bioihbjkbjnl/mcl2 huggingface dataset:
Toric Eye Strain and Stability Study
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The purpose of this study is to determine the benefits of fitting low astigmats with soft
      toric contact lenses versus spherical contact lenses with regard to visual comfort,
      eyestrain, fitting efficiency, and visual performance.
    


Intervention name(s): etafilcon A; etafilcon A for Astigmatism
Intervention type(s): Device; Device
Intervention description(s): Soft contact lens to be worn in a daily wear, daily disposable modality for one week; Soft contact lens to be worn by participants in a daily wear, daily disposable modality for one week.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged Between 18 and 60 Years
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian
      virus. Prevention and control of a pandemic will depend on the rapid production and worldwide
      distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be
      developed and tested in clinical trials to determine the most optimal formulation and the
      best vaccination schedule.This study is designed to test in healthy adults aged between 18-60
      years the reactogenicity and immunogenicity of one and two administrations of a candidate
      pandemic H5N1 vaccine formulated from Split Virus. The vaccines contain different antigen
      doses . For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to
      detect the optimal formulation for immunization against the H5N1 influenza strain.
    


Intervention name(s): 4 adjuvanted pandemic influenza candidate vaccines; 4 non-adjuvanted pandemic influenza candidate vaccines
Intervention type(s): Biological; Biological
Other intervention name(s): 4 adjuvanted pandemic influenza candidate vaccines
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: prophylaxis of pandemic influenza
Expression of Toll-Like Receptors 2 and 4 in Asthmatic Patients.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Introduction: Recently it has involved the role of TLR (toll-like receptors) in the
      pathogenesis of asthma. TLRs are a family of proteins responsible for the recognition of
      Pathogen-Associated Molecular Patters (PAMPs). The possible role that TLRs play in
      IgE-dependent asthma (not eosinophilic) and its recognition as a new endotype asthma, could
      open new therapeutic expectations.

      Objective: To analyze the expression of TLR 2 and 4 in monocytes/ macrophages and neutrophils
      in peripheral blood and induced sputum from asthmatic patients
    

Detailed description: 
      The investigators studied patients with asthma. All patients underwent the same day an
      induced sputum, pulmonary function studies, fractional exhaled nitric oxide, blood total IgE
      and skin test by prick technique. Asthmatic patients were classified according to the
      criteria of the GINA 2012. The cellular composition was analyzed by flow cytometry.
      Expression of TLR2 and TLR4 were analyzed using monoclonal antibodies conjugated with
      fluorochromes appropriate.
    

Intervention name(s): TLRs
Intervention type(s): Other
Intervention description(s): Recently it has involved the role of TLR (toll-like receptors) in the pathogenesis of asthma.The possible role that TLRs play in the asthma and its recognition as a new endotype asthma, could open new therapeutic expectations.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: asthma; toll like receptor; innate immunity
Safety Evaluation of SS-POR11
Condition: Acne
Study type: Interventional

Summary: 
      The goal of the present study is to assess the safety of a topical probiotic (probiotic
      strain; SS-POR11) on acne prone-skin, and the impact of SS-POR11 on the distribution of
      porphyrins, in subjects with mild-to-moderate acne [Investigator's Global Assessment (IGA)
      1-3].
    


Intervention name(s): SS-POR11
Intervention type(s): Other
Intervention description(s): Topical composition containing probiotic strains derived from human skin (SS-POR11). Participants will be instructed to apply it topically to face, twice weekly for the duration of the trial.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Sensory Properties of Bowel Cleansing Solutions
Condition: Laxative Bowel Cleansing Solutions
Study type: Interventional

Summary: 
      Samples of 4 commercially available bowel cleansing solutions, namely PEG-electrolyte +
      ascorbic acid (PEG-Asc, Moviprep®, Norgine, UK), PEG-electrolyte (PEG, Fortrans® Ibsen,
      France), sodium picosulfate/magnesium citrate (SPS, Picoprep®, Ferring, Switzerland), and
      oral sodium sulfate (OSS, Izinova®, Ibsen, France) were prepared according to the
      manufacturer's instructions. Descriptive analysis was conducted with trained panelists (N=
      14) to create a sensory profile for the solutions and generated attributes were rated on an
      unstructured 15-cm line scale using the Compusense at-hand® (Guelph, Canada) sensory
      evaluation software. Acceptability testing was carried out with untrained participants (N=80)
      and samples were rated on the 9-point hedonic scale. Moreover, a Just-About-Right (JAR) scale
      was included for the four basic tastes to determine their compatibility with optimum
      taste/acceptability levels in the products.
    


Intervention name(s): Descriptive analysis; acceptability test
Intervention type(s): Behavioral; Behavioral
Intervention description(s): subjects were asked to assess the sensory profile by tasting the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova; subjects were asked to assess the acceptability of the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: laxatives; sensory evaluation; acceptability; colonoscopy
Online Study of Colorectal Cancer and Prostate Cancer Screening Decision Making
Condition: Colorectal Cancer; Colon Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Colorectal Neoplasms
Study type: Interventional

Summary: 
      Participants will be recruited from the United States and Australia to take an online survey
      about colon cancer screening or prostate cancer screening. Individuals selected for both the
      prostate cancer survey and the colon cancer study will be randomized to take one of three
      survey types - balance sheet, rating and ranking or conjoint analysis. These surveys will
      help participants clarify their values and opinions about screening options for colon cancer
      or prostate cancer. Participants' responses to the online survey are measured at one point in
      time - the time at which the participant takes the survey.
    

Detailed description: 
      This study will compare effect of a conjoint analysis based values clarification exercise,
      ranking and rating, and a balance sheet on screening test preferences for colorectal cancer
      screening and prostate cancer screening using online surveys. Recruitment will be conducted
      through Survey Sampling International (SSI), an online survey research firm. Participants
      will be randomized to one of three arms to take online surveys. Patients will complete either
      a conjoint analysis task, in which they will be asked to make a series of choices between
      hypothetical screening testing strategies with different attributes; a rating and ranking
      task for these same attributes; or they will make a choice after viewing a balance sheet of
      attributes.
    

Intervention name(s): Rating and Ranking Task; Discrete Choice Task; Balance Sheet Task
Intervention type(s): Other; Other; Other
Intervention description(s): Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a rating and ranking format. The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.; Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a discrete choice format. The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.; Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a balance sheet format. The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Colon; Prostate; Cancer
Exploring the Effects of Diazepam and Lorazepam
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      Aims :

        -  exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy
           volunteers, on the neural correlates of encoding and retrieval of information during a
           word-stem completion task (implicit memory), using fMRI

        -  comparing lorazepam effects to diazepam (0.3 mg/kg)effects

        -  exploring benzodiazepines effects, after a single oral intake, on the neural correlates
           of successful encoding of information within explicit memory using fMRI

      Hypothesis :

        -  both diazepam and lorazepam will impair explicit memory performance, but lorazepam only
           will impair perceptual priming

        -  lorazepam and diazepam will modify the normal correlates of information encoding within
           explicit memory

        -  lorazepam only will alter the neural correlates of perceptual priming
    


Intervention name(s): Diazepam; Lorazepam; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Diazépam drug (0,3 mg/kg) on a single oral intake; Lorazépam drug (0,038 mg/kg) on a single oral intake; lorazépam placebo or Diazépam placebo
Intervention MeSH terms: Diazepam; Lorazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Benzodiazepines; Lorazepam; Diazepam; Memory; Perceptual priming; Functional brain imaging; FMRI
Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery
Condition: Spinal Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for
      outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be
      compared.
    

Detailed description: 
      The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for
      outpatient lower limb surgery.

      Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal
      anesthesia for out-patient lower limb surgery, e.g. knee arthroscopy, foot and varices
      surgery. Patients will recover faster and less complications will be expected.

      Articaine is said to act faster and shorter than a low dose of bupivacaine. There are not
      enough data available to establish that articaine is as safe as and more effective by
      outpatient lower limb surgery than bupivacaine.

      Spinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a
      randomized double blind clinical trial.

      Endpoints are:

        -  onset of sensory and motor block

        -  maximum spread of sensory level

        -  recovery from sensory and motor block

        -  time to micturition

        -  complications
    

Intervention name(s): spinal administration of articaine; spinal administration of bupivacaine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bupivacaine; Carticaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: spinal; anesthesia; articaine; bupivacaine; outpatient; surgery; limbs
A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study
      comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC)
      administered, viscous antibody solution of with and without human recombinant hyaluronidase
      (rHuPH20) in volunteer subjects.

      The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous
      antibody with rHuPH20 will be comparable or shorter than the time required for the injection
      without rHuPH20.
    


Intervention name(s): Hylenex
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Health Services Research
Keywords: hyaluronidase; subcutaneous drug delivery; Volunteer Subjects
Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon
Condition: Hand Laceration; Tendon Involved; Clean Laceration; No Bone Involved
MeSH terms: Lacerations
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators assume that simple hand lacerations involving flexors or extensors tendons,
      do not require prophylactic antibiotic treatment to prevent wound infection.
    

Detailed description: 
      Hand lacerations are divided to "complicated" which involves tendons, nerves, bones, and
      joints, and "simple" which involves only cutaneous and subcutaneous tissue.

      prophylactic antibiotic should not be given in a clean simple lacerations, and should be
      given when a bone is involve (open fracture). But there is not enough data, weather
      prophylactic antibiotic treatment should be given when only tendons are involved. The
      investigators will examine 2 groups of 30 patients each with clean hand lacerations involving
      tendons. One group will be treated with prophylactic antibiotic and the other wont be
      treated, randomly. The investigators assume that the rate of wound infection wont be
      different between the 2 groups.
    

Intervention name(s): Antibiotic-Cefamezin
Intervention type(s): Drug
Other intervention name(s): Ceforal; Keflex
Intervention MeSH terms: Anti-Bacterial Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lacerations; Tendons; Antobiotic
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects
      from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old
      in other countries and determine if it is similar to that observed in adults with moderately
      to severely active Crohn's disease (CD). Also to assess the safety, immunogenicity and
      efficacy of ustekinumab in the treatment of moderately to severely active CD. The main part
      of the study continues to Week 16, at which point all subjects who are receiving benefit from
      ustekinumab maintenance therapy (as determined by the investigator) are eligible to enter the
      long-term extension (LTE) and continue to receive ustekinumab. The study extension ends at
      Week 268 or upon availability of the LTE basket study (CNTO1275ISD3001) whichever occurs
      first. If participants do not consent/assent to the LTE basket study, they will continue
      safety follow-up for approximately 20 weeks after the last study agent administration.
    


Intervention name(s): Ustekinumab
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single IV administration of ustekinumab (3 mg/kg for subjects <40 kg or 130 mg for subjects >= 40 kg in Group 1 and 9 mg/kg for subjects < 40 kg or 390 mg for subjects >= 40 kg in group 2) at week 0 followed by SC administration of ustekinumab (2 mg/kg for subjects < 40 kg or 90 mg for subjects >= 40 kg at Week 8.
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of
      participants with MDD.
    

Detailed description: 
      This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): SAGE-217; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAGE-217 oral capsules.; SAGE-217 matched-placebo oral capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Depressive disorder; SAGE-217
ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
Condition: Breast Density; Breast Cancer Female
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This trial will test a decision support web based intervention for women at increased risk
      for breast cancer due to breast density and other risk factors (age, race/ethnicity, family
      history of breast cancer, history of prior breast biopsies), and to consider MRI and/or
      chemoprevention to manage their breast cancer risk.
    

Detailed description: 
      Along with better-known risk factors such as family history having dense breasts is one of
      the strongest breast cancer risk factors. Extremely dense breast tissue affects about 10% of
      women, with an additional third having heterogeneously dense breasts. Women in these
      categories have 3-6 times the risk of breast cancer as compared to women with least density.
      Although breast density is measured on routine screening mammograms, it is not typically
      communicated to patients. This is changing as a result of legal mandates and approaches need
      to be tested to effectively integrate this clinical information in care. Therefore,we have
      developed an intervention to support decision making about cancer risk management (MRI and
      chemoprevention) for women at clinically elevated risk using a web-based intervention that
      will evaluate the efficacy of a web based intervention with personalized risk information
      communication versus usual care.
    

Intervention name(s): Usual Care Arm; Personalized Web Intervention Arm
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Health information provided by the American Cancer Society Website; Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Breast Cancer; Breast Density
Oxygen Consumption After Acute Whole Body Vibration Session
Condition: Aged; Oxygen Consumption
Study type: Interventional

Summary: 
      Noninvasive assessment of VO2 during a single session of whole body vibration and changes in
      blood flow caused by the acute activity.
    

Detailed description: 
      A single whole body vibration session into two groups, a young adults groups and elderly
      group, booth healthy, will be held with concomitant collection of VO2 consumed during the
      session, by MetaMax cortex. Immediately after the session, it will be checked peripheral
      blood flow through US surface in color Doppler mode.
    

Intervention name(s): whole body vibration training in vibrating platform in young; whole body vibration training in vibrating platform in elderly
Intervention type(s): Other; Other
Other intervention name(s): WBV; WBV
Intervention model: Single Group Assignment
Intervention model description: acute wbv session, measuring ergospirometric variables during protocol and blood pressure, borg exertion, borg dyspnoea, blood lactate, heart rate and SpO2 before and after protocol.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Oxygen Consumption; Aged; Whole Body Vibration
A Trial of PF-06252616 in Ambulatory Participants With LGMD2I
Condition: LGMD2I
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigational product PF 06252616, a humanized anti myostatin monoclonal antibody that
      neutralizes myostatin (GDF8) is in development for the treatment of Limb Girdle Muscular
      Dystrophy 2I (LGMD2I) to preserve and/or improve muscle function.

      This study will provide the clinical assessment of the safety, tolerability, Pharmacokinetics
      and Pharmacodynamics of PF 06252616 following repeat IV doses in ambulatory adults with
      LGMD2I.
    

Detailed description: 
      This study is a Phase 1b/2, open-label multiple ascending dose escalation study to evaluate
      the safety, tolerability, efficacy, PK and PD of PF 06252616 in ambulatory adults with
      LGMD2I. The study design is intended to determine the optimal safe and pharmacologically
      active dose of PF 06252616 in LGMD2I while providing an opportunity for all subjects to
      receive active drug for a rare and disabling disorder. The study will be conducted in three
      periods: Lead-In, Treatment and Follow-up periods. The Lead-In and Follow-up periods will
      each be 16 weeks to allow an assessment of the change of various outcome measures of this
      period of time and comparison of change in function before, during and after treatment. The
      Treatment period will be 32 weeks. Three cohorts of participants will be enrolled and receive
      escalating doses of PF 06252616. The first cohort will have the option to crossover to the
      highest dose.
    

Intervention name(s): PF 06252616
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment