bioihbjkbjnl/mcl2 huggingface dataset:
Development and Validation of a New Pain Scale for Children
Condition: Pain
Study type: Interventional

Summary: 
      In clinical practice with young children, gold standard rating scales used to evaluate the
      pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are
      self-assessment tools. These scales present however certain limitations: the VAS is not
      applicable if the child does not know how to estimate the distances, as young children, or
      children with mental retardation. As for FPS-R, it can be frightening for children by the
      aspect of faces looking like impersonal masks.

      For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face
      Legs Activity Cry Consolability (FLACC) can be used, according to the current
      recommendations.

      We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural
      and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide
      sample of children. We made the hypothesis that the teddy scale would enable to evaluate the
      pain in the same way that the FPS-R, being better accepted and preferred by children.

      The first phase of this study will be to develop the teddy scale with a sample of 30 healthy
      children from 4 to 11 year-old, having already experienced pain. This stage allows the
      validation of the images chosen for the scale, to make sure of their relevance and their
      optimal recognition by the children.

      The scale will then be validated with a sample of 218 hospitalized children from 2 to 11
      years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years
      old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to
      determine which scale they preferred. Children from 2 to 4 years old will have the teddy
      scale; the FLACC will be filled in by parents.

      Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that
      of the FPS-R scale The validation of the teddy scale will enable to objectify children's
      pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to
      check the efficiency of these decisions. This teddy scale could be used in current practice
      as a replacement of the FPS-R.

      Following this study, we planned to set up a second project in which the teddy scale will be
      adapted to electronic form (touchpads), to test its adaptability with the children.
    


Intervention name(s): Pain scales testing
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Children; Pain; Pain scale evaluation
Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to characterize the absorption, distribution, metabolism and
      excretion (ADME) of a single oral dose of [14C]AZD1981
    


Intervention name(s): AZD1981
Intervention type(s): Drug
Intervention description(s): Oral tablet, 250 mg, single dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ADME; Healthy volunteers
Endosleeve in Adolescents
Condition: Obesity, Childhood
MeSH terms: Pediatric Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, the investigators assess the safety and efficacy of endoscopic sleeve
      gastroplasty in adolescents with obesity.
    

Detailed description: 
      Endoscopic bariatric therapy (EBT) is an emerging, rapidly evolving field that aims to serve
      as a middle ground between safe, albeit poorly effective medical weight loss strategies and
      drastic but effective bariatric surgery. Endoscopic sleeve gastroplasty (ESG) is a procedure
      that restricts the stomach to a sleeve-like configuration by utilizing full-thickness sutures
      that plicate the greater curvature of the stomach. Emerging data from adult populations shows
      an acceptable safety, tolerability and efficacy profile. Based on analysis that confirmed the
      safety and efficacy of ESG in adult patients who undergo the procedure under a standardized
      protocol and clinical care pathway, the investigators planned to study its effects on
      adolescents in a specialized center that offers surgical, endoscopic, and medical management
      of obesity under a standardized protocol and care pathway.
    

Intervention name(s): Endoscopic Sleeve Gastroplasty
Intervention type(s): Procedure
Intervention description(s): Endoscopic full-thickness suture system to plicate the greater curvature of the stomach
Other intervention name(s): Endosleeve
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone
      cream in the treatment of melasma.
    

Detailed description: 
      Hydroquinone (HQ) is considered the gold standard depigmenting agent for melasma,
      nevertheless, many patients are recalcitrant to this treatment.

      Recent studies have shown that tranexamic acid, a plasmin inhibitor, can prevent UV-induced
      pigmentation.
    

Intervention name(s): Tranexamic Acid Oral Product; Hydroquinone 4% Cream; Sunscreen; Placebo
Intervention type(s): Drug; Drug; Other; Device
Intervention description(s): Encapsulated tranexamic acid 250 mg; Hydroquinone 4% Cream; Sunscreen SPF 30; Encapsulated placebo
Other intervention name(s): TA; HQ; Sun Protection
Intervention MeSH terms: Sunscreening Agents; Tranexamic Acid; Hydroquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: melasma; tranexamic acid; hydroquinone; mMASI; mexameter
Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability
Condition: Type 2 Diabetes Mellitus; Menopause; Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to
      compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone
      Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes.

      A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. The
      active treatment will include a 50 mg dose of vildagliptin OD twice a day. As comparator,
      gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.
    

Detailed description: 
      This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to
      compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone
      Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes.

      Target population of clinical trial subjects A total of 38 women with documented Type 2
      Diabetes and menopause will be enrolled. To be as close to a real life scenario as possible,
      clinical trial subjects which are treated with glucose-lowering medication (except incretin
      or sulfonylurea based therapies) and treatment-naive subjects will be included.

      Investigational Product, posology and method of administration The active treatment will
      include a 50 mg dose of vildagliptin OD twice a day.

      Comparator, posology and method of administration As comparator, gliclazide MR will be
      administered at a dose of 60 to 120 mg OD once a day.

      Treatment duration The study will have an expected total duration of 18 months, 12 months of
      active treatment.
    

Intervention name(s): Vildagliptin; Gliclazide MR
Intervention type(s): Drug; Drug
Intervention description(s): Vildagliptin 50mg bid orally for 12 months; Gliclazide MR 60 or 120mg orally for 12 months
Other intervention name(s): Galvus; Diamicron MR
Intervention MeSH terms: Vildagliptin; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; type 2 diabetes mellitus; osteopenia; osteoporosis; glycemic variability; bone markers; osteocalcin; NTX; CTX; BALP
The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of food on the absorption of canagliflozin
      in the body when canagliflozin is taken with and without food by healthy volunteers
    

Detailed description: 
      This is a single-center, single-dose, open-label (volunteers will know the identity of
      assigned treatment), randomized (one of 2 study drug sequences assigned by chance) study to
      evaluate the oral bioavailability (the degree to which the drug is absorbed in the body when
      taken orally by mouth) of canagliflozin when taken with and without food in healthy
      volunteers. Healthy Volunteers will take 1 canagliflozin tablet orally for 1 day in 2
      treatment periods (canagliflozin will be taken with food in 1 treatment period and
      canagliflozin will be taken without food in 1 treatment period); the 2 treatment periods will
      be separated by a 10- to 14-day washout period.
    

Intervention name(s): Canagliflozin
Intervention type(s): Drug
Intervention description(s): Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Single tablet taken with or without a meal during 2 treatment periods
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Canagliflozin (JNJ-28431754); Pharmacokinetic; Oral Bioavailability; Food effect
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the
      body build an immune response and kill tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who
      have metastatic melanoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety and tolerability of antigen pulsed dendritic cell therapy
      in patients with metastatic melanoma. II. Perform serial analysis of T cell and B cell
      function in these patients after this treatment. III. Determine objective response and
      response duration in these patients after this treatment.

      OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SQ) on days 1-6, then undergo
      leukapheresis for 2-3 days, beginning on day 6. Mononuclear cells are selected for CD34+
      cells in the laboratory, made into dendritic cells, and then pulsed with MART-1, gp100,
      tyrosinase, MAGE-3 peptides and flu matrix. These antigen pulsed dendritic cells (ApDCs) are
      used for vaccinations. Prior to vaccination, ApDCs are mixed with MART-1, gp100, tyrosinase,
      MAGE-3, and flu matrix. Patients receive this dendritic cell vaccine mixture SQ every 2 weeks
      for 4 priming doses. Patients receive 4 boost vaccinations SQ at 2 months, 5 months, 9
      months, and 15 months following the last priming vaccination. Patients are followed monthly
      for 2 years.

      PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
    

Intervention name(s): MART-1 antigen; filgrastim; flu matrix peptide p58-66; gp100 antigen; recombinant MAGE-3.1 antigen; tyrosinase peptide; in vitro-treated peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Procedure
Intervention MeSH terms: Lenograstim
Primary purpose: Treatment
Keywords: stage IV melanoma; recurrent melanoma
Vigorous Cool Room Treadmill Training
Condition: Multiple Sclerosis; Rehabilitation; Gait Disorders, Neurologic; Neuronal Plasticity
MeSH terms: Multiple Sclerosis; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      People with multiple sclerosis (MS) are often offered walking aids and compensatory
      strategies rather than restorative rehabilitation. We have developed a cool room treadmill
      training method that uses body-weight support that people with MS fatigue and heat
      sensitivity can tolerate. Our previous research shows that people with advanced MS use three
      times more energy for essential tasks such as walking. This project will test whether 10
      weeks of body-weight supported treadmill training in a room cooled to 16°C improves walking,
      fitness and fatigue in people with advanced MS.
    


Intervention name(s): Body-weight supported treadmill training in a room cooled to 16°C
Intervention type(s): Other
Intervention description(s): A total of 30 training sessions will be conducted in 10 weeks for 30 minutes per session and 3 times per week in a cool room (16⁰ C) on a treadmill that is equipped with safety straps to prevent falls. A pneumatic harness system will be used to provide 10% body-weight support during training sessions. The participants will start exercising on the treadmill at 80% of their self-selected walking speed with 1% incline and will increase as per their tolerance (will progress weekly based on 40-65% heart rate reserve). Heart rate, perceived fatigue and rating of perceived exertion will be monitored continuously during exercise sessions. Initial training will commence with intermittent rest periods [1 to 5 minutes] as requested by the participants and will be progressed to a maximum of 30-minute continuous treadmill walking.
Other intervention name(s): Vigorous cool room treadmill training
Intervention model: Single Group Assignment
Intervention model description: This is a 'proof-of-principle/feasibility' within group repeated measures study.
Masking: None (Open Label)
Primary purpose: Treatment
High-Resolution Ultrasound Imaging of the Retina and Choroid for Detection on Age Related Macular Degeneration
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      The macula is the site of central vision within the retina. The retina is oxygenated by the
      underlying choroid. These tissues are less than 1 mm thick in total. While optical techniques
      can reveal much about the structure of the retina, ultrasound allows imaging of the choroid
      and deeper tissues. This study will investigate use of high frequency (20 MHz) ultrasound for
      imaging of the retina and choroid in patients with age-related macular degeneration, a prime
      cause of blindness. The investigation will involve use of novel post-processing methodologies
      to achieve maximum resolution of the fine tissue structures involved in this disease.
    

Detailed description: 
      Age-related macular degeneration (AMD), a condition affecting over 40% of individuals 70
      years or age or more, causes progressive loss of central vision. Photocoagulation has long
      been used to slow the progress of AMD, but new vision-preserving methods are currently under
      investigation. Because destroyed photoreceptors are permanently lost, early management is
      essential for preservation of vision. The aim of this project will be to study AMD using a
      suite of new high-resolution ultrasound imaging techniques that have been developed.
      Specifically, high-resolution ultrasound will be used to generate images of the retina and
      choroid, including perfusion measurements using slow-flow methods developed by our research
      group. Ultrasound studies will be performed in conjunction with optical coherence tomography
      (OCT) imaging in a series of patients and age-matched control subjects with the aim of
      determining if choroidal thickness and/or perfusion might be used as an early indicator of
      AMD and thus aid in patient management.

      We will study 20 subjects diagnosed with AMD. We will attempt to have an approximately equal
      number of subjects with wet and dry forms of AMD. A control group consisting of 20 non-AMD
      age-matched subjects will also be recruited. Ultrasound scan sequences will consist of B-mode
      images of the macula and surrounding tissues.
    

Intervention name(s): Ultrasound examination
Intervention type(s): Procedure
Intervention description(s): one ultrasound examination
Other intervention name(s): High Frequency Ultrasound
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ophthalmology practice
      
Keywords: Age Related Macular Degeneration; Ultrasound; OCT; Eye
Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy
Condition: Acute Appendicitis; Postoperative Pain; Postoperative Nausea and Vomiting
MeSH terms: Appendicitis; Pain, Postoperative; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Intravenous lidocaine - a potent local anesthetic with analgesic and anti-inflammatory
      properties has been shown to be an effective adjunct that reduces intra and postoperative
      opioid consumption and facilitates pain management in adults. In children population
      promising but limited evidence is available. The study was planned to evaluate the efficacy
      of continuous intravenous infusion of lidocaine to reduce opioid consumption during and after
      laparoscopic appendectomy in children.
    

Detailed description: 
      Postoperative pain in children is still one of the most under diagnosed and under treated
      medical problems. It affects post-surgery recovery, mortality and morbidity, limits mobility.
      Untreated pain not only causes child's suffering but can decrease the pain threshold in the
      future or lead to the development of chronic pain. Postoperative analgesia has been
      traditionally based on opioids but as their use can be associated with adverse effects
      prolonging hospital stay and affecting recovery current guidelines focus on multimodal
      approaches involving numerous analgesics with different mechanism of action. Growing evidence
      suggests that intravenous lidocaine reduces intra- and postoperative requirement for opioids.
      Lidocaine has been proved to have analgesic and anti-inflammatory properties. It is also a
      potent peripheral nervous system modulator inhibiting peripheral and central sensitization.
      The studies performed in adult population have proved the efficacy of systemic lidocaine in
      postoperative pain treatment. It is an effective adjunct that reduces opioids consumption and
      facilitates pain management. As such lidocaine infusion has been included in postoperative
      pain management guidelines for adults. Studies on children population have promising results
      but high quality randomized controlled trials are still missing.

      The proposed study has been planned to evaluate the efficacy of continuous infusion of
      lidocaine as an adjunct to standard general anesthesia (involving fentanyl and sevoflurane)
      in reducing opioids consumption and facilitating postoperative pain control in children
      undergoing laparoscopic appendectomy.
    

Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): Lidocaine infusion during surgery
Other intervention name(s): Intravenous lidocaine infusion
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: systemic lidocaine; nalbuphine; postoperative pain; multimodal analgesia; laparoscopic appendectomy; laparoscopy; recovery
Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a
      screening/orientation session. The next 5 visits will be (full day) outpatient sessions
      taking place Monday through Friday during one week. All full day visits will be drug
      administration sessions with subjects randomized to one of two groups. The primary purpose is
      to investigate the time course of development of analgesic tolerance (loss of pain relieving
      effect) to morphine on experimentally produced skin tenderness in healthy volunteers.
    

Detailed description: 
      30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a
      screening/orientation session. The next 5 visits will be (full day) outpatient sessions
      taking place Monday through Friday during one week. All full day visits will be drug
      administration sessions with subjects randomized to one of two groups. Group A will receive
      two daily intramuscular injections of 8 mg morphine on Monday through Thursday and two
      intramuscular injections of placebo on Friday. Group B will receive two daily intramuscular
      injections of placebo on Monday through Thursday and two intramuscular injections of 8 mg
      morphine on Friday. During the Monday through Friday sessions the painfulness of experimental
      heat application and the area of skin tenderness (primary and secondary hyperalgesia) will be
      assessed before and two times after the intramuscular injections. Heat will be applied by
      using a computer controlled probe that applies heat (450 C/1130 F) on the thigh for 3 minutes
      (Brief Thermal Sensitization model.)
    

Intervention name(s): intramuscular injections of morphine
Intervention type(s): Drug
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety profile, tolerability, Pharmacokinetics
      (PK) and Pharmacodynamics (PD) following single and multiple oral doses of BMS-963272 in
      healthy subjects.
    

Detailed description: 
      Study Classification: Safety, PK/PD
    

Intervention name(s): BMS-963272; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: subjects