bioihbjkbjnl/mcl2 huggingface dataset:
Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To describe the safety findings from Days 0 to 44 following injection of the 2003-2004
      pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in
      the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to <
      36 months.

      To describe the immunogenicity findings from Days 0 to 44 following injection of the
      2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®,
      given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6
      months to < 36 months
    

Detailed description: 
      The study is to collect sera from healthy children being administered the 2003-2004
      formulation of the inactivated, split-virion influenza vaccine Fluzone®.
    

Intervention name(s): Influenza virus vaccine (Pediatric formulation)
Intervention type(s): Biological
Intervention description(s): 0.25 mL, Intramuscular
Other intervention name(s): Fluzone®
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Fluzone®; Children
Randomized Population-Based Study on Chlamydia Trachomatis Screening
Condition: Chlamydia Trachomatis; Infertility; Ectopic Pregnancy
MeSH terms: Chlamydia Infections; Infertility; Pregnancy, Ectopic
Study type: Interventional

Summary: 
      30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two
      groups. The intervention group received an invitation to be tested for urogenital Chlamydia
      trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group
      received no intervention (21,000 individuals). Outcome measures: Number of tested
      individuals, number of detected infections, number of women developing PID, ectopic pregnancy
      or infertility, number of women giving birth to a child, number of women receiving IVF
      treatment and number of men developing epididymitis.

      The hypothesis was that more individuals would be tested and treated for infections and that
      number of long term fertility complications would decline in the intervention group compared
      to control group.
    


Intervention name(s): Screening for urogenital Chlamydia trachomatis
Intervention type(s): Behavioral
Intervention description(s): Receeiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: mass screening
Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered Catheters
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      The purpose of this study is to compare two different marketed PICC (peripherally inserted
      central catheter) designs. Clotting rates, procedural bleeding and ease of catheter insertion
      will be compared. It is hypothesized that the non-tapered design has a lower clotting rate
      and is easier to place than the tapered design. Bleeding rates are expected to be about the
      same.
    


Intervention name(s): Tapered PICC; Non-tapered PICC
Intervention type(s): Device; Device
Intervention description(s): Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins; Standard peripheral central catheter placement in the Brachial, Basilic or Cephalic veins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inpatients; Requiring; DL PICC; Access; Medications; Blood
Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      There is an urgent need for HIV prevention methods that women can initiate and control
      themselves. Topical microbicides, substances that kill microbes, represent one such method.
      The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w
      SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days
      in healthy, sexually active HIV uninfected women.
    

Detailed description: 
      Women continue to comprise a growing proportion of the new HIV infections around the world. A
      growing body of data suggests that a safe and effective topical microbicide will be a real
      option of prevention for women in the future. The purpose of this study is to assess the
      safety and acceptability of 3% SPL7013 Gel when administered intravaginally, twice daily for
      14 consecutive days in healthy, sexually-active, HIV-uninfected women.

      The expected duration of this study for each participant is 21 days. Study participants will
      be randomly assigned to one of two arms. Participants in Arm 1 will apply 3.5 g of SPL7013
      gel intravaginally twice daily for 14 consecutive days. Participants in Arm 2 will apply a
      placebo gel intravaginally twice daily for 14 consecutive days. Starpharma produces SPL7013
      gel (VivaGel) and will provide it for this study.

      After enrollment, participants will attend three study visits. These visits will occur on
      Days 7, 14, and 21. A follow-up safety visit will occur if necessary. Medical and menstrual
      history, targeted physical exam, urine and blood collection, cervical swabs, and vaginal
      smears will occur at all visits. A colposcopy will occur at least once. On Day 2,
      participants will take part in a phone assessment.
    

Intervention name(s): 3% SPL7013 Gel (VivaGel); Placebo Gel; HEC Placebo Gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3% vaginal gel; Placebo for SPL7013 gel; HEC Placebo gel intravaginally bd for 14 days
Other intervention name(s): VivaGel; Universal Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety and Acceptability
Effects of Mobile Application-based Lifestyle Counselling on Body Weight Loss in Obese Subjects
Condition: Obesity
MeSH terms: Weight Loss; Body Weight
Study type: Interventional

Summary: 
      The aim of the trial is to study the effect of a mobile application-based lifestyle change
      program on body weight loss in adult subjects with obesity. The main focus is to motivate and
      support beneficial lifestyle changes targeting long-term weight management.

      This study comprises two randomly assigned study arms: mobile application-based lifestyle
      change program and "waiting-list" control. The mobile application-based lifestyle change
      program consists of twice a week content for the first 6 months, continuing with less
      frequent contents for the following 6 months (the length of intervention 12 months). The
      "waiting-list" control group will receive mobile application-based lifestyle change program
      after 6 months followed by intervention for 12 months. The main aim is to demonstrate that
      the users of mobile application-based lifestyle change program lose more weight than controls
      at 6 month timepoint and weight loss is maintained for 18 months (6 months after the end of
      mobile application-based lifestyle change program use). Weight is measured and blood samples
      (lipids, glucose and metabolic syndrome measures) are collected at 0, 6, 12, and 18 months.

      The mobile application-based counselling contains aspects of cognitive behavior therapy and
      persuasive system design and consists of twice a week reminders, tasks, self-monitoring, and
      reflection.

      The main outcome is the decrease in body weight. Secondary outcomes are changes in eating
      behavior, psychological factors, components of metabolic syndrome (waist circumference,
      plasma lipid and glucose values, blood pressure), and calculated scores of metabolic
      condition and adiposity.
    


Intervention name(s): Mobile application-based lifestyle change program
Intervention type(s): Device
Intervention description(s): Usage of the Mobile application-based lifestyle change program
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the current Study is to determine the safety and effectiveness of Galnobax®
      plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU).
      In addition, Study is designed to investigate the safety of Galnobax® vehicle for
      establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU.
      The study is being conducted in 350 subjects being recruited in about 30 centers in India.
    

Detailed description: 
      The current study is a Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to
      Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in
      Treating Diabetic Foot Ulcers. The study evaluates the safety and effectiveness of Galnobax®
      plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU).
      In addition, Study is designed to investigate the safety of Galnobax® vehicle for
      establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU.
    

Intervention name(s): Esmolol Hydrochloride; Only Standard of Care; Vehicle Gel
Intervention type(s): Drug; Other; Other
Intervention description(s): Galnobax-14% gel application along with Standard of Care; Only Standard of Care treatment; Vehicle gel application along with Standard of Care
Other intervention name(s): Galnobax
Intervention MeSH terms: Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Multicenter, Randomized, Double-Blind, Parallel groups
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is 1) to test the safety of S-equol in healthy volunteers and 2) to
      see how quickly S-equol enters the bloodstream, is distributed in the body, and broken down
      and removed, when taken with food or without food.
    

Detailed description: 
      The study is a double blind, randomized, placebo-controlled, dose-escalation study of the
      safety and tolerability of single doses of S-equol up to 320 mg in healthy male and female
      adult subjects. Approximately 8 qualified volunteers will be selected at each dose level and
      randomly assigned to receive S-equol or placebo, in the fasted state. For the 20 mg dose
      group, subjects will complete two treatment periods, one in the fasted state, and one in the
      fed state.

      A safety review of study results for each dose group will occur when Day 8 follow-up visit
      safety data are available, and prior to enrollment/dosing of the next subsequent dose group.
      Given favorable safety review of a dose group's experience, the subsequent dose group will be
      enrolled/dosed at least 10 days after the previous group's dosing.

      Pharmacokinetic evaluations consist of determination of plasma and urine concentrations of
      free and total conjugated S-equol at various time points. Safety evaluations include physical
      examination,vital signs, ECG, serum chemistry, hematology, and urinalysis, 12-lead telemetry,
      and assessment of clinical signs and symptoms.
    

Intervention name(s): S-equol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule, oral, single dose; capsule, oral, single dose
Other intervention name(s): AUS-131
Intervention MeSH terms: Equol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: healthy volunteers; pharmacokinetics
Taping Technique With Supervised Exercises Protocol on Pain and Functional Status in Individuals With Arthritis
Condition: Patellofemoral Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Osteoarthritis (OA) is claimed to be a global burden and a key health issue that affects the
      large weight-bearing joints of the lower extremity such as the knee and hip joints. The study
      was aimed to find out the efficacy of the tapping technique in addition to the supervised
      exercise protocol on pain intensity and functional status of an individual with
      patella-femoral arthritis.
    

Detailed description: 
      The study was based on a controlled pretest-posttest experimental group design. After initial
      screening, forty individuals (mean age 55years, ranged 40-60years) with patello-femoral
      arthritis randomly (n=20each) assigned into two group A and B. Group A received taping
      technique in addition to the supervised exercises protocol while group B received supervised
      exercises protocol only. Both the groups received their specified treatment 5 consecutive
      days in a week for 4weeks. Data collected for the variables (VAS and WOMAC) at day1
      pre-intervention (baseline) and at day 28th post-intervention. The t-test used for within and
      between group analysis with keeping the p<0.05.
    

Intervention name(s): Taping technique; A supervised exercise protocol
Intervention type(s): Other; Other
Intervention description(s): Fixmull stretch and Leukotape (rigid tape) were used in taping to guide the patellar trajectory orientation while performing the movement. Individuals were asked to lay down in supine position with knee in a slightly bent position. Fixomull stretch was used as an adhesive pre-wrap to protect the skin and provide some of the checking force. The main check strap was provided by stripes of rigid tape (Leukotape). The knee cap was taped, started on the outer aspect of the knee cap and pulled inwards. Finished at the back of the inside of the knee. Two further pieces of tape (Fixomull Stretch and Leukotape) applied distal to the patella unloaded the infrapatellar fat pad.; Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm parallel groups randomized control trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patellofemoral osteoarthritis; Therapeutic exercises; VAS; WOMAC; Taping
Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study to evaluate the safety of a vaccine to protect against influenza
      viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of
      vaccine or placebo one month apart.
    

Detailed description: 
      The aim of this study is to evaluate the safety profile of two intranasal doses of LAIV
      A/17/California/66/395 (H2N2) in healthy adults in Russia. A(H2N2) viruses which are
      antigenically similar to the pandemic strain A/Singapore/1/57, continue to circulate in
      domestic and wild bird populations, as confirmed by routine moni¬toring of avian influenza
      viruses.

      40 adults aged 18-40 will be enrolled. They will be randomized to receive vaccine or placebo.
      Blood and urine will be collected during the week following each vaccination and before the
      next vaccination to monitor safety. Blood samples will also be collected at several
      timepoints to assess the volunteer's immune response to the vaccine. The total duration of
      the study is 16 weeks for each volunteer.
    

Intervention name(s): LAIV H2N2; Placebo
Intervention type(s): Biological; Other
Intervention description(s): vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28; placebo delivered intranasally. .25cc to each nostril at day 0 and day 28
Other intervention name(s): Monovalent A/17/California/66/395 (LAIV H2N2) vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: H2N2; vaccine
A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated the safety and pharmacokinetics of multiple ascending doses of VX-440 in
      combination with tezacaftor/ivacaftor (TEZ/IVA) (triple combination [TC]) administered for 13
      days to healthy male and female subjects
    


Intervention name(s): VX-440; TEZ; IVA; Matched Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): VX-440 was administered in TC with TEZ and IVA.; TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA); IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet; Placebos matched to VX-440, TEZ, and IVA.
Other intervention name(s): Tezacaftor; VX-661; Ivacaftor; VX-770
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
M-gCBT for Women With Provoked Localized Vulvodynia
Condition: Provoked Localized Vulvodynia
MeSH terms: Vulvodynia
Study type: Interventional

Summary: 
      The purpose of this study is to learn more about Mindfulness based Group Cognitive Behavior
      Therapy (M-gCBT) as a treatment for Provoked Localized Vulvodynia (PLV). M-gCBT is a
      counseling technique that has been shown to reduce pain and anxiety with other medical
      conditions, including chronic pain conditions. The investigators wish to see if participation
      in M-gCBT course will help reduce anxiety, fear, and pain in women with PLV greater than
      education alone. Both techniques use a group setting including other women with PLV.
      "Mindfulness-Based Group Cognitive Behavior Therapy for Women with Localized Vulvodynia" is a
      study designed to learn more about the use of mindfulness based group cognitive behavior
      therapy for PLV pain and anxiety over education alone. Participants will be randomized to one
      of two groups: mindfulness based cognitive behavior therapy or group education seminars.
    

Detailed description: 
      M-gCBT is a type of counseling that teaches women to have more control over their pain.
      Educational seminars teach women about the different aspects of PLV that affect emotional and
      physical health. Both groups will be given a binder containing course material at the first
      session and homework at each session that you will be asked to complete. The group education
      seminars will include an informational video clip reviewing an aspect of PLV and sexuality
      and will be followed by a group discussion facilitated by an instructor. Each session will
      involve a teacher and a small group of 6 to 12 women with PLV. Additionally, women in both
      groups will be asked to perform a weekly test to measure pain and to complete a daily diary.
    

Intervention name(s): Mindfulness Based Group Cognitive BehaviorTherapy; Educational Seminars
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness Based Group Cognitive Behavior Therapy is a type of counseling that teaches women to have more control over their pain.; Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.
Other intervention name(s): M-gCBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mindfulness group therapy; vulvodynia; vulvar pain
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Food Effect and DDI of Ascending Doses of the MEK Inhibitor Zapnometinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of ascending doses of
      the MEK-inhibitor zapnometinib (ATR-002) given as single doses (SAD Part) and as multiple
      doses for 7 days (MAD Part) in healthy subjects.
    

Detailed description: 
      This is a Phase 1, single-center, randomized, double-blind, controlled clinical trial
      (zapnometinib vs. placebo in the SAD/MAD Parts; 'fed' vs. 'fasted' in the FDI Part, 'probe
      substance' (repaglinide or celecoxib) in combination with zapnometinib vs. probe substance
      alone in the DDI part). The study will assess the safety, tolerability, PK (applicable to
      SAD/MAD Part) and PD (applicable to SAD Part only) effects of zapnometinib versus a matching
      placebo (applicable to SAD/MAD Part) in healthy subjects. The FDI cohorts will investigate
      the possible impact of a standard breakfast high in fat content in comparison to
      administration in fasted state. The DDI cohorts with celecoxib and repaglinide will
      investigate a possible drug-drug interaction.
    

Intervention name(s): ATR-002; Placebo; Repaglinide; Celecoxib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 300 mg tablets for oral intake; matching tablets for oral intake; 0,5 mg tablets for oral intake; 100 mg capsules for oral intake
Other intervention name(s): Zapnometinib; Repaglinide-ratiopharm; CELEBREX
Intervention MeSH terms: Repaglinide; Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, mono-centre; SAD, MAD, FDI, DDI part
Masking: Double (Participant, Investigator)
Primary purpose: Other
FOREVR Peds VR Pilot
Condition: Pain, Postoperative; Pain; Anxiety
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      To determine the feasibility and acceptability of using immersive virtual reality
      technologies to impact clinical outcomes (e.g., pain and anxiety) and medication utilization
      (e.g., narcotics) in pediatric patients with acute and chronic pain.
    


Intervention name(s): VR - Distraction; VR - Biofeedback
Intervention type(s): Other; Other
Intervention description(s): Participants will be instructed to use any application.; Participants will be instructed to use the Mindful Aurora application.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other