bioihbjkbjnl/mcl2 huggingface dataset:
Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months
Condition: Erectile Dysfunction Following Radical Prostatectomy
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      This study evaluates the retinal and choriocapillary vascular features in patients under the
      effects of Tadalafil 20mg for more than 6 months, using optical coherence tomography
      angiography.
    

Detailed description: 
      Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood
      flow to the penis thus promoting the erection.

      This drug represents an treatment for erectile dysfunction in patients after radical
      prostatectomy.

      The optical coherence tomography angiography represents a novel and noninvasive diagnostic
      technique that allows a detailed and quantitative analysis of retinal and choriocapillary
      vascular features.

      The study evaluates the changes in optical coherence tomography angiography features after
      the somministration of Tadalafil 20 mg orally for more than 6 months.
    

Intervention name(s): Tadalafil 20 MG
Intervention type(s): Drug
Intervention description(s): To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.
Other intervention name(s): Cialis
Intervention MeSH terms: Tadalafil
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 45 years with diagnosis of erectile dysfunction due to
        surgery of radical prostatectomy. They did not receive previous treatment before Tadalafil.
        They did not present any ophthalmological disease, diabetes, heart diseases and
        hypertension.
A Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults
Condition: Tobacco Use; Tobacco Smoking; Cigarette Smoking
Study type: Interventional

Summary: 
      This is a randomised, open-label, confined, cross-over study to evaluate the nicotine
      pharmacokinetics (PK) of modern oral nicotine pouches and nicotine lozenges carried out in 36
      healthy adult subjects who smoke cigarettes and who may have experience using smokeless
      tobacco (loose or pouches).
    

Detailed description: 
      Starting on Day 1, subjects will check-in at the clinical site to complete procedures to
      confirm eligibility. Following basic check-in procedures (e.g., urine pregnancy test, urine
      drug screen, alcohol test and vital signs), subjects will continue with a 7-day confinement.
      Subjects will be randomized to a product sequence (using a Williams design).

      Test sessions will occur every day during the remainder of the study. The active period of
      each test session will last for approximately 4 hours after the start of Investigational
      Product (IP) use. During each test session, a subject will be required to use their
      randomized IP and during the session, PK blood draws and a subjective effects questionnaire
      will be collected.

      The day prior to each test session, subjects will participate in a product familiarization
      period in which they will use one pouch or lozenge of their randomized IP. The product
      familiarization period will occur after the scheduled test session (or after enrollment and
      randomization on Day 1) and before the 12-hour tobacco and nicotine abstinence period.
      Subjects should use the IP pouch for at least 30 minutes or allow the lozenge to dissolve
      slowly.

      Subjects will provide usual brand (UB) cigarettes for use during study confinement and have
      access to their UB cigarettes for ad libitum use with the exception of 1) during the test
      session, 2) during the the minimum 12-hour tobacco and nicotine abstinence period prior to
      each test session and 3) a minimum of one hour after IP use during the product
      familiarization period. Each UB cigarette must be requested from site staff and used butts
      returned to site staff for accountability.
    

Intervention name(s): Product A; Product B; Product C; Product D; Product E; Product F
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): A 4mg nicotine pouch product; A 4mg nicotine pouch product; A 2mg nicotine lozenge product; A 2mg nicotine lozenge product; A 2mg nicotine lozenge product; A 2mg nicotine lozenge product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Mat Pilates Method in the Treatment of Women With Fibromyalgia
Condition: Fibromyalgia, Primary
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Introduction: Physical exercises have been recommended to improve overall well-being in
      patients with fibromyalgia, with the main goal of repairing the effects of lack of physical
      conditioning, and improving symptoms especially pain and fatigue. Very well estimated and
      widely known are the studies that support the use of the pilates method as effective in
      improving the symptoms of the disease.

      Objective: To evaluate the effectiveness of the soil method in improving pain in women with
      fibromyalgia in the city of Santa Cruz, RN.

      Methodology: This is a randomized controlled trial with blind evaluator, where 60 patients
      with fibromyalgia diagnosis are divided into two groups. The intervention group, perform an
      exercise program based on the pilates method in soil and another, considered control group,
      participate in a program of aerobic exercises in the pool. Both groups conduct supervised
      exercise programs 2 times a week for a period of 12 weeks. The evaluation instruments used in
      an EVA (visual pain scale); FIQ Questionnaire - Fibromyalgia Impact Questionnaire; Functional
      ability by the "Timed Up and Go" test and 6-minute walk test; A quality of sleep by the
      Pittsburgh Sleep Quality Index (PSQI-BR) and an ESS-BR (Epworth Sleepiness Scale); Finally, a
      general quality of life for the SF-36.

      Statistical analysis: Data are analyzed by t-student, Mann-Whitney test, repeated-measures
      ANOVA and intention-to-treat analysis.
    


Intervention name(s): Mat Pilates exercises; Aquatic aerobic exercises
Intervention type(s): Other; Other
Intervention description(s): The exercise program based on the pilates method will be performed on the ground in the group room of the FACISA / UFRN Physiotherapy School Clinic in Santa Cruz. The room has ample space and air conditioning for better patient accommodation. The exercises will be performed twice a week for 12 weeks. Each session will last about 50 minutes and will be supervised by a physical therapy student along with the research coordinator. A total of 10 exercises will be performed.; The aerobic exercise program will be held in the therapeutic pool of the Physiotherapy School Clinic of FACISA / UFRN in Santa Cruz. The pool is heated and provides better effects to the proposed treatment.
The exercises will be performed twice a week for 12 weeks. Each session will last about 50 minutes and will be supervised by another physical therapy student along with the research coordinator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia, pilates, exercises
Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding
Condition: Variceal Bleeding, Cirrhosis
MeSH terms: Hemorrhage; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide
      in patients with variceal bleeding for the control of variceal bleeding in combination with
      endoscopic therapy.
    

Detailed description: 
      In patients who are suspected to have variceal bleedings, pharmacologic therapy with
      vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as
      possible, even before endoscopy. However, it is still unclear whether the efficacies of these
      drugs are same or not. This study is performed to compare the efficacy of terlipressin,
      somatostatin, and octreotide in patients with variceal bleeding for the control of variceal
      bleeding in combination with endoscopic therapy.
    

Intervention name(s): Terlipressin; Somatostatin; Octreotide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days; loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days; loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days
Other intervention name(s): Glypressin; Somatosan; Sandostatin
Intervention MeSH terms: Octreotide; Terlipressin; Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cirrhosis, Esophagus Disorders, Varicose Veins
Feasibility Study: Lifting and Tightening of the Elbows
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on
      the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will
      be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
    

Detailed description: 
      This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the
      Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and
      post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and
      patient satisfaction questionnaires will also be obtained.
    

Intervention name(s): Ulthera System Treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Interscalene Block Versus Costoclavicular Block for Shoulder Surgery
Condition: Pain, Postoperative; Shoulder Pain; Surgical Procedure, Unspecified; Diaphragmatic Paralysis
MeSH terms: Shoulder Pain; Respiratory Paralysis; Paralysis; Pain, Postoperative
Study type: Interventional

Summary: 
      Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder
      surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP)
      that may not be tolerated by patients with chronic pulmonary disease. This randomized
      controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and
      costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder
      surgery.

      The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit
      (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is
      that interscalene and costoclavicular infraclavicular blocks will result in equivalent
      postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.
    


Intervention name(s): Interscalene Block; Costoclavicular Infraclavicular Block
Intervention type(s): Procedure; Procedure
Intervention description(s): Injection with ultrasound guidance of 20mL of levobupivacaine 0.5% with 5 micrograms of epinephrine per mL in the interscalene groove of the brachial plexus.; Ultrasound guided brachial plexus block injecting 20mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in between the cords of the brachial plexus at the costoclavicular infraclavicular space.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Postoperative Shoulder Analgesia; Hemidiaphragmatic Paralysis; Alternative blocks
A Phase 1/2 Multicenter, Randomized, Study to Evaluate the Safety and Efficacy of VS101 Subconjunctival Latanoprost Insert in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy
      with topically administration of commercially available latanoprost in patient with glaucoma
      and ocular hypertension
    


Intervention name(s): VS101 Insert Dose A; VS101 Insert Dose B; VS101 Insert Dose C; Latanoprost 0.005% eye drops
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sustained release of latanoprost into the eye; Sustained release of latanoprost into the eye; Sustained release of latanoprost into the eye; Latanoprost 0.005% eye drops administered once daily on the eye
Intervention MeSH terms: Ophthalmic Solutions; Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Glaucoma; Intra-ocular pressure; Slow Release; Controlled release
Treatment of Tendon Injury Using Mesenchymal Stem Cells
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow; Tendon Injuries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived
      mesenchymal stem cells(ALLO-ASC) in treatment of tendon injury. ALLO-ASC will be
      administrated to the patients with lateral epicondylitis by ultrasonographic guided
      injection.
    

Detailed description: 
      Injection volume depends on the size of lesion on ultrasound examination. And all injection
      will be done under ultrasound guidance. First the investigators will administrate 1 million
      cells/ml (Group 1 for 6 participants). After monitoring the safety of injection for 2 weeks
      (the investigators will use WHO recommendations for grading of acute and subacute toxic
      effects), the investigators decide to increase the quantity as 10 million cells/ml (Group 2
      for participants).

      The investigators will compare the efficacy difference as quantity increase. For efficacy
      measurement, VAS/modified Mayo clinic performance index for elbow/lesion measurement by
      ultrasound will be used at 6 and 12 weeks after injections.
    

Intervention name(s): ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adipose derived mesenchymal stem cell; allogeneic stem cell
Safe Access: Trial With RemovAid Device
Condition: Removal of a Contraceptive Subdermal Implant
Study type: Interventional

Summary: 
      This randomized trial will compare different approaches to removing a subdermal contraceptive
      implant from the upper arm of 225 women in Uganda. The experimental approach is a hand-held
      device (RemovAid) that incises the skin and grasps the implant for extraction. Safety and
      efficacy endpoints will be compared to the traditional removal approach (scalpel, forceps,
      tweezers).
    

Detailed description: 
      The trial assigns participants to one of three arms: RemovAid+lidocaine patch (n=75),
      RemovAid+lidocaine injection (n=75) or traditional approach+lidocaine injection(n=75).
      Complication rates in the different arms will be compared. Efficacy (successful implant
      removal) will be the secondary comparisons. Finally, pain during removal and duration of
      removal procedure will be compared. Participants will return to the clinic within 4 weeks of
      the removal procedure to record the healing process and final interventions (if any).
    

Intervention name(s): RemovAid device + lidocaine patch; Standard technique + lidocaine injection; RemovAid device + lidocaine injection
Intervention type(s): Device; Procedure; Device
Intervention description(s): The RemovAid device incises the skin and grasps the implant for removal. A lidocaine patch will be used prior to incision.; Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.; The RemovAid device incises the skin and grasps the implant for removal. A lidocaine injection will be used prior to incision.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Associations of Exposure to Bisphenol A With Blood Pressure and Epigenetic Change
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      -  Bisphenol A(BPA) is an endocrine disrupting chemical, which mimics the action of
           estrogen.

        -  Previous studies reported that BPA exposure is associated with increased risk of
           cardiovascular diseases.

        -  Exposure to BPA occur mainly through oral route, and epoxy coating of canned food is one
           of the well established source.

        -  The investigators hypothesis is that increased BPA exposure from canned beverage would
           disrupt normal physiology in a short term.

        -  In the present trial the investigators are to investigate whether increased BPA exposure
           by consuming canned beverage actually affect cardiovascular indices and epigenetic
           feature.

        -  For this aim, the investigators will conduct a cross-over trial.
    


Intervention name(s): Can 1; Can 2; Glass
Intervention type(s): Other; Other; Other
Intervention description(s): drink the beverage in a can and a glass bottle; Consume two canned beverage; consume two glass bottled beverage
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic Hepatitis B Virus (HBV) Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Endotoxemia; Hepatitis
Study type: Observational

Summary: 
      This study was designed for changes in endotoxaemia, endotoxin-binding factors, sICAM-1
      (soluble intracellular adhesion molecule-1), and cytokines during progression of chronic HBV
      infection. Patients with chronic HBV infection and healthy control are included. A limulus
      assay was used to measure plasma endotoxin level and ELISAs were used to measure the
      concentrations of interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-α
      (TNFα), sICAM-1, and soluble CD14 (sCD14).
    

Detailed description: 
      1. Patients Patients with chronic HBV infection and healthy volunteers were enrolled. There
           were asymptomatic carriers group, patients with chronic hepatitis, patients with hepatic
           cirrhosis, and patients with acute on chronic liver failure.

        2. Endotoxin assay Blood samples were obtained under aseptic conditions by peripheral
           venipuncture and using pyrogen-free syringes, needles, and glassware. Plasma samples
           were heated at 70℃ for 10 min. Plasma concentration was then measured in duplicate using
           a commercially available Limulus amebocyte lysate assay following the manufacturer's
           protocol.

        3. ELISA ELISA kits were used to assess in duplicate the plasma concentrations of IL-6,
           IL-10, TNFα, sICAM-1 and sCD14.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with chronic HBV infection admitted to The Third Affliated Hospital of Sun Yat-sen
        University
      
Keywords: endotoxaemia
Population Research of Sublingual Microcirculation Data of Healthy Volunteers
Condition: Healthy
Study type: Observational

Summary: 
      This study will enrolled 90 healthy volunteers. The sublingual microcirculation will be
      examined by sidestreamdark-field videomicroscopy (MicroScan;Microvision Medical, Amsterdam,
      The Netherlands). Five video sequences (20 s) was obtained from different sublingual sites,
      and digitally stored the images with code numbers that did not reflect volunteers'
      information for later offline analysis by automated analysis software (AVA 3.0; Academic
      Medical Centre, University of Amsterdam, Amsterdam, The Netherlands).
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No Intervention
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy Volunteers
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Acceptability - Stay on Frutal
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To prove the safety of the gynecological formulation in normal conditions of use.
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Treatment duration: 21 consecutive days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children
Condition: Healthy or Stable Chronic Illness
MeSH terms: Chronic Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate the immunologic noninferiority of
      Q/LAIV to FluMist in children 2 to 17 years of age.
    

Detailed description: 
      The randomized, double-blind study was designed to demonstrate the immunologic noninferiority
      of Q/LAIV compared to FluMist in children 2-17 years by comparing the strain-specific
      post-dose geometric mean titers of hemagglutination inhibition antibodies. Children were
      randomized 3:1:1 to receive Q/LAIV or one of two FluMist vaccines. Subjects 9-17 years of age
      received a single dose, and those 2-8 years of age received two doses one month apart. Serum
      was obtained 1 month after dose 1 except in influenza vaccine-naive subjects 2-8 years old,
      when it was obtained after dose 2. Safety and tolerability were also assessed.
    

Intervention name(s): Q/LAIV (MEDI3250); FluMist/B/Yamagata; FluMist/B/Victoria
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 10 ^7.0 ± 0.5 FFU/dose of each of 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria; 10 ^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Yamagata; 10 ^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention