bioihbjkbjnl/mcl2 huggingface dataset:
Single Dose Safety Study for Compound to Treat Post-Operative Nausea and Vomiting (PONV)
Condition: Post-Operative Nausea and Vomiting (PONV)
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the safety and tolerability and pharmacokinetics of
      a single intravenous administration of the new, Sulfobutyl Ether-7-Beta-Cyclodextrin
      (Captisol™) based, formulation in Healthy Adult Subjects.
    


Intervention name(s): GW597599; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose IV infusion; Single dose IV infusion
Intervention MeSH terms: Vestipitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Repeatability Study of Fatty Acid Uptake Using PET/MR Imaging in Patients With T2DM and Non-diabetic Control Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The main purpose of this study is to evaluate the overall variation in the assessment of
      fatty acid uptake and blood flow in adipose tissue and skeletal muscle in the fasted and
      postprandial states by evaluating the repeatability of whole-body three-dimensional kinetic
      (4D) combined positron emission tomography and magnetic resonance imaging (PET/MRI) readouts
      in participants with type 2 diabetes mellitus (T2DM), and non-diabetic control participants.
      Each volunteer participates 4 scanning sessions.
    

Detailed description: 
      A total of approximately 13 T2DM and 6 control subjects (a total of 19 subjects) are planned
      to be enrolled to achieve 11 T2DM and 5 control subjects to complete the study, assuming a
      15% drop-out rate. The test-retest repeatability of the ratio of FTHA uptake rates in
      subcutaneous adipose tissue (SAT) to skeletal muscle is measured using the intra-class
      correlation coefficient (ICC). Assuming an ICC of 0.85, with a 5% two-sided type I error
      rate, a sample size of 16 completers will yield approximately 90% power to detect an ICC
      statistically significantly greater than 0.4 (usually considered as a criterion for moderate
      agreement).

      The total radiaooin burden for tshi sitdu yis 27.4 mSv. The study is approved by the local
      Ethical committtee and Fimea.
    

Intervention name(s): Imaging Biomarkers
Intervention type(s): Other
Intervention description(s): One arm: Subjects are studied under two consecutive conditions, after overnight fasting and after a liquid meal ingestion. During each condition they are examined for fatty acid uptake in subcutaneous fat and skeletal muscle by FTHA([18F]-FTHA) PET/MRI as well as adipose and skeletal muscle blood perfusion by radioactive water([15O]-H2O ) PET/MRI. This was done at two occasions, 2-14 days apart, to assess repeatability of the measurements.
Assigned interventions:
[18F]-FTHA tracer injections [15O]-H2O tracer injections
PET/MRI imaging
Overnight fasting Liquid meal ingestion
Other intervention name(s): Assessment of repeatability of fatty acid uptake in adipose using PETMRI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy
Condition: Unilateral Ureteral Stone; Renal Stone Fragments ≤ 2mm
MeSH terms: Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis; Calculi
Study type: Interventional
Phase: Phase 1

Summary: 
      A prospective, single-center, single-arm, trial to demonstrate safety and device performance
      of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man
      clinical study in a small human population.
    

Detailed description: 
      Primary Objective: To assess the safety and feasibility of the Uriprene® Stent by assessing
      the time to complete degradation or the passage of stent fragments from the bladder by
      radiological assessment.

      Subject Population: Patients with clinical symptoms consistent with unilateral ureteral or
      renal stone fragments ≤ 2mm, post-uncomplicated ureteroscopy (UURS).
    

Intervention name(s): Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent
Intervention type(s): Device
Intervention description(s): Renal stent placed after uncomplicated uteroscopy
Other intervention name(s): Renal ureteral stent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Stone; Ureteroscopy; Ureteral Stent; post-uncomplicated ureteroscopy; UURS
A Pharmacokinetic Study of TS-142 in Patients With Hepatic Impairment
Condition: Patients With Mild or Moderate Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label pharmacokinetic study of TS-142 in patients with hepatic impairment
    


Intervention name(s): TS-142 5 mg
Intervention type(s): Drug
Intervention description(s): Single-dose of 5 mg of TS-142
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Propofol vs Placebo in the Prevention of Coughing During Emergence of General Anesthesia Under Desflurane
Condition: Elective Surgery; Coughing
MeSH terms: Cough
Study type: Interventional

Summary: 
      Emergence of general anesthesia is a critical period, in the same way as the induction of
      anesthesia, during which several adverse events may occur. Extubation may even be more
      difficult than the intubation, with a higher respiratory complications rate. Among these,
      cough is common and expected. It can be associated with significant complications including
      hypertension, tachycardia, increased intracranial pressure, bleeding at the surgical site or
      even wound dehiscence.

      The incidence of coughing during emergence of general anesthesia varies depending on the type
      of airway instrumentation, the population under study, agents used for the maintenance of the
      anesthesia and techniques used to prevent coughing. In the literature, the incidence of
      coughing during emergence of general anesthesia under endotracheal intubation varies from 38
      to 96%. In our center, the incidence of coughing during emergence of general anesthesia under
      desflurane and endotracheal intubation is 30 % according to a local preliminary study.

      Propofol is well-known to inhibit airway reflexes. Total intravenous anesthesia (TIVA) is
      associated with a lower incidence of coughing compared to inhalated anesthesia. The efficacy
      of propofol at a subhypnotic dose to reduce coughing during emergence has recently been
      demonstrated in patients undergoing nasal surgery under sevoflurane. However, the most
      effective antitussive dose remains unknown and its efficacy during anesthesia under
      desflurane has not yet been demonstrated.

      Propofol is rapidly available, simple to administer and has an interesting pharmacological
      profile, among others due to its short half-life.

      The aim of this study is to evaluate if an intravenous bolus of 0.5 mg/kg of propofol is more
      effective than placebo administration to decrease the incidence of coughing during emergence
      of general anesthesia under desflurane (PROPOREV). Propofol could also reduce the incidence
      of postoperative nausea and vomiting (PONV).
    


Intervention name(s): Intravenous dose of 0.5 mg/kg of propofol; Intravenous dose of 0.05 mL/kg of saline solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ambulatory surgery; Perioperative outcomes; General anesthesia under desflurane; Prevention of coughing; Propofol
The Effect of Anemia in Infancy on the Microbiome and Systemic Metabolism
Condition: Anemia; Iron-deficiency; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Observational

Summary: 
      Serum and fecal samples were collected from infants at either 6-7 m of age or 12-13 m of age.
      Serum and feces were analyzed locally for hemoglobin status or evidence of parasites, and
      standard of care was provided. Excess serum was transported to UC Davis for metabolomics
      analysis and the University of Hohenheim for iron status assessment and measurement of
      inflammatory markers. Fecal samples were transported to UC Davis for measurement of the
      microbiome structure and function.
    

Detailed description: 
      Sample collection occurred between August and November 2014. A total of 203 infants and their
      parents (101 at 6-7 m of age and 102 at 12-13 m of age) receiving care at the Moronacocha
      Health Center in Iquitos, Peru were recruited. All subjects were residents of Moronochocha,
      Iquitos, Loreto, outwardly healthy, and born at term with a birth weight of at least 2,500 g.
      Venous blood samples were collected by a lab technician at the local health center.
      Hemoglobin concentrations were immediately measured, and treatment given if warranted.
      Samples were subsequently transported to Selva Amazonica clinic, centrifuged, and serum was
      stored at -80 °C. Stool samples were collected by caregivers from diapers at home, taken to
      Selva Amazonica Clinic, and aliquoted. Fecal samples were analyzed for parasites at Selva
      Amazonica, and any necessary treatment was provided at the local health center. Serum and
      stool samples were shipped to UC Davis on dry ice, where they were stored at -80 °C until
      metabolomics and microbiome analyses. Serum aliquots were also shipped to the University of
      Hohenheim, Stuttgart, Germany for iron assessment, and measurement of inflammatory markers.
      All data integration and interpretation was performed at UC Davis.
    

Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Outwardly healthy 6-7 month, and 12-13 month male and female infants born at term with a
        birthweight > 2,500 g.
      
Keywords: Anemia; Iron-deficiency; Iron-deficiency anemia; Infants; Metabolomics; Microbiome
Comparison of Triazolam and Midazolam for Anxiolysis During Dental Treatment in the Pediatric Patient
Condition: Dental Anxiety
Study type: Interventional

Summary: 
      This study will evaluate the perceptions of the effects of two anxiolytic medications
      commonly used during dental treatment in patients weighing 40 kilograms or more.
    

Detailed description: 
      Midazolam and nitrous oxide are commonly used in pediatric patients requiring anxiolysis
      during dental treatment. Triazolam and nitrous oxide are commonly used in adult patients
      requiring anxiolysis during dental treatment. The participants in this study are patients
      already scheduled for 2 sedation appointments to complete their dental treatment. The
      medications are both benzodiazepines that have similar risks, neither medication has greater
      adverse effects than the other. This study will evaluate the perceptions of the effects of
      the medications via a parent survey and chart review. The goal of the study is to determine
      which anxiolytic medication is perceived to provide a better sedation experience for older
      pediatric patients based on parent perception of the medication's effects and the patient's
      behavior during dental treatment.
    

Intervention name(s): Midazolam Hydrochloride 2Mg/mL Syrup; Triazolam 0.125 MG
Intervention type(s): Drug; Drug
Intervention description(s): Midazolam HCl Syrup 0.5mg/kg (Max: 15mg) taken 10-15 minutes prior to dental treatment.; Triazolam: 0.125mg tablet taken 30 minutes prior to dental treatment.
Intervention MeSH terms: Midazolam; Triazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Gastroesophageal Reflux Treatment in Scleroderma
Condition: Gastroesophageal Reflux Disease; Systemic Sclerosis; Scleroderma
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators purposes are to define the prevalence of omeprazole resistance
      gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy
      of omeprazole in combination with algycon versus omeprazole in combination with domperidone
      on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the
      efficacy of omeprazole in combination with algycon versus omeprazole in combination with
      domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.
    


Intervention name(s): Alginic acid; placebo (for domperidone); Domperidone; placebo (of alginic acid)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Algycon 1 tab chew tid after meal; placebo (for domperidone) 1 tab oral tid before meal; domperidone (10 mg) 1 tab oral tid before meal; placebo (for alginic acid) 1 tab chew tid after meal
Other intervention name(s): Algycon; Molax
Intervention MeSH terms: Domperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gastroesophageal reflux disease; heart burn; regurgitation; systemic sclerosis; scleroderma; proton pump inhibitor; alginic acid; omeprazole; prokinetic
Acute and Chronic Effects of Ecologic Barrier© on Mood and Cognition
Condition: Cognitive Change; Mood
Study type: Interventional

Summary: 
      This study aims to investigate the acute and chronic effects of an 8 week probiotic
      intervention (Ecologic Barrier©) on mood and cognitive outcomes in healthy adults.
    

Detailed description: 
      This study will employ a double-blind, randomised, placebo-controlled crossover design to
      investigate the acute and chronic effects of an 8 week probiotic intervention (Ecologic
      Barrier©) on mood and cognitive outcomes in healthy older adults. A total of 30 participants
      will be enrolled and counterbalanced to receive the active probiotic treatment (2g per day
      Ecologic Barrier©) or a matched placebo in the first arm, before having a 4 week washout
      period and continuing with 8 weeks of the second treatment not consumed within the first arm.
      Outcome measures will be assessed at baseline, 24 hours and 8 weeks within each arm. These
      will include cognitive measures of affective processing, immediate and delayed verbal memory,
      visuospatial working memory and executive functions, and mood measures of depressive
      symptoms, cognitive reactivity, anxiety, stress and general mood. In addition, faecal samples
      will be collected at all timepoints in order to explore faecal microbiota profiles before and
      after probiotic treatment.
    

Intervention name(s): Ecologic Barrier©; Placebo powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5x10^9 CFU/ 2g per day of Ecologic Barrier©; matched placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent
Condition: Dry Eyes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      This is a clinical trial where 44 subjects dry eyes were instilled with Virgin Coconut Oil
      (VCO CL) using contact lenses as its vehicle. All subjects are healthy subjects with no other
      ocular diseases except for having some dry eye symptoms (included with McMonnies
      questionnaires). Parameters measured at baseline and after 15 minutes of insertion and were
      compared. The control eyes were inserted with contact lenses soaked in saline (CCL). The eye
      that wears the VCO CL or the CCL were chosen randomly by masked operator. At the end of this
      study, the parameters measured will indicate if the VCO CL was able to retain tears in the
      eye and remove the dry eyes symptoms.
    

Detailed description: 
      A new study using contact lens pre-soaked in virgin coconut oil (VCO CL) was conducted to
      determine the safety of the agent on dry eye human. Efficacy of the VCO CL was assessed by
      measuring TBUT, anterior eye assessment, corneal staining, pH, and Schirmer value and the
      measurement of residual VCO volume in tears before instillation (0 minute) and at 15 minutes
      after insertion. Wilcoxon Signed Rank and Mann Whitney U Test were used to analyse any
      changes in all the measurable variables. The differences of the TBUT, corneal staining and
      residual VCO volume in tears value in both eyes were analyzed. These study data will suggest
      if the VCO CL is safe and effective and can be recommended to be used as an option for dry
      eyes in human
    

Intervention name(s): organic product - Virgin Coconut Oil
Intervention type(s): Other
Intervention description(s): A commercially available sterilized contact lens was soaked in VCO for 4 hours in a sterile condition to allow absorption of VCO into the contact lens polymer. The contact lens here is a vehicle to transport the VCO into the eye.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Both eyes of subjects will be instilled with either one of the study contact lens or the control lens at random.
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Contact lens; VCO; TBUT; dry eyes
Sensor-based Technology for Upper Limb Rehabilitation
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Sensor-based technological therapy devices may be good candidates for neuromotor
      rehabilitation of people with Multiple Sclerosis (MS), especially for treating upper
      extremities function limitations. The sensor-based device rehabilitation is characterized by
      interactive therapy games with audio-visual feedback that allows training the movement of
      shoulders, elbows and wrist, measuring the strength and the active range of motion of upper
      limb, registering data in an electronic database in order to quantitatively monitoring
      measures and therapy progress. The aim of this study is to evaluate the effects of
      sensor-based motor rehabilitation in add-on to the conventional neurorehabilitation, on
      increasing the upper limbs functions of MS patients. The training consisting of twelve
      sessions of upper limb training, was compared with twelve sessions of upper limb
      sensory-motor training, without robotic support. Both rehabilitation programs were performed
      for 40 minutes three times a week, for 4 weeks, in addition to the conventional therapy. All
      patients were evaluated at baseline (T0) and after 4 weeks of training (T1)
    


Intervention name(s): Sensor-based Training; Upper limb motor training
Intervention type(s): Other; Other
Intervention description(s): Sensor-based Training consists of twelve sessions of upper limb training with PABLO®-Tyromotion. For each session the training consists in interactive-games based on virtual reality which allowed a task-oriented approach and a neurocognitive feedback. The exercises require precision tasks and one-dimensional and bidimensional reaction, allowing to train the attention, the strength control and movement control, the coordination and the movement precision. The interactive-games were chosen from those proposed by the Tyromotion PABLO® System.; Upper limb motor training, without robotic support. Subjects performed specific exercises aimed to recovery global upper limb functions, to control hand grasp and to improve hand's fine movements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Brain-Computer Interface and Mind-Body Awareness Training
Condition: Healthy Subjects
Study type: Observational

Summary: 
      Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices,
      has become increasingly prevalent due to an increase in awareness of the potential health
      benefits, and improvements in concentration that this training can provide to practitioners.
      In the present study, we investigate the role of Mind-Body Awareness Training (MBAT) in the
      initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI).

      The PI's hypothesis is that MBAT will improve performance in SMR based BCI.
    

Detailed description: 
      In this protocol, we will test the PI's hypothesis that MBAT including yoga will improve the
      ability for subjects to concentrate on control the SMR thus improving the performance of BCI.

      Subjects will be recruited for short term MBAT and then undergo BCI training. The performance
      of subjects with MBAT will be compared with those without MBAT to test the hypothesis.
      Procedures involved include 6 weeks yoga classes with at least 3 classes per week, and a EEG
      brain noninvasive brain computer interface study.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy population in Minneapolis area
PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Whether a once-daily basal injection of insulin glargine with mealtime injections of insulin
      lispro achieves equivalent glycaemic control (HbA1c) to administration of insulin lispro by
      continuous subcutaneous insulin infusion in Type 1 diabetic patients.
    


Intervention name(s): Insulin Glargine
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Yoga Therapy for Chronic Tension-Type Headache
Condition: Chronic Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      Chronic tension headache represents a considerable social burden in terms of both costs to
      the health services and also the costs of lost productivity. Episodic tension-type headache
      can be treated with rest and analgesics, while chronic tension-type headache demands a more
      fundamental treatment.

      Effectiveness of yoga therapy in the management of chronic tension type headache is limited.
      In this study, yoga therapy was used to explore its effect on chronic tension-type headache.
    


Intervention name(s): Yoga Therapy
Intervention type(s): Other
Intervention description(s): Yoga therapy is therapeutic application of yoga, specifically designed to treat the condition using physical posture, breathing exercises, guided relaxation and meditation.
Other intervention name(s): Yoga
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment