 laser vaporization in surgical treatment of patients with ovarian
      endometrioma (OE).

      Design: A prospective, randomized, blinded, pilot study, including 33 patients. Setting:
      Tertiary university hospital from April 2015 to June 2017. Patients: 33 women with unilateral
      OE undergoing laparoscopic surgery. Intervention: Patients were randomly selected to undergo
      either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.

      Measurements and Main results: Blood samples were collected before surgery, and at 2 hours,
      24 hours, 1 month, and 3 months after surgery. MPs generation curve after ovarian
      endometrioma surgery was performed.
    


Intervention name(s): Stripping versus laser CO2
Intervention type(s): Procedure
Intervention description(s): Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Impact of COVID-19 on Sinus Augmentation Surgery
Condition: Bone Loss
Study type: Interventional

Summary: 
      The risk of Schneiderian membrane perforation and the postoperative complications of the
      sinus floor elevation surgery were evaluated for patients with and without history of
      COVID-19 infection.
    

Detailed description: 
      COVID-19 induced chronic sinusitis with subsequent increased Schneiderian membrane thickness
      could increase the risk of its perforation during the sinus floor elevation. The aim of the
      study is to compare the incidence of Schneiderian membrane perforation and the postoperive
      complications of the sinus floor elevation in patients with and without history of COVID-19.
    

Intervention name(s): Sinus lift in patients with positive COVID-19 history; Sinus lift with negative COVID-19 history
Intervention type(s): Procedure; Procedure
Intervention description(s): Sinus augmentation in the posterior atrophic maxilla in patients with positive COVID-19 history; Sinus augmentation in the posterior atrophic maxilla in patients with negative COVID-19 history
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dermacyd Breeze (Lactic Acid) Pocket BR - Compatibility
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated
      dermic irritability) and allergy (sensibilization) of the product Dermacyd Breeze (Lactic
      Acid) Pocket BR.
    


Intervention name(s): Lactic Acid
Intervention type(s): Drug
Intervention description(s): Lactic Acid (Dermacyd Breeze)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Design : A randomized, open-label, four-sequence, four-period, crossover, single
      dosing, phase 1 study
    

Detailed description: 
      To evaluate the safety, tolerability and pharmacokinetic characteristics of SOL-804-F and
      Zytiga tablets following a single oral dose and Zytiga 1,000 mg in healthy male volunteers.
    

Intervention name(s): SOL-804-F; Zytiga
Intervention type(s): Drug; Drug
Intervention description(s): All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period.; All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period.
Other intervention name(s): SOL-804-F 181.5mg/242.0mg/302.5mg; Zytiga 500mg
Intervention MeSH terms: Abiraterone Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Abiraterone
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Condition: Pain; Cancer
MeSH terms: Breakthrough Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl
      when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.
    


Intervention name(s): OraVescent fentanyl (OVF)
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; pain; Breakthrough Pain in cancer patients
Fenfluramine and Cognition
Condition: Cognitive Function
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators will investigate the cognitive effects of fenfluramine, a
      drug that directly stimulates the release of serotonin in the brain and positively modulates
      σ1 function. The investigators will use fenfluramine to assess the cognitive effects of
      modulating serotonin and σ1 function in healthy volunteers using a battery of cognitive tasks
      that measure learning and memory, executive functioning, reward processing, and emotional
      processing. The study design is double-blind, and participants will be randomised to either
      seven days of fenfluramine or placebo administration. All participants will attend two
      screening visits to assess eligibility. There are two main study visits; during the first,
      participants will undertake cognitive tasks and questionnaires before taking the initial
      study dose. One the second study visit, participants will once again complete these tasks and
      questionnaires after a week of fenfluramine/placebo administration.
    


Intervention name(s): Fenfluramine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Fenfluramine (30mg daily) will be dispensed in a cherry flavoured aqueous solution. Fenfluramine is both a serotonin releasing agent and sigma-1 receptor agonist. Fenfluramine is FDA approved for the treatment of Dravet syndrome, a rare form of epilepsy.; The placebo is a liquid designed to be identical to the interventional drug fenfluramine in terms of both taste and visual appearance. It will be administered at 30mg daily and dispensed in a cherry flavoured aqueous solution
Other intervention name(s): Fintepla (trade name); Fenfluramine Hydrochloride (ZX008)
Intervention MeSH terms: Fenfluramine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly allocated to one of two groups (fenfluramine or placebo), stratified on group allocation, gender and cognitive task version administered. Participants in the fenfluramine group will receive oral solution of fenfluramine 15mg twice daily (BID) for seven days. Participants in the placebo group will receive a placebo oral solution 15mg twice daily (BID) for seven days. The study is assessing the effects of fenfluramine on cognitive ability, it is not an efficacy or safety study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug; Cognition; Dravet Syndrome; 5-HT; Sigma-1; Healthy Volunteers
Hypertension in Patients Hospitalized With COVID-19
Condition: COVID-19; Hypertension
MeSH terms: COVID-19; Hypertension
Study type: Observational

Summary: 
      Some studies have shown that the main pathogenesis of patients with covid19 is related to
      ACE2 receptor. Lung is one of the main organs, and there are many ACE2 receptors in
      cardiovascular system. ACEI / ARB is the main target of antihypertensive drugs. Previous
      reports suggested that there were large number of patients with covid19 also suffered from
      hypertension, suggesting that patients with hypertension may be the susceptible to covid19.
      Therefore, we try to follow up the patients admitted to Hankou hospital to explore the impact
      of hypertension and hypertension treatment on the severity and prognosis of patients with
      covid19, so as to provide new methods for the treatment of patients with covid19 in the
      future.
    

Detailed description: 
      In December, 2019, a cluster of severe pneumonia cases of unknown cause emerged in Wuhan,
      China, with clinical presentations greatly resembling viral pneumonia1. Deep sequencing
      analysis from lower respiratory tract samples indicated a novel coronavirus, which was named
      2019 novel coronavirus (2019-nCoV, then named COVID-19). Up to Mar 16, 2020, the total number
      of patients had risen sharply to 153,546 confirmed cases worldwide
      (http://2019ncov.chinacdc.cn/2019-nCoV/global.html). The data extracted from 1099 patients
      with laboratory-confirmed COVID-19 in China from January 29, 2020 showed that hypertension is
      the most common coexisting illness of COVID-19 patients, ranging from 13.4% in nonsevere
      patient vs. 23.4% in severe patients, and the total incidence is as high as 15%2.
      Interestingly, ACE2 is involved in the pathogenesis of both hypertension and SARS-COV-2
      pneumonia. The above reasons prompted us to speculate that the organs attacked by SARS-COV-2
      might not only be lungs, but also include other ACE2 expression organs, especially
      cardiovascular system. In addition, patients with comorbid hypertension, especially those
      with long-term oral ACEI/ARB medication for hypertension, might have different susceptibility
      and severity levels of pneumonia upon SARS-COV-2 attack. Therefore, we investigated and
      compared the demographic characteristics, coexisting disease, severity of pneumonia, and the
      effect of antihypertensive drugs (ACEI/ARB versus non-ACEI/ARB) in patients with COVID-19
      coexisting hypertension, thereby, hopefully, to reduce the mortality and morbidity associated
      with hypertension in patients with COVID-19.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with clinically confirmed COVID-19 admitted to Hankou Hospital, Wuhan, China from
        January 5 to March 8, 2020.
      
Biospecimen description: 
      Blood
    
Keywords: COVID-19; Hypertension; ACE2
Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine.
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release
      formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca
      S.A., under a single-dose, two-way crossover design.
    


Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention description(s): A fixed 50 mg exteded release formulation.
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, two-way crossover.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Quetiapine
A Study of JNJ-40411813 in Healthy Japanese Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      after single dose and multiple dose administrations of JNJ-40411813 in Japanese healthy adult
      male participants.
    


Intervention name(s): JNJ-40411813; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-40411813 will be administered orally.; Matching placebo will be administered orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia
Condition: Dementia; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole
      in acutely agitated patients diagnosed with Dementia.
    


Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IM Solution, IM, Cohort 1 - 2.5mg (.33cc) maximum dose 5.0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 5.0mg (.67cc) maximum dose 10 mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 10 mg (1.3cc) or 5.0 mg (.67cc) maximum dose 15mg; 1 injection, 24 hour observation for all cohorts.; IM Solution, IM, Cohort 1 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 0mg; 1 injection, 24 hour observation for all cohorts.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute agitation in patients diagnosed with Dementia