bioihbjkbjnl/mcl2 huggingface dataset:
Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin
Condition: Healthy
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out if presurgical antiseptic preparations affect how
      well surgical drapes adhere to skin.
    

Detailed description: 
      Adhesive incise drapes are often used to provide a physical sterile barrier between the
      surrounding skin and the open wound at the beginning of a surgery. This study sought to
      determine the effect of presurgical skin antiseptic preparation on the adhesion of various
      incise drapes to the skin.
    

Intervention name(s): ChloraPrep; DuraPrep
Intervention type(s): Drug; Drug
Intervention description(s): The application sites (subjects' backs) will be prepped with ChloraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule; The application sites (subjects' backs) will be prepped with DuraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule
Other intervention name(s): ChloraPrep® with Tint (Scrub Teal®); 3M™ DuraPrep™ Surgical Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Study in Healthy Subjects to Examine the Safety and Tolerability of ACT-1004-1239 Given as Multiple, Gradually Increasing Doses and to Examine the Effects of ACT-1004-1239 on the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-1004-1239
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy subjects to examine the safety and tolerability of ACT-1004-1239 given as
      multiple, gradually increasing doses and to examine the effects of ACT-1004-1239 on the body
      and the way the body takes up, distributes, and gets rid of ACT-1004-1239
    


Intervention name(s): ACT-1004-1239; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ACT-1004-1239 administered as hard capsules for oral use.; Matching placebo administered as hard capsules for oral use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness
Condition: Corneal re-Epithelialization
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 randomized, prospective, double-masked, vehicle-controlled, dose-escalation study to
      evaluate the safety, tolerability and clinical effect of Nexagon™ in subjects following
      bilateral PRK for the correction of mild to moderate myopia.
    


Intervention name(s): Nexagon™ or Nexagon™ vehicle
Intervention type(s): Drug
Intervention description(s): Dose-escalation design in which cohorts of 6 subjects will be studied sequentially.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Photorefractive keratectomy; Re-epithelialization; Nexagon; PRK; Coda
A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin
Condition: Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of a topiramate
      controlled-release formulation in the treatment of obese, type 2 diabetic patients managed
      with diet alone or combined with metformin.
    

Detailed description: 
      Topiramate is not approved for the treatment of obesity. Studies have shown that an immediate
      release formulation of topiramate reduces body weight in obese patients with or without type
      2 diabetes. A novel controlled-release formulation of topiramate using OROS® technology has
      the potential for better efficacy and safety in the treatment of obesity. This double-blind,
      placebo controlled study will evaluate the effectiveness and safety of the controlled-release
      formulation in the treatment of obese subjects with type 2 diabetes. The study consists of 2
      screening visits, a baseline visit, 7-week titration phase (topiramate dose will be increased
      from 25mg daily to 175mg daily), 9-week maintenance phase, 2-week taper phase and a 2-week
      follow-up. Effectiveness will be evaluated by the percent change in body weight, body mass
      index, and anthropometric measurements (waist and hip circumferences and their ratio). Safety
      evaluations (incidence and severity of adverse events, physical measurements and clinical
      laboratory tests) will be conducted throughout the study. The study hypothesis is that
      topiramate 175 mg daily, when administered as the OROS® controlled-release formulation, is
      effective (in terms of percent reduction in body weight from baseline to week 16) and safe,
      as compared with placebo, in the treatment of obese, type 2 diabetic patients managed with
      either diet alone or combined with metformin. During the titration phase, topiramate (in the
      OROS® controlled-release formulation) will be gradually increased to 175mg daily by mouth,
      and the dose will be maintained for 9 weeks, and then slowly discontinued over 2 weeks.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obesity; Type 2 Diabetes Mellitus; Metformin; Diabetic Diet; Topiramate; Adult-Onset Diabetes Mellitus (AODM)
Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation
Condition: Spinal Stenosis, Lumbar Region; Spondylolisthesis
MeSH terms: Spinal Stenosis; Spondylolisthesis
Study type: Interventional

Summary: 
      This study assesses clinical outcomes following the use of the MvIGS spine navigation system
      for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in
      adults. There will be separate study arms for cases utilizing the three-dimensional (3D)
      MvIGS spine navigation system and cases that utilize conventional two-dimensional (2D)
      fluoroscopy.
    

Detailed description: 
      This is a single center, randomized, prospective cohort study to comparatively evaluate the
      implementation of the MvIGS spine navigation system to conventional 2D fluoroscopy for
      pedicle screw fixation for the treatment of spinal stenosis with degenerative
      spondylolisthesis of the lumbar spine. Fluoroscopy and the MvIGS navigation system are both
      intraoperative imaging options available to aid spine surgeons.

      Fluoroscopy uses X-rays to obtain images of patient anatomy. The MvIGS spine navigation
      system provides patient specific, high quality intraoperative imaging with no radiation
      exposure. After the spine is exposed, intraoperative images are obtained using visible light
      then registered to the patient's preoperative computed tomography scan. Use of the
      proprietary integrated surgical light with embedded tracking technology and Instant Flash™
      registration allows for continuous and direct visualization of the surgical field without
      disturbing surgeon workflow.
    

Intervention name(s): 3D MvIGS Spine Navigation; 2D Fluoroscopy
Intervention type(s): Device; Other
Intervention description(s): The 7D Surgical MvIGS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. The surgical light containing the machine vision cameras is the sole luminaire during image guided surgery.; Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single center, prospective, randomized cohort study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Image guided surgery; Computer-assisted surgery; Machine vision; Navigation; Image guidance; Spine; Lumbar spine
Ambulatory Blood Pressure Monitoring in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The primary objective of this proposal is to demonstrate that ABPM can be used to improve
      study design for interventional trials in children with hypertension.
    

Detailed description: 
      ABPM is a standard technique in adult antihypertensive trials to study the magnitude and
      duration of effect of investigational drugs. These methods are needed for pediatric studies.
      Before such methods can be developed, preliminary information must be collected to
      demonstrate that the device can be used for antihypertensive studies in children (i.e, to
      determine the dropout rate following the first ABP study, to determine the frequency of white
      coat hypertension in a selected population, to compare casual (office) blood pressures
      commonly used to diagnose hypertension in children with those obtained by ABPM, and to assess
      the placebo effect in children with borderline and mild hypertension).

      All participants will be asked to complete 24 hour ABPM on two occasions within one week.
      During the ABPM parents and children will be asked to keep a diary recording the times that
      the child slept. A crossover design will be used, where subjects are initially randomized to
      either drug or placebo and then will be crossed over to the other intervention at a set time
      during the study.
    

Intervention name(s): Ambulatory Blood Pressure Monitoring (ABPM)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: Hypertension; ABPM; Ambulatory Blood Pressure Monitoring
Prospective Observational Study of Trimetazidine Influence on Mitochondrial Metabolism in Human Heart Ventricle
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      Trimetazidine (1-[2,3,4-trimethoxybenzyl] piperazine dihydrochloride) is a clinically
      effective antianginal agent. Despite these clinical successes, the understanding of
      trimetazidine's mechanism of action remains incomplete, particularly influence of
      trimetazidine on mitochondrial function in isolated human cardiomyocytes. The investigators
      will perform this study to seek possible differences in mitochondrial respiration related to
      standard preoperative enrolled trimetazidine therapy.
    

Detailed description: 
      Background:

      Different types of medication are used for treatment of ischemic heart disease. One of
      recently developed drugs is trimetazidine. Although it clinical benefits are clear, mechanism
      by which this occurs is as yet undefined. In few animal studies authors try to define what
      effects trimetazidine has on both fatty acid and glucose metabolism in heart. Data collected
      from human cardiomyocytes are rare. Available data suggest that trimetazidine may act as a
      potent inhibitor of beta oxidation, with no significant effect on glucose oxidation.

      Objective:

      Primary objective: collection of mitochondrial respiration data using human heart ventricular
      samples. Secondary objective: define possible differences in mitochondrial respiration
      depending on preoperative trimetazidine usage.

      Methods:

      Regularly scheduled patients for coronary artery bypass grafting surgery who accept to
      participate in study will be enrolled in further protocol. Patients with inclusion criteria
      and without exclusion criteria will be enrolled in the study. At the end of operation,
      surgeon will take biopsy sample of left ventricle for mitochondrial function and metabolic
      activity analysis.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with coronary artery disease planned for coronary artery bypass grafting
      
Biospecimen description: 
      Parts of human left ventricular muscle
Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations
Condition: Respiratory Distress Syndrome, Newborn; Respiratory Failure
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether there are differences in bioelectrical
      function (measured by amplitude integrated electroencephalography) and brain oxygenation
      (measured by near infrared spectroscopy) while and after instillation of two different
      surfactant preparations.
    

Detailed description: 
      Patients randomized to one of the treatment groups: 1) SRT with porcine preparation -
      poractant alfa; 2) SRT with bovine preparation - beractant. Continuous monitoring and
      simultaneous recordeding of 1) saturation (SpO2) and heart rate (HR) measured with pulse
      oximetry, cerebral tissue oxygenation measured with near-infrared spectroscopy,
      amplitude-integrated electroencephalography.
    

Intervention name(s): Poractant alfa instillation; Beractant instillation
Intervention type(s): Drug; Drug
Intervention description(s): aEEG and NIRS monitoring during poractant alfa instilation; aEEG and NRs monitoring during beractant instillation
Intervention MeSH terms: Poractant alfa; Beractant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain oxygenation; NIRS; aEEG; surfactant
A First in Human Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514
Condition: Cancer Cachexia
MeSH terms: Cachexia
Study type: Interventional
Phase: Phase 1

Summary: 
      Oncocross is developing OC514, a drug-drug combination product containing 2 active
      pharmaceutical ingredients for cancer cachexia. This study is designed to assess the safety
      and tolerability of single and multiple oral doses of OC514 in healthy adult volunteers.
    

Detailed description: 
      This is a single-center study in which a total of 24 subjects will be enrolled into 1 of 3
      dose level cohorts in an ascending fashion. Each cohort will consist of 8 subjects randomized
      to receive OC514 or matching placebo at a ratio of 3:1. Eligible subjects will be admitted to
      the clinical research unit (CRU) from Day -1 to 5 and again from Day 15 to Day 17 and will be
      discharged upon completion of post-dose assessment. The subjects will attend the CRU for
      outpatients visits on Day 8 and Day 12. The subjects will return for a follow-up visit on Day
      19 and End of Study visit on Day 21.

      The total study duration is up to 9 weeks consisting of up to 6 weeks of screening, 2 weeks
      of blinded treatment, and 1 week of safety follow-up.

      Safety oversight will be provided by a Safety Review Committee (SRC).
    

Intervention name(s): OC514 (Low dose); OC514 (Mid dose); OC514 (High dose); Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Low dose level of OC514; Mid dose level of OC514; High dose level of OC514; Placebo to match
Other intervention name(s): OC514; OC514; OC514
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Myfortic vs. Cellcept in Kidney Transplant Recipients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150
      sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first
      and second living or deceased donor renal transplant recipients.
    

Detailed description: 
      Purpose and Description:

      The purpose of the study is to determine if gastrointestinal toxicity of an anti-rejection
      medication Myfortic® (mycophenolic acid delayed release) is less than equivalent doses of a
      similar anti-rejection medication Cellcept® (mycophenolate mofetil, MMF) in patients
      receiving their first or second kidney transplant from cadaver or living donors.

      This study consist of two randomized groups, 75 patients given 3 doses of Thymoglobullin
      (Group I) vs. 75 patients given 3 doses of Thymoglobulin and 2 doses of Basiliximab (Group
      II).

      Our standard maintenance protocol dosing of tacrolimus, IMPDH inhibitor (vide infra) and one
      week course of corticosteroids.

      Patients will be randomized to receive Myfortic® 1,440 mg/day vs. Cellcept® 2,000 mg/day,
      each in two divided doses (induced with either the IL-2 receptor inhibitors or
      thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml.
      Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1
      mg/kg by 3-6 months post-operatively.
    

Intervention name(s): Mycophenolate Sodium Delayed Release Tablets; Mycophenolate Mofetil
Intervention type(s): Drug; Drug
Intervention description(s): Myfortic® 1,440 mg/day; Cellcept® 2,000 mg/day
Other intervention name(s): Cellcept®
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastrointestinal toxicity
Bioelectric Field Imaging Near Human Skin Wounds
Condition: Wounds
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The investigators have developed a new non-invasive medical device called the Bioelectric
      Field Imager. They plan to use this device to measure the electric field near small lancet
      wounds in 60 volunteers. Their hypothesis is that the electric field is an early stimulus for
      wound healing and the magnitude of this field will vary with wound healing capability. The
      investigators will compare the electric fields near arm and leg wounds in males and females
      in the age groups of 18-30 and 65-80. In addition they will measure these wound fields in
      diabetics and near chronic ulcers.
    

Detailed description: 
      We will first characterize the lateral electric field near reproducible skin wounds in
      healthy male and female subjects 18-30 years of age. A standard superficial, dermal wound 0.5
      mm long will be inflicted using the Ascensia Microlet Vaculance by Bayer Health Care with a
      21 gauge lancet on its deepest setting. This setting will penetrate the epidermis and stop
      within the dermis. We will first determine variability within the same individual by
      measuring the electric field near two wounds close to each other on the volar forearm. We
      will then determine the variability between different body regions by comparing the wound
      field near a lancet wound in the volar forearm and one in the leg. If hair is present it will
      be removed by shaving the wound site prior to wounding. By collecting these data from 10
      males and 10 females in both age groups we can determine if there is a gender or age
      dependence to the field strength. Finally we will determine the lateral electric field near
      lancet wounds in diabetics and near chronic skin wounds. If these fields are smaller than
      fields found near acute wounds, it would provide a rationale for future studies imposing
      electric fields to enhance wound healing.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Two age groups will be studied: 1. Young adults 18-19 years old; and 2. older adults 65-80
        years old.
      
Keywords: electric field; wound current; wound healing; bioelectric field; chronic ulcer; diabetic; Diabetes; aging
Repeated Food Exposure Via the Olfactory and Gustatory Systems
Condition: Habituation
Study type: Interventional

Summary: 
      Increasing exposure to a single orosensory cue without ingestion of additional energy may
      promote an increased rate of habituation, more rapid satiation, and reduced intake. This
      exposure can occur via smell (olfactory) and taste (gustatory) systems.It is not clear if
      repeated exposure via the combined olfactory and gustatory systems increases the rate of
      habituation more so than repeated exposure through one of these systems. Thus, the purpose of
      this investigation is to examine the amount of salivation occurring in 12 trials of exposure
      to a food via the olfactory, gustatory, and combined olfactory and gustatory systems. The
      primary dependent variable will be the amount of salivation in the 12 trials. It is
      hypothesized that a more rapid decrease in salivation will occur across trials in the
      combined olfactory and gustatory exposure as compared to the other two conditions, indicating
      a more rapid rate of habituation.
    

Detailed description: 
      Approximately two of every three adults in the U.S. are overweight or obese. The high
      prevalence of overweight/obesity negatively affects the health of the population, as obese
      individuals are at increased risk for developing several chronic diseases.

      Successful control of body weight depends on effectively regulating eating. Satiation, the
      process by which an eating bout ends, assists with eating regulation, and factors that
      quicken the onset of satiation may aid with decreasing intake. One factor believed to
      influence satiation is the rate of decrease in consummatory response (habituation) to
      repeated presentations of food orosensory cues. Habituation is a basic form of learning, in
      which behavioral and physiological responses decrease in response to repeated presentations
      of a stimulus, with the decrease in response unrelated to sensory adaptation/fatigue or motor
      fatigue.

      In one condition, participants will smell lemon and lime across 12 trials (olfactory
      exposure), in another condition participants will taste the juices across 12 trials
      (gustatory exposure), and in the last condition participants will smell and taste the juices
      across 12 trials (olfactory + gustatory exposure). The primary dependent variable will be the
      amount of salivation in the 12 trials. It is hypothesized that a more rapid decrease in
      salivation will occur across trials in the combined olfactory and gustatory exposure as
      compared to the other two conditions, indicating a more rapid rate of habituation
    

Intervention name(s): Habituation
Intervention type(s): Other
Intervention description(s): Habituation will be measured for each the conditions (olfactory, gustatory, olfactory and gustatory) of the study.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: gustatory response; olfactory response