bioihbjkbjnl/mcl2 huggingface dataset:
Sildenafil Effects on Pulmonary Haemodynamics and Gas Exchange in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of
      pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric
      oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries
      of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary
      disease (COPD), we hypothesized that sildenafil might improve pulmonary hemodynamics and
      increase exercise tolerance in this condition. However, in COPD sildenafil may also impair
      gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. The research
      project is aimed to evaluate these effects.

      It is a prospective, randomized, double-blind study to evaluate the acute effects of a single
      dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. Subjects: 20
      patients (10 in each group). Measurements: pulmonary hemodynamics, arterial blood gasses and
      ventilation-perfusion distributions; at rest and during sub-maximal exercise.
    


Intervention name(s): Sildenafil; Sildenafil
Intervention type(s): Drug; Drug
Intervention description(s): sildenafil 20 mg orally; sildenafil 40 mg orally
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COPD
The Effect of Intra-Articular Injection of RegenoGel-OSP™ (Self-Plasma) and RegenoGel™ on Knee Pain in People Suffering From Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ and
      RegenoGel™ to treat knee pain and effect on subject's activity and quality of life. During
      the study the subjects will receive two treatments at a 3-month interval. The study is
      double-blinded. The subjects will be randomized and sequentially assigned to RegenoGel-OSP™,
      RegenoGel or placebo treatment in the first treatment. In the second treatment after interval
      of three months all the subjects will necessarily receive one of the two active products. The
      follow-up period will continue for one year after first treatment.
    


Intervention name(s): RegenoGel-OSP, RegenoGel
Intervention type(s): Device
Intervention description(s): RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus
      coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab.
      2mg(pitavastatin Ca 2mg) under fed condition in healthy male volunteers.
    

Detailed description: 
      To develop combination product of micronized fenofibrate plus pitavastatin, we would like to
      evaluate the comparative pharmacokinetics and safety of fixed-dose combination(micronized
      fenofibrate160mg+pitavastatin Ca 2mg) versus coadministration of Lipilfen
      cap.160mg(micronized fenofibrate160mg) and Livalo tab. 2mg(pitavastatin Ca 2mg) under fed
      condition in healthy male volunteers.
    

Intervention name(s): Livasupril Cap.160/2mg; Lipilfen cap. 160mg; Livaro tab. 2mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg; Micronized fenofibrate 160mg; Pitavastatin Ca 2mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Brain Response to Emotional Pictures Using a Magnetic Resonance Imaging (fMRI) While on Escitalopram
Condition: Major Depression
MeSH terms: Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out what parts of the brain have increased or decreased
      activity when people are depressed and how antidepressant medicine changes this activity in
      depressed patients. The genetic samples collected are to look at variation in a gene
      (serotonin transporter gene), which affects the functioning of the chemical serotonin in the
      brain
    

Detailed description: 
      This study will measure the activity in different parts of the brain, while the patients are
      seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI
      scans will be conducted. One before the patient begins on any medication, one during the
      study after 3 weeks of treatment and one after six more weeks of treatment with a standard
      antidepressant called Escitalopram(trade name: Lexapro).
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): 10 mg of Escitalopram by mouth once a day for 8 weeks
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Escitalopram; Lexapro; fMRI; pictures
St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety
Condition: Depressive Disorder, Major; Anxiety Disorders
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      SJW has the greatest evidence of herbal medicine efficacy in treating MDD. In treating
      anxiety, kava has the greatest evidence of efficacy. As comorbidity of MDD and anxiety
      commonly occurs, it is conceivable that a combination of an established antidepressant agent
      such as SJW and an established anxiolytic agent such as kava may effectively treat MDD
      presenting with comorbid anxiety. It is possible that a beneficial synergistic effect may
      also occur between SJW and kava, improving the treatment outcomes in MDD with comorbid
      anxiety, than by the individual substances alone. Determination of this is not addressed in
      this study due to limitations of time and resources. The determination of the strength of the
      SJW-kava combination will be ascertained by comparing similar trials using SJW and kava
      mono-therapy in addressing MDD and GAD.

      The hypothesis is that a combination of SJW and kava will reduce MDD occurring with comorbid
      anxiety more than placebo.
    


Intervention name(s): Herbal medicine (St. John's wort and Kava)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Plant, medicine; Psychiatry; Major depressive disorder; Anxiety; Major Depressive Disorder with comorbid anxiety
Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to compare the immunogenicity, safety, and viral shedding of a
      new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the
      2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine
      in the 2015-2016 influenza season.
    

Detailed description: 
      This randomized, double-blind, multi-center study will enroll approximately 200 children 24
      to less than (<) 48 months of age. Participants will be randomized in a 1:1:1 ratio to
      receive two doses of either FluMist quadrivalent 2017-2018, FluMist quadrivalent 2015-2016
      formulation, or FluMist trivalent 2015-2016 formulation.

      Participants will be screened within 30 days prior to randomization. Randomization will be
      stratified according to whether the participant ever received prior influenza vaccination.
      Approximately 50% of the participants will not have been previously vaccinated. All
      participants will receive two doses of investigational product on Study Days 1 and 28, and
      followed for a 28-day follow-up period after each dose. Blood and nasal samples will be
      collected and safety evaluations perfomed.

      The duration of participants participation is approximately 2 to 3 months. The study will be
      conducted during the influenza "off-season" in the US. After completion of the study all
      participants will be offered and strongly encouraged to receive an inactivated influenza
      vaccine approved for use in the US for the 2017-2018 influenza season.
    

Intervention name(s): FluMist trivalent (2015-2016); FluMist Quadrivalent (2015-2016); FluMist Quadrivalent (2017-2018)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.; 0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.; 0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: FluMist Quadrivalent; Trivalent; Influenza; Vaccine; Prevention
An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of
      three pregabalin controlled release tablets as compared to multiple doses of the pregabalin
      immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three
      pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate
      release capsule and 3) evaluate the safety and tolerability of multiple doses of three
      pregabalin controlled release tablets as compared to multiple doses of the pregabalin
      immediate release capsule.
    


Intervention name(s): Pregabalin controlled release, 82.5 mg; Pregabalin controlled release, 165 mg; Pregabalin controlled release, 330 mg; Pregabalin immediate release, 150 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 82.5 mg controlled release tablet administered once daily for three days.; 165 mg controlled release tablet administered once daily for three days.; 330 mg controlled release tablet administered once daily for three days.; 150 mg immediate release capsules administered every 12 hours for three days
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregabalin pharmacokinetics bioavailability bioequivalence
Determining an Effective Site (Groin Versus Arm) for Giving HIV Vaccines
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and immune system response to the TBC-3B
      HIV vaccine when it is injected either into the groin area or into the arm. The goal is to
      determine which injection site is better at producing a particular type of immune response.
      This study is not evaluating the effectiveness of the vaccine, so volunteers must maintain
      low risk behavior for HIV transmission throughout the study.
    

Detailed description: 
      The goal of this vaccination study is to evaluate the safety and immunogenicity of the
      Therion Biologic Corporation (Cambridge, MA) TBC-3B vaccine. TBC-3B consists of live,
      recombinant vaccinia virus expressing the env and gag/pol genes of HIV-1 strain IIIB. TBC-3B
      will be administered by subcutaneous injection in the groin and in the deltoid region, with
      the aim of determining which site is better at inducing mucosal immune responses. Because the
      groin area drains to the inguinal lymph nodes, vaccines given there may stimulate local
      immunologic activity in the draining rectal mucosa as well as systemic immunologic activity
      in the blood.

      Volunteers will be followed for 20 months. The first 2 months of the study will be an
      evaluation of volunteers' normal immune function. Volunteers will then be randomly selected
      to receive the TBC-3B experimental HIV vaccine in either the groin area or in the deltoid
      region. Neither volunteers nor study personnel will know which group the volunteer will be in
      until the day of the first immunization. All volunteers will receive TBC-3B.

      During the 20 months of the study, volunteers will be asked to donate blood up to 14 times,
      undergo seven flexible sigmoidoscopies with biopsies, and receive three pairs of vaccine
      injections. For up to 36 days after each experimental vaccination, volunteers will be asked
      to abstain from activity that might spread the virus in the vaccine and put others at risk.
      Volunteers will receive specific instructions on how to avoid these risks. Volunteers will
      also be asked not to engage in receptive anal intercourse during the study.
    

Intervention name(s): TBC-3B
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV seronegativity; HIV preventive vaccine
Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult
      volunteers.
    

Detailed description: 
      A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral
      Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult Subjects
    

Intervention name(s): naproxen; esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 250mg, oral dose; 20mg, oral dose
Intervention MeSH terms: Naproxen; Esomeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Juvenile Idiopathic Arthritis; Pharmacokinetics; VIMOVO; fasting state; Amount of VIMOVO in the blood; taken on empty stomach
Music Therapy as Procedural Support for Young Children Undergoing Immunizations
Condition: Immunization
Study type: Interventional

Summary: 
      Many young children undergo medical procedures that are painful and distressing. Negative
      experiences during medical procedures can have serious long-term effects, including fear and
      avoidance of medical procedures during adulthood. Distraction interventions can help prevent
      children from forming negative memories of medical procedures. Live music therapy has been
      shown to alleviate pediatric distress during both invasive and non-invasive procedures. The
      objective of this study is to examine the effects of music therapy on the child's distress
      behaviors and time to calm, as well as the length of the procedure and use of restraint, and
      parents' and healthcare staffs' behaviors during the procedure, for young children undergoing
      immunizations and influenza vaccinations. It is hypothesized that children receiving music
      therapy will show fewer distress behaviors, calm more quickly, and have shorter procedures
      with fewer instances of restraint compared to children who receive standard care. In
      addition, it is predicted that adults (parents and staff) will show fewer distress-promoting
      behaviors during, before, and after the procedures.
    


Intervention name(s): Music Therapy
Intervention type(s): Behavioral
Intervention description(s): Live music therapy is interactive and incorporates behavioral cues for coping techniques during the procedure, using patient-preferred music.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Music Therapy; Child Psychology; Vaccination
Comparative Effects of Different Noninvasive Ventilation Mode on Neural Respiratory Drive in Recovering AECOPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Background: The efﬁciency of Neural respiratory drive (NRD)expressed by a ratio of
      ventilation to the diaphragm electromyogram (EMGdi) decreases in patients with COPD
      .Improving the neural respiratory drive efficiency of COPD will help to relieve the clinical
      symptom and make the patients feel comfort.Noninvasive positive pressure ventilation(NPPV)is
      a good treatment to AECOPD patients.It is unknown the effects of different mode of
      noninvasive positive pressure ventilation(NPPV) such as proportional assist ventilation (PAV)
      and pressure-support ventilation (PSV) on the efﬁciency of Neural drive of AECOPD and which
      mode benefit the patients more.

      Objective: To compare the short-term effects of mask pressure support ventilation (PSV) and
      proportional assist ventilation (PAV) on Neural respiratory drive in recovering patients of
      AECOPD
    

Detailed description: 
      Methods: After the baseline data of spontaneous breathing was collected, 20 hypercapnic
      recovering AECOPD patients were placed on different mode of noninvasive positive pressure
      ventilation(NPPV, such as the PAV or PSV mode) randomly. For each mode, three levels (PA-,
      PA, PA+or PS-, PS, PS+), ) of support were applied.PS and PA are set for the patient's
      comfort . On the basis of these two levels, 25% increase and reduction assisted level of
      pressure were set both for PS and PA (PA-, PA+or PS-, PS+). At each level, the patients were
      ventilated at least 20 minutes until the breathing was stable. The respiratory frequency
      (RR), tidal volume (VT), transdiaphragmatic pressure (pdi) the pressure-time product (PTP)
      and root-mean-square(RMS) of EMGdi were calculated. Esophageal and gastric balloon-catheters
      were used to detect the intra-thoracic and abdominal pressure. Airway pressure was also
      measured simultaneously. EMGdi was recorded from a multipair esophageal electrode .During
      ventilation Airflow and ventilation were measured with pneumotachograph.
    

Intervention name(s): noninvasive positive pressure ventilation
Intervention type(s): Device
Intervention description(s): the assisted level of the noninvasive proportional assist(PAV) and pressure support ventilation(PSV) on Neural respiratory drive(NRD) in recovering patients with acute exacerbation of chronic obstructive pulmonary disease
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Neural respiratory drive in different level of NPPV
Strengthening Exercise and Quadriceps Force During Walking
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This is a longitudinal, randomized, controlled interventional multi centric study on the
      effects of lower leg strengthening exercise on quadriceps force during walking in people with
      knee osteoarthritis. At each study centre twenty subjects will be included, for a total of 40
      participants. Subjects will be randomized equally (1:1) into 1 active arm and 1 control arm.

      The objective of the study is to evaluate the effect of twelve weeks of quadriceps
      strengthening on the mechanical output of the quadriceps during locomotion. A secondary
      purpose is to explore the relationship between quadriceps strengthening and compressive knee
      loadings. The hypothesis is that quadriceps strength training will not change quadriceps
      force, power, and work in locomotion in people with knee osteoarthritis.

      Primary outcome is quadriceps force during walking, secondary outputs are quadriceps power
      and work and knee compressive loads during walking. Explorative measures are isometric and
      concentric isokinetic leg muscle strength, radiographic score of the knee (Kellgren and
      Lawrence), a one-leg rise from chair test (maximum number of reps) and a lateral step-up test
      (maximum number of reps).
    


Intervention name(s): Strength Training
Intervention type(s): Other
Intervention description(s): The exercises will be performed in standard strength training equipment. Prior to each of the strengthening exercise sessions, a warm up phase is performed by 5-10 minutes of ergometer cycling at a moderate intensity. Muscle strengthening exercises will be performed according to the standard progressive resistance and overload principle. The exercise programme consists of three exercises performed with three sets of 10 repetitions at 60%-85% of patient's 10RM. Training load will be progressed by means of bi-weekly estimates of muscle strength to ensure a constant load of 60%-85% RM. Exercises are: 1. Leg extension, 2. Leg press, and 3. Forward lunges.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Strength training; Biomechanics; Quadriceps; Gait
Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain
Condition: Endometriosis
MeSH terms: Endometriosis; Pelvic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 3-arm, multicenter, double-blind, randomized, placebo-controlled study to evaluate
      the efficacy of DR-2001 in endometriosis-related symptoms, primarily nonmenstrual pelvic
      pain, over a 12-week treatment period.
    

Detailed description: 
      This multicenter, double-blind, randomized, placebo-controlled study is designed to evaluate
      the ability of DR-2001 to produce beneficial changes in endometriosis-related symptoms,
      primarily nonmenstrual pelvic pain, over a 12-week treatment period. The overall study
      duration for each patient will be about 20 weeks.

      Patients who meet all study entrance criteria will be randomly assigned to one of three
      treatment groups.

      The change in endometriosis-related clinical symptoms will be assessed in two ways: through a
      combined physician/patient assessment and also with a patient self-assessment. Patients will
      undergo a gynecologic exam at each study visit.
    

Intervention name(s): DR-2001a; DR-2001b; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): DR-2001a administered vaginally each month; DR-2001b administered vaginally each month; Placebo administered vaginally each month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: endometriosis; pelvic pain; hormonal treatment