bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the human tolerance and pharmacokinetics of LY03003.
    


Intervention name(s): LY03003
Intervention type(s): Drug
Intervention description(s): Rotigotine,extended-release microspheres
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LY03003
Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure
Condition: SARS Pneumonia
MeSH terms: COVID-19; Pneumonia; Respiratory Insufficiency
Study type: Observational

Summary: 
      Data on respiratory mechanics and gas exchange in acute respiratory failure in COVID-19
      patients is limited. Knowledge of respiratory mechanics and gas exchange in COVID-19 can lead
      to different selection of mechanical ventilation strategy, reduce ventilator-associated lung
      injury and improve outcomes. The objective of the study is to evaluate the respiratory
      mechanics, lung recruitability and gas exchange in COVID-19 -associated acute respiratory
      failure during the whole course of mechanical ventilation - invasive or non-invasive.
    

Detailed description: 
      In December 2019, an outbreak of a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China and
      rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a
      pandemic on March 11th, 2020. The clinical disease (COVID-19) results in critical illness in
      about 5% of patients with predominant acute respiratory failure.

      The goal of the study is the evaluation of the respiratory mechanics (peak inspiratory
      pressure (PIP), plateau pressure (Pplat), static compliance (Cstat), driving pressure (DP) at
      different positive end-expiratory pressure (PEEP) levels and different tidal volumes (Vt)
      (6-8 ml/kg ideal body weight), lung recruitability (by change of DP and oxygenation) and gas
      exchange (PaO2/FiO2 ratio and alveolar dead space) in COVID-19 -associated acute respiratory
      failure during the whole course of mechanical ventilation - invasive or non-invasive for
      selection of safe and effective PEEP level, Vt, respiratory rate (RR) and inspiratory oxygen
      fraction (FiO2) during the whole course of mechanical ventilation - invasive or non-invasive.

      This study is multicentral observational trial in 3 University clinics.
    

Intervention name(s): Respiratory mechanics measurement; Gas exchange measurement
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Measurement of peak inspiratory pressure, plateau pressure, calculation of static compliance and driving pressure; Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio and alveolar dead space
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with COVID-19 requiring respiratory support
      
Keywords: SARS Pneumonia; ARDS; COVID-19; compliance; recruitability
Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, randomized, 3-way crossover study. Each subject will
      receive each of the three study treatments once, followed by in-clinic monitoring and
      extensive blood sample collection for plasma PK analysis.

      Dosing will occur at least 48 hours apart from the time of patch application, until
      completion of dosing in randomized order per the treatment sequence schedule. After
      completion dosing, subjects will be assessed one final time.
    

Detailed description: 
      This is a single-center, open-label, randomized, three-way crossover study. Each subject will
      receive each of the three study treatments once, followed by in-clinic monitoring and
      extensive blood sample collection for pharmacokinetic analysis.

      Dosing will occur at least 48 hours apart from the time of patch application, until
      completion of dosing in randomized order per the treatment sequence schedule. Subjects may be
      dosed in 2 or more separate groups in each period, for example, 24 subjects on one day and 24
      subjects on another day.

      Plasma samples from the dosing days will be sent to the analytical laboratory for analysis.
      Tolerability scores for each of the dose levels will be summarized.

      After completion of the three dosing days, subjects will be assessed one final time and
      dismissed from the study.
    

Intervention name(s): Treatment A: M207 3.8 mg "MiniMac"; Treatment B: M207 3.8 mg "MACAP"; Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment A: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a "MiniMac" coater and packaged in foil cups; Treatment B: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a "MACAP" coater and packaged in foil cups; Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0
Other intervention name(s): MiniMac; M207; MACAP; M207; Zomig
Intervention MeSH terms: Zolmitriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects are randomized to receive one of six treatment sequences of three open-label treatments 48 hours apart.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Healthy; Volunteer
Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the potential effect of the moderate CYP3A inducer
      modafinil and the weak CYP3A inducer pioglitazone on the pharmacokinetics of palbociclib.
    


Intervention name(s): Palbociclib alone; Palbociclib plus Modafinil; Palbociclib alone; Palbociclib plus pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection.; For Cohort 1, modafinil 200 mg once daily for 7 days, followed by 400 mg once daily for 25 days; on Day 28, a single oral 125 mg dose of palbociclib will be given with modafinil after a meal, followed by 120 hours of PK sample collection.; A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection.; For Cohort 2, pioglitazone 45 mg once daily for a total of 19 days; On Day 15, a single oral 125 mg dose of palbociclib will be given with pioglitazone after a meal, followed by 120 hours of PK sample collection.
Other intervention name(s): Palbociclib, PD-0332991; Palbociclib (PD-0332991); Modafinil (Provigil); Palbociclib, PD-0332991; Palbociclib (PD-0332991); Pioglitazone (Actos)
Intervention MeSH terms: Pioglitazone; Palbociclib; Modafinil
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Palbociclib; Modafinil; Pioglitazone; Pharmacokinetics; Drug-Drug Interaction Study; Healthy Volunteers; CYP3A Inducers
Pilot Study to Determine Efficacy of Cyclamen Europaeum Extract Nasal Spray in Patients With Acute Sinusitis
Condition: ACUTE SINUSITIS
MeSH terms: Sinusitis; Acute Disease
Study type: Interventional

Summary: 
      To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to
      placebo in subjects with acute sinusitis
    


Intervention name(s): Cyclamen Europaeum
Intervention type(s): Drug
Intervention description(s): Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SINUSITIS; CYCLAMEN
Bosentan Therapy in Children With Functional Single Ventricle
Condition: Congenital Heart Defects; Functional Single Ventricle
MeSH terms: Heart Defects, Congenital; Univentricular Heart
Study type: Interventional
Phase: Phase 2

Summary: 
      Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to
      investigate if Bosentan therapy can modify the outcome of children with functional single
      ventricle.
    

Detailed description: 
      Increased pulmonary vascular resistance (PVR) is a serous issues in children with functional
      single ventricle during the staged operative period. The purpose of this study is to
      investigate if Bosentan therapy can improve the survival and life quality after staged Fontan
      procedure in the children with high risk of increased PVR.
    

Intervention name(s): Bosentan
Intervention type(s): Drug
Intervention description(s): Bosentan 2mg/kg/dose twice a day and routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.
Other intervention name(s): Tracleer
Intervention MeSH terms: Bosentan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary vascular resistance; Heart defects, Congenital; Receptors, endothelin; Bosentan
Trial to Evaluate the Use of Pomegranate Concentrate (POMx) for the Prevention of Experimental Rhinovirus Infection
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 2

Summary: 
      Pomegranate has a long history of use in folk medicine. There is vast data on the health
      benefits of pomegranate fruit and juice. Multiple studies have established the strong
      antioxidative effects of pomegranate polyphenols (primarily the ellagitannin punicalagin) and
      their health effects. A vast number of animal and human clinical studies have provided
      evidence on effect of pomegranate products on reducing symptoms of common cold, reducing
      blood pressure, improving endothelial function, anti-tumor activity, and its
      anti-atherosclerotic activity. This study will evaluate the protective effect of a
      pomegranate concentrate (POMx) in decreasing the incidence and duration of the common cold
      among healthy adults.
    


Intervention name(s): Pomegranate Concentrate (POMx); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3.3 oz bottle containing antioxidants equivalent to 8 oz of pomegranate juice taken once daily for 7 days prior to infection and for 4 days after.; 3.3 oz bottle containing fruit flavored juice low in antioxidants taken once daily for 7 days prior to infection and for 4 days after.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Punicaceae; Pomegranate
Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male
      and female volunteers with high or low schizotype characteristics.
    

Detailed description: 
      The study is a randomized, double-blind, placebo-controlled functional magnetic resonance
      imaging (fMRI) study of the effects of a single dose of SEP-363856 and amisulpride on blood
      oxygen level dependent (BOLD) signal in healthy male and female volunteers with high or low
      schizotype characteristics.
    

Intervention name(s): SEP-363856; Amisulpride; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SEP-36385625 as a single oral dose of 50 mg; Amisulpride as a single oral dose of 400 mg; single oral dose placebo
Intervention MeSH terms: Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
Domiciliary Monitoring to Predict Exacerbations of COPD
Condition: COPD Exacerbation
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is a common, long term condition of the lungs
      that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in
      activities, patients are prone to developing chest infections called 'exacerbations'.
      Exacerbations are a big problem: unpleasant for patients, and sometimes severe enough to
      cause hospital admission (and therefore health facilities pressures) and death. Reducing the
      impact of exacerbations is very important. Investigators have previously shown that earlier
      treatment of COPD exacerbations results in faster recovery, and reduced chance of hospital
      admission. Helping patients to detect exacerbations early is therefore important.
      Investigators have also recently shown that monitoring heart rate and oxygen saturation via a
      finger probe may assist in this. However, measuring these variables when the patient is awake
      means they can be affected by other things, such as exercise and anxiety. Our new idea is
      that measuring heart rate and oxygen level overnight, when a patient is asleep, will give the
      best chance of detecting COPD exacerbations early and our study will test that. Investigators
      will randomly allocate 77 patients with COPD recruited from our service in London to standard
      monitoring, or overnight monitoring, for up to six months or the first exacerbation,
      whichever is sooner. Investigators will then analyse whether overnight monitoring was able to
      detect exacerbations earlier, and therefore could be used to help patients get treatment
      earlier. A subset of participants will also wear an activity monitor overnight for the first
      two weeks, so that Investigators can assess the effect (if any) of overnight awake periods
      (such as trips to the bathroom) on the heart rate and saturation recording.
    


Intervention name(s): Nonin
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Cognitive Behavior Therapy for Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      Atopic dermatitis is an inflammatory skin disease characterized by itching, dry skin and
      recurrent inflammatory eczema. It is one of the most common skin diseases and is associated
      with reduced quality of life, functional impairment and sleep difficulties. The present study
      aims to investigate a new exposure-based cognitive behavioral psychological treatment for the
      disorder. The trial is a small scale open trial (n=25) with assessments at baseline,
      post-treatment and 6-month follow-up. The primary outcome is the SCORAD.
    

Detailed description: 
      Atopic dermatitis (AD)is an inflammatory skin disease characterized by itching, dry skin and
      recurrent inflammatory eczema. It is one of the most common skin diseases and is associated
      with reduced quality of life, functional impairment and sleep difficulties. There are
      currently no pharmacological treatments that are effective in curing the disorder in the
      longer-term. Itching is one of the core symptoms in AD and it has been shown that the
      behavioral response to itching, scratching, has a maintaining function in AD. Reducing
      scratching may therefore play an important role in alleviating AD. Although behavioral
      aspects play a significant role in AD only a few studies have investigated the effect of
      psychological treatment for AD. These studies have shown promising results and the present
      study aim to add to the body of knowledge by testing a new form of cognitive behavioral
      treatment for AD. This new treatment is based on the idea that patients could benefit from
      training in exposure to events that could lead to increase in itching while refraining from
      scratching. To enable this the treatment incorporates more recently developed cognitive
      behavioral components such as mindfulness training.

      The present study aims to investigate a new exposure-based cognitive behavioral psychological
      treatment for the disorder. The trial is a small scale open trial (n=25) with assessments at
      baseline, post-treatment and 6-month follow-up. The primary outcome is the SCORAD.
    

Intervention name(s): Cognitive behavior therapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive behavior therapy based on exposure and response prevention. The treatment also incorporates mindfulness training as a means to increasing tolerance for aversive thoughts and emotions associated with AD. The treatment is delivered by a licensed psychologist and comprises 10 individual weekly sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive behavior therapy
Activity Prescription in Clinical Practice
Condition: Physical Activity; Sedentary Lifestyle
Study type: Interventional

Summary: 
      Most adults do not achieve the US aerobic physical activity (PA) guidelines (≥150
      minutes/week of at least moderate intensity PA). Inadequate PA is considered a major risk
      factor for cardio-metabolic diseases and other poor health outcomes. Recommendations now
      endorse PA in reducing risk for certain diseases. Unfortunately, low PA levels are seldom
      identified and treated within clinical practice. This study will build on previous prevention
      efforts by focusing on the identifying and treating low PA levels in adults clinical care
      patients and referring them to an intervention that is feasible for delivery through clinical
      care.
    

Detailed description: 
      This study involves designing/ implementing a patient-centered, individually-focused physical
      activity (PA) intervention designed for integration into clinical care. We will recruit adult
      patients (aged 21-70; n=80) from the general internal medicine practice of a local health
      system who are not meeting the US aerobic activity goal of 150 minutes/ week of at least
      moderate intensity PA and who can safely increase PA without supervision. As low PA levels
      have been associated with numerous poor health outcomes, the primary intervention goal will
      be achievement of the US PA goal. A secondary goal will be to reduce sedentary behavior
      (SED), which is related to poor health outcomes (independent of PA achievement). Intervention
      materials will be developed using a patient/provider centered approach and delivered weekly
      over 3 months via an existing online platform with participants self-tracking behavior
      outcomes will be examined using a three month wait-listed control design in which all
      participants will eventually receive the intervention.
    

Intervention name(s): ActiveGOALs
Intervention type(s): Behavioral
Intervention description(s): 13 week, online self-directed intervention. Once weekly sessions are based on social-cognitive theory models of behavior changes. Coaches will provide weekly feedback . Behavior tracking tools will be provided. Links to tools that support physical activity will also be provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 month wait-listed control trial in which participants are randomized to immediate intervention or intervention after 3 months.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      This study objectives to assess the role of endothelial monocyte-activating polypeptide II
      (EMAP II) as a marker of endothelial dysfunction and disturbed angiogenesis in sickle cell
      disease and to identify its correlation With the oxidative status.
    

Detailed description: 
      Study design:

      Screening/Baselie Phase

        -  Detailed medical history with special emphasis on demographic data, transfusion and
           chelation therapy, disease modifying therapy

        -  Thorough clinical examination

        -  Laboratory investigations to be done will include:

             -  Liver function test

             -  Marker of hemolysis

             -  Serum ferritin .

             -  Complete blood count(CBC)

             -  Hemoglobin electrophoresis

             -  Determination of serum levels of EMAP II

             -  Lipid Peroxidation (Malondialdehyde Concentration.), Superoxide Dismutase activity,
                Catalase activity, Glutathione Peroxidase activity, Glutathione Reductase activity,
                Vitamin E concentration, GSH

      The patients under investigations will receive vitamin E supplementation for three months

      Patients will be followed up for clinical assessment lying stress on frequency and severity
      of sickling crisis, length of hospital admission, and frequency and severity of painful
      crisis

      The biochemical investigations, EMAPII and oxidative stress biomarkers will be measured also
      after the three months vitamin E oral administration.

      Statistical analysis Result will be expressed as the mean (+/-) standard deviation (SD). For
      all tests significance was set at P<0.05. All statistical analysis will be performed using
      software package SPSS version 17.0 (SPSS Inc,Chicago, IL, USA). Differences over time will be
      tested with analysis covariance (ANOVA) repeated measures. Repeated measures analysis will be
      used to test treatment and time effects in addition to group -by- time interaction for
      clinical laboratory parameters. In cases where interactions will be identified, post hoc
      comparisons will be adjusted using Bonferroni correlations.
    

Intervention name(s): Vitamin E
Intervention type(s): Drug
Intervention description(s): vitamin E supplementation for three months (400-600 mg/day) (400 mg/day in those weighed less than 20 kg and 600 mg/day in those weighed at least 20 kg)
Other intervention name(s): Antioxidant
Intervention MeSH terms: Vitamin E; Antioxidants
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care