bioihbjkbjnl/mcl2 huggingface dataset:
Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates
Condition: Psychopathy; Personality Disorders
MeSH terms: Personality Disorders; Cognition Disorders; Cognitive Dysfunction; Antisocial Personality Disorder
Study type: Interventional

Summary: 
      This is a 2 -year NIDA funded grant (Co-PIs: Joseph P. Newman, John Curtin, and Carl Lejuez)
      that examines whether recent progress in characterizing the cognitive deficits associated
      with psychopathic and externalizing offenders may be used to develop better therapeutic
      interventions to treat their substance abuse and other self-control problems. Inmates with
      externalizing or psychopathy will receive one of two computer-based interventions to
      remediate the core cognitive skills that have been linked to self-regulation deficits in the
      two groups. One intervention (ACC) targets the affective cognitive control deficits
      associated with externalizing offenders whereas the other intervention (ATC) targets the
      attention to context deficits associated with psychopathic offenders. The specific components
      of the project include: selection and randomization of inmates; pre- and post-treatment
      behavioral and brain-related (ERP and Startle) measures to evaluate the impact and
      specificity of the ACC and ATC treatments; and 6 sessions of behavioral (e.g. computerized)
      and verbal training in ACC or ATC.
    


Intervention name(s): Cognitive Remediation; Cognitive Remediation
Intervention type(s): Other; Other
Intervention description(s): Computer training on 3 tasks that targets the attention to context deficits associated with psychopathic offenders. Participants complete 6 training sessions, that include the tasks, feedback and real-world translational examples.; Computer training on 3 tasks that targets the affective cognitive control deficits associated with externalizing offenders. Participants complete 6 training sessions, that include the tasks, feedback and real-world translational examples.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Incarcerated offenders; emotionally reactive; emotionally stable; psychopathy
Desaturation Validation of INVSENSOR00037
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry
      measurement of somatic oxygen saturation. One investigational sensor (INVSENSOR00037) will be
      placed on the somatic site of the volunteer. The values obtained by the test sensor will be
      compared to the reference value obtained from an FDA-cleared sensor placed on the somatic
      site on the contralateral side.
    


Intervention name(s): INVSENSOR00037
Intervention type(s): Device
Intervention description(s): Noninvasive regional oximeter.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Pharmacokinetic Study With Colchicine in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label, single group, sequential dose study will compare the single dose
      pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10
      days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.
    

Detailed description: 
      This open label, single group, sequential dose study will compare the single dose
      pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10
      days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers. After a
      fast of at least 10 hours, fourteen healthy non-smoking, non-obese, non-pregnant volunteers
      will receive a single oral dose of colchicine 0.6 mg. Fasting will continue for 4 hours after
      the dose, at which time a standard meal will be served. Blood will be drawn from all
      participants at times sufficient to adequately define the single dose pharmacokinetics of
      colchicine and its 3 major metabolites, 2, 3 and 10 demethylcolchicine. Following a 14 day
      washout period, all participants will begin a 10 day regimen of colchicine 0.6 mg orally
      every 12 hours. On the morning of day 25, after a fast of at least 10 hours, all participants
      will receive their final dose of colchicine 0.6 mg. Again blood will be drawn at times
      sufficient to determine the pharmacokinetics of colchicine and its 3 major metabolites after
      chronic dosing. The pharmacokinetic parameters for each dosing situation will be derived and
      compared for relevant differences. Though not a specific goal of this study, all participants
      will be monitored for adverse events by observation and query during periods of confinement
      on days 1, 15 and 25, as well as by complete blood count (CBC) with differential and clinical
      chemistry, sitting and standing blood pressures, and heart rate and 12-lead electrocardiogram
      (EKG) before and after dosing, on days 1 and 25.
    

Intervention name(s): colchicine tablets; colchicine tablets
Intervention type(s): Drug; Drug
Intervention description(s): 0.6mg colchicine tablet; 0.6mg q12 hours for 10 days
Other intervention name(s): COLCRYS TM; COLCRYS TM
Intervention MeSH terms: Colchicine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy; pharmacokinetics
The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery
Condition: Patients Undergoing Neurosurgery
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      This study aims to find an excellent drug in terms of hemodynamic stability when comparing
      the propofol and remifentanil with the combined use of remimazolam and remifentanil. When the
      mean blood pressure falls by 20% or more from the baseline mean blood pressure, it is
      considered hypotension, and a vasopressor such as ephedrine, phenylephrine, or norpin is used
      to control the blood pressure to within 20% of the baseline blood pressure. If the blood
      pressure increases by 20% or more above the baseline mean blood pressure, nicardipine
      infusion or remimazolam, propofol or remifentanil should be increased to control the blood
      pressure.
    


Intervention name(s): propofol; remimazolam
Intervention type(s): Drug; Drug
Intervention description(s): during the induction, remimazolam dose was controlled according to sedline (Psi target 40); During induction, remimazolam dose was controlled according to sedline (Psi target 40)
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      Evidence from preliminary studies suggests that people with PTSD have heightened fear
      responses and that cortisol suppression reduces this heightened fear. Research has shown the
      drug dexamethasone (DEX), a cortisol suppressor, reduces the startle response in civilians
      with PTSD. This current research proposal represents a blinded, randomized,
      placebo-controlled efficacy study with the goal of determining whether a drug that suppresses
      the stress hormone cortisol will increase the efficacy of exposure therapy. Specifically, it
      is proposed that a dose of DEX, given the night before (approximately 10 hours before) each
      of 5 to 11 individual virtual reality exposure (VRE) therapy sessions, will significantly
      enhance the rate of response and possibly the efficacy of treatment. Participants will be
      treated until they have experienced at least a 70% reduction in PTSD symptoms from baseline
      or up to 12 sessions or until they and their therapist agree treatment should be terminated,
      a minimum of 6 sessions to a maximum of 12 sessions. Comprehensive multi-modal outcomes will
      be assessed by independent assessors blind to subject condition on interviews, self-report
      measures, and psychophysiological measures. Participants will be assessed pre- and
      post-treatment and at a follow-up of 3, 6 and 12 months to assess long term effects.
    


Intervention name(s): Virtual reality exposure therapy; 0.5 mg DEX
Intervention type(s): Behavioral; Drug
Intervention description(s): Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.; A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions.
Other intervention name(s): Dexamethasone
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexamethasone; Virtual Reality; Military; PTSD
Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of age on the pharmacokinetic profile
      of BIA 2-093 and its active metabolites.
    

Detailed description: 
      This was a single-centre, open-label, parallel group, non-randomised study with a single-dose
      phase (Phase A) followed by a multiple-dose phase (Phase B), in 12 healthy elderly and 12
      healthy young subjects. During the whole study, subjects were to receive a single 600 mg dose
      of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B
      was to begun 96 hours post-Phase A dose.
    

Intervention name(s): BIA 2-093
Intervention type(s): Drug
Intervention description(s): During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
Other intervention name(s): Eslicarbazepine acetate
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eslicarbazepine acetate; BIA 2-093
The Effect of an Acute Increase in Plasma IL-6 on Glucose Tolerance When a Meal is Administered Intraduodenally
Condition: Postprandial Glucose Homeostasis
Study type: Interventional

Summary: 
      The aim of the study is to investigate and clarify whether the effect of IL-6 on glucose
      tolerance and insulin secretion are secondary to the changes in gastric emptying.

      The literature provides no information regarding a role for interleukin-6 (IL-6) in the
      regulation of beta cell function (glucose or meal-stimulated insulin secretion) in humans.
      Previous studies infusing IL-6 into humans have primarily focused on insulin action and the
      effects on peripheral insulin sensitivity whereas a potential effect on insulin secretion has
      been neglected.

      We have demonstrated that an acute increase in IL-6, obtained by a single bolus of IL-6,
      potentiated glucose-induced insulin secretion in a glucagon-like peptide-1 (GLP-1) dependent
      manner in mice1. In mice, IL-6 enhanced insulin secretion in a dose- and glucose-dependent
      manner, along with increasing concentrations of GLP-1. Interleukin-6 had no effect on insulin
      secretion in GLP-1 receptor knock-out mice or in mice treated with the GLP-1 receptor
      antagonist. Thus, in mice, GLP-1 has proven an essential mediator of IL-6 actions on beta
      cell function.

      Importantly, a single bolus of IL-6 also significantly increased glucose-stimulated insulin
      secretion in several mouse models of obesity and diabetes (diet-induced obesity, the ob/ob
      and the db/db mouse).

      Own data show that an infusion of IL-6 causes a significant delay in the rate of gastric
      emptying (GE) after a mixed meal in healthy young men. Data showed that this delay in GE is
      associated with much improved glucose tolerance and insulin secretion (unpublished data).

      In the present study we wish to investigate whether the beneficial effects of IL-6 on
      postprandial glucose tolerance and insulin secretion are dependent on a delay in gastric
      emptying. We will bypass the ventricle and infuse a mixed meal directly into the duodenum of
      healthy young men.

      This study has the potential to show that the known effect of IL-6 on postprandial glucose
      tolerance is dependent on a delayed GE.
    


Intervention name(s): Infusion of a liquid meal intraduodenally
Intervention type(s): Procedure
Intervention description(s): Infusion of IL-6/NaCL before a liquid meal intraduodenally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines
Condition: Skin Aging
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a safety and efficacy study of botulinum toxin type A in subjects with lateral
      canthal lines.
    


Intervention name(s): Botulinum toxin type A; Placebo comparator
Intervention type(s): Biological; Biological
Intervention description(s): Topical botulinum toxin type A; Topical placebo comparator
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: REALISE 1
Acute Cardio-metabolic Responses to Montmorency Tart Cherry Supplementation in Metabolic Syndrome Patients
Condition: Metabolic Syndrome; Insulin Resistance; Hypertension
MeSH terms: Hypertension; Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      The present study examined the effect of Montmorency tart cherry juice and capsules on
      functional and blood-based cardio-metabolic markers in humans with Metabolic Syndrome.
      Participants received a single bolus of Montmorency tart cherry juice, Montmorency tart
      cherry capsules and placebo in a random, crossover trial. Outcome variables were measured
      immediately pre- and up to 5 hours post-bolus. It was hypothesised that Montmorency tart
      cherry juice and capsules would improve cardio-metabolic markers. Furthermore, it was
      hypothesised that Montmorency tart cherry capsules would be more beneficial than Montmorency
      tart cherry juice due to increased bioavailability of phytochemicals.
    


Intervention name(s): Montmorency Tart Cherry Capsules; Montmorency Tart Cherry Juice; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules are made from 100% natural, tart Montmorency cherries. Carefully prepared Montmorency cherry skins are freeze-dried and milled into a fine powder to protect the cherry phytonutrients and optimise absorbtion. This powder is then encapsulated into a 100% vegetarian shell.; 100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water.
Concentrate contains no sweeteners, preservatives, flavourings or added sugar.; 130ml serving
Placebo composition: Water (100ml), Cherry Cordial Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Montmorency Tart Cherry; Anthocyanins; Polyphenols; Metabolic Syndrome; Insulin Resistance; Hypertension; Lipid Profile
Rehabilitation of Children With Multiple Disabilities
Condition: Cerebral Palsy; Autism; Down's Syndrome; Brain Injury
MeSH terms: Brain Injuries; Cerebral Palsy; Down Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to compare the usual care and treatment of children and youth
      (0-19 years) with multiple developmental delays and disabilities and their families in Simcoe
      York with a co-ordinated, navigated approach to care using the Children's Treatment Network
      (CTN) services.
    

Detailed description: 
      The Children's Treatment Network (CTN)links existing children's services rather than creating
      a new Centre. The purpose of the evaluation is to compare the effectiveness and efficiency of
      this service with the usual care that people receive. 500 Children will be randomized to
      receive either usual care (250) or the co-ordinated, navigated care from CTN (250). The
      primary question to be addressed is whether the more integrated CTN model of service improves
      family-centered services, parent mental health, parenting, family function and the quality of
      the child's life and the families resource needs as well as reduce expenditures for the
      families' use of all other health and social services compared to the outcomes of usual care
      alone. What children and families with what characteristics and circumstances most benefit
      from which approach to the treatment of childhood disability in Simcoe-York? At what cost?

      Agencies providing services to children will be evaluated as to how effective their
      integration of teams are functioning, their partnership with each other and capacity building
      in the community.
    

Intervention name(s): CTN model of care for children and their families
Intervention type(s): Other
Intervention description(s): Parental reports on the quality of life of their children and service needs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Children; Rehabilitation; Family Functioning; Mental Health; Costs; Integration
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg
Condition: Bacterial Infection
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the steady-state plasma pharmacokinetics
      (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar
      macrophages (AM) of healthy volunteers.
    

Detailed description: 
      No applicable.
    

Intervention name(s): TR-701 FA
Intervention type(s): Drug
Intervention description(s): 200 mg, oral, once daily for 3 days.
Intervention MeSH terms: Tedizolid phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: antibiotic; healthy subjects; pharmacokinetics
An Innovative Taping Technique for Improved Intravenous (IV) Catheter Securement
Condition: Dislodged Catheter; Catheter Related Complication
Study type: Interventional

Summary: 
      This is a prospective, single-blinded, randomized study to assess the ability of taping
      methods used to secure intravenous (IV) catheters to resist the IV from being pulled away
      from the skin. Participants will have IV catheters taped on top of the skin (without
      insertion into the skin) using three taping methods, BCH Emergency Department (BCH ED),
      Chevron, and our novel method. Six measurements will be obtained per subject (3 random taping
      methods measuring their resistance to force in two directions, retrograde direction or
      towards the wrist and 90-degree angle to the arm).
    

Detailed description: 
      Accidental removal of IV catheters delay patient care and can cause additional medical
      anxiety and pain that is heightened in the pediatric population. Moreover, such failed
      catheters create an increased burden economically and emotionally to patients, hospitals, and
      clinicians. To facilitate the most accurate, consistent results, a calibrated hand wheel test
      stand with a force gauge will be used to obtain force measurements. We will obtain the amount
      of force is required to remove the IV catheter form the skin of the subjects to compare the
      three taping measurements in two different directions. The retrograde direction will be
      pulling the IV distally from the IV site, towards the participant's wrist. The 90-degree
      angle will be pulling the IV medially away from the IV site.
    

Intervention name(s): Novel Taping Method; BCH Emergency Department Taping Method; Chevron Taping Method
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.; Subjects will be asked to have the BCH emergency department taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.; Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Catheter Taping Methods; Catheter securement; Catheters; Intravenous catheters
Postpartum Glucose Tolerance With Levonorgesterel IUD Use in Women With Recent Gestational Diabetes
Condition: Gestational Diabetes; Glucose Intolerance; Type 2 Diabetes; Intrauterine Contraception
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Glucose Intolerance
Study type: Observational

Summary: 
      The study is being done in order to gain information on the most suitable types of birth
      control in women who recently had gestational diabetes, or diabetes diagnosed during
      pregnancy. The intrauterine device (IUD) is a highly effective form of birth control. It is
      inserted into the uterus and prevents pregnancy for either 5 or 10 years, depending on the
      type of IUD (hormone-releasing or copper). The hormone-releasing IUD works for 5 years and
      releases a hormone called a progestin into the uterus. The copper IUD contains no hormones
      and works for 10 years. The IUD is an excellent form of birth control postpartum, but it is
      unknown if the hormone-releasing IUD will affect blood sugars and increase a woman's risk of
      becoming diabetic when she's not pregnant. The hypothesis is that the hormone-containing IUD
      will NOT increase blood sugars, so women who use the hormone-containing IUD will have similar
      blood sugars to those who use the copper IUD or have had their tubes tied (no hormones).
    


Intervention name(s): Mirena (Levonorgestrel IUD); Paragard (Copper IUD ) or Tubal Ligation
Intervention type(s): Device; Device
Intervention description(s): Release of intrauterine levonorgestrel for contraception, approved for up to 5 years' use; Copper IUD placed to provide contraception for up to 10 years
Other intervention name(s): Mirena IUD; Paragard IUD
Intervention MeSH terms: Copper; Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Postpartum women with gestational diabetes in the last pregnancy
      
Keywords: Intrauterine device; Gestational diabetes; Postpartum contraception; Postpartum birth control