bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion
Condition: Anesthesia; Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is the assessment of the systemic absorption of local anesthetics during
      continuous epidural infusion for postoperative pain control.
    

Detailed description: 
      In literature the systemic toxicity of bupivacaine is widely demonstrated, like the minor
      toxicity of levobupivacaine and ropivacaine at the same anesthetic potency. The are actually
      no studies in humans confronting levobupivacaine and ropivacaine under the aspect of efficacy
      and toxicity.The aim of the study is the assessment of the systemic absorption of local
      anesthetics during continuous epidural infusion for postoperative pain control.

      Primary outcome:

      Assessment of the plasmatic equimolar concentrations of levobupivacaine and ropivacaine
      during continuous epidural infusion

      Secondary outcome:

      Assessment of the safety level of the local anesthetic (major difference between haematic
      concentration of the local anesthetic and neuro-cardiotoxic dose).

      Difference of the analgesic efficacy between levobupivacaine and ropivacaine. Differences in
      collateral effects due to the local anesthetic: hypotension and sensitive block.

      Prospective randomized double-blinded clinical trial
    

Intervention name(s): local anesthetic
Intervention type(s): Drug
Intervention description(s): postoperative 48h epidural continuous infusion,
ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml
levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml
Other intervention name(s): Chriocaina; Naropina
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: local anesthetic; epidural; pharmacokinetics; plasmatic concentration; epidural continuous infusion
Pharmacokinetic Study on N-acetylneuraminic Acid
Condition: Nonaka Myopathy; Hereditary Inclusion Body Myopathy
MeSH terms: Muscular Diseases; Distal Myopathies
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate pharmacokinetics and safety of N-acetylneuraminic
      acid in patients with Distal myopathy with rimmed vacuoles (DMRV) - hereditary inclusion body
      myopathy (hIBM). Dosages are 800mg single and three times a day and 800mg 3 times a day for 5
      consecutive days. N-acetylneuraminic acid and N-glycolylneuraminic acid in serum and urine
      are measured before and after oral administration of N-acetylneuraminic acid.
    


Intervention name(s): NPC-09
Intervention type(s): Drug
Intervention description(s): NPC-09 tablet NPC-09 contains 50mg or 100mg N-acetylneuraminic acid (anhydride)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: N-acetylneuraminic acid,; pharmacokinetics; hIBM
Education Program for Burn Patients
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of an educative program including telephone
      follow-up for burn patients regarding the impact of this intervention on the health status
      and return to work at six months after hospital discharge.
    


Intervention name(s): educational program+telephone follow up
Intervention type(s): Behavioral
Intervention description(s): burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: burns; rehabilitation
Cerebral Palsy: Short-burst Interval Training
Condition: Cerebral Palsy Spastic Diplegia
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study examines the effect of short burst interval treadmill training in ambulatory
      children with cerebral palsy. Half the sample will receive 20 sessions of training over 4
      weeks, while half will receive the training over 10 weeks.
    

Detailed description: 
      Ambulatory children with cerebral palsy (CP) experience activity limitations which negatively
      influence their ability to physically participate in day to day life. Therefore, these
      children are at greater risk for inactivity and functional decline with age. In contrast,
      typically developing (TD) children engage in short bursts of intense physical activity
      interspersed with varying intervals of low and moderate intensity within their natural
      environment. These physical activity patterns are very different from adult patterns Despite
      these inherent differences, locomotor treadmill training (LTT) protocols designed to improve
      walking activity in children with CP simulate adult protocols, consisting of continuous low
      to moderate walking endurance activity. Body weight supported or robot assisted LTT is based
      on the underlying premise of modifying neural circuitry via spinal pathways. However, this
      type of training has not been shown to be more effective than other comparable interventions
      and presents with significant fiscal and logistical barriers to clinical translation.

      This study will determine the effect of short-burst interval LTT without body weight support
      on the primary outcomes of walking performance and capacity and the secondary outcomes of
      day-to-day mobility based participation in children with CP with functional walking
      limitations. To identify key muscular mechanisms associated with improved walking mobility,
      the investigators will examine the effects of short-burst interval LTT on quadriceps muscle
      performance and architecture. Secondarily, the study team will collect preliminary data on
      two LTT dosing frequencies.
    

Intervention name(s): Short Burst Interval Locomotor Treadmill Training (SBLTT)
Intervention type(s): Behavioral
Intervention description(s): SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT.,
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pre/post intervention design with participants randomized to two different frequency of intervention
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision
Condition: Sutures
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of two types of
      absorbable surgical sutures -- STRATAFIX Spiral PDS Knotless Plus Tissue Control Device and
      STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (hereinafter referred to as
      Spiral PDS Plus and Spiral MONOCRYL Plus) used in thyroid surgery to suture surgical
      incision.
    

Detailed description: 
      This study adopts a multicenter, prospective, randomized controlled design. The study
      population are subjects who undergo thyroid surgery.

      Before the surgery, subjects are randomized in 1:1:1 ratio to the investigational group 1
      (using Spiral PDS Plus), investigational group 2 (using Spiral MONOCRYL Plus) and control
      group. See the table below for the specific suture levels, materials and techniques of each
      group.

      A blinded central imaging evaluation will be performed on the healing condition of surgical
      incision on Day 5-7 post-surgery. The subjects will be blinded to the type of suture used for
      wound closure.
    

Intervention name(s): Spiral PDS Plus; Spiral MONOCRYL Plus; PDS Plus; MONOCRYL Plus; VICRYL Plus
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): The Spiral PDS Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral PDS Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.; The Spiral MONOCRYL Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral MONOCRYL Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.; PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.; MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.; VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      The purpose of this clinical study is to evaluate the metrological properties of a
      questionnaire that aims to identify the vitamin D status in reference to a vitamin D blood
      dosage.
    

Detailed description: 
      Each subject will perform only one visit (visit V1). The study duration per subject will last
      about 2 hours. During this visit V1, the subjects will perform a medical exam in order to
      check their eligibility (general statement and check of inclusion / non-inclusion criteria).
      The eligible subjects will fill up a study questionnaire and will perform a blood sampling
      for a dosage of serum vitamin D.
    

Intervention name(s): Blood sampling; Predictive questionnaire for vitamin D insufficiency
Intervention type(s): Procedure; Other
Intervention description(s): One blood sampling will be performed for a serum vitamin D dosage. The volume of blood collected will not exceed 4 ml.; The questionnaire includes 19 questions concerning the following topics : a) sun exposure, b) living situation, c) eating habits and Vitamin D dietary intakes. In addition, two questions will capture demographic data.
Intervention MeSH terms: Vitamin D
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers
      
Keywords: Vitamin D; Vitamin D Deficiency; Vitamin D Insufficiency; Healthy adults; Predictive questionnaire
Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients
Condition: Osteoarthritis, Knee; Chronic Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Intra-articular injection of corticosteroid and hyaluronic acid is a common treatment for
      osteoarthritis of the knee. As a treatment drug for patients with depression, duloxetine has
      been shown in many studies to effectively relieve the pain of osteoarthritis and improve the
      function of the knee joint. However, there is no evidence regarding the efficacy of
      Intra-articular injection of corticosteroid and hyaluronic acid combined with duloxetine for
      pain management in patients with knee osteoarthritis. The aim of the study was to test the
      hypothesis that Intra-articular injection of corticosteroid plus hyaluronic acid combined
      with duloxetine could achieve superior pain management effects to Intra-articular injection
      of corticosteroid plus hyaluronic acid alone in patients undergoing knee osteoarthritis pain.
    


Intervention name(s): Duloxetine; intra-articular injection of corticosteroid and hyaluronic acid
Intervention type(s): Drug; Drug
Intervention description(s): Participants will start on duloxetine 30 mg per day for one week and then titrated up to duloxetine 60mg per day for 23 weeks.; Participants will receive a 3.5 ml intra-articular injection of 30mg of hyaluronic acid plus 10mg of triamcinolone acetonide.
Intervention MeSH terms: Duloxetine Hydrochloride; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; Chronic Pain; hyaluronic acid; corticosteroid; duloxetine; Intra-articular injection
Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease
Condition: Metabolic Syndrome; Triglycerides; Blood Pressure; Diabetes
MeSH terms: Metabolic Syndrome; Chronic Disease
Study type: Interventional

Summary: 
      The investigators previously established that there was a high burden of disease among all
      categories of staff at the University of the West Indies, St. Augustine and in many ways,
      this group is typical of the working class of the Caribbean population. Many had poor
      lifestyle behaviors, 23.8% had Metabolic Syndrome (MS) with many having one or more MS
      components. Since most time is spent at work, the workplace is understandably the most
      logical location to address issues pertaining to health, disease prevention and wellness and
      on-site programs have yielded many health and other benefits to employees and employers
      alike. Onwards of the 1980s, numerous studies have been done on work-site intervention
      programs and these have shown that if a company is able to identify employees at risk for
      developing health problems and then intervene, health risks and the resulting medical
      problems are reduced. Such a program, if tailored to meet the needs of participants, may
      yield similar benefits among the staff of the University of the West Indies.
    

Detailed description: 
      To conduct a randomized controlled intervention of lifestyle modifications among individuals
      with a high burden of metabolic syndrome components such as high body mass index, high
      fasting blood glucose and abnormal lipid profile.

      A 6-month intervention is designed for implementation to detect a 20% reduction in MS
      components with 90% confidence. Participants (n=148) had 2 or more MS components and will be
      randomly assigned to intervention or control group. Intervention will comprise individual
      diet counseling, an exercise plan and monthly lifestyle workshops. Controls will receive
      printed material on healthy eating and lifestyle modification.
    

Intervention name(s): Therapeutic lifestyle
Intervention type(s): Behavioral
Intervention description(s): This is a 6-month intervention in which participants with 2r more MS components are randomly assigned to intervention or control group. Intervention comprise individual diet counseling, an exercise plan and monthly lifestyle workshops. Controls receive printed material on healthy eating and lifestyle modification.
Other intervention name(s): diet counseling; exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lifestyle; diet; exercise
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single ascending dose study of HSD-016 to provide the initial assessment of the
      safety, tolerability, how the drug is absorbed and eliminated, and its effect on the body.
    


Intervention name(s): HSD-016; placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety and tolerability of HSD-016
Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses
Condition: Inflammation; Obesity; Inflammatory Response; Cardiovascular Diseases; Overweight
MeSH terms: Cardiovascular Diseases; Overweight; Inflammation
Study type: Interventional

Summary: 
      Cardiometabolic disorders are a leading cause of death worldwide. Replacing saturated fatty
      acids (SFA) with unsaturated fatty acids is recommended as a way of lowering cardiometabolic
      disease risk.

      Consuming a diet rich in SFA may lead to a greater metabolic-inflammatory response in white
      adipose tissue during the fasting state, when compared to eating a diet rich in
      monounsaturated fatty acids (MUFA). Since individuals spend most of the day in the fed (or
      postprandial) state, it is important to see how different types of dietary fatty acids affect
      postprandial white adipose tissue and systemic metabolic-inflammatory responses.

      This study will investigate the effect of a SFA-rich meal on markers of white adipose tissue
      and systemic metabolic-inflammation, compared to a MUFA-rich meal in overweight adults. In a
      randomised, single blind controlled, cross-over manner participants will consume either a
      SFA- or MUFA-rich meal and sequential blood and white adipose tissue samples will be
      collected before and until 6 hours postprandially.
    


Intervention name(s): SFA-Rich Meal; MUFA-Rich Meal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Saturated fatty acid-rich test meal, containing 75g test fat; Monounsaturated fatty acid-rich test meal, containing 75g test fat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria Judaica(2000DPP/ml).
Condition: Allergy; Rhinitis; Rhinoconjunctivitis; Seasonal Asthma
MeSH terms: Rhinitis; Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerance of a rush build
      up administration of Depigoid forte pollen and the first maintenance dose administered 4
      weeks later.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and tolerance of a rush build
      up administration of Depigoid forte pollen and the first maintenance dose administered 4
      weeks later. The treatment period consists, thus, of 4 weeks.

      Primary variable:

      •Number of subjects [%] suffering at least one immediate or delayed systemic reaction of
      grade 2 or higher during the 4-weeks treatment period [grading according to the 2006 EAACI
      standards
    

Intervention name(s): Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml); Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel arm study. The study
      population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to
      severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel arm study. The study
      population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to
      severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD,
      2011). The primary analysis will compare each of the EP-101 (SUN101) dose groups to placebo
      with respect to the change from baseline in morning trough FEV1 on Day 29. Trough FEV1 is
      defined as the mean of the two FEV1 values obtained at 23 hours 30 minutes and 24 hours after
      Day 28 AM dose (ie, approximately 12 hours after the previous PM dose).
    

Intervention name(s): Placebo; EP-101 12.5 mcg; EP-101 25 mcg; EP-101 50 mcg; EP-101 100 mcg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): EP-101 Placebo AM + EP-101 Placebo PM; EP-101 12.5 mcg AM + EP-101 12.5 mcg PM; EP-101 25 mcg AM + EP-101 25 mcg PM; EP-101 50 mcg AM + EP-101 50 mcg PM; EP-101 100 mcg AM + EP-101 100 mcg PM
Other intervention name(s): SUN101; SUN101; SUN101; SUN101; SUN101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adapting and Expanding the Asthma-Educator App
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This project seeks to test and refine an adapted/expanded version of a previously created
      ASTHMAXcel app.
    

Detailed description: 
      The study will test the adapted app on participants ages 15-21 (recruited from outpatient
      primary and specialty care sites at Montefiore) with asthma, for a period of 4 and a half
      months, and will conduct formative and summative evaluation of the application's
      functionality and usability. The investigators will also be collecting process and clinical
      outcomes.
    

Intervention name(s): ASTHMAXcel App
Intervention type(s): Other
Intervention description(s): ASTHMAXcel includes interactive games, educational videos, quizzes and personalized feedback to teach different aspects of asthma management.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Study will eventually compare health outcomes between a group given the ASTHMAXcel intervention and a group given Usual Care
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Asthma