bioihbjkbjnl/mcl2 huggingface dataset:
A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective annual release study was designed to assess the safety of a monovalent
      influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not
      previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy
      adults received a single dose of vaccine or placebo and were followed for 180 days.
    

Detailed description: 
      This prospective, randomized, double-blind, placebo-controlled release study enrolled 300
      healthy adults 18 to 49 years of age. Eligible participants were randomly assigned in a 4:1
      fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. This
      study was conducted at multiple sites in the United States. Randomization was stratified by
      site.

      Each participant received one dose of investigational product on Day 1. The duration of study
      participation for each participant was the time from receipt of investigational product
      through 180 days after receipt of investigational product.
    

Intervention name(s): Monovalent influenza virus vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of the cold-adapted, attenuated, 6:2 reassortant influenza strain B/Brisbane/60/2008 (Victoria lineage).; Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza; FluMist
The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation
Condition: Peripheral Arterial Occlusive Disease
MeSH terms: Arterial Occlusive Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to investigate the effect of a 24- hrs L-arginine infusion on
      hemodynamic and on parameters of microcirculation in patients with peripheral arterial
      occlusive disease (PAOD).
    


Intervention name(s): Arginine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours; NaCl 0.9% intravenously for 24h
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake
Condition: Thirst; Water-Electrolyte Imbalance
MeSH terms: Water-Electrolyte Imbalance
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to elucidate whether GLP-1 analogues influence not only appetite but
      also thirst perception. It is hypothesized that GLP-1 analogues reduce fluid intake in
      healthy volunteers compared to Placebo.
    

Detailed description: 
      GLP-1 analogues are well known to stimulate glucose-induced insulin secretion and to reduce
      energy intake. Recent findings from animal and human studies suggest a role of GLP-1 in
      regulating water and salt homeostasis. GLP-1 has been shown to reduce fluid intake after an
      oral salt load or during a meal - pointing to a hypodipsic effect. The aim of this study is
      to elucidate whether these putative hypodipsic properties of GLP-1 analogues reduce fluid
      intake in healthy volunteers compared to placebo assessed during an evaluation visit of 8
      hours.
    

Intervention name(s): Dulaglutide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Evaluation visit with assessment of fluid intake; Evaluation visit with assessment of fluid intake
Other intervention name(s): Verum
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, placebo control, cross-over design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to investigate the relative bioavailability of two
      different doses of BI 201335, administered as soft gelatine capsule in comparison to the
      equivalent doses of three different oral solution per dose of BI 201335.
    


Intervention name(s): BI 201335 (Reference); BI 201335 (Test); BI 201335 (Test); BI 201335 (Test); BI 201335 (Reference); BI 201335 (Test); BI 201335 (Test); BI 201335 (Test)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): soft gelatine capsule, oral administration; oral solution 3; oral solution 3; oral solution 2; soft gelatine capsule, oral administration; oral solution 1; oral solution 1; oral solution 2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Time of Permanence of Dressing Following Breast Reconstruction
Condition: Surgical Site Infection
MeSH terms: Infections; Surgical Wound Infection
Study type: Interventional

Summary: 
      This randomized clinical trial was designed to assess the influence of time of dressing after
      breast reconstruction procedures on surgical site infections rates and skin colonization.
    

Detailed description: 
      The rates of surgical site infections (SSI) after clean operations range from 1 to 2%.
      However, infection rates in the breast surgical literature tend to be higher, with reported
      rates ranging from 2 to 30%. In plastic surgery operations, to minimize the risk of SSI is
      imperative, since even minor infections are able to complicate the healing process and harm
      the cosmetic result.

      The Centers for Disease Control and Prevention has established guidelines for postoperative
      incision care. However, there is no recommendation to cover an incision closed primarily
      beyond 48 hours, nor on the appropriate time to shower or bathe with an uncovered incision.
      This remains an unresolved issue.
    

Intervention name(s): Incisions covered for 1 day; Incisions covered for 6 days
Intervention type(s): Other; Other
Intervention description(s): Dressing was removed on the first postoperative day.; Dressing was removed on the 6th postoperative day.
Other intervention name(s): PO1; PO6
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: breast; plastic surgery; bandages; surgical site infection; skin colonization
Muscle Stretching - the Potential Role of Endogenous Pain Inhibitory Modulation on Stretch Tolerance
Condition: Muscle Stretching Exercises; Pain Threshold
Study type: Interventional

Summary: 
      This study investigates the influence of a remote, painful stimulus on stretch tolerance.
      Half of the participants will receive a conditioning painful stimulus following static
      stretching while the other half will rest quietly.
    

Detailed description: 
      The effect of stretching on joint range of motion is primarily related to changes in the
      tolerance to stretch, but the mechanisms underlying this change are still largely unknown.

      The nervous system has an inbuilt ability to modulate the perceived magnitude of afferent
      noxious stimuli via supraspinally mediated endogenous pain inhibition or facilitation and by
      engaging endogenous mechanisms pain tolerance in healthy individuals is known to increase.
      Thus increasing the tolerance to pain could potentially increase range of motion following
      stretching.
    

Intervention name(s): Cold pressor test
Intervention type(s): Other
Intervention description(s): Participants placed their non-dominant hand into cold water for 2 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A sample of convenience was recruited for this cross-sectional study. Participants were randomly assigned to a pain group or a control group using counterbalanced block randomization. Passive knee extension range of motion was measured three consecutive times with five-minute intervals between measurements. Both groups underwent a static stretch protocol consisting of two bouts of thirty-second constant-angle static stretching of the knee flexors with a one-minute rest between bouts. Subjects were instructed to keep the limb relaxed as the lower leg was passively moved towards extension. Following stretching, the post-stretch measurement was performed. Finally, subjects in the pain group were instructed to immerse their non-dominant hand into a container with circulating water at 1˚C to 4˚C and keep it there for 2 minutes. A Biodex system 4 pro dynamometer was used to quantify range of motion and passive resistive torque. Muscle activity was recorded as surface electromyography.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Stretch tolerance; Range of Motion
Treating Contact Lens Discomfort With Orthokeratology
Condition: Dry Eye; Contact Lens Complication
MeSH terms: Dry Eye Syndromes
Study type: Interventional

Summary: 
      The primary aim of this study is to understand if orthokeratology can be used to improve
      contact lens comfort and the secondary aim is understand patient adaptation to
      orthokeratology.
    

Detailed description: 
      Orthokeratology has yet to be fully explored for the treatment of contact lens discomfort
      (CLD), though some support for this practice exists in the literature. Carracedo et al.,
      Lipson et al., and Garcia-Porta et al. found that orthokeratology resulted in better ocular
      comfort than soft contact lenses. Nevertheless, all three studies excluded subjects who had
      been diagnosed with dry eye and all three studies used symptoms surveys that were not
      specific to assessing CLD. Garcia-Porta et al.'s study was also limited by including both
      neophytes and established contact lens wearers. Yet, these studies overall suggest that
      orthokeratology could be used as a treatment for CLD, and one case report has even found that
      orthokeratology is a viable option for treating contact lens intolerance.

      To date, there has yet to be a study fully investigating orthokeratology as an alternative to
      soft contact lens use in patients with CLD. Therefore, the purpose of this study is to
      formally investigate if orthokeratology is a good alternative to soft contact lenses for
      patients who are experiencing CLD or for patients who have dropped out of contact lenses
      because of CLD. This study will also simultaneously evaluate the neophyte orthokeratology
      wearing experience with hopes of finding additional means for improving contact lens comfort.
      Knowing the success of orthokeratology in wearers with CLD will allow practitioners to better
      help and prescribe for those who may have experienced or at risk for experiencing CLD. It may
      also be a way to allow patients additional years of contact lens wear.
    

Intervention name(s): Orthokeratology
Intervention type(s): Device
Intervention description(s): Orthokeratology is a type of contact lens that is worn over night to reduce refractive error, so patients do not need to wear vision correction during the day.
Intervention model: Single Group Assignment
Intervention model description: All subjects will be fit in orthokeratology contact lenses and be monitored for three months.
Masking: None (Open Label)
Primary purpose: Treatment
Post-op Pain After Fistula Laser Closure or Ligation of the Intersphincteric Tract for Anal Fistula
Condition: Fistula in Ano
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      This is a prospective, double-blinded randomised controlled trial conducted at two tertiary
      hospitals by a credentialed colorectal surgeon.
    

Detailed description: 
      Patients with high transphincteric fistulas were blinded and randomized to either laser or
      ligation of the fistula tract (LIFT). Pain scores at rest and movement, at 6 and 24 hours
      post operatively were measured using the visual analogue scale (VAS). Operative time was
      measured in minutes Continence and quality of life was assessed via the Wexner incontinence
      scale and SF-36 questionnaire respectively at 0, 3 and 6 months post-operatively.
    

Intervention name(s): Laser; LIFT
Intervention type(s): Procedure; Procedure
Intervention description(s): Diode laser used to effect closure of the anal fistula tract; The intersphincteric portion of the fistula is excised and ligated.
Other intervention name(s): FiLAC; Ligation of the Intersphincteric Fistula Tract
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children
Condition: Children
Study type: Interventional

Summary: 
      The study was designed to define the interaction of intravenous infusion of dexmedetomidine,
      an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum
      alveolar concentration which can block adrenergic and cardiovascular responses to
      incision(MACbar) of sevoflurane as the measure of anesthetic potency.
    

Detailed description: 
      The investigators observed the effects of different doses of dexmedetomidine on the minimum
      alveolar concentration of sevoflurane to blockade adrenergic response to surgical incision in
      50% of children (MACBAR). And to explore the safety of use of dexmedetomidine in pediatric
      patients.
    

Intervention name(s): dexmedetomidine
Intervention type(s): Drug
Intervention description(s): children received intravenous infusion with a bolus dose dexmedetomidine and followed by a continuous infusion before induction. use sevoflurane for induction and a steady-state end-tidal sevoflurane concentration was maintained for at least 15 min before skin incision.
Other intervention name(s): precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: dexmedetomidine; sevoflurane; MAC bar; drug interaction; anesthesia
Examining Endogenous Antioxidant Levels in Well Trained Cyclists
Condition: Oxidative Stress
Study type: Observational

Summary: 
      This study will investigate whether increased habitual intake of antioxidant supplements
      effects the concentration of endogenous antioxidants, the response of antioxidants to
      exercise, and differences in oxidative damage compared to a non-supplemented group.
    


Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Cyclist from the local West Midlands (United Kingdom) area will be invited to take part in
        the study.
      
Keywords: Endogenous antioxidants; Antioxidant supplements; Vitamin Supplements; Exercise adaptations; Oxidative stress; Redox regulation; Cycling - exercise
Drug Utilisation and Lifestyle Intervention Study in Patients Attending Cardiac Outpatient Clinic
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      This study has two parts: A drug utilization study and a Health-related quality of life
      study.
    

Detailed description: 
      This study has two parts: A drug utilization study and a Health-related quality of life
      study.

      Drug utilisation study is an open label, cross sectional, descriptive drug utilization
      analysis of the primary cardiovascular drug classes prescribed to coronary artery disease
      patients attending cardiology OPD of a North India hospital.

      Quality of life study intended to evaluate impact of a mobile based patient education program
      on the health related quality of life, physical activity and body mass index of coronary
      artery disease patients. It is a two arm study.
    

Intervention name(s): Education program
Intervention type(s): Behavioral
Intervention description(s): A mobile application plus short message service (SMS) program to deliver disease-related health education and reinforcement to experimental group patients and see its impact on their health related quality of life, physical activity and Body mass index
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Embryo Aneuploidies and Ovarian Stimulation
Condition: Embryo Aneuploidies
MeSH terms: Aneuploidy
Study type: Interventional
Phase: Phase 4

Summary: 
      There is a considerable concern about the effects of controlled ovarian hyperstimulation
      (COH) for In Vitro Fertilization- Embryo Transfer (IVF-ET) on embryo quality and on the
      incidence of chromosomal abnormalities in oocytes and embryos.

      The main question remaining is if COH may increase the aneuploidies rate in young and healthy
      women. Therefore, the primary endpoint of the present study is to analyse the incidence of
      chromosomal abnormalities in this group of patients (oocyte donors), either in oocytes
      obtained after a natural cycle or in those retrieved after a COH cycle. To get rid of the
      male factor influence, donated sperm will be used.
    


Intervention name(s): Preimplantation Genetic Diagnosis
Intervention type(s): Procedure
Intervention description(s): Preimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: aneuploidies, natural cycle, stimulated cycle, preimplantation genetic diagnosis
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not
      previously been immunized with Pneumococcal vaccine.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine
Intervention type(s): Biological
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal Vaccines
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of guselkumab following
      single-dose intravenous (IV) infusion in Japanese healthy male participants.
    


Intervention name(s): Guselkumab Dose 1; Guselkumab Dose 2; Guselkumab Dose 3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive Dose 1 of guselkumab on Day 1.; Participants will receive Dose 2 of guselkumab on Day 1.; Participants will receive Dose 3 of guselkumab on Day 1.; Participants will receive matching placebo on Day 1.
Other intervention name(s): CNTO1959; CNTO1959; CNTO1959
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Head-to-head Comparison of Empagliflozin and Dapagliflozin
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational [Patient Registry]

Summary: 
      This open-labeled, prospective, observational, 3-year, clinical study was conducted to
      compare the effectiveness and safety between empagliflozin (25 mg once daily) and
      dapagliflozin (10 mg once daily) in patients with inadequately controlled type 2 diabetes
      despite preexisting triple OAD combination.
    

Detailed description: 
      All participants included in this study were initially requested to initiate therapy with
      insulin, but they insisted on another form of OAD. When participants declined insulin
      injection and requested another OAD, they were not randomly assigned to each groups. It is
      fairly common among participants with T2D to decline insulin therapy, despite being aware of
      its importance and the benefits in controlling blood glucose. Their lack of willingness to
      use insulin is explained by their avoidance of painful injections, the potential for body
      weight gain and their fear of hypoglycemia. The investigators conducted a regimen consisting
      of four OADs, including empagliflozin or dapagliflozin, to confirm which regimen would be
      effective and safe.
    

Intervention name(s): Empagliflozin; Dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Empagliflozin 25 mg once daily add on the background OADs for 3 years; Dapagliflozin 25 mg once daily add on the background OADs for 3 years
Other intervention name(s): Metformin; Glimepiride; DPP4 inhibitor; Metformin; Glimepiride; DPP4 inhibitor
Intervention MeSH terms: Metformin; Dapagliflozin; Empagliflozin; Glimepiride; Dipeptidyl-Peptidase IV Inhibitors
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The targeted population consists of adult patients with type 2 diabetes mellitus treated in
        outpatient setting by specialists
      
Keywords: Empagliflozin; Dapagliflozin; Sodium-glucose cotransporter 2 inhibitors; Quadruple combination antidiabetic drugs
Study to Investigate Effects of CAL-101 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and effect of CAL-101 in subjects with
      allergic rhinitis.
    

Detailed description: 
      A Phase I, randomized, double-blind crossover study of CAL-101, an oral inhibitor of
      phosphatidylinositol 3-kinase (PI3K) delta, in patients with allergic rhinitis.
    

Intervention name(s): CAL-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CAL-101 100mg capsules administered orally twice a day (BID) for 7 days; Placebo capsules administered orally BID for 7 days
Other intervention name(s): Idelalisib; GS-1101
Intervention MeSH terms: Idelalisib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic Rhinitis; Allergy; Phosphatidylinositol 3-kinase