bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa
Condition: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis
MeSH terms: Otitis; Ear Diseases; Otitis Externa; Otorhinolaryngologic Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3%
      Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of
      Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7
      days.
    

Detailed description: 
      Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal,
      which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common
      infections encountered by otolaryngologists, pediatricians and family physicians. Diagnosis
      of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal
      inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes
      accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C)
      diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge
      (otorrhea).
    

Intervention name(s): Ciprodex Otic Suspension; Ciprodexa Otic Foam
Intervention type(s): Drug; Drug
Intervention description(s): 4 gtt b.i.d. for 7 days.; 0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days
Other intervention name(s): Ciprodex; Ciprodex b.i.d.; Ciprofloxacin, Dexamethasone Otic Foam; Ciprodexa foam once-a-day
Intervention MeSH terms: Ciprofloxacin; Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: swimmer's ear; ear drops; ear foam; otic foam; ear infection; ear pain; ear inflammation
PK Effects of Bifeprunox & Valproate in Bipolar I
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is to evaluate the effect of bifeprunox on the pharmacokinetics of valproate in
      subjects with Bipolar I Disorder after multiple dose administration.
    


Intervention name(s): Bifeprunox
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: drug interaction; pharmacokinetics; valproate; bipolar
Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability as well as the
      pharmacodynamic effects of multiple doses of AVX-470 administered orally in patients with
      active ulcerative colitis.
    

Detailed description: 
      There is a significant unmet medical need for effective oral pharmacologic therapies for
      inflammatory bowel diseases such as ulcerative colitis. Current anti-TNF therapies, including
      infliximab and adalimumab, are effective treatments for these conditions, but they must be
      administered by intravenous or subcutaneous injection. The major safety concerns associated
      with the use of injectable anti-TNF therapies are infection, demyelinating disease, and
      lymphoma, all of which are the result of systemic exposure. These uncommon but serious side
      effects have limited the use of systemic anti-TNF antibody therapy to patients with severe
      disease that have failed to respond to first-line treatments.

      AVX-470 is purified immunoglobulin (Ig) from the colostrum (early milk) of cows immunized
      with recombinant human tumor necrosis factor (rhTNF). AVX-470 is formulated in
      delayed-release enteric-coated capsules designed to protect the capsule contents from gastric
      acids following oral administration and to provide localized delivery to sites of
      inflammation in the distal intestine. Prior clinical experience with bovine Ig therapies in
      other human diseases suggests that AVX-470 will not be absorbed to any significant extent,
      meaning that systemic exposure could be minimized. The development of oral anti-TNF therapy
      targeting local intestinal disease activity might reduce the risks associated with injectable
      anti-TNF therapy and allow the convenience of oral dosing.

      The present study is a first-in-human, Phase 1 clinical study. It is primarily intended to
      evaluate the safety and tolerability of multiple doses of AVX-470 administered orally to
      patients with active ulcerative colitis.

      Animal models of ulcerative colitis using a mouse-specific TNF antibody derived from bovine
      colostrum demonstrated a 50% or more reduction in tissue TNF, TNF-messenger ribonucleic acid
      (mRNA), interleukin (IL)-6 mRNA, and myeloperoxidase and lowering of colonic inflammatory
      activity. Twenty-eight-day toxicology studies demonstrated no clinical or histologic findings
      in exposures above the intended clinical dose range.
    

Intervention name(s): AVX 470; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative colitis
Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
Condition: Coronavirus Disease 2019
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to
      evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate
      symptoms of respiratory illness caused by coronavirus 2019 infection.
    

Detailed description: 
      This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to
      evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate
      symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be
      randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab
      (PRO 140) and placebo will be administered via subcutaneous injection.

      The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period.

      A total of 75 subjects will be randomized 2:1 in this study.
    

Intervention name(s): Placebo; Leronlimab (700mg)
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Other intervention name(s): PRO 140
Intervention MeSH terms: Leronlimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID-19
Fibre and Appetite Regulation Trial (FART)
Condition: Obesity; Diabetes
MeSH terms: Obesity
Study type: Interventional

Summary: 
      High intake of cereal fibre has been shown to be associated with reduced weight gain and
      improved insulin sensitivity. We hypothesize these effects are due to the short chain fatty
      acids derived from the bacterial fermentation (breakdown) of fibre in the colon (large
      intestine). Insulin resistant subjects will be randomized to receive 2 servings of a
      low-fibre cereal (eg. puffed rice) or 2 servings of a high-fibre cereal (wheat bran cereal)
      per day for one year. The effects of the diets on body weight, appetite, abdominal fat, blood
      short chain fatty acids, glucose, insulin, lipids and hormones will be measured
    


Intervention name(s): Low fibre breakfast cereal (puffed rice/cornflakes); High fibre cereal (All Bran/Bran Flakes)
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Human nutrition; Dietary fibre; Insulin resistance; Obesity; Glucose; Colonic fermentation; Short chain fatty acids; GLP-1; Appetite; Abdominal fat
Abdominal Adiposity and Muscle Mitochondrial Functions
Condition: Mitochondrial Respiratory Chain Deficiencies
MeSH terms: Mitochondrial Diseases
Study type: Observational

Summary: 
      Numerous studies have demonstrated that excess perivisceral adipose tissue is associated with
      metabolic diseases such as insulin resistance.

      In skeletal muscle, insulin resistance has been correlated with reduced mitochondrial
      oxidative functions. According to the actual theory, mitochondrial dysfunctions are proposed
      to play a causal role in the aetiology of insulin resistance. Mechanisms involve increased
      intramyocellular lipids storage. Yet, the causes responsible for the decline in muscle
      mitochondrial functions remain to be elucidated.

      The investigators hypothesize that these alterations are induced by combined changes in
      plasma profiles of lipids and adipokines, which originate from perivisceral adipose tissue.
      The study aims at answering the following questions :

        -  Are muscle mitochondrial functions altered in association with increased perivisceral
           adipose tissue storage?

        -  Do changes in the pattern of plasma lipids and adipokines explain this correlation?
    

Detailed description: 
      Sixty 35 to 50-years old sedentary men will be included based on their abdominal
      circumference (from 75 to over 102 cm).

      Body composition will be evaluated using dual-energy X-ray absorptiometry and perivisceral,
      intramuscular and intrahepatic adiposity will be assess by MRI and proton-NMR spectroscopy.
      Subjects will be also characterized by their glucose tolerance (OGTT), basal metabolism
      (indirect calorimetry) and maximal oxygen consumption (maximal aerobic power test on exercise
      bike).

      Blood samples will be collected in the fasted state to assess lipids and adipokines
      concentrations.

      Biopsies will be obtained from the vastus lateralis muscle to examine mitochondrial functions
      (respiration rates, ATP and superoxide anion production rates, maximal activity of oxidative
      enzyme). Gene expression of key enzymes, protein and transcription factors involved in lipid
      and energy metabolism will be assessed using real-time quantitative PCR.

      Finally, whole body and muscle protein metabolism will be investigated in half of the
      subjects using tracer infusion (incorporation of L-[1-13C]leucine) and biopsies from vastus
      lateralis, both in the post-absorptive and post-prandial states (test meal)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  60 Male subjects

          -  Age between 35 and 50

          -  waist circumference (Waist) > 75 cm

             15 men with Waist between 75 and <87cm, 15 men with Waist between 87 and <94cm, 15 men
             with Waist between 94 and <102cm, and 15 men with Waith equal or higher than 102cm.
      
Keywords: Nutritional and Metabolic Diseases; Insulin resistance; Energy Metabolisms; Skeletal muscle; Visceral Adipose Tissue
Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients
Condition: Neoplasm
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a visual assessment of diagnostic PET/CT images obtained after a single
      intravenous injection of BAY85-8050 in patients with cancer
    


Intervention name(s): F-18 (BAY85-8050); F-18 (BAY85-8050)
Intervention type(s): Drug; Drug
Intervention description(s): Cancer patients, injection of BAY 85-8050, PET/CT; Healthy volunteers, injection of BAY 85-8050, whole body PET/CT for determination of effective dose, kinetics of BAY 85-8050 in blood
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Neoplasm; PET/CT diagnosis; PET tracer
Dietary and Lifestyle Habits During the Pandemic of COVID-19 in Greece
Condition: Eating Behavior; COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The aim of this study was to examine potential changes in children' and adolescents' dietary
      and lifestyle (physical activity, sedentary behaviour and sleep) habits during the quarantine
      that was implemented in Greece due to COVID-19. An online survey in a random sample of
      families across Greece was conducted. Parents self-reported their children's and their own
      dietary and lifestyle habits, as well as information about their sociodemographic status.
    

Detailed description: 
      Since December 2019, the world is facing a new disease (COVID-19), which is caused by the
      Coronavirus (Sars CoV-2). WHO declared the disease of COVID-19 as a pandemic in February
      2020. Since then, many countries around the world have imposed lockdown (quarantine at home),
      as the main measure to prevent the spreading of the disease. In Greece, the lockdown was
      officially imposed from March, 23rd, 2020. This unprecedented situation may have caused
      changes in adults' and children's dietary and lifestyle habits.

      Data were collected via an online survey consisting of 70 questions. Study participants were
      enrolled after signing an informed consent form. The questionnaire self-reported by
      volunteers (parents of children aged between 2-18 years old). The survey had 3 sections. The
      first section focused on participants' sociodemographic data (e.g. gender, age, city of
      residence and socioeconomic level). The second and third sections contained questions about
      the parents' (section 2) and their children's (section 3) dietary and lifestyle habits before
      and during quarantine.

      The scientific community raises concerns about the health implications that will be caused
      due to the COVID-19 lockdown. The results of this study are expected to shed light into
      children and adolescents, as well as their parents', changes in dietary and lifestyle
      behaviours and feed the development of effective strategies to prevent the adoption of
      unhealthy lifestyle behaviours and weight gain in the event of a second wave of COVID-19 in
      the coming months.
    

Intervention name(s): Online Survey about Dietary and Lifestyle Habits
Intervention type(s): Other
Intervention description(s): An online survey was conducted in a random sample of families. Parents self-reported their child's and their own dietary and lifestyle habits, as well as information about their sociodemographic status.
The survey consisted of 70 questions in 3 sections.
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Parents of children and adolescents, aged 2-18 years, during the lockdown period due to the
        COVID-19 pandemic in Greece.
      
Keywords: Eating Habits; Sedentary Behavior; Childhood Obesity; Quarantine; COVID-19; School Closings
Non-invasive Neuromodulation NESA in Neuroefficiency in Basketball Players
Condition: Basketball Player
Study type: Interventional

Summary: 
      Competitive team sports calendars are becoming increasingly compressed, generating changes in
      the effort-recovery cycle. Given this new situation, it seems necessary to analyze how it
      affects the physiological and performance level of semi-professional players, as well as how
      to observe if the non-invasive neuromodulation technique NESA helps the neuroefficiency and
      concentration values of said players.
    

Detailed description: 
      The design of this study is a randomised, triple blind clinical trial with placebo control.

      The general configuration of the study consists of capturing the second basketball team of FC
      BARCELONA. For this, a double-blind capture system will be available (neither the specialist
      nor those responsible for recovery will know which patients are entering the complementary
      treatment) and two NESA XSIGNAL® devices operating in double-blind (due to the imperceptivity
      of the stimulation performed, there will be a placebo machine and another that applies the
      treatment).

      At the end of the study, the results obtained between the different groups of patients will
      be able to be compared; those additionally treated with a device, those treated with a
      placebo device and those in the standard rehabilitation procedure without a device.

      The variables of the study will be collected at three time points: before the intervention,
      during the intervention and at the end of the intervention.

      The statistical analysis will be an intention-to-treat analysis. For the main outcomes
      variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis
      with kruskal wallis correction correction. Statistical significance will be defined as p
      <0.05
    

Intervention name(s): Non-invasive Neuromodulation; Placebo Non-invasive Neuromodulation
Intervention type(s): Device; Device
Intervention description(s): The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents:
pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA.; The same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: physical therapy modality; Electric Stimulation Therapy; basketball
Nalbuphine and Flurbiprofen for Oculoplastic Surgery
Condition: Surgery; Anesthesia; Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the postoperative pain and discomfort using
      flurbiprofen axetil or nalbuphine administration after oculoplastic surgery under general
      anesthesia.
    

Detailed description: 
      In this randomized controlled clinical trial, we evaluated the postoperative analgesic
      efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients
      undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or
      nalbuphine.
    

Intervention name(s): Nalbuphine; Flurbiprofen Axetil; Nalbuphine and Flurbiprofen Axetil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nalbuphine administration during surgery; Flurbiprofen axetil administration during surgery; Nalbuphine and Flurbiprofen Axetil administration during surgery
Intervention MeSH terms: Flurbiprofen; Flurbiprofen axetil; Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative pain; general anesthesia; postoperative discomfort
Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed
      doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets
      will be administered to patients starting at an initial dose, followed by up-titration to a
      fixed dose (low, medium or high) for 14 days.
    


Intervention name(s): Cariprazine 3 mg; Cariprazine 6 mg; Cariprazine 12.5 mg
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Cariprazine(INN); RGH-188
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; antipsychotics; dopamine D3/D2 antagonist
Optical Coherence Tomography (OCT) Data Collection Study
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      Collect OCT data to evaluate the range and age trend of ocular measurements.
    

Detailed description: 
      This is a prospective, multi-center study. Ocular history and examination will be conducted
      on consented subjects to determine further participation in the study. Subjects qualified to
      continue will undergo imaging of both eyes using the SPECTRALIS OCT.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        No eye disease.
Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate substantial equivalence between two medical
      devices which measure nitric oxide in exhaled breath, NIOX MINO® and NIOX® in Symptomatic
      Asthmatic Adults and Children.
    

Detailed description: 
      Asthma is a chronic inflammatory disorder of the airways. Chronically inflamed airways are
      hyperresponsive; they become obstructed and airflow is limited (by bronchoconstriction, mucus
      plugs, and increased inflammation) when airways are exposed to various risk factors. Asthma
      causes recurring episodes of wheezing, breathlessness, chest tightness, and coughing
      particularly at night or in the early morning.

      NO is an important endogenous regulatory molecule that is widely distributed throughout the
      body. The detection of NO in exhaled air was first reported in 1991, and, soon after it was
      shown that the levels NO in exhaled air are elevated in patients with asthma. There is now
      much evidence showing that measurement of the concentration of NO in exhaled air offers a
      useful non-invasive method of assessing inflammatory airway disease.

      Exhaled NO is not increased during bronchospasm unless there is coexisting inflammation.
      Exhaled NO may have a valuable role in differentiating between the inflammatory and
      bronchospastic components of clinical asthma, and is also useful for guiding the therapeutic
      use of steroids and other anti-inflammatory agents.

      A study on asthmatics and non-asthmatics subjects has shown that substantial equivalence
      exists between the stationary device NIOX® and the hand held device NIOX MINO® when comparing
      NO measurements, when similar conditions are considered and examinations are made as
      consistently as possible.

      In a study with the stationary device NIOX®, exhaled NO was measured before and after two
      weeks of inhaled corticosteroid treatment in unstable steroid-naïve adult and paediatric
      asthmatic subjects. The result was a 50.5% mean reduction of exhaled NO. The change in
      exhaled NO was also compared to change in standard asthma outcome measures, asthma symptoms
      and spirometry.
    

Intervention name(s): The Aerocrine NIOX MINO® Airway Inflammation Monitor
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Asthma; adult; paediatric; NIOX MINO®; NIOX®; nitric oxide; airway inflammation; open-label; single-cohort