bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to investigate the effect of various modified low volume polyethylene glycol
      (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool
      output in healthy subjects. In addition, the study is to assess and compare the safety and
      tolerance of the modified PEG+ASC formulations following oral administration with the safety
      profile of MOVIPREP®.
    


Intervention name(s): NER1006; NER1006; NER1006; Moviprep; NER1006; NER1006; NER1006; NER1006
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.; Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.; Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.; Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.; Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.; Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.; Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.; Single evening dose containing formulation selected from Part A of study. Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Moviprep; PEG3350; Laxative; Stool Output
A Safety Study of LY3372689 Given By Mouth to Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine the safety profile of the study drug after it is
      given by mouth to healthy participants. Blood tests will be performed to check how much
      LY3372689 gets into the bloodstream and how long the body takes to get rid of it. Each
      enrolled participant will receive up to 3 doses of LY3372689 or placebo. The study will last
      about 12 weeks, including screening.
    


Intervention name(s): LY3372689; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver
      disease that predisposes patients to the development of hepatocellular carcinoma (HCC).
      Active hepatitis B virus (HBV) replication is the key driver of liver injury and disease
      progression. Majority of Chinese patients are infected with genotype B and C HBV, which is
      different from Caucasian counterparts. This prospective multi-center cohort open-label study
      is designed to investigate the long-term effect of TDF on prevention of HCC and disease
      progression as well as to evaluate the efficacy and safety of long-term TDF in Chinese CHB
      subjects with advanced liver diseases. The study will enrol 240 subjects.
    


Intervention name(s): Tenofovir disoproxil fumarate
Intervention type(s): Drug
Intervention description(s): White, almond-shaped, film-coated tablet containing 300 mg of TDF, debossed with "GILEAD" and "4331" on one side of the tablet.
Intervention MeSH terms: Tenofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tenofovir disoproxil fumarate; hepatocellular carcinoma; chronic hepatitis B; Cirrhosis
Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children
Condition: Pain, Acute; Fear; Anxiety State
MeSH terms: Acute Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      This randomized controlled study was planned to evaluate the effects of distraction methods,
      using virtual reality or a stress ball, on the emotional appearance, pain, fear, and anxiety
      associated with the procedure, during the phlebotomy in children aged 6-12 in a private blood
      collection unit.
    

Detailed description: 
      H1: There is a difference between the groups in terms of pain, fear, anxiety and emotional
      appearance scores related to the intervention during the blood draw attempt.

      A standard approach will be applied to all children. Standard approach; giving information
      about the procedure, the nurse introducing herself, choosing the area together, being with
      the parent and talking to the child during the procedure, "I'm starting now, I'm cleaning the
      area, take a deep breath, I'm applying it now, it may hurt a little, you shouldn't move, it
      will take a very short time, I will cover it with tape " contains.

      In the virtual reality glasses group, a tourniquet will be attached to the extremity where
      the intervention will be performed. By wearing virtual glasses, the video will be started.

      In the stress ball group, before the intervention is applied, the other hand will be given a
      stress ball and asked to squeeze it.

      In the control group, communication with the child will continue during the intervention with
      the questions mentioned above.

      When the nurse decides on the area where the PICT will be performed (the minute will be
      recorded), she will use the words "I am cleaning the area, take a deep breath, now I am
      applying the injection, it may hurt a little, you should not move, it will be very short".

      The intervention will be stopped when the blood draw attempt fails in all groups.

      5 minutes after the blood draw attempt, the child will be asked to rate the most painful
      moment felt during the procedure using the Facial Expressions Rating Scale. The Child Fear
      Scale (CDS) and Child Anxiety Scale-State (CAS-D) will be given to the child to assess how
      anxious and frightened he is during the procedure. The child will be asked to mark with a
      pencil. The Emotional Appearance Scale for Children will be evaluated by the nurse after the
      procedure.
    

Intervention name(s): virtual reality; stress ball
Intervention type(s): Device; Behavioral
Intervention description(s): wearing virtual reality glasses; squeezing the stress ball during the attempt
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised
Masking: Single (Investigator)
Primary purpose: Supportive Care
Evaluation of the Root Resorption and Dehiscence Formation Between Two Methods of Leveling and Alignment of Lower Teeth
Condition: Crowding of Anterior Mandibular Teeth
MeSH terms: Root Resorption
Study type: Interventional

Summary: 
      The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain.
      Several methods have been suggested to reduce the duration of orthodontic treatment
      classified to surgical and non-surgical methods.

      Researchers used minimally invasive surgical methods like corticision, piezocision,
      micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate
      dental movement by 20 - 40%.

      The effect of corticision as a minimally invasive procedure on root resorption and dehiscence
      formation during orthodontic tooth movement has not been studied yet.

      Applying corticision on the lower anterior teeth using a surgical blade and a hammer may
      accelerate tooth alignment during orthodontic treatment. This study consists of two groups,
      patients will be randomly assigned to one of these two groups.
    

Detailed description: 
      Orthodontically induced external root resorption accompanying orthodontic treatment is
      defined as a microscopic loss of root tissue as a result of the inflammatory reaction that
      occurs in the area of application of orthodontic force. It can be diagnosed and measured
      using conventional radiography or cone-beam computed tomography (CBCT).

      Dehiscence is a loss of alveolar bone on the facial (rarely lingual) aspect of a tooth that
      leaves a characteristic v-shaped, root-exposed defect from the cementoenamel junction
      apically. Bone dehiscence cannot be detected through conventional radiography or clinical
      examination. Actually, CBCT can be considered the best accessible technique providing 3D
      data.

      Corticision is one of the minimally invasive surgical procedures that is not associated with
      flap lifting. It was used to accelerate tooth movement in animals and case report studies.
      Its application on humans may aggravate their fear and anxiety towards the pain that may
      accompany this technique.

      No randomized controlled trial (RCT) has compared flapless corticision in the
      non-extraction-based orthodontic decrowding of lower anterior teeth (LAT) with the
      conventional treatment in terms of external apical root resorption (EARR) and dehiscence
      formation (DF).
    

Intervention name(s): Corticision; Traditional Non-accelerated Treatment
Intervention type(s): Procedure; Other
Intervention description(s): A special instrument will be used to cut the cortex of the alveolar bone at different locations between the lower anterior teeth; The normal sequence of treatment steps will be followed in this group without using any kind of acceleration methods
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics following increasing doses of 2 h (Part A) and 5 day (Part B) continuous IV
      infusions of BMS-962212 in healthy subjects across the expected pharmacodynamic dose range.
    


Intervention name(s): BMS-962212; Aspirin; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Intravenous Infusion administration over 2 hours or 5 days; Oral administration; Oral administration
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00
Condition: Cataract Extraction; Phacoemulsification; Glistenings; Intraocular Lens Implant; Hydrophobic Acrylic; Cataract Surgery; Light Scatter; Patient Satisfaction; Patient Related Outcome Measures
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This is a bilateral randomised controlled study to compare visual performance, refractive
      outcome, forward light scatter, patient satisfaction and objective measurement of glistenings
      following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses
      (IOLs). A new product is compared with an established one.
    


Intervention name(s): Cataract surgery
Intervention type(s): Device
Intervention description(s): Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cataract; cataract extraction; interocular lens implant; glistenings; phacoemulsification; hydrophobic acrylic; light scatter; patient related outcome measures
ELASTANCE: Prospective Physiological Study of Lung Elastance in Recruitment and Derecruitment in Early Onset Mechanically Ventilated ARDS Patients
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The recruitment strategy in Acute respiratory distress syndrome (ARDS) patients mechanically
      ventilated combines recruitment maneuvers and positive end expiratory pressure (PEEP).
      Recruitment maneuvers promote alveolar recruitment leading to increased end-expiratory lung
      volume in order to prevent repetitive opening and closing of unstable lung units and reduce
      the strain induced by ventilation. In addition, recruitment is effective in improving
      oxygenation. Variety of recruitment maneuver have been described, the most commonly used is
      the application of sustained continuous positive airway pressure at 40 cmH2O for 40 seconds.
      Staircase recruitment maneuver (SRM) is an alternative with good hemodynamic tolerance.
      Staircase recruitment maneuver (SRM) involves a progressive increase in positive end
      expiratory pressure (PEEP) (up to 40 cmH2O), in pressure control ventilation, in order to
      increase end-expiratory lung volume (EELV); then a decreasing PEEP trial is performed. The
      positive end expiratory pressure (PEEP) to prevent alveolar collapse depends on ratio between
      lung elastance and chest wall elastance. If chest wall elastance is high, the PEEP to obtain
      a positive end-expiratory transpulmonary pressure is high. The only way for the time being to
      know the transpulmonary pressure and the ratio between lung and chest wall elastance is the
      use of esophageal catheter. A non-invasive method for measuring the lung elastance by
      measuring volume recruited during a change of pressure (∆PEEP/∆EELV) could be used to avoid
      the use of esophageal catheter.
    


Intervention name(s): Measure lung and chest wall elastance with esophageal catheter; non-invasive method for measuring the lung elastance
Intervention type(s): Procedure; Other
Intervention description(s): Patients will be in supine position with 30-45° head of bed elevation. The cuff of the endotracheal tube will be transiently overinflated to 60 cmH2O to ensure there will be no air leaks. NMBA (cisatracurium) will be administrated [9]. The fraction of inspired oxygen (FiO2) will be adjusted for continuously monitored oxygen saturation (SpO2) between 90 to 94%. Patients will be ventilated in pressure control with 15 cmH2O of driving pressure.
A low flow pressure/volume curve from 0 to 40 cmH2O will be performed.; by measuring volume recruited during a change of pressure (∆PEEP/∆EELV)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Acute respiratory distress syndrome (ARDS); positive end expiratory pressure (PEEP); Staircase recruitment maneuver (SRM); Lung elastance; chest wall elastance
A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health
Condition: Erectile Dysfunction; Premature Ejaculation
MeSH terms: Erectile Dysfunction; Premature Ejaculation
Study type: Interventional

Summary: 
      Sexual function is a part of a normal healthy life and considered to be essential for mental,
      physical and marital well-being. Any derangement in normal function though is a distressing
      situation for the individual, is often not reported due to embarrassment or due to social
      stigma. Sexual disorders in men are categorized according to the stage of sexual response
      affected in terms of disorders of erectile function, ejaculatory function or libido, albeit
      there is considerable potential for overlap amongst the disorders. The use of current
      intervention has many side-effects and has been prohibited in cardiovascular condition and
      also to be taken with caution with other medical condition.

      This has led to the development of multiple alternate therapies which are helpful for a
      limited number of cases but the major concern for all these therapies is their late onset of
      action and not having a sustained effect.
    

Detailed description: 
      Enovate Biolife is trying to improvise further their already marketed product HeezOn® by
      adding new botanicals thus naming it HeezOn Ultra. HeezOn®has been studied on 148 subjects
      and has proven to be beneficial for subjects with mild to moderate ED. The previous study
      fell short to capture the data for subjects who were also suffering from PE and their overall
      quality of life-related to sexual health. Therefore, the trial is designed to study the
      speedy and sustained effect of the improvised formula on different aspects of sexual
      dysfunctions.
    

Intervention name(s): HeezOn Ultra-1; HeezOn Ultra-2; Placebo
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Oral Processing Behavior of Gluten-free and Gluten-containing Breads
Condition: Oral Processing Behavior; Mastication; Swallowing
Study type: Interventional

Summary: 
      To attend the increasing demand for gluten-free products, new gluten-free formulations
      emerged in the market containing alternative ingredients to mimic the protein functionality
      of wheat. The replacement of wheat, however, has consequences in the sensorial properties of
      gluten-free products, which can compromise the acceptability of products. This study aims to
      investigate the oral processing behaviour of gluten-free and gluten-containing breads. Two
      commercial products, one gluten-free and one gluten-containing bread will be tested either
      without spread or with butter or mayonnaise. Spreads will be added to the breads to resemble
      a sandwich consumption which is a more realistic approach than that previously used. The
      investigators hypothesize that changes in the structure of gluten-free breads resulting from
      the absence of a strong gluten network can have a prominent impact on the way gluten-free
      bread is orally processed. The investigators also hypothesize that the addition of spreads
      will facilitate the oral processing of bread due to an increase in moisture content and
      lubrication.

      The number of chews, number of swallows and eating duration will be determined through video
      recording of 20 subjects. The texture attributes predominantly at the beginning of
      mastication and at the swallowing point will be accessed using a check-all-that-apply test.
      Additionally, the amount of saliva incorporated during chewing will be determined from the
      spat out food bolus.
    


Intervention name(s): Chewing of breads
Intervention type(s): Other
Intervention description(s): During the video recording session, participants were asked to place the whole sample (5-6 g) in the mouth (e.g. single bite) and chew naturally until the bolus is ready for swallowing.
During the second section, participants were asked to place the whole sample in the mouth and chew naturally. After 5 chewing cycles, participants checked all the attributes that describe the texture sensations perceived at the beginning of mastication. A list of attributes and their definitions were provided to guide the participants. Participants proceeded with chewing until the swallowing point when they again checked all the attributes that characterize the texture sensations perceived at the end of mastication. The food bolus was then spat in a container.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: food oral processing; gluten-free bread; mastication; texture; saliva; food bolus
Virtual Sailing Simulator in Individuals With Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The research is being done to look at the benefits of a recreational and therapeutic program
      for people with spinal cord injury using the VSail-Access sailing simulator.
    

Detailed description: 
      The VSail-Access is the first sailing simulator available for people with disabilities. The
      VSail-Access simulator is a variation on the VSail where the cockpit is fitted with a seat.
      The VSail simulator is a generic sailboat cockpit powered by a pneumatic ram and custom
      designed software. The sailor sails the simulator around virtual courses displayed on a
      computer screen in the same way as a real sailboat on water. Electronic sensors provide real
      time feedback to match the movements of the virtual sailboat displayed on the screen with
      those of the simulator. Sailors can select wind strength and conditions to suit their
      ability.

      Adults with spinal cord injury may take part in this study.
    

Intervention name(s): The VSail-Access simulator
Intervention type(s): Device
Intervention description(s): You will be transferred to the VSail cockpit and secured. Following the trainer's instruction, you will sail the simulator around virtual courses displayed on a computer screen, using a joystick to control the rudder angle and a mainsheet to control the set of the sail. You will do this for 1 hour.
Other intervention name(s): VSail-Access simulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury; Virtual sailing; Vsail
A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP)
Condition: Acute Intermittent Porphyria
MeSH terms: Porphyria, Acute Intermittent; Porphyria, Erythropoietic; Porphyrias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of givosiran (ALN-AS1)
      in AIP patients as well as to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of
      ALN-AS1 in AIP patients.
    


Intervention name(s): givosiran (ALN-AS1); Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Single or multiple doses of ALN-AS1 by subcutaneous (sc) injection; calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: RNAi therapeutic; Porphyria; AIP